Department of Reproductive Health and Research, including UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction annual technical report

Publication date: 2002

Department of Reproductive Health and Research including UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction Annual Technical Report 2002 World Health Organization Department of Reproductive Health and Research Family and Community Health A n n u al Tech n ical R ep ort 2002 1 WHO Library Cataloguing-in-Publication Data World Health Organization. Dept. of Reproductive Health and Research. Department of Reproductive Health and Research, including UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction annual technical report : 2002. 1.Reproductive medicine 2.Reproduction 3.Family planing 4.Contraception 5.Research I.UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction II.Title. ISBN 92 4 159075 0 (NLM classification: WP 630) © World Health Organization 2003 All rights reserved. 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A n n u al Tech n ical R ep ort 2002 1 Contents Executive summary. 3 Section 1 – Promoting family planning. 19 Users’ perspectives in the context of reproductive health . 20 Development of improved and new methods of fertility regulation. 28 Safety and effectiveness of existing methods of fertility regulation. 54 Norms and guidelines for use of methods of fertility regulation. 67 Section 2 – Making pregnancy safer. 73 Generating new evidence for maternal and perinatal health. 74 Implementation of evidence-based programmes. 85 Section 3 – Controlling sexually transmitted and reproductive tract infections. 99 Section 4 – Preventing unsafe abortion. 123 Section 5 – Promoting sexual and reproductive health of adolescents. 137 Section 6 – Gender and reproductive rights in reproductive health. 151 Section 7 – Technical cooperation with countries. 161 Overview of activities—interregional activities and collaboration with regional offices. 162 The WHO Regions of Africa and the Eastern Mediterranean. 165 The WHO Region of the Americas. 180 The WHO Regions of South-East Asia and the Western Pacific. 188 Central and Eastern Europe, including the Newly Independent States and Central Asian Republics. 194 Policy and programmatic issues. 198 Section 8 – Implementing best practices. 207 Section 9 – Monitoring and evaluation. 221 Section 10 – Communication, advocacy and information. 227 Section 11 – Clinical trials and informatics support. 233 Appendix 1 – Staff of the Department, December 2002. 237 A n n u al T ec h n ic al R ep or t 2 00 2 2 A n n u al Tech n ical R ep ort 2002 3 A n n u al T ec h n ic al R ep or t 2 00 2 2 A n n u al Tech n ical R ep ort 2002 3 Executive summary A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 4 A n n u al Tech n ical R ep ort 2002 Executive summary 5 Executive summary THE DEPARTMENT The Department of Reproductive Health and Research (RHR—referred to in this document as “the Department”) sees its mission as helping people to lead healthy sexual and reproductive lives. In pursuit of this mission the Depart- ment endeavours to strengthen the capacity of countries to enable people to promote and protect their own health and that of their partners as it relates to sexuality and reproduc- tion and to have access to and receive quality reproductive health services when needed. The Department of Reproductive Health and Research was created in November 1998 by joining the UNDP/UNFPA/ WHO/World Bank Special Programme of Research, Devel- opment and Research Training in Human Reproduction (HRP—referred to in this document as “the Programme”) and the former WHO Division of Reproductive Health (Technical Support) (RHT). The purpose of bringing these two entities together was to facilitate integration of research and pro- gramme development in reproductive health within WHO. UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) The Programme was established in 1972 by WHO. In 1988, the United Nations Development Programme (UNDP), the United Nations Population Fund (UNFPA), and The World Bank joined WHO as the Programme’s cosponsors. The four cosponsoring agencies, together with the major finan- cial contributors and other interested parties, make up the Programme’s governing body, the Policy and Coordination Committee (PCC), which sets policy, assesses progress, and reviews and approves the Programme’s budget and programme of work. Broad strategic advice on the Pro- gramme’s work is provided by the Scientific and Technical Advisory Group (STAG) (Annex 1). (In 1999, STAG assumed the responsibility for reviewing, and advising on, the work of the whole Department.) The Scientific and Ethical Review Group (SERG) Panel (Annex 2) reviews all projects involving human subjects and research in animals and contributes to ethical debate on matters relating to reproductive health. The Toxicology Panel (Annex 3) is a complementary review body to the SERG Panel. It provides expertise in the evaluation of pharmacokinetic, metabolic, endocrinological, toxicological, teratogenicity, carcinogenicity and mutagenicity studies of drugs or devices developed or studied by the Programme or referred to it for advice. In addition, the Programme has several specialist panels that advise on detailed research strategies. PROMOTING FAMILY PLANNING Research on users’ perspectives Research on users’ perspectives provides scientifically sound information on the needs and preferences of women and men for reproductive health technologies and serv- ices. This information is central to informed policy-making and programmes, and for designing services which better address the needs of users and of potential users. Research findings also provide the basis for developing appropriate evidence-based norms and tools and improving existing, or developing new, reproductive health technologies. In 2002, a workshop with country investigators was held in Nairobi, Kenya, to review and plan further work on a study A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 4 A n n u al Tech n ical R ep ort 2002 Executive summary 5 on pregnancy prevention in the era of HIV/AIDS in Kenya, South Africa, Uganda, United Republic of Tanzania, Zambia and Zimbabwe. Findings from Kenya were presented at the XIV International AIDS Conference, held in July 2002 in Bar- celona, Spain. Collaboration continued with scientists from the University of London School of Hygiene and Tropical Medicine, London, United Kingdom, on analysis of data from the Demographic and Health Surveys (DHS) on contracep- tive choice and discontinuation and switching of methods. Work was also undertaken to estimate the extent of child- lessness and primary or secondary infertility using DHS data for 495 000 women from 47 developing countries. Three new projects were launched under the research initiative on qual- ity of care. Selected highlights •• A study in Kenya showed that communities perceived HIV/AIDS to be a serious problem. Paradoxically, how- ever, the majority of sexually active individuals believed their own risk of HIV to be low or non-existent. Individu- als surveyed recommended condom use to prevent the spread of HIV in the community, but the vast majority engaged in risky sexual behaviours, including not using condoms. •• A policy brief was produced based on findings from a study in China. It highlighted the need to provide repro- ductive health information and services to young female migrants. The policy brief was translated into Chinese and disseminated widely. •• Research on users’ perspectives resulted in 12 pub- lications in national or international journals, provid- ing evidence for developing informed policies and programmes. Research on the development of new methods for fertility regulation The key objective of the Programme’s research on the devel- opment of methods of fertility regulation is to broaden the choice of methods for users and potential users, by improv- ing existing approaches and technologies, and by developing entirely new ones. The Programme has successfully collabo- rated with other funding partners and, in several cases, with the private sector in identifying research and development needs and in designing and executing relevant research in this area. The Programme’s portfolio includes work on meth- ods for women and men and ranges from basic research designed to identify novel and innovative approaches, to clinical trials of improved and new methods in a variety of settings; behavioural and acceptability research is also con- ducted, as appropriate. Selected highlights •• At the end of 2002, a Phase II study of a combined androgen and progestogen regimen for male hormonal contraception was completed in Indonesia. The definitive results of this study demonstrated that depot-medroxy- progesterone acetate, when used in conjunction with testosterone undecanoate, was an effective and long- acting suppressor of spermatogenesis. •• Investigations of the efficacy of low-dose mifepristone as an emergency contraceptive demonstrated that in Chinese women a 10 mg dose of the antiprogestogen was just as effective as a 25 mg dose; the pregnancy rate following either treatment regimen was 1.1%. •• Preliminary data from studies in monkeys suggested that levonorgestrel will disturb ovulation if given prior to ovulation, but that it seemed to have no effect on preg- nancy rates if ovulation had already occurred. These data imply that the primary action of levonorgestrel as an emergency contraceptive is through suppression of ovulation. •• A series of pre-clinical studies on the development of an immunocontraceptive method for women showed that a prototype human chorionic gonadotrophin (hCG) immu- nogen appeared to be safe, highly immunopotent and stable. An application has been submitted to the regula- tory authorities in Sweden to carry out a Phase I clinical trial with this matrix formulation. •• Microspheres appear to be a successful alternative delivery system for a chimeric peptide containing hCG beta subunit for immunocontraception. Recent tests demonstrated that this delivery system could be manipu- lated to produce a high level of immunogenicity with minimal irritation at the injection site. •• A study to evaluate two possible treatments for the irregular vaginal bleeding patterns in Norplant users demonstrated that neither Vitamin E nor low-dose aspi- rin provided significant relief from this troublesome side- effect. •• The collaborative initiative between the Programme and The Rockefeller Foundation for basic research in implan- tation has completed its fourth year. New data obtained on structural and functional changes that occur at the site and time of implantation have been reviewed, and each centre will concentrate efforts on its most promising lead in the upcoming fifth and final year of the initiative. •• The Phase III trial of testosterone undecanoate alone as a male contraceptive was progressing according to schedule in China. This study marks the first-ever Phase III trial of a male hormonal contraceptive method. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 6 A n n u al Tech n ical R ep ort 2002 Executive summary 7 Research on safety and effectiveness of contraceptives The overall objectives of research in the area of safety and efficacy of existing methods of fertility regulation are (i) to assess evidence on the safety and effectiveness of different methods of contraception among women and men with par- ticular emphasis on developing countries, and (ii) to address priority unanswered questions on existing methods of fertility regulation when used in developing countries. Selected highlights •• Research continued on the safety and effectiveness of the levonorgestrel-releasing intrauterine device and on the long-term safety and effectiveness of the TCu380A intrauterine device. •• A multicountry study was launched on the comparative clinical performance of two second-generation implant- able progestogen-only contraceptive methods, Implanon and Jadelle. •• A review on the association between cervical cancer and long-term use of combined oral contraceptives was in progress. •• Research was under way (including a review of available evidence) to assess the safety and practicality of reuse of the female condom. • Recent research has found that among women with per- sistent human papilloma virus infection, those who have used hormonal contraceptives for longer than five years are at a higher risk of developing cervical cancer com- pared with non-users. In order to put these new results in a public health perspective, a consultation was con- vened in March 2002, which recommended no changes in contraceptive prescribing practice or use since the number of cervical cancers that might result from the use of hormonal methods is likely to be very small. •• A study was started on the contraceptive effectiveness of the female condom compared with the male condom. This study is being assessed in volunteers from family planning clinics in China, Nigeria, Panama and South Africa. A total of 500 women electing to use the female condom as their method of fertility regulation will be enrolled, together with a similar number of male condom users. Promoting family planning norms and tools The overall objective of this area of work is to create evi- dence-based and consensus-driven guidance to support the provision of high-quality family planning services globally. Selected highlights •• The document Selected practice recommendations for contraceptive use—a guide for policy-makers, family planning programme managers and the scientific com- munity—was published. Whereas the previously pub- lished document Improving access to quality care in family planning: medical eligibility criteria for contracep- tive use addresses who can safely and effectively use contraceptive methods, Selected practice recommenda- tions for contraceptive use address how contraceptive methods can be used safely and effectively. The docu- ment includes guidance on common clinical issues, such as what a woman should do if she forgets to take one or more of her oral contraceptive pills. •• Initial field-testing was under way of the Decision-making tool for family planning clients and providers—an inter- active tool derived from and supported by the Improv- ing access to quality care in family planning: medical eligibility criteria for contraceptive use and the Selected practice recommendations for contraceptive use. This decision-making tool is designed for use during the client–provider family planning encounter to help both the client and the provider in choosing the most appro- priate method of family planning, including dual protec- tion for those at risk of both pregnancy and HIV/sexually transmitted infections. •• Initial planning was done to develop a handbook for family planning providers, which is intended to provide detailed information to providers on the provision of high-quality family planning services. •• A system was developed for ensuring that family plan- ning guidance is created, and maintained, on the basis of the best available evidence. This system includes a continuous and comprehensive process of identifying, critically appraising, and synthesizing new evidence as it becomes available. MAKING PREGNANCY SAFER The Making Pregnancy Safer (MPR) initiative represents WHO’s contribution to the global safe motherhood move- ment. It strives to contribute to the attainment of the United Nations Millennium Declaration targets, which include the reduction of the maternal mortality ratio by three-quarters, between 1990 and 2015, and the reduction by two-thirds of under-five mortality by 2015 through a reduction in the number of newborn deaths. The work of the Department in this area consists of: (i) conducting research to map effective interventions and to improve the quality of services (see Generating new evi- dence for maternal and perinatal health); and (ii) providing normative guidance and technical support to countries for A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 6 A n n u al Tech n ical R ep ort 2002 Executive summary 7 the development, implementation and evaluation of cost- effective interventions to reduce maternal and newborn mor- bidity and mortality (see Implementation of evidence-based programmes). Generating new evidence for maternal and perinatal health The objective of research in this area is to find ways of reducing maternal and perinatal morbidity and mortality by: (i) evaluating promising biomedical and public health inter- ventions; (ii) conducting systematic reviews; (iii) improving the understanding of sociocultural and economic factors that influence maternal health (e.g. studies of cost-effectiveness and quality of care); (iv) reviewing methodological issues; (v) conducting follow-up studies of the populations included in maternal and newborn research (e.g. long-term follow-up studies of babies); and (vi) mapping the magnitude of mater- nal ill-health. During 2002, the main reports of several trials were pub- lished: the evaluation of a new model for routine antenatal care, the effectiveness of oxytocin in the prevention of postpartum haemorrhage, the treatment of pre-eclampsia with magnesium sulfate, and the strategy for the reduction of unnecessary caesarean sections. Additional publications reported findings on women’s and providers’ perception of care, and the economic evaluation of interventions tested in these trials. A new project, entitled “From Research to Practice”, was initiated to facilitate the implementation of the new WHO antenatal care model and of the prevention of postpartum haemorrhage. Implementation of the new model of antenatal care was under way in Argentina, Brazil, Chile, Cuba, Ethiopia, Haiti, Italy, Oman, Pakistan, Spain, Syrian Arab Republic, Thailand and Zambia. Selected highlights •• The calcium supplementation trial for the prevention of pre-eclampsia, which was started at the beginning of 2002 and which involved over 6500 women, was near- ing completion. •• The results of the so-called “MAGPIE” trial that evalu- ated the effect of magnesium sulfate for the prevention of eclampsia among 10 141 women, showed that the use of the compound could more than halve the risk of eclampsia. This trial is expected to lead to a major change in practice. •• In order to document the magnitude of maternal ill-health in developing countries a systematic review of epidemio- logical data, that became available between 1997 and 2002, was being conducted. This unique systematic review will be completed during 2003. •• A new comprehensive collaborative research and ser- vice project entitled “Global Programme to Conquer Pre-eclampsia–Eclampsia” was launched. The initial phase of this project includes the preparation of system- atic reviews on screening for pre-eclampsia, promising etiological and pathophysiological hypotheses to be tested in future research, and treatment recommenda- tions, including recommendations to treat impaired fetal growth. Implementation of evidence-based programmes The foci of this area of work are: (i) development of a strat- egy for global action on skilled care for pregnant women; (ii) documentation of current knowledge and experience regard- ing the relationship between maternal and neonatal health and poverty; and (iii) development of a concept and strategy paper for working with individuals, families and communities for improved maternal and neonatal health. Cost–effective- ness studies are also being conducted and are expected to guide recommendations for maternal and neonatal health interventions. Selected highlights—development of tools and guidelines •• The different tools for the Integrated Management of Pregnancy and Childbirth (IMPAC) were being used in countries through worldwide distribution of the manual entitled Managing complications in pregnancy and child- birth: a guide for midwives and doctors and its transla- tion into several languages including Bahasa Indonesia, French, Laotian, Russian and Spanish. The Arabic and Chinese translations of this guide are expected to be completed in 2003. The following tools were in press: Managing newborn problems: a guide for doctors, nurses and midwives and Pregnancy, childbirth and newborn care: a guide for essential practice. Plans were under way for the adaptation and utilization of these guides in several countries. •• Other clinical and programme tools/guidelines that were being finalized for publication included (provisional titles): Standards for maternal and newborn care; Handbook for communicating and counselling for pregnancy, childbirth and newborn care; and Kangaroo mother care: a practi- cal guide. A manual on surgical obstetrics care for use at the district level was in the field-testing phase. •• A set of education tools/guidelines were also under preparation: the revised WHO midwifery education mod- ules and the Strengthening midwifery toolkit. An educa- tion and training strategy was being developed with the WHO Department of Child and Adolescent Health and Development for improving health practitioners’ perfor- mance. •• Several management tools were either under prepa- ration (Making pregnancy safer planning guide and Beyond the numbers: a tool for reviewing maternal deaths and complications), or were at the field-test- A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 8 A n n u al Tech n ical R ep ort 2002 Executive summary 9 ing stage (Making pregnancy safer workshop planning manual; the Health and human rights assessment tool for maternal and neonatal health; and Making pregnancy safer—essential health technology package). Selected highlights—technical support to countries •• The Department continued to help countries: (i) to strengthen their political commitment to, and strategies for, maternal and neonatal health in national health and development plans; and (ii) to review/establish national as well as regional policies and strategies in order to ensure that issues related to maternal and neonatal health are adequately addressed. •• In the area of programme development and implementa- tion, the Department contributed to the strengthening of existing maternal and neonatal health programmes in an increasing number of countries. •• Specific areas that received substantial support in 2002 included: improving provider skills in order to enhance the quality of care; introducing and adapting IMPAC norms and tools into national standards and protocols; improving reporting of maternal mortality and severe morbidity to assess provider performance and improve quality of care. •• The Department collaborated with various partners in establishing or revitalising Making Pregnancy Safer/ Safe Motherhood ministerial committees, taskforces or partners’ coordination committees at national level. •• Web pages related to the Making Pregnancy Safer initia- tive were updated and expanded and an edition of the Safe motherhood newsletter that focused on the topic of skilled attendants was published. CONTROLLING SEXUALLY TRANSMITTED AND REPRODUCTIVE TRACT INFECTIONS The key objectives of the Department in the area of sexually transmitted infections (STIs) and reproductive tract infections (RTIs) are: (i) to increase the availability of high-quality, cul- ture- and gender-sensitive and non-stigmatizing services for the prevention, care and management of STIs and RTIs and their complications; (ii) to broaden the range of safe, effective and affordable methods to prevent and manage STIs and RTIs and mother-to-child transmission (MTCT) of HIV and STIs; and (iii) to contribute to the strengthening of national health system capacity to deliver these services. Selected highlights •• Work was under way to develop a comprehensive package of guidelines and tools designed to assist programme managers to plan and implement effective and appropriate interventions to prevent, control and manage STIs and RTIs. The package includes: an STI/ RTI programme guidance tool; STI/RTI management in reproductive health care settings: a guide for essential practice; Guidelines for the management of sexually transmitted infections and a set of training modules for the management of sexually transmitted infections. •• The Department held a technical consultation involving academic institutions and the private sector to assess the increasing threat of the herpes simplex virus becom- ing a major driving force for HIV transmission. The con- sultation also reviewed the launch of new collaborative work within WHO and with external partners, which aims to accelerate the implementation of research and other strategies to prevent and control genital herpes infec- tion, thus diminishing its impact on HIV transmission. •• A protocol was finalized to study the impact of highly active antiretroviral therapies (HAART) on mother-to- child transmission (MTCT) of HIV and maternal health. This research will address key issues of acceptability, safety and effectiveness of HAART in MTCT prevention and the impact of a triple-combination antiretroviral pro- phylactic regimen on the rate of MTCT. •• As part of ongoing efforts to develop microbicides to fight STIs/HIV, the Department, in collaboration with CONRAD, is conducting a three-centre randomized double-blind Phase I study of the safety and acceptabil- ity of a 6% cellulose sulfate gel compared with placebo among healthy women volunteers in India, Nigeria and Uganda. •• Work was in progress to develop an updated global STI strategy that reflects recent national, regional and global evidence and experience in STI control and its impact on the HIV epidemic. The new strategy is expected to facilitate the dissemination, adaptation and adoption of the recommended policies and strategies for STI pre- vention, care and control. PREVENTING UNSAFE ABORTION The two main objectives of the Department’s work in this area are prevention of unsafe abortion and its consequences and assessment of the safety of current abortion procedures. To achieve these objectives, the work plan focuses on gen- erating scientifically sound evidence for providers and policy- makers in order to enable them to make informed decisions on implementing best practices and resource allocation. Projects include documentation of global and regional preva- lence rates of unsafe abortion and associated morbidity and mortality, social science research to understand better the pathways to safe and unsafe abortion, clinical trials to evalu- ate medical abortion techniques, the development of guide- lines for safe abortion, and technical support on request to countries on issues related to abortion care. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 8 A n n u al Tech n ical R ep ort 2002 Executive summary 9 Selected highlights •• A document entitled Safe abortion: technical and policy guidance for health systems was completed in 2002 and sent to print. Over the next year, the document will be translated into French, Russian and Spanish, and pos- sibly Portuguese and Romanian. •• As part of the Department’s commitment to maintaining up-to-date information on unsafe abortion, new global and regional estimates of unsafe abortion were made available in 2002. The Department’s work on estimating unsafe abortion provided inputs to WHO’s work on the Global Burden of Disease 2000. •• A national conference was supported in Bucharest, Romania, in April 2002 to disseminate the findings of the 2001 Strategic Assessment on abortion in Romania. The conference included a wide range of stakeholders from across the country, who formulated a new policy requir- ing all obstetrics/gynaecology departments in the country to provide safe, high-quality abortion services, including post-abortion contraception, at an affordable price set by the Romanian Ministry of Health and Family. •• Results from a study on the pharmacokinetics of sub- lingual administration of misoprostol suggest great potential for the sublingual route to be developed into a method of medical abortion. PROMOTING SEXUAL AND REPRODUCTIVE HEALTH OF ADOLESCENTS The objective of the Department’s work on adolescent sexual and reproductive health is to generate evidence for the pro- motion of healthy sexual development and maturation and strengthening the capacity of adolescents to have equitable and responsible relationships. Activities primarily focus on supporting research and developing the evidence base on the sexual and reproductive health situation and needs of adolescents in developing countries. Related to this work are activities intended to strengthen national capacity for research in this area and dissemination of findings. Selected highlights •• Analysis of Demographic and Health Survey (DHS) data for never-married young women in Colombia and Peru showed that over the course of the 1990s, an increas- ing percentage of younger women were sexually active. While use of contraceptives, especially condoms, had increased, there had been an even greater rise in sexual activity and an increasing percentage of young, never- married women had experienced unintended pregnancy and abortion. •• Research undertaken to generate global estimates for unsafe abortion found that nearly 40% of all unsafe abor- tions occur among women aged 15–24 years. Overall, 7.3 million unsafe abortions were estimated to take place each year in this age group. •• A total of 43 studies were being supported under the social science research initiative on adolescent sexual and reproductive health; 41 were ongoing, with two new studies being initiated in 2002. Thirty-six papers report- ing on evidence accumulated through this initiative were published in national and international journals and in the proceedings of two international conferences, held in Bangkok (Thailand) and Kunming (China). •• Various research capacity strengthening activities continued for the network of investigators engaged in research on adolescents, including assistance in devel- oping papers for presentation at conferences and for submission to journals. •• Core instruments developed for the study of adoles- cent sexual risk behaviours (focus-group discussion guidelines, in-depth interview guides and a survey ques- tionnaire) and an annotated bibliography of relevant materials were provided to a large number of research- ers working in this area. These instruments and a related bibliography were also published on the Department’s web site. •• Research was under way to investigate: the extent to which hormonal contraception depresses peak bone mass achieved among adolescents, thus placing them at greater risk of osteoporosis in later life; factors under- lying reports of unusually high levels of lower genital tract infection among pre-adolescents in Mongolia; and the reproductive health needs of young migrants in the Greater Mekong region. GENDER AND REPRODUCTIVE RIGHTS IN REPRODUCTIVE HEALTH The Department’s objectives in this area are: to develop and evaluate strategies and mechanisms for promoting gender equality and human rights in reproductive health research, programming and technical support; to support countries to ensure that reproductive health programmes and policies respect, protect and fulfil human rights and promote gender equity and equality; and to ensure that the promotion of gender equity and equality and human rights principles are integrated into the Department’s work. Selected highlights •• The Department published the CD-ROM version of a document entitled Transforming health systems: gender and rights in reproductive health—a three-week training curriculum in gender and rights in reproductive health for health managers—and made arrangements for transla- tion of the English document into Chinese and Spanish. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 10 A n n u al Tech n ical R ep ort 2002 Executive summary 11 •• A three-day training of trainers workshop was conducted on the rights module from the above curriculum in order to provide additional training to the five regional centres (in Argentina, Australia, China, Kenya and South Africa) that are already running the full course. The aim was to train experienced trainers in running a two- to three-day module on human rights and reproductive health within their region. •• The Department provided to United Nations Treaty Bodies sexual and reproductive health data for a number of countries that were required to report to the Treaty Bodies in 2002 about their adherence to various rights-related international treaties. The main purpose of the United Nations treaty monitoring system is to encourage governments to comply more fully with their legally-binding obligations to respect, protect, and fulfil the human rights enshrined in the various treaties. The Department’s concern is to ensure that key sexual and reproductive problems, such as maternal mortality, are included in the monitoring of States’ efforts to protect the rights of their citizens. •• The Department is developing a tool to help govern- ments to become more accountable for their interna- tional commitments—among others, to international human rights treaties, conventions and consensus document targets—to promote and protect their citizens’ rights to maternal and neonatal health care. A study was commissioned to validate the internal consistency of this tool. •• A Technical Consultation on Sexual Health was held, which resulted in the formulation of new definitions of sex, sexuality, sexual health and sexual rights for the field. • Two reviews were commissioned on Integration of sexual health into reproductive health services: needs, evidence and implications (Royal Tropical Institute of the Netherlands, Amsterdam, Netherlands), and Searching for sex: a systematic literature review of international research related to sexuality and sexual behaviour (La Trobe University, Melbourne, Australia). TECHNICAL COOPERATION WITH COUNTRIES The main objective of the Department in its technical coop- eration with countries is to assist countries to enhance their capacity to develop and implement national and regional research and programme activities aimed at improving reproductive health. Specifically, the aims are: (i) to assist developing countries with the identification of areas where research is required to address reproductive health needs; (ii) to support national planning and programming including the introduction of reproductive health technologies and the adaptation and application of practice guidelines essential for improving reproductive health; (iii) to provide assistance to developing countries to strengthen their capacity to under- take research, and to disseminate and apply results of repro- ductive health research; and (iv) to collaborate with countries in the monitoring of effects of policies and initiatives related to health sector reforms in reproductive health programmes and outcomes. Overview •• Nineteen Long-term Institutional Development (LID) grants and eight Resource Maintenance Grants (RMGs) were awarded to the network of collaborating research institutions. Research Training Grants (RTGs) were also awarded to 27 scientists from these institutions, most of whom received their training within their respective regions. • With support from HRP and from national and interna- tional sources, up to 204 research projects were ongoing in the above institutions in 2002, and findings from a total of 730 research articles were published and/or dissemi- nated through presentations during the year. The WHO Regions of Africa and the Eastern Mediterranean The main objective of the Department in the WHO Regions of Africa and the Eastern Mediterranean is to build and develop the research capacity of institutions in order to enhance their potential to implement reproductive health research relevant to national and regional needs, and to facilitate their partici- pation in the global research effort. In 2001–2002, the Department collaborated with 37 institu- tions or research groups in 24 countries of the two regions. Six institutions in these countries received Long-term Institutional Development (LID) grants and three received Resource Maintenance Grants (RMGs), while 17 were awarded small grants for library support and the purchase of consumable laboratory supplies. Three centres were partici- pating in regional research projects. Selected highlights •• A call for proposals on sociocultural aspects of female genital mutilation (FGM) yielded many concept propos- als; several of these were selected for further develop- ment. •• In 2001 (most recent year for which complete data are available), 72 studies were carried out by the nine cen- tres receiving LID grants or RMGs. Of these projects, 13% received financial support from the Programme, while 51% received support from other international agencies. The highest number of projects concerned maternal health, followed by family planning and HIV/ AIDS. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 10 A n n u al Tech n ical R ep ort 2002 Executive summary 11 •• The nine centres receiving a LID grant or RMG pub- lished 57 papers in national and international journals, and staff of these centres served in 53 different advisory roles at national, regional and international levels. •• Ten staff members from these nine centres attended courses outside their home countries and six research- ers received a Research Training Grant (RTG). •• Workshops and short courses were organized on sev- eral themes: research methodology, semenology, and ethical issues in reproductive health research. The WHO Region of the Americas The Department collaborated with eight institutions in the Region of the Americas which are implementing a large number of research projects on topics relevant to regional and national reproductive health problems. Ongoing projects supported by Long-term Institutional Development (LID) grants include basic science work in the area of male fer- tility, an assessment to identify priority interventions that would improve access to and quality of family planning and of maternal and neonatal health care, and social science research in the area of male involvement in reproductive health. Selected highlights •• During 2001 (most recent year for which complete data are available), from the overall number of 106 projects, four were implemented with support from the Programme’s capacity building grants, 51 with support from national sources (48%), 21 (20%) were supported by the specific work areas of the Department, and 30 (28%) were funded by international agencies other than WHO. •• Ten staff from regional centres underwent training out- side their home countries and the eight centres receiving research capacity strengthening support trained in turn 112 professionals and technical staff from other local institutions. Thirty-one fellows participated in formal courses and 653 attended short, group-learning activi- ties, such as seminars and workshops organized by the centres. •• During 2001, a total number of 143 research articles (128 original papers and 15 review articles) were pub- lished and 34 books and book chapters were authored by staff from the centres receiving research capacity strengthening support. •• In an effort to enhance the dissemination and utilization of research findings, two national workshops—attended by researchers, policy-makers and other stakeholders—were organized in Argentina and in Peru to disseminate research findings and discuss the policy implications for programmes and services. A regional workshop was convened in coordina- tion with the FRONTIERS Program of the Population Council to bring together researchers and policy-makers to discuss barriers and facilitators to the process of utilization of research findings. •• Steps were taken to strenghten the coordination with the WHO Regional Office for the Americas: during 2002, eight joint missions were undertaken to participate in site visits or in meetings held in various countries of the region. The WHO Regions of South-East Asia and Western Pacific The primary strategic objectives of the Department in supporting developing countries in the WHO Regions of South-East Asia and the Western Pacific are to assist the countries of the regions: (i) to identify their needs in national reproductive health policies and programmes for improving reproductive health, and in areas where research is required to address these needs; (ii) to build their own capacity to plan, implement, monitor and evaluate such programmes and policies and to participate in national, regional and global research in accordance with the highest scientific and ethical standards; (iii) to disseminate and apply the results of repro- ductive health research and to adopt, adapt and implement new updated norms, standards, tools and approaches; and (iv) to develop appropriate strategic approaches to improv- ing the quality of reproductive health services. Through such support, the countries will ultimately develop and sustain their ability to address a broad range of reproductive health research and service-related areas, and to establish and strengthen an enabling national reproductive health research system and research culture. Continued development of rel- evant skills for enhancing national leadership, priority-set- ting, advocacy, communication, networking, negotiation, use of research results and partnerships is an integral part of the process. Selected highlights •• The Programme continued to provide institution-based support in nine countries through award of seven Long- term Institutional Development (LID) grants and four Resource Maintenance Grants (RMGs). •• Three new Research Training Grants (RTGs) were awarded to scientists from China (2) and Mongolia (1), one of whom will be trained within the region. •• Two regional joint research programmes involving most of the recipients of LID grants were in the process of being implemented. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 12 A n n u al Tech n ical R ep ort 2002 Executive summary 13 The WHO Region of Europe, including Central and Eastern Europe, the Newly Independent States and Central Asian Republics The main objectives of the Department in the WHO Euro- pean Region are: (i) to strengthen national capacity in repro- ductive health research, with a particular focus on providing training opportunities for scientists in the countries of Cen- tral and Eastern Europe, the Newly Independent States and Central Asian Republics; and (ii) to assist the WHO Regional Office for Europe (EURO) in providing technical support to countries to implement their programmes in reproductive health. Selected highlights •• The second meeting of the European Regional Advisory Panel (RAP), was held at The Netherlands School of Public Health, Utrecht, Netherlands, on 29–30 May 2002. •• The Programme continued to provide support to the former participants in the first WHO/FRONTIERS course on operations research to help them to implement their research proposals. •• Continued technical support was provided for coun- try adoption and adaptation of WHO evidence-based policies and standards for maternal and newborn care. Clinical guidelines on evidence-based medicine and appropriate use of technologies were issued, targeting specific categories of health care providers and were used in Kazakhstan, Republic of Moldova, Turkmeni- stan, and Uzbekistan. •• Support was provided to a retrospective study that is reviewing some examples of interventions that had an influence on the reduction of maternal mortality in Europe. The report on this study will be available in 2003. •• Preparatory steps were undertaken for the second WHO/FRONTIERS course on operations research to be held at the Kazakhstan School of Public Health, Almaty, Kazakhstan, in April 2003, for Russian-speaking scien- tists. •• Technical support was provided to the postgraduate course on reproductive medicine and reproductive biology, organized annually by the WHO Collaborating Centre, University of Geneva, Geneva, Switzerland. Policy and programme issues The Department’s objectives in this area are to review, develop and test methodologies to assist countries in the planning and implementation of reproductive health services. Central to this work are the testing, refinement and promo- tion of the Strategic Approach1 to improving the quality of care of reproductive health services. Selected highlights •• Dissemination of the Strategic Approach in 2002 included the implementation of regional training work- shops in Africa and Asia. A field guide for implementing strategic assessments was published, as was as a docu- ment providing an overview of the Strategic Approach and summarizing experiences with its implementation in 18 countries. •• The Strategic Approach continued to be adapted for strategic planning in a range of areas of reproductive health: for example, in Bolivia, the approach was used to address issues related to cervical cancer screening and treatment; and in Yunnan, China, an assessment was made of comprehensive, integrated reproductive health services, with emphasis on access and utilization of services by the poor. In Romania and Viet Nam, inter- ventions recommended in prior assessments of issues related to abortion are currently being tested. •• Stage II activities were ongoing in China, Ethiopia, Myanmar and Viet Nam. Scaling-up of tested interven- tions was under way in Stage III activities in Bolivia, Brazil, Viet Nam and Zambia. •• An initiative examining the impact of health sector reforms on reproductive health services and outcomes began with development and implementation by the World Bank Institute of a course on this topic for Departmental, regional office and country office staff. The Department also collaborated with the South African Women’s Health Project on their “Sexual rights and reforms” project, con- ducting regional and global literature reviews of existing knowledge concerning the relationships between health reforms and reproductive health. MONITORING AND EVALUATION Monitoring and evaluation activities aim: (i) to map maternal and newborn morbidities and mortality in a comprehensive and systematic manner; and (ii) to develop tools to facilitate 1The Strategic Approach is a three-stage process to assist national- level decision-making to improve the quality of care of reproductive health service. Stage I strategic assessments examine users’ needs and perspectives, the available technologies and services, and the capacity of the service delivery system, so as to determine appro- priate strategies for improving the quality of care. Stage II involves action research to design and test optimal models for introducing or re-introducing technologies or services. Stage III uses research results and lessons learned in Stage II for policy and programme development and the scaling-up of activities. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 12 A n n u al Tech n ical R ep ort 2002 Executive summary 13 the collection and distribution of data on indicators to monitor progress towards the achievement of the Millennium Devel- opment Goals (MDGs) for improving maternal health. Selected highlights •• Substantial progress was made in the systematic review of epidemiological evidence on maternal morbid condi- tions and mortality. The methodological challenges of summarizing data from observational studies have been discussed within a methodology working group. Over 9000 published and unpublished reports from 1997 were evaluated for possible inclusion in the review, and data were extracted from 417 that fulfilled the inclusion crite- ria. It is expected that for the entire period 1997–2002, evaluation of around 60 000 reports will result in the inclusion of approximately 3000 articles in this unique systematic review, which will be completed in mid-2003. This is the first ever systematic attempt to map the situ- ation of a group of medical conditions with data. •• The global, regional and subregional estimates of the proportions of births attended by a skilled health worker were updated and published on the Department’s web site. •• A systematic review to estimate the prevalence, asso- ciated factors and consequences of genital organ pro- lapse was initiated, and the first draft was completed. •• An analysis of levels, trends and differentials of ante- natal care in developing countries using data from the Demographic Health Surveys (DHS), the Multiple Indi- cator Cluster Surveys (MICS) and the Pan Arab Proj- ect for Child Development (PAPCHILD) surveys from 1990–2001 was completed. •• A database of reproductive health indicators to provide up-to-date information at the national, regional and global levels of the 17 reproductive health indicators short-listed for global monitoring was under develop- ment and will be published on the Department’s web site in early 2003. IMPLEMENTING BEST PRACTICES The Department is the leading institution in the efforts to map best reproductive health practices and to develop a strategic approach that helps developing country health profession- als to capture, adapt according to their needs and apply best practices. The activities of the Department in this area include primary research, research synthesis, dissemination and capacity strengthening in evidence-based decision- making worldwide. Selected highlights •• The randomized controlled trial of an active dissemina- tion strategy for evidence-based reproductive health information using The WHO Reproductive Health Library (RHL) was ongoing in 40 hospitals in Mexico and Thai- land. The intervention has been completed and data col- lection on clinical outcome was under way. A qualitative research component evaluating the experiences of staff was being developed. •• Eight new Cochrane reviews and three Cochrane review protocols were published. Nine systematic reviews were updated. Six systematic reviews were under way. •• Subscriptions to RHL exceeded 12 000 in 2002 and a total of 29 000 copies in English and Spanish were dis- tributed. Work was progressing on the Chinese transla- tion of RHL, which is expected to be published in 2003. •• RHL editors and scientists from partner institutions con- ducted more than 100 RHL presentations or workshops worldwide. •• The training initiative developed jointly with the WHO Regional Office for Africa and the South African Cochrane Centre was pilot-tested and the first workshop was held in South Africa. Implementing Best Practices (IBP) Initiative The Department is leading the development of a programme to support the adaptation and application of best practices, known as the Implementing Best Practices (IBP) Initiative. This collaborative partnership aims to use innovative strategies to support the transfer of knowledge, harmonize approaches and reduce duplication of efforts at country level in order to help health care professionals access and apply the latest research and best practices in reproductive health. Selected highlights •• All 17 partners have agreed to sign a Memorandum of Understanding to form the Implementing Best Practice Consortium. The Department will act as the Secretariat for the first two years of operation. •• The IBP Initiative continued to attract more members in 2002, including two country-based nongovernmental organizations. •• In collaboration with the WHO Regional Office for the Eastern Mediterranean Region the IBP Initiative was introduced to seven country teams from Egypt, Jordan, Lebanon, Pakistan, Palestine, Turkey and Yemen at a meeting held in Cairo, Egypt, in 2002. The country teams A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 14 A n n u al Tech n ical R ep ort 2002 Executive summary 15 have initiated action to implement the plans they agreed to during this meeting and IBP partners are providing a programme of supportive follow-up. COMMUNICATION, ADVOCACY AND DISSEMINATION OF INFORMATION Through this area of work, the Department seeks to facilitate access to reproductive health knowledge within and outside the Department. Selected highlights •• A total of 23 information products were issued. •• The Department’s annual technical report for 2001 and two biennial reports for 2000–2001 were published in electronic format on an elegantly designed, interactive CD-ROM. •• Issue No. 5 of The WHO Reproductive Health Library was issued and widely distributed. •• The Department’s web site continued to grow and, in December 2002, housed some 3300 pages. •• In a workshop in Mumbai, India, 20 scientists were trained in how to write good scientific research articles. •• Twenty senior faculty members of a collaborating insti- tute in India were trained in teaching scientific writing. •• Twenty-two physicians were trained in communication skills in a workshop in Malaysia. CLINICAL TRIALS AND INFORMATICS SUPPORT This area of work relates to the provision of statistical and data-processing support for all multicentre and some single- centre research projects undertaken by the Programme. It also provides support to research capability strengthening in the formulation and execution of institution strengthening policies in biostatistics and data processing. Informatics sup- port is also provided to the administration and management area of the Department. Selected highlights •• Statistical data and entry support was provided to 68 single and multicentre projects. •• Work continued on the editing of Standard Operating Procedures drafted for implementation of the WHO Good Clinical Practice guidelines in all of the Programme’s research activities. •• Work was ongoing on methodological research on statis- tical issues related to cluster randomization trials and on the meta-analysis of observational studies. • The statistical and data-processing capabilities of selected collaborating institutions were strengthened. A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 14 A n n u al Tech n ical R ep ort 2002 Executive summary 15 Annex 1 SCIENTIFIC AND TECHNICAL ADVISORY GROUP IN 2002 Members Lawrence Adeokun, Association for Reproductive and Family Health, Ibadan, Nigeria Yagob Y. Al-Mazrou, Assistant Deputy Minister, Ministry of Health, Riyadh, Saudi Arabia Robert W. Blum, University of Minnesota, Minneapolis, MN, USA John Cleland, London School of Hygiene and Tropical Medicine, University of London, London, United Kingdom Jock Findlay, Prince Henry’s Institute of Medical Research, Clayton, Australia (Chairman) Catherine Hankins, McGill University AIDS Center, Montreal, Canada Barbara Hulka, University of North Carolina, Chapel Hill, NC, USA (Vice-chairperson) Angela Kamara, Regional Prevention of Maternal Mortality Programme, Accra, Ghana Hoda Rashad, The American University in Cairo, Cairo, Egypt Reijo Vihko, The Academy of Finland, Helsinki, Finland Xiao Shaobo, State Family Planning Commission, Beijing, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 5 45 6 55 11 Women 2 18 2 18 4 from: AFRO 2 18 2 AMRO 3 27 3 EMRO 2 18 2 EURO 2 18 2 SEARO WPRO 1 9 1 9 2 A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 16 A n n u al Tech n ical R ep ort 2002 Executive summary 17 Annex 2 SCIENTIFIC AND ETHICAL REVIEW GROUP PANEL IN 2002 Gordon Ada, John Curtin School of Medical Research, Canberra, Australia Abdul-Aziz Al Meshari, King Saud University, Riyadh, Saudi Arabia Karen Beattie, EngenderHealth, New York, NY, USA Chai Podhisita, Institute for Population and Social Research, Nakorn Prathom, Thailand Jean Cohen, Paris, France Rebecca Cook, University of Toronto, Toronto, Canada Ian Diamond, University of Southampton, Southampton, United Kingdom Dwip Kitayaporn, Mahidol University, Bangkok, Thailand Murdoch Elder, Biggar, Lanarkshire, United Kingdom Andrea Genazzani, Institute of Obstetrics and Gynaecology, Modena, Italy Ron Gray, Johns Hopkins University, Baltimore, MD, USA Kerstin Hagenfeldt, Karolinska Hospital, Stockholm, Sweden (Chairwoman) Tim Hargreave, Western General Hospital, Edinburgh, United Kingdom Korrie de Koning, Royal Tropical Institute, Amsterdam, the Netherlands Fernando Larrea, National Institute of Nutrition, Mexico City, Mexico Ruth Macklin, Albert Einstein College of Medicine, Bronx, NY, USA Manee Piya-Anant, Siriraj Hospital, Bangkok, Thailand Oscar Mateo de Acosta, National Institute of Endocrinology, Havana, Cuba Marvellous Mhloyi, Population Studies Center, Harare, Zimbabwe Yuji Murata, Osaka University Medical School, Osaka, Japan Ngeow Yun Fong, University of Malaya, Kuala Lumpur, Malaysia Charles Ngwena, Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa Edith Pantelides, Population Studies Centre, Buenos Aires, Argentina Kazuo Satoh, Nihon University School of Medicine, Tokyo, Japan Jack Sciarra, Northwestern University Medical School, Chicago, IL, USA Carmel Shalev, The Gertner Institute for Health Policy, Tel Hashomer, Israel Carlos Simon, Institute of Infertility, Valencia University, Valencia, Spain Sonia Tabacova, National Centre of Hygiene, Ecology and Nutrition, Sofia, Bulgaria Godfrey B. Tangwa, University of Yaoundé I, Yaoundé, Cameroon Zhao Baige, State Family Planning Commission, Beijing, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 13 43 1 3 16 53 30 Women 6 20 1 3 5 17 12 from: AFRO 3 10 3 AMRO 3 10 5 17 8 EMRO 1 3 1 EURO 1 3 1 3 8 27 10 SEARO 3 10 3 WPRO 2 7 3 10 5 A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 16 A n n u al Tech n ical R ep ort 2002 Executive summary 17 Annex 3 TOXICOLOGY PANEL IN 2002 Colin L. Berry, The London Hospital Medical College, London, United Kingdom Ranjit R. Chaudhury, National Institute of Immunology, New Delhi, India Ralph Heywood, The Larches, The Lanes, Huntingdon, United Kingdom Alex Jordan, Division of Reproductive and Urologic Drug Products, Food and Drug Administration, Rockville, MD, USA Shirley Price, University of Surrey, Guildford, United Kingdom Sonia Tabacova, National Centre of Hygiene, Ecology and Nutrition, Sofia, Bulgaria Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 1 17 1 17 4 67 6 Women 1 17 1 17 2 from: AFRO AMRO 1 17 1 EMRO EURO 1 17 3 50 4 SEARO 1 17 1 WPRO A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 18 A n n u al Tech n ical R ep ort 2002 19 A n n u al T ec h n ic al R ep or t 2 00 2 Annual Technical Report 2002 18 A n n u al Tech n ical R ep ort 2002 19 Section 1 Promoting family planning A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 20 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 21 Users’ perspectives in the context of reproductive health I.H. Shah and I.K. Warriner INTRODUCTION As part of the global effort to achieve improved levels of reproductive health through informed policies, programmes and services, understanding men’s and women’s reproduc- tive health needs and preferences as well as the constraints to the use of services has become increasingly important. The perspectives and needs of users are shaped by their interactions with providers, the available reproductive health services and supplies, and their assessment of the dual risks of unwanted pregnancy and sexually transmitted infections (STIs). Their reproductive health behaviour, including con- traceptive practice, and the acceptability of various methods, are also influenced by the quality of the care they receive, their perceptions and attitudes and the sociocultural context of these services. The primary objective of the Department’s work in this area is to understand better men’s and women’s behaviours and perspectives as users or potential users of reproductive health services and emerging or currently available fertility regulating methods. The second objective is to understand the constraints and sociocultural contexts that influence users’ practices, behaviours and perspectives. The third objective is to address neglected aspects of quality of care that have an important bearing on the access to and use of reproductive health services. Findings on users’ perspec- tives provide policy-makers and programme managers with evidence-based recommendations for improving care. The findings also indicate the acceptability of reproductive health services and technologies for both users and potential users while identifying the unmet needs of clients. The Depart- ment’s work also covers selected issues related to infertility, which is an integral, but often neglected, aspect of reproduc- tive health. RESEARCH ACTIVITIES Specific objectives of research Research on users’ perspectives aims to understand better men’s and women’s reproductive health decision-making, and their needs for and perspectives on reproductive health technologies and services. Projects focus on various aspects of users’ perspectives, some of which are supported under a social science research initiative on quality of care. Progress Family planning in the era of HIV/AIDS In a pioneering attempt to assess the interactions between family planning and risk behaviour related to HIV/AIDS, a multicountry research project has been ongoing in six east- ern and southern African countries where the HIV epidemic is most severe: Kenya, South Africa, Uganda, United Republic of Tanzania, Zambia and Zimbabwe. The project is designed to address three main objectives: (i) to determine the per- spectives of sexually active individuals on the dual risks of STIs (including HIV/AIDS) and unintended pregnancy; (ii) to develop strategies that sexually active individuals would con- sider appropriate, practical and effective in coping with these risks; and (iii) to explore opportunities for and constraints to behavioural change. An analysis workshop with country investigators was held in Nairobi, Kenya, on 3–8 March 2002, jointly sponsored by the African Population and Health Research Centre, Nairobi, Kenya. The main objectives of the workshop were: (i) to review results from the study; (ii) to plan and initiate further analysis and write-up; and (iii) to develop plans for dissemi- nation and further work. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 20 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 21 The workshop consisted of a series of focused discussions, individual presentations, and individual work with investiga- tors and resource persons. Discussions focused on issues associated with the questionnaire, defining concepts from items measured in the questionnaire, and addressing ways to integrate findings from the qualitative data into overall find- ings. Drafts of research papers were developed, based on interpretations of preliminary findings and their programmatic implications. Investigators submitted papers to an upcoming International Union for the Scientific Study of Population (IUSSP) conference, Taking Stock of the Condom in the Era of HIV/AIDS, to be held in Gaborone, Botswana, in July 2003. Findings from the Kenyan component of the study were presented at the XIV International AIDS Conference held in Barcelona, Spain, in July 2002. The data were collected during 1998–2000 from sexually active individuals in Nakuru district, Kenya. Four male and eight female focus group dis- cussions (FGDs), were conducted, and a household survey consisting of a structured questionnaire was administered to couples comprising 1422 male and female respondents in total (743 men and 679 women; the partners of 64 men could not be interviewed). In-depth interviews were held with 40 survey respondents selected for their high risk behaviours. Findings confirm that HIV/AIDS is perceived as a very seri- ous community problem. “It is a big problem because almost every month we bury someone who died of AIDS. That means that AIDS cases have really increased in this area” (male, rural). “HIV/AIDS is a very serious problem in this area. You are aware that there are many soldiers here as well as women who are not married. In such a situation, there is no control over sex, and this results in the high spread of AIDS” (male, married, rural). Nonetheless, participants in the study felt their own risk of contracting HIV to be low. Figure 1.1 presents data on study participants’ own assessment of their risk of contracting HIV/ AIDS. Less than 10% felt that their risk was high and approxi- mately 40% of sexually active individuals felt that they were at no risk of contracting the disease. Although the majority of participants were aware that condom use prevents the spread of HIV/AIDS, condom use was low. Only one in three who had casual sexual partners reported using the condom. The study concluded that HIV/AIDS is perceived to be highly prevalent and to be a serious problem in the study commu- nity. Paradoxically, personal risk of HIV is perceived to be low or non-existent. Individuals recommend condom use to prevent HIV in the community but nevertheless engage in risky sexual behaviour without using condoms themselves. Condom use in long-term relationships is perceived to imply a lack of mutual trust. Improving family planning services to reduce unwanted pregnancies Findings from a Chinese study on ways to provide better family planning services in order to improve contraceptive use-effectiveness, and to reduce unwanted pregnancies and induced abortion, were made available in 2002. The back- ground to the study is as follows. In 1993, the Chinese State Family Planning Commission initiated an “informed choice” programme to upgrade quality of care and respond to users’ needs and demands. In 1995, the Jiangsu Family Planning Figure 1.1. Perceived level of personal risk of HIV infection among respondents in Kenya, by sex P er ce nt ag e of re sp on de nt s Male Female Total High Medium Low None 50 40 30 20 10 0 10 10 44 36 6 14 34 46 8 11 40 41 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 22 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 23 Commission conducted a pilot intervention to improve and integrate family planning services with reproductive health care for clients. Four villages in Jiangsu Province were selected to receive the intervention and four comparable vil- lages were selected as controls. About 1000 eligible women in each of the intervention villages and control villages were interviewed in 1993. A follow-up survey was conducted in 1998. As part of the project, providers were given intensive training in examinations, conducting regular follow-ups and in reproductive health knowledge. Service settings and equip- ment were upgraded and facilities were equipped with televi- sions, videotapes, handbooks, computers, etc. Clients were provided with tools for informed decision-making, were given information about the proper use of contraceptives, and were provided with a greater choice of modern methods. Findings demonstrated that, compared to the control villages, women in the intervention villages had a higher percentage of IUD use (78% vs. 65%), and more women shifted from tra- ditional to more effective methods during the experiment. A higher percentage of women chose their contraceptive meth- ods by informed choice compared to the control group (19% vs. 2%) and there was a higher continuation rate of contra- ceptive use over 60 months (75% vs. 61%). Furthermore, a much lower percentage of women in the intervention group who already had one child had an induced abortion (11% vs. 22%) as a result of lower contraceptive failure and unwanted pregnancy during the experiment. The same model for improving quality of services could be duplicated in other areas. The paper was presented at the Sixth Asia-Pacific Social Sciences and Medicine Conference (APSSAM), in Kunming, China, on 14–18 October 2002. Understanding women’s status and condom use Findings from a study on “Culture, Gender, Sexual Behav- iours and STI/AIDS” conducted in central and west Cam- eroon among 1679 men and women aged 15–49 years will be published in the next issue of International Family Planning Perspectives. The study compared sexual risk behaviours from two very different ethnic groups, the Beti, where relatively permissive sexual norms prevail in society, and the Bamileke, where more conservative mores prevail. Multivariate logistic regression models were used to analyse the effects of women’s, men’s, and couples’ education levels on condom use initiated by women, and the effects of inter- spousal communication on condom use. In both populations, analyses demonstrate that the probability of condom use increases with men’s and women’s educational levels. Other factors significantly associated with greater condom use among women include: a smaller age gap between women and their partners; increased frequency of discussion about sexual matters; and increased women’s decision-making power within couples. Interestingly, pregnancy prevention was reported as the most common (72%–82%) reason for the use of the condom by both men and women in the two ethnic groups. In spite of the major differences in sexual norms and cultural mores, attitudes toward condom use and sexual behaviours in the two ethnic groups were broadly similar. These and other findings on the relationship between women’s status and condom use are noted as being critically important for the development of effective AIDS prevention programmes, irrespective of the ethnicity of the population. Improving knowledge of STIs and condom use Further findings from a study on sexual behaviour and condom use in China became available in 2002. The study examined the effectiveness of a video-based reproductive health education intervention in increasing knowledge of STIs and condom use, and in improving attitudes towards condom use among 2266 male STI clients attending a large STI clinic in Shanghai from May to December 1998. Study participants were randomly assigned to one of three groups: (i) regular treatment (control group); (ii) regular treatment and video viewing; and (iii) regular treatment, video view- ing, and participating in a discussion group facilitated by a physician. Data on knowledge of STIs and attitudes toward condom use were collected at baseline and at 2 to 3 weeks following the intervention. Results showed a very significant relationship between higher scores and participating in either the video group or the video and discussion group. The findings indicate that video-based interventions have a significant impact on clients’ knowledge of STIs and favourable attitudes toward condom use. Video viewing is an inexpensive, feasible and practical approach to education about STIs and condom use, and shows promise for integration into different STI clinic settings. Social science research initiative on quality of care In 2000, a research initiative on quality of care was launched, focusing on supporting research that seeks to assess the quality of reproductive health services from the perspec- tives of clients, potential clients, providers, and/or objective standards of care. Additionally, the initiative sought propos- als designed to assess the effects of improved service quality on intermediate outcomes (e.g. provider behaviour, client knowledge, client satisfaction, or client behaviour with regard to the continuation of contraceptive use). Research that explores quality of care in such relatively under-studied areas of reproductive health as maternal health, providers’ perspectives, abortion or STI treatment, was especially encouraged. Ongoing studies include: (i) the quality of maternal care in Turkey; (ii) provider perspectives on family planning quality of care in Egypt, Peru, and Uganda; (iii) barriers to con- traceptive access in Mali and Senegal; and (iv) improving quality of care in STI clinics in Shanghai, China. Results are expected in 2003–2004. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 22 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 23 New projects initiated during the year Quality of care One new project on quality of care was approved from 13 submissions that were reviewed during 2002. A number of variables affect the quality of reproductive health services. The main objective of this newly approved Argentinian study is to evaluate the quality of family planning care in three hospitals in Buenos Aires by comparing, among other factors, the experiences of both Argentinian and foreign women. Specific objectives include: (i) defining users’ expec- tations and evaluations of reproductive health services; (ii) assessing the quality of care using the Quick Investigation of Quality (QIQ) method; and (iii) developing new indicators of quality of care as appropriate. The study will use several methodologies. In-depth interviews and structured interviews using the QIQ method will be conducted with 90 clients, 30 per facility, half of whom are migrants. Fifteen providers, including doctors, nurses, and administrative personnel, will also be interviewed. In addition, non-participant observation of the three study sites will be conducted to assess facility conditions, adequacy of supplies, etc. Social science policy briefs and dissemination of findings The series of Social science research policy briefs, launched in 1999 by the Programme, continued in 2002. The briefs are intended to highlight the policy relevance and programmatic impact of social science research and to build the analytical capacity and technical writing skills of in-country investiga- tors through extensive collaboration during the development of these publications. A brief on the reproductive health information and service needs of young female migrants in China was produced in 2002. The brief is based on a study that investigated the knowledge, attitude, and practice of young female migrants to five large Chinese cities (Reproductive Health Matters, 2001, 9:118–127). The methodology was entirely qualita- tive: 22 focus group discussions and 58 in-depth interviews were conducted with young migrant women. In addition, key informant interviews were conducted with 16 health providers and personnel from floating-population management offices. Major findings suggest that premarital sex is no longer taboo in the study population and that norms and behaviours are changing; nonetheless, self-reporting of premarital sexual experience is relatively uncommon. Knowledge about con- traceptives among female migrants is low, as is method use. Consequently, unwanted pregnancy and induced abortion are not uncommon among the sexually active. Policy recom- mendations include the need to make reproductive health information and services in urban areas accessible to young migrant workers. Registration offices could provide young migrants with information about family planning methods and services, and employers of migrants could distribute pamphlets produced by the local government family planning and health departments. Finally, urban family planning work- ers could visit workplaces where large numbers of migrants are employed to offer reproductive health information and services. Infertility and childlessness in developing countries In collaboration with Opinion Research Cooperation (ORC) Macro, work has been undertaken on a comparative report on “Infecundity, infertility and childlessness in less developed countries”. Demographic and Health Surveys data from nationally representative surveys conducted in 1995–2000 in 47 developing countries were analysed. Data were collected from 495 000 women between the ages of 15 and 49 years. Topics covered in the analyses included the level of child- lessness, primary involuntary infertility, self-reported infecun- dity, secondary involuntary infertility, secondary infecundity, and differentials and trends in childlessness and infertility. Overall, 2.5% of couples in the developing world, excluding China, were estimated to experience primary involuntary infertility. Important regional, socioeconomic, and demo- graphic differentials were noted. Results were presented at the Second Global Conference on Infertility in the Third Mil- lennium: Implications for the Individual, Family and Society, held in Prague, Czech Republic, on 16–17 November 2002. The report is expected to be issued by mid-2003. Future work plans In the coming years, the work on users’ perspectives will focus on four major activities. First, the results from the mul- ticountry study on “Pregnancy prevention in the era of HIV/ STIs” will be summarized and disseminated. Country papers from the study will be presented at the upcoming IUSSP con- ference, Taking Stock of the Condom in the Era of HIV/AIDS, to be held in Gaborone, Botswana, in July 2003. A report with comparative results and policy implications will be completed for publication and dissemination. Second, in collaboration with staff of the University of London School of Hygiene and Tropical Medicine, London, United Kingdom, a compendium will be developed to provide com- parative information on contraceptive use, continuation and switching in developing countries. This compendium will also provide information on such key aspects as unmet need, unwanted fertility, postpartum contraceptive protection, and antecedents of sterilization. Third, research proposals on quality of care and on users’ perspectives on reproductive health services and technolo- gies will continue to be considered for support. Fourth, a comparative report on involuntary childlessness and infertility in developing countries will be completed and published. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 24 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 25 TECHNICAL COOPERATION WITH COUNTRIES Technical cooperation with countries in 2002 primarily con- cerned the research workshop held in Nairobi, described above. Technical assistance was also provided to the State Family Planning Commission of China and its affiliate institu- tions on the implementation of the Quality of Care project, including activities on informed choice. As part of the team visiting Uzbekistan, the Secretariat participated in discus- sions on gaps in research and capacity building needs in that country. Missions were also undertaken to China, Thailand and Turkey to respond to requests for technical assistance in social science research on users’ perspectives. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 24 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 25 Annex 1 SPECIALIST PANEL FOR SOCIAL SCIENCE AND OPERATIONS RESEARCH ON REPRODUCTIVE HEALTH Members Kofi Awusabo-Asare, University of Cape Coast, Cape Coast, Ghana (Co-chairman) Mario Bronfman, National Institute for Public Health, Cuernavaca, Mexico Aykut Turkiz Gokgol, Willows Foundation, Istanbul, Turkey Gu Baochang, China Family Planning Association, Beijing, China Veronica Kaune, John Snow Inc./Mothercare/Bolivia, La Paz, Bolivia Mike Koenig, Johns Hopkins University, Baltimore, MD, USA (Co-chairman) Akim Jasper Mturi, University of Natal, Durban, South Africa Leela Visaria, Institute of Economic Growth, New Delhi, India Bencha Yoddumnern-Attig, Mahidol University, Nakhon Pathom, Thailand Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 8 89 1 11 9 Women 4 44 4 from: AFRO 2 22 2 AMRO 2 22 1 11 3 EMRO EURO 1 11 1 SEARO 2 22 2 WPRO 1 11 1 Collaborating agency scientists John Casterline, Population Council, New York, NY, USA Ondina Fachel Leal, Ford Foundation, Rio de Janeiro, Brazil Sarah Harbison, Agency for International Development, Washington, DC, USA Vasantha Kandiah, United Nations Population Division, New York, NY, USA Suman Mehta, United Nations Population Fund, New York, NY, USA John Townsend, Population Council, Washington, DC, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 26 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 27 Annex 2 SCIENTISTS IN 2002 Principal investigators Shamina Ali, Maternity and Child Welfare Association of Pakistan, Lahore, Pakistan Evasius Bauni, African Population Policy Research Centre, Nairobi, Kenya Aysen Bulut, University of Istanbul, Istanbul, Turkey Şanda Cali, Marmara University, Istanbul, Turkey Fatimata Diallo, Cellule de Recherche en Santé de la Reproduction au Mali, Bamako, Mali Thierno Dieng, Centre de Formation et de Recherche en Santé de la Reproduction, Dakar, Senegal Graciela Dominguez, Centro de Estudios de Poblacion, Buenos Aires, Argentina Maria Garate, Branoe SA, Lima, Peru Pimonpan Isarabhadki, Mahidol University, Salaya, Nakhon Pathom, Thailand Magdalena Kleincsek, Education para el Mejoramiento de la Calidad de Vida, Santiago, Chile Liu Yun-rong, National Research Institute for Family Planning, Beijing, China Sarah Loza, Social Planning, Analysis and Administration Consultants, Cairo, Egypt Pranitha Maharaj, University of Natal, Durban, South Africa Osegbemi Makanjuola, University of Jos, Jos, Nigeria Amir Mehryar, Institute for Research in Planning and Development, Tehran, Islamic Republic of Iran Farid Midhet, The Asia Foundation, Islamabad, Pakistan Janet Molzan Turan, University of Istanbul, Istanbul, Turkey Frank Mugisha, Institute of Public Health, Kampala, Uganda William Muhwava, Union for African Population Studies, Dakar, Senegal Andrew Mushingeh, University of Zambia, Lusaka, Zambia Peter Mwarogo, Development Communications Support Programme, Nairobi, Kenya Marilyn Nations, Tropical Institute of Applied Social Medicine, Fortaleza, Brazil Stella Neema, Makerere Institute of Social Research, Kampala, Uganda Somchai Niruthisard, Chulalongkorn Hospital, Bangkok, Thailand Silvina Ramos, Centro de Estudios de Estado y Sociedad, Buenos Aires, Argentina Helen Rees, University of Witwatersrand, Bertsham, South Africa Peter Riwa, Healthscope Tanzania Ltd., Dar es Salaam, United Republic of Tanzania Mburano Rwenge, Institut de Formation et de Recherche Démographique, Yaounde, Cameroon Alejandro Villa, Centro de Estudios de Estado y Sociedad, Buenos Aires, Argentina Wei Yuan, Shanghai Institute of Planned Parenthood Research, Shanghai, China Wu Junqing, Shanghai Institute of Planned Parenthood Research, Shanghai, China Zhao Peng-Fei, Shanghai Institute of Planned Parenthood Research, Shanghai, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 32 100 32 Women 15 47 15 from: AFRO 13 40 13 AMRO 6 19 6 EMRO 4 13 4 EURO 3 9 3 SEARO 2 6 2 WPRO 4 13 4 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 26 A n n u al Tech n ical R ep ort 2002 Users’ perspectives in the context of reproductive health 27 Annex 3 PUBLICATIONS IN 2002 Ali MM, Cleland JG, Shah IH. Neglected HIV intervention: condom use within marriage (forthcoming). Fang K, Li X, Hang Y. The effectiveness of reproductive health education intervention on increasing knowledge about sexually transmitted diseases and condom use and improving attitude towards condom application among male patients with sexually transmitted diseases in Shanghai. Journal of Reproductive Medicine, 2002, 11(2):84–90. Ganapathy S, Matthews Z, Ramakrishna J, Mahendra S, Kilaru A. Sociocultural determinants of maternal health in rural south India. In: Koenig M, Jejeebhoy S, eds. Reproductive health in India: new evidence (forthcoming). Guo YN, Davin D, Ng EML, Chan K, Shah I. Dynamics of contraceptive desire among Shanghai couples and their determi- nants. In: Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science Conference (APSSAM 2002). Kunming, Institute of Health Sciences (forthcoming). Kilaru A, Matthews Z, Mahendra S, Ramakrishna J, Ganapathy S. ‘She has a tender body’: Postpartum care and care-seeking in rural south India. In: Unnithan M, ed. Anthropology, reproduction and health policy (forthcoming). Li Y, Chen CHC, Yue H, Sun Z, Stupp PW, Wu Y, Shah I. The effect of improved quality of family planning services on reduc- tion in the rate of induced abortion in six years follow-up. In: Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science Conference (APSSAM 2002). Kunming, Institute of Health Sciences (forthcoming). Liu Y. Role of Chinese men in reproductive health. In: Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science Confer- ence (APSSAM 2002). Kunming, Institute of Health Sciences (forthcoming). Ramakrishna J. Ganapahty S, Matthews Z, Mahendra S, Kilaru A. Health, illness and care in the obstetric period: a prospec- tive study of women in rural Karnataka. Bangkok, United Nations Economic and Social Commission for Asia and the Pacific (ESCAP), 2002. Rwenge M. Women’s status and condom use in Cameroon (Centre and West Provinces). International Family Planning Per- spectives (forthcoming). Szulik D, Ramos S, Gogna M, Romero M, Petracci M. La responsabilidad de los médicos ante las políticas públicas sobre anti- concepción y aborto. Serie seminarios “Salud y Publíca” CEDES. Buenos Aires, Argentina, Seminario VI, septiembre 2002. Xiao Y, Sanders S, Wu Shizhong, Luo L. The effect of women’s employment on breast-feeding in urban areas of Sichuan. Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science Conference (APSSAM 2002). Kunming, Institute of Health Sciences (forthcoming). A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 28 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 29 Development of improved and new methods of fertility regulation C. d’Arcangues, P.D. Griffin, H. von Hertzen, M. Mbizvo, E. Vayena, K.M. Vogelsong INTRODUCTION In 2001, the United Nations Population Division reported that approximately 648 million couples worldwide regularly used a method of family planning. Because use does not neces- sarily mean acceptance, this statistic offers only a glimpse of the behaviours that determine a couple’s decision to use a method of fertility regulation. Nearly one-half of users of a reversible method discontinue use within a year, for a variety of reasons including health concerns and the occurrence of an unplanned pregnancy. On the other hand, at least 120 million couples do not use any method of family planning, despite expressing a desire to space or limit the number of their children. Obstacles to the use of contraceptive methods include ambivalence towards modern contraception, espe- cially because of the fear of side-effects, and lack of access to high-quality services. Experts have determined that the availability of improved or totally new methods of family planning could lead to a significant public health benefit and could meet the needs and demands of millions of men, women, and families. The Programme’s research on improved and new methods for fertility regulation provides one of the several interconnect- ing building blocks required for the delivery of quality family planning services. The Programme has pursued high-priority leads for new methods and approaches that are easier to use and simplify service delivery, that are associated with fewer and less severe side-effects, and that respond to the needs of various users, including men. The Programme’s goals link this work to the introduction of methods, and sub- sequent large-scale trials of their safety and efficacy. Users’ perspectives are gathered during the product development, introduction and routine service provision phases; together with clinical trial data, this information provides a basis for the development of norms, guidelines and other tools for provid- ers and for family planning acceptors. RESEARCH ACTIVITIES Emergency contraception Specific objectives of research For the past ten years, the Programme has been in the fore- front of research on new technologies for emergency con- traception. The aim is to improve further the safety, efficacy, acceptability, and ease of service delivery of methods for this indication. After demonstrating the superiority of levonorg- estrel (LNG) over the regimen of combined oral contracep- tives, the aim was to simplify further the LNG regimen and to compare it to low-dose mifepristone. The efficacy and safety of the copper-IUD and gestrinone are being assessed as alternative methods of emergency contraception. Progress Levonorgestrel Previous research by the Programme has demonstrated that a single 10 mg dose of mifepristone and two 0.75 mg doses of LNG taken 12 hours apart are effective for emergency contraception. A new three-arm, randomized study inves- tigated the efficacy and side-effects of these two methods, compared with a single 1.5 mg dose of LNG, when given up to 120 hours after unprotected intercourse. A total of 4136 women were enrolled at 15 family planning clinics in Asia and Europe. Of 4071 women with known outcome, pregnancy rates did not differ among treatment groups and were 1.6 % in women given mifepristone, 1.5 % in women assigned single-dose LNG, and 1.8 % in women assigned two-dose LNG (see Table 1.1). Side-effects were mild and did not differ greatly between the groups; most women menstruated within two days of the expected date. The results of this ran- A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 28 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 29 domized, double-blind multinational study were published in The Lancet in December 2002. Women and providers can benefit immediately from these new findings, since the now widely accepted LNG-only regimen will become even easier to use in a single dose. Guidelines for emergency contracep- tion need to be modified accordingly. A double-blind, multicentre study carried out in collabora- tion with investigators in Hong Kong Special Administrative Region of China compared the effectiveness of two regi- mens, one with a 12-hour interval between the two doses of LNG and one with a 24-hour interval. The study included over 2000 women; results will be available by mid-2003. LNG is also being studied in a seven-centre study in Nigeria. The efficacy and side-effects of a one-dose regimen of 1.5 mg will be compared to a two-dose regimen of 0.75 mg taken twice, with a 24-hour interval between doses. This study will include a total of 3150 women and is expected to be com- pleted by the end of 2003. An additional aim of this study is to develop the capacity of the centres to carry out research according to Good Clinical Practice (GCP) standards. Mifepristone Based on the above and previous results, mifepristone does not seem to have any advantages over LNG, in terms of effectiveness or side-effects. In addition to more frequent delays in menses, women in the mifepristone group also had a high pregnancy risk after treatment. The research conducted to date suggests that, from the service delivery point of view, mifepristone may be a less feasible and less acceptable method. To test further the low-dose mifepristone regimen for emer- gency contraception, the Programme collaborated with Chi- nese investigators in a three-year initiative funded by The Rockefeller Foundation. Two large multicentre trials were carried out during this initiative. The first trial, a randomized, double-blind study, compared the effectiveness and side-effects of 10 mg and 25 mg doses of mifepristone among 3052 women in 10 centres. The results of the study indicated that the two doses are equally effective, with a crude pregnancy rate of 1.1%. The treat- ments led to very few, if any, reported side-effects. Women treated after 48 hours following unprotected sex had a risk of pregnancy 2.3 times higher than women treated within 48 hours (relative risk = 2.3; 95% confidence interval 1.2 to 4.5; p=0.02). The results were published in December 2002 in the journal Human Reproduction. The second trial is a prospective study of the efficacy and side-effects of 10 mg mifepristone among nearly 5000 women in 30 centres. The results are being analysed and should be available in early 2003. Gestrinone Gestrinone is registered and used in more than 40 coun- tries for the treatment of endometriosis. In addition to its antigonadotrophic activity, the compound also has some antiprogestogenic activity. It is anticipated that, owing to its fairly long duration of action, one dose of gestrinone might be sufficient for effective emergency contraception. A randomized, double-blind study is continuing in China to compare 10 mg of gestrinone with 10 mg of mifepristone for emergency contraception when administered up to 120 hours after unprotected intercourse. The study will include 1200 women. Recruitment has been slower than anticipated because emergency contraception is now widely available in China and women do not necessarily come to family plan- ning clinics when they need it. Mechanism of action studies Several studies are being undertaken by the Programme’s collaborating centres to investigate possible mechanisms of action of emergency contraceptives. A study in Santiago, Chile, is looking at the effects of LNG in the Cebus apella monkey. Preliminary results suggest that, if administration takes place before ovulation, ovulation is disturbed; however, the progestogen seems to have no effect on pregnancy rates if it is administered after ovulation has occurred. Another study in Chile examined the effects of a single 1.5 mg dose of LNG on follicular growth and ovulation in the human. The pharmacokinetics as well as the levels of the steroid in endometrial tissue were examined after oral and vaginal administration. The results should be available in early 2003. Table 1.1. Efficacy of mifepristone and two regimens of levonorgestrel as emergency contraceptives Group Women Observed pregnancies Rate Mifepristone 10 mg 1359 21 1.55 % LNG 1.5 mg x 1 1356 20 1.47 % LNG 0.75 mg x 2 1356 24 1.77 % A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 30 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 31 Six-monthly, non-steroidal, injectable immunocontraceptive for women Specific objectives of research The development of a totally new method of contraception, based on a controlled and time-limited immune response to reproduction-specific molecules, has been the subject of extensive investigation supported by a number of interna- tional and national agencies for several decades. The research being supported by the Programme in this area is the development of an immunocontraceptive based on, and directed against, hCG. The objective of this work is to develop a long-acting, non-hormonal method of contra- ception that could provide perhaps as much as six months of protection following a single injection and which would be free of the endocrine and other metabolic disturbances often experienced with long-acting steroid hormone preparations currently on the market and under investigation. Progress An application was submitted to the regulatory authorities in Sweden in May 2002 to carry out a Phase I clinical trial with the current formulation of the hCG immunocontraceptive. A manufacturer meeting the required regulatory requirements has been identified and preparation of the clinical trial sup- plies is awaiting the availability of funds. The initiation of the second stage of the preclinical safety studies, to run in parallel with the first stage of the Phase I clinical trial, is also awaiting the availability of funds. In 2002, the development work on this project was mainly concerned with supporting the forthcoming Phase I clinical trial in Sweden, as described below. Dose–response studies Several doses of the new matrix delivery system for the hCG immunogen were tested in rabbits, with each dose adminis- tered twice at an interval of 24 weeks. All doses elicited puta- tively protective levels of antibodies by four weeks which, at higher doses, were sustained for 24 weeks. Tissue reactions were considered to be within clinically acceptable limits. Adequate antibody levels were also elicited when the dose of the booster injection was half that of the initial injection, with the added advantage that the frequency and severity of the tissue reactions were reduced. These studies are continuing in order to identify the optimal dose regimen. Stability testing The immunopotency of the matrix formulation was tested using freshly prepared particles, and particles stored at 4°C for 12 months and for more than 24 months. The antibody profiles elicited by these three batches of materials were nearly identical. Additional testing of material stored for two years is in progress. Studies for improving manufacturing procedures Preparing materials for the forthcoming clinical trial has required weighing very small quantities of the matrix particles for the individual doses. To make the weighing easier and more accurate, larger amounts of particles with a reduced loading of immunogens, or the addition of “blank” particles to keep the immunogen dose constant, have been tested. The expected level of antibody was elicited by these materi- als but the tissue reactions were greater than those of the standard preparation. Testing of chimeric peptides in microspheres During the past two years, studies have been conducted to test the immunogenicity and safety of chimeric immunogen peptides, containing B-cell epitopes of hCG beta subunit and at least one T-cell epitope from tetanus toxoid or measles protein, formulated in polylactide/glycolide microspheres and administered in phosphate buffered saline. This approach requires the preparation of separate microspheres contain- ing adjuvant and the mixing of the two before use. The incor- poration of an inorganic salt into the same microspheres as the immunogens might be an alternative to the adjuvant in that this formulation elicits high levels of antibodies that are sustained for several months from a single injection with minimal tissue reaction at the injection site. New projects initiated during the year Testing an improved formulation for manufacture The method currently used to manufacture the hCG immuno- contraceptive involves weighing doses of dry particles into sterile syringes and mixing them with the emulsion vehicle (containing the adjuvant compound) immediately prior to injection. The weighing of small amounts of particles is diffi- cult and would not be practical for large-scale manufacturing. Mixing at the time of injection could introduce errors in the mixing procedure or improper dosing. During the past year, tests have been conducted on the immunogenicity of a fully formulated preparation stored at 4°C for periods of up to 270 days. A test of material stored for 360 days is in progress. The data obtained so far indicate that this preparation is equally immunogenic in rabbits after storage at this temperature for up to 9 months. In addition, no change in the physical appearance of the formulation was noted. These data suggest that it may be possible to prepare a stable preformulated version of the hCG immunocontra- ceptive which could be developed and provided in a “ready to use” form. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 30 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 31 Injectable hormonal contraceptives Specific objectives of research A number of long-acting injectable esters of LNG were pre- pared in a chemical synthesis programme conducted by the National Institute of Child Health and Human Development (NICHD) of the United States National Institutes of Health (NIH) and the Programme, in the late 1970s and early 1980s. One of these, LNG butanoate (LNG-B), is being investigated as a possible improved alternative to depot-medroxypro- gesterone acetate (DMPA), which could be used for female and/or male contraception. Progress Levonorgestrel butanoate Discussions have taken place with collaborating agencies and industry in connection with the preparation of supplies of LNG-B for use in pharmacokinetic and pharmacodynamic studies and for comparative efficacy studies with DMPA. Suitable sites have been identified for the bulk manufacture and processing of the steroid. The terms and conditions under which the production of clinical trial supplies will be prepared are under discussion. Combined vaginal ring Specific objectives of research Acceptability studies show that women need long-acting methods of contraception that do not require daily inter- ventions and that are under the user’s control. The vaginal ring meets these needs. It has several positive attributes: most steroid hormones are absorbed efficiently through the vaginal wall and can be released from a Silastic ring; the ring can be easily inserted and replaced by the woman herself; it can be worn continuously for a number of weeks; its use is not coitally related; it provides a constant rate of drug release resulting in a steady plasma level of the minimum dose required for contraception; metabolic side-effects are reduced by avoiding the first-pass effect through the liver; and upon removal, fertility rapidly returns. The Programme has discontinued its development of a levonorgestrel-releas- ing vaginal ring and is planning to support the Population Council’s efforts to develop a combined contraceptive vagi- nal ring. Progress The Population Council will launch a Phase III clinical trial of a combined contraceptive vaginal ring that releases 150 μg of nestorone and 15 μg of ethinyl estradiol daily over the course of a year. The initiation of the trial has been delayed owing to the need to establish analytical methods for inproc- ess quality control and quality assurance assessments for large-scale manufacture. The trial is scheduled to begin in 2004; the Programme is planning to provide support to two clinical research centres. Basic research on implantation Specific objectives of research An anti-implantation or menses-inducing agent is an attrac- tive approach to fertility regulation since it would need to be taken only on one occasion in any menstrual cycle, and then only on an as-needed basis or as a backup method—for example, in the case of condom breakage. Such a method would be free of the logistical problems and side-effects associated with many existing methods of family planning and, because of its infrequent use, should be relatively inex- pensive. A collaborative initiative in the area of basic research in implantation was established in 1998 between The Rockefel- ler Foundation and the Programme, with financial support being provided by The Rockefeller Foundation and technical oversight being provided by the Programme. The primary objective is to identify promising leads for development, in eventual collaboration with industry, of novel anti-implantation or menses-inducing agents which would be woman-controlled, effective, safe and acceptable in their mode of administration and their mechanism of action. The continuing focus of the research is on: (i) the implanta- tion window in the primate, at the endometrial level; (ii) the development and demise of the primate corpus luteum; and (iii) preimplantation embryo–uterus–corpus luteum interac- tions. The work is being carried out in a network of six cen- tres in Australia, China, Germany, India, the United Kingdom and the USA. Progress During the past year, further information has been obtained on the complicated and interactive structural and functional changes that occur in the monkey corpus luteum and in the mouse, monkey and human uterus at the site and time of implantation. These changes include both increased and decreased production of specific molecules, the proliferation of blood vessels, and the controlled destruction of certain cell types. New projects initiated during the year Further studies have been carried out to investigate the spatial and temporal expression of genes and their products in the pregnant and non-pregnant uterus and in the corpus luteum. Further evidence of an antifertility effect was obtained when antibodies raised against angiogenic factors were administered to monkeys at a fixed and predetermined time A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 32 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 33 post ovulation. Future studies are planned, involving larger numbers of animals, higher doses of antibodies and a variety of treatment regimens, to further investigate their antifertility potential. Studies are continuing in all six centres with an emphasis to be placed during this final year of the initiative on the most promising leads in each location. Basic research on endometrial bleeding Specific objectives of research A large proportion of the more than 20 million women using progestogen-only methods of contraception endure the irregularities in vaginal bleeding that these methods induce. This has significant implications for their sexual lives and impacts on the sociocultural, economic and, for some, religious dimensions of their lives. Few options are available to women to prevent or alleviate this problem. As a result, counselling is the main assistance that women who experience bleeding irregularities can expect from providers. Clearly, there is a need to understand better the mechanisms of menstruation and of irregular bleeding, and how these are affected by contraceptive steroids, particularly progestogens, in order to formulate appropriate treatments and to develop new methods free of these side-effects. Progress A double-blind, randomized, placebo-controlled clinical trial was conducted to test the effect of vitamin E as an antioxidant, and of low-dose aspirin as an anti-inflamma- tory agent, alone and in combination, on Norplant-induced prolonged bleeding. Participating centres were located in Beijing (China), Jakarta (Indonesia), Santiago (Chile), Santo Domingo (Dominican Republic) and Tunis (Tunisia). Treat- ment with vitamin E had no beneficial effect on bleeding patterns in the study population. Although treatment with low-dose aspirin often led to a more rapid cessation of pro- longed bleeding episodes, significant differences were rarely observed. A systematic review of the evidence for the efficacy of vari- ous therapies in the treatment or prevention of progestogen- induced irregular endometrial bleeding is being supported by the Programme, through the Fertility Regulation Group of the Cochrane Collaboration. The protocol for the review was published in the Cochrane Library Issue 1, 2002, available on CD-ROM and online. The review is ongoing and should be completed in early 2003. A basic science project, “Studies on the Role of Progestogens in Endometrial Breakthrough Bleeding”, was initiated in 2002. It was designed to provide insight into the cellular and molecular mechanisms that underlie progestogen-induced breakthrough bleeding. In the first year of this three-year project, it has been found that progesterone receptors are expressed by human myometrial microvascular endothelial cells in culture, but no changes in cellular gene expression resulted from ligand stimulation of these receptors. Chem- okines stimulate the migration and activation of leukocytes, which are important mediators of endometrial breakdown. Additional data from the study have demonstrated that the specific chemokine, fractalkine, is found in uterine luminal and glandular epithelial cells and in decidualized stromal cells, with maximal production occurring in the secretory phase in cycling women. In endometria of women using DMPA or Mirena (the levonorgestrel-releasing IUD), frac- talkine was strongly expressed in the decidualized stroma; uterine tissue from women using Norplant exhibited lower- than-normal levels of this chemokine. Fractalkine may there- fore contribute to the endometrial fragility seen in women using these methods. Preliminary evidence using a mouse model of menstruation indicates that doxycycline, a broad- spectrum matrix metalloproteinase inhibitor, does not alter the integrity of blood vessels when given from day 5 to day 16 of decidualization, as induced by chronic progesterone exposure. Male hormonal contraception—clinical and social science research Specific objectives of research The family planning community is becoming increasingly aware of the need for, and public-health benefits of, male participation. The Programme has taken a leadership role in the development of male contraceptives, as a step toward the goal of increased shared responsibility in this area. A research agenda in male contraceptive development must identify and exploit the leads that are feasible and show the most promise, such as a hormonal method that suppresses spermatogenesis and produces temporary infertility. The Programme’s clinical trials are complemented by acceptabil- ity and behavioural research. Progress Androgen alone A Phase III study of the safety and contraceptive efficacy of the injectable androgen, testosterone undecanoate (TU), was initiated in late 2001. This four-year trial will evaluate the effects of a monthly injection of 500 mg TU on the fertility of 1000 men, from 10 centres in China. Volunteers receive monthly injections of TU (1000 mg in the first injection and 500 mg thereafter) and are followed for sperm suppression during the first 6 months (Suppression phase). If sperm con- centrations are suppressed to £ 1 million/ml, the volunteers continue to receive monthly injections and are followed for contraceptive efficacy for 24 months (Efficacy phase). If sperm concentrations are not adequately suppressed, the volunteer is discontinued from the study; all men who discon- tinue early for any reason are followed until their sperm con- centrations return to levels generally considered to be fertile A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 32 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 33 (20 million/ml or more). The study is progressing accord- ing to schedule, though no preliminary data are available yet (Table 1.2). Table 1.2. Current status of 1040 volunteers enrolled in Phase III trial of TU alone as a male contraceptive Study Phase Number of Volunteers Suppression (first 6 months) 175 Efficacy (24 months) 681 Early discontinuation: Lost to follow-up 45 Change in contraceptive method 35 Inadequate response 34 Missed injection 31 Other 39 Total 1040 Androgen/progestogen combinations This year saw the completion of a Phase II trial to evalu- ate the suppression of spermatogenesis resulting from the administration of an androgen/progestogen combination, TU + DMPA, to Indonesian men. The study compared the efficacy of the administration of 500 mg TU at 6 week inter- vals with that of the same regimen of TU combined with 250 mg DMPA administered at 12 week intervals. The combined regimen was more effective than TU alone and suppressed sperm counts to a level of infertility in all study participants. The duration of sperm suppression was longer than antici- pated; all volunteers were followed until their sperm concen- trations recovered to fertile levels. In order to simplify the injection regimen, lengthen the interval between injections, and determine the lowest effective doses of both TU and DMPA, the study will be revised and expanded when a new formulation of TU is available. The initiation of a multicentre Phase IIb trial of TU combined with the progestogen norethisterone enanthate (NET-EN) was again delayed due to the non-availability of the study compounds. The protocol has been finalized and negotia- tions with the manufacturer are ongoing. The study would be funded and conducted in collaboration with CONRAD. Behavioural and social science research In conjunction with the clinical trial of the TU + DMPA regi- men in Indonesia, a study to assess users’ perspectives and acceptability of the study compounds was completed. The study participants and their wives generally found the regi- mens to be acceptable. Reasons for participating included the opportunity to have a health check and the desire to relieve partners of the responsibility for family planning. Many men did report short-lived pain at the injection site and increased sexual activity and energy levels during the study. The Programme is supporting a study to pilot test instru- ments to assess the acceptability of, and mood or behav- ioural changes following, the administration of the TU + NET-EN regimen as a potential contraceptive in Italian men. Instruments have been developed and validated; preliminary evidence indicates that sexual behaviour and mood are not altered as a result of the hormonal administration. Data col- lection will be completed in early 2003. New projects initiated during the year A protocol to evaluate the pharmacokinetics and pharmaco- dynamics of a novel formulation of TU is under development. The Xianju Pharmaceutical Corporation, Zhejiang, China, has developed a high-concentration preparation of the steroid; this will allow the injection volume to be halved and should reduce pain at the injection site and improve accept- ability. A study of the pharmacokinetics of this formulation in monkeys is under review; the clinical trial will begin once the monkey study is completed (expected to be in 2003). Basic science leads toward the development of novel approaches to male fertility regulation Specific objectives of research As a complement to the clinical research related to regulation of male fertility, the Programme supports innovative, goal- oriented basic research on male physiology related to sper- matogenesis and spermiogenesis. Potential research targets include the identification, characterization and manipulation of developmental events such as acrosome and flagellar formation; the expression and function of sperm-specific pro- teins; and specific intracellular pathways or events required for sperm function. Investigators are required to focus on the unique aspects of their research with implications for male contraceptive development. Progress In 1998/99 and 2000/01, the Programme issued calls for proposals for basic science activities targeted toward the identification of a novel male contraceptive approach. The following activities were approved through a competitive peer-review process and are currently ongoing. Delivery of antibodies to the male reproductive ducts to achieve immunocontraception This study seeks to determine whether a sufficient titre of antibody can be delivered to the lumen of the male reproduc- tive ducts to saturate a target antigen, in order to achieve immunocontraception. Results indicate that Immunoglobu- lin G and Immunoglobulin A do enter the rete testes and prostatic fluids of the mouse and rat. The investigators are A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 34 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 35 currently using a preparation of sperm surface antigen to immunize male mice and to prepare antibodies that will be used to assess whether sufficient antibody enters the male reproductive ducts to saturate these antigens. Investigation of the possible presence of the C proges- terone isoform at the level of the human sperm plasma membrane In order to characterize and clone a sperm membrane progesterone receptor, the investigators have extracted ribonucleic acid (RNA) from selected human spermatozoa and have performed reverse transcriptase polymerase chain reaction (RT-PCR) on these samples using oligoprimers designed from different regions of the human progesterone receptor RNA sequence. Since it seems that a deoxyribo- nucleic acid (DNA) transcript corresponding to the specific membrane progesterone receptor is not present in human sperm, post-transcriptional or post-translational modifica- tions of the genomic receptor may occur. The study is now investigating the novelty of the receptor protein. Anti-spermatogenic effects of luteinizing and thyroid hormones Data from this pilot study indicate that, in three-month-old Sprague Dawley rats, thyroxin, administered continuously by means of a subcutaneous pump, exerts an anti-sperma- togenic effect. Studies are ongoing to determine the optimal doses of the two peptide hormones, with respect to arresting spermatogenesis and maintaining androgen concentrations. The prostasome as a potential new target for fertility regulation in men Work in the first year of this study has demonstrated that, of 116 infertile men with anti-sperm antibodies, 97% have antibodies against prostasomes. This suggests that prosta- somes are a major target for anti-sperm antibodies. Eighty- five per cent of these men had antibodies to proteins of 70–75 kDa; 80% reacted with a protein of 50–55 kDa. These two potential immunogens may therefore be candidates as antifertility targets. Work is ongoing to identify the proteins and genes of interest. Human sperm mitogen-activated protein kinase cas- cades and their role in sperm functions Natural and potential sperm ligands are being used to investigate the presence and role of a series of kinases in ligand-stimulated human sperm function in this study. Initial results have demonstrated localization of kinases and their upstream regulators in human sperm. Inhibitors of these enzymes seem to alter sperm motility and ligand-induced stimulation of the sperm acrosome reaction in vitro. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 34 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 35 Annex 1a RESEARCH GROUP ON POST-OVULATORY METHODS FOR FERTILITY REGULATION IN 2002 Members György Bartfai, Albert Szent-György Medical University, Szeged, Hungary Cheng Linan, Shanghai Institute of Family Planning Technical Instruction, Shanghai, China Luigi Devoto, University of Chile, Santiago, Chile Kristina Gemzell-Danielsson, Karolinska Hospital, Stockholm, Sweden Ho Pak Chung, University of Hong Kong, Hong Kong Special Administrative Region of China (Chairman) Jayasree Sengupta, All India Institute of Medical Sciences, New Delhi, India Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 4 67 1 17 1 17 6 Women 2 33 1 17 3 from: AFRO AMRO 1 17 1 EMRO EURO 1 17 1 17 2 SEARO 1 17 1 WPRO 2 33 2 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 36 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 37 Annex 1b RESEARCH GROUP ON IMMUNOCONTRACEPTIVES IN 2002 Members John Beale, Cranbrook, Kent, United Kingdom Marc Bygdeman, Karolinska Hospital, Stockholm, Sweden Richard Elton, Tuscon, AZ, USA Warren Jones, Flinders Medical Centre, Adelaide, Australia (Chairman) Rob Loblay, Clinical Immunology Research Centre, Sydney, Australia Viveca Odlind, University Hospital, Uppsala, Sweden Susan Pierce, Northwestern University, Evanston, IL, USA Faye Schrater, Smith College, Project on Women and Social Change, Northampton, MA, USA Shobha Sehgal, Postgraduate Institute of Medical Education and Research, Chandigarh, India Gennadi Sukhikh, International Institute of Biological Medicine, Moscow, Russian Federation Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 1 10 1 10 8 80 10 Women 1 10 3 30 4 from: AFRO AMRO 3 30 3 EMRO EURO 1 10 3 30 4 SEARO 1 10 1 WPRO 2 20 2 Collaborating agency scientist Doug Colvard, CONRAD, Arlington, VA, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 36 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 37 Annex 1c RESEARCH GROUP ON METHODS FOR THE REGULATION OF MALE FERTILITY IN 2002 Members Richard Anderson, MRC Human Reproductive Sciences Unit, Edinburgh, United Kingdom Kiagus Arsyad, Sriwijaya University, Palembang, Indonesia Hermann Behre, Martin-Luther-University, Halle, Germany William Bremner, University of Washington, Seattle, WA, USA Gu Yi-Qun, National Research Institute for Family Planning, Beijing, China Ilpo Huhtaniemi, University of Turku, Turku, Finland Robert McLachlan, Prince Henry’s Institute of Medical Research, Victoria, Australia Cristina Meriggiola, University of Bologna, Bologna, Italy Nukman Moeloek, University of Indonesia, Jakarta, Indonesia Christina Wang, Harbor-University of California at Los Angeles Medical Center, Torrance, CA, USA (Chairwoman) Frederick Wu, University of Manchester, Manchester, United Kingdom Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 3 27 8 73 11 Women 2 18 2 from: AFRO AMRO 2 18 2 EMRO EURO 5 45 5 SEARO 2 18 2 WPRO 1 9 1 9 2 Subcommittee for the review of male basic science research Stella Campo, Endocrinology Research Centre (CEDIE), Buenos Aires, Argentina Patricia Cuasnicu, Institute of Biology and Experimental Medicine, Buenos Aires, Argentina Anton Grootegoed, Erasmus University Rotterdam, Rotterdam, Netherlands David Hamilton, University of Minneapolis Medical School, Minneapolis, MN, USA Norman Hecht, University of Pennsylvania, Philadelphia, PA, USA Ilpo Huhtaniemi, University of Turku, Turku, Finland (Chairman) Collaborating agency scientists Mark Barone, EngenderHealth, New York, NY, USA Douglas Colvard, CONRAD, Arlington, VA, USA Henry Gabelnick, CONRAD, Arlington, VA, USA Robert Spirtas, National Institute of Child Health and Human Development, Bethesda, MD, USA Judy Manning, United States Agency for International Development, Washington, DC, USA Elof Johansson, Population Council, New York, NY, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 38 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 39 Annex 1d WHO/ROCKEFELLER FOUNDATION INITIATIVE ON IMPLANTATION RESEARCH IN 2002 Members Ruben Gonzalez, Boston Biomedical Research Institute, Watertown, MA, USA Michael Harper, The Consortium for Industrial Collaboration in Contraceptive Research (CICCR), Arlington, VA, USA Hideharu Kanzaki, Kansai Medical University, Osaka, Japan Stephen Killick, The Princess Royal Hospital, Hull, United Kingdom John White, Hammersmith Hospital, London, United Kingdom Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 5 100 5 Women from: AFRO AMRO 2 40 2 EMRO EURO 2 40 2 SEARO WPRO 1 20 1 Collaborating agency scientists Mahmoud Fathalla, The Rockefeller Foundation, Assiut, Egypt Evelyn Majidi, The Rockefeller Foundation, New York, NY, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 38 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 39 Annex 2a RESEARCH GROUP ON POST-OVULATORY METHODS FOR FERTILITY REGULATION Scientists in 2002 Principal investigators Oyunbileg Amindavaa, State Research Centre on Human Reproduction and Maternal and Child Health, Ulaanbaatar, Mongolia Dan Apter, The Family Federation of Finland, Helsinki, Finland David Baird, University of Edinburgh, Edinburgh, United Kingdom György Bártfai, Albert Szent-György Medical University, Szeged, Hungary Cheng Li-cun, Shanghai Changning Obstetrics and Gynaecology Hospital, Shanghai, China Cheng Linan, Shanghai Institute of Family Planning Technical Instruction, Shanghai, China Cheng Wei-yu, Tianjin Municipal Research Institute for Family Planning, Tianjin, China Horacio Croxatto, Chilean Institute of Reproductive Medicine, Santiago, Chile Olukayode Dada, Ogun State University Teaching Hospital, Sagamu, Nigeria Dai Jiejie, Medical Primate Research Centre of China, Kunming, China Luigi Devoto, University of Chile, Santiago, Chile Ding Ju-hong, Jiangsu Family Planning Research Institute, Nanjing, China Robert Garfield, University of Texas Medical Branch, Galveston, TX, USA Kristina Gemzell-Danielsson, Karolinska Hospital, Stockholm, Sweden Archil Khomassuridze, Zhordania Institute of Human Reproduction, Tbilisi, Georgia Rosemary Kirkman, University Hospital of South Manchester, Manchester, United Kingdom Laszlo Kovacs, Albert Szent-Györgyi Medical University, Szeged, Hungary Frank Lüdicke, University of Geneva, Geneva, Switzerland Lena Marions, Karolinska Institute, Stockholm, Sweden Suneeta Mittal, All India Institute of Medical Sciences, New Delhi, India Ernest Ng, University of Hong Kong, Hong Kong Special Administrative Region of China Cora Ngai, University of Hong Kong, Hong Kong Special Administrative Region of China Maria Elena Ortiz, Catholic University of Chile, Santiago, Chile Alenka Pretnar-Darovec, University Medical Centre, Ljubljana, Slovenia Shi Shao-Qing, University of Texas Medical Branch, Galveston, TX, USA Song Si, Shanghai Institute of Planned Parenthood Research, Shanghai, China Wang Jie-dong, National Research Institute for Family Planning, Beijing, China Wu Shang-chun, National Research Institute for Family Planning, Beijing, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 16 57 4 14 8 29 28 Women 10 36 1 4 3 11 18 from: AFRO 1 4 1 AMRO 3 11 2 7 5 EMRO EURO 4 14 6 22 10 SEARO 1 4 1 WPRO 11 40 11 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 40 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 41 Annex 2a (continued) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 9 75 4 33 12 Women 6 50 2 17 8 from: AFRO AMRO EMRO EURO 3 25 3 SEARO 1 8 1 WPRO 8 67 8 Other scientists Bao Gui-xia, Shanghai Changning Obstetrics and Gynaecology Hospital, Shanghai, China Mark Bygdeman, Karolinksa Institute, Stockholm, Sweden Maria Condrea, University of Geneva, Geneva, Switzerland Fang Pei-ying, Wuxi Maternal and Child Health Hospital, Wuxi, China Oskari Heikinheimo, Helsinki University Central Hospital, Helsinki, Finland Ho Pak Chung, University of Hong Kong, Hong Kong Special Administrative Region of China Sunesh Kumar, All India Institute of Medical Sciences, New Delhi, India Wang Yi-fang, Wuxi Maternal and Child Health Hospital, Wuxi, China Wei Fei-ying, Shanghai Changning Obstetrics and Gynaecology Hospital, Shanghai, China Wu Er-ruo, National Research Institute for Family Planning, Beijing, China Xiao Bilian, National Research Institute for Family Planning, Beijing, China Zhu Peng-di, National Research Institute for Family Planning, Beijing, China A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 40 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 41 Annex 2b RESEARCH GROUP ON LONG-ACTING SYSTEMIC AGENTS FOR FERTILITY REGULATION Scientists in 2002 Principal investigators Hany Abdel-Aleem, Assiut University, Assiut, Egypt Rim Ben Aissa, Research Centre for Human Reproduction, Tunis, Tunisia Vivian Brache, PROFAMILIA, Santo Domingo, Dominican Republic Gu Sujuan, Beijing Municipal Research Institute for Family Planning, Beijing, China Rebecca Massai, Chilean Institute of Reproductive Medicine (ICMER), Santiago, Chile Peter Rogers, Monash Medical Centre, Clayton, Australia Lois Salamonsen, Prince Henry’s Institute of Medical Research, Clayton, Australia Sri Bekti Subakir, University of Indonesia, Jakarta, Indonesia Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 6 75 2 25 8 Women 5 62 1 12 6 from: AFRO AMRO 2 25 2 EMRO 2 25 2 EURO SEARO 1 12 1 WPRO 1 12 2 25 3 Other scientists Frank Alvarez, PROFAMILIA, Santo Domingo, Dominican Republic Melissa Brasted, Prince Henry’s Institute of Medical Research, Clayton, Australia Horacio Croxatto, Chilean Institute of Reproductive Medicine (ICMER), Santiago, Chile Rebecca Jones, Prince Henry’s Institute of Medical Research, Clayton, Australia Hayet Mansour, Research Centre for Human Reproduction, Tunis, Tunisia Marion Marsh, Prince Henry’s Institute of Medical Research, Clayton, Australia Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 3 50 3 50 6 Women 1 17 3 50 4 from: AFRO AMRO 2 33 2 EMRO 1 17 1 EURO SEARO WPRO 3 50 3 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 42 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 43 Annex 2c RESEARCH GROUP ON IMMUNOCONTRACEPTIVES Scientists in 2002 Principal investigators Richard Ascione, Aphton Corporation, Woodland, CA, USA James Hampton, Peninsula Laboratories, San Carlos, CA, USA Vernon Stevens, Ohio State University, Columbus, OH, USA Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 3 100 3 Women from: AFRO AMRO 3 100 3 EMRO EURO SEARO WPRO Other scientists Faz Chowdury, Aphton Corporation, Loughborough, United Kingdom Theo de Roij, Aphton Corporation, Tervuren, Belgium Peter Fagan, Quintiles Pharmaceutical Services, Edinburgh, United Kingdom Frederick Frye, Comparative Medical, Surgical and Pathology Consultation, Davis, CA, USA Stephen Grimes, Aphton Corporation, Woodland, CA, USA Susan Hagan, Aphton Corporation, Loughborough, United Kingdom Pravin Kaumaya, Ohio State University, Columbus, OH, USA Dov Michaeli, Aphton Corporation, Woodland, CA, USA John Powell, Ohio State University, Columbus, OH, USA Peter Rees, Huntingdon Life Sciences, Huntingdon, United Kingdom Peter White, Nova Laboratories Limited, Leicester, United Kingdom Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 11 100 11 Women 1 9 1 from: AFRO AMRO 5 45 5 EMRO EURO 6 55 6 SEARO WPRO A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 42 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 43 Annex 2d RESEARCH GROUP ON METHODS FOR THE REGULATION OF MALE FERTILITY Scientists in 2002 Principal investigators Kiagus Arsyad, Sriwijaya University, Palembang, Indonesia Gianni Forti, University of Florence, Florence, Italy Gu Yi-Qun, National Research Institute for Family Planning, Beijing, China Chandindrami Handagama, University of Tennessee, Knoxville, TN, USA Russell Jones, The University of Newcastle, New South Wales, Australia Maria Cristina Meriggiola, University of Bologna, Bologna, Italy Nukman Moeloek, University of Indonesia, Jakarta, Indonesia Zvi Naor, Tel-Aviv University, Ramat Aviv, Israel Ove Nilsson, Uppsala University, Uppsala, Sweden Anthony Tan, University of Indonesia, Jakarta, Indonesia Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 5 50 5 50 10 Women 2 20 2 from: AFRO AMRO 1 10 1 EMRO EURO 1 10 3 30 4 SEARO 3 30 3 WPRO 1 10 1 10 2 Other scientists Elisabetta Baldi, University of Florence, Florence, Italy Hermann Behre, International Society of Andrology, Halle, Germany Richard Blye, National Institute of Child Health and Human Development, Bethesda, MD, USA Cheng Li-Fa, Henan Family Planning Research Institute, Henan, China Antonietta Costantino, S. Orsola Hospital, Bologna, Italy Patricia Cuasnicu, Institute of Biology and Experimental Medicine, Buenos Aires, Argentina Gustavo Doncel, CONRAD, Norfolk, VA, USA Ralph Heywood, Huntingdon Life Sciences, Huntingdon, United Kingdom Li Han-Min, Birth-Control Institution, Guizhou, China Liang Xiaowei, National Research Institute for Family Planning, Beijing, China Lin Peng, Yunnan Family Planning Research Institute, Yunnan, China Michaela Luconi, University of Florence, Florence, Italy Sabrina Ritchie, American Society of Andrology, Walnut Creek, MN, USA Song Shu-Xiu, Hebei Family Planning Research Institute, Hebei, China Tong Jian-Sun, Jiangsu Family Planning Institute, Jiangsu, China Gerhard van der Horst, University of the Western Cape, Bellville, South Africa Donald Waller, College of Pharmacy, Chicago, IL, USA Ronald Weiss, University of Ottawa, Ottawa, Ontario, Canada Wen Ren-Qian, Family Planning Research Institute, Guandong, China Xiao Hong, Asian Journal of Andrology, Shanghai, China Yao Kang-Shou, Zhejiang Institute of Planned Parenthood Research, Zhejiang, China A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 44 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 45 Kathryn Yount, Emory University, Atlanta, GA, USA Yu Guobin, Anhui Family Planning Institute, Anhui, China Zhao Heng, National Research Institute for Family Planning, Beijing, China Annex 2d (continued) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 13 54 11 46 24 Women 2 8 5 21 7 from: AFRO 1 4 1 AMRO 1 4 6 25 7 EMRO EURO 5 21 5 SEARO WPRO 11 46 11 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 44 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 45 Annex 2e RESEARCH GROUP ON NATURAL REGULATION OF FERTILITY Scientists in 2002 Stan Becker, Johns Hopkins University, Baltimore, MD, USA Shakuntala Bhatnagar, National Institute of Health and Family Welfare, New Delhi, India Len Blackwell, Massey University, Palmerston North, New Zealand James Brown, Royal Women’s Hospital, Melbourne, Australia Hernan Delgado, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala Kathy Kennedy, Denver, CO, USA Pablo Lavin, University of Chile, Santiago, Chile Nicholas Mascie-Taylor, University of Cambridge, Cambridge, United Kingdom Cui Nian, Sichuan Family Planning Research Institute, Chengdu, China Chandrika Subasinghe, The Family Planning Association of Sri Lanka, Colombo, Sri Lanka Kamani Tennekoon, University of Colombo, Colombo, Sri Lanka Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 6 55 5 45 11 Women 4 36 1 9 6 from: AFRO AMRO 2 18 2 18 4 EMRO EURO 1 9 1 SEARO 3 27 3 WPRO 1 9 2 18 3 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 46 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 47 Annex 2f WHO/ROCKEFELLER FOUNDATION INITIATIVE ON IMPLANTATION RESEARCH Scientists in 2002 Principal investigators Peter Kaufmann, University of Aachen, Aachen, Germany Liu Yi-Xun, State Key Laboratory of Reproductive Biology, Institute of Zoology, Beijing, China Lois Salamonsen, Prince Henry’s Institute of Medical Research, Clayton, Australia Jayasree Sengupta, All India Institute of Medical Sciences, New Delhi, India Stephen Smith, The Rosie Maternity Hospital, Cambridge, United Kingdom Richard Stouffer, Oregon Regional Primate Research Center, Beaverton, OR, USA Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 2 33 4 67 6 Women 1 17 1 17 2 from: AFRO AMRO 1 17 1 EMRO EURO 2 33 2 SEARO 1 17 1 WPRO 1 17 1 17 2 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 46 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 47 Annex 3a RESEARCH GROUP ON POST-OVULATORY METHODS FOR FERTILITY REGULATION Publications in 2002 Brown A, Cheng L, Lin S, Baird DT. Daily low-dose mifepristone has contraceptive potential by suppressing ovulation and menstruation: a double-blind randomized control trial of 2 and 5 mg per day for 120 days. Journal of Clinical Endocrinology and Metabolism, 2002, 87:63–70. Trussell J, Ellertson C, von Hertzen H, Bigrigg A, Webb A, Evans M, Ferden S, Leadbetter C. Estimating the effectiveness of emergency contraceptive pills. Contraception, 2003, 67:259–265. UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduc- tion. Task Force on Post-ovulatory Methods of Fertility Regulation. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. The Lancet, 2002, 360:1803–1810. Xiao BL, von Hertzen H, Zhao H, Piaggio G. A randomised double blind comparison of two single doses of mifepristone for emergency contraception. Human Reproduction, 2002, 12:3084–3089. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 48 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 49 Annex 3b RESEARCH GROUP ON LONG-ACTING SYSTEMIC AGENTS FOR FERTILITY REGULATION Publications in 2002 Long-acting methods of fertility regulation Brache V, Faundes A, Alvarez F, Cochon L. Nonmenstrual adverse events during use of implantable contraceptives for women: data from clinical trials. Contraception, 2002, 65:63–74. Cekan SZ. A dedicated External Quality Assessment system for immunoassays of reproductive hormones. Accreditation Qual- ity Assurances, 2002, 7:73–76. Chikamata DM, Miller S. Health services at the clinic level and implantable contraceptives for women. Contraception, 2002, 65:97–106. Croxatto H. Progestin implants for female contraception. Contraception, 2002, 65:15–19. Croxatto H. Mechanisms that explain the contraceptive action of progestin implants for women. Contraception, 2002, 65: 21–27. Curtis KM. Safety of implantable contraceptives for women: data from observational studies. Contraception, 2002, 65:85–96. d’Arcangues C, Vogelsong K. Recent advances in family planning methods. Archives of Ibadan Medicine, 2002, 3:6–9. Diaz S. Contraceptive implants and lactation. Contraception, 2002, 65:39–46. Dorflinger L. Metabolic effects of implantable steroid contraceptives for women. Contraception, 2002, 65:47–62. Glasier A. Implantable contraceptives for women: effectiveness, discontinuation rates, return of fertility and outcome of preg- nancies. Contraception, 2002, 65:27–37. Hickey M, d’Arcangues C. Vaginal bleeding disturbances and implantable contraceptives. Contraception, 2002, 65:75–84. Jordan A. Toxicology of progestogens of implantable contraceptives for women. Contraception, 2002, 65:3–8. Meirik O, Fraser IS, d’Arcangues C for the WHO Consultation on Implantable Contraceptives for Women. Implantable contra- ceptives for women. Human Reproduction Update, 2003, 9(1):1–11. Ortayli N. Users’ perspectives on implantable contraceptives for women. Contraception, 2002, 65:107–111. Petta CA, Hays M, Brache V, Massai R, Yang H, Alvarez-Sanchez F et al. Delayed first injection of the once-a-month inject- able contraceptive containing 25 mg of medroxyprogesterone acetate and 5 mg of E2-cypionate: effects on cervical mucus. Contraception, 2001, 64:363–368. Shastri P. Toxicology of polymers of implantable contraceptives for women. Contraception, 2002, 65:9–13. Sivin I, Moo-Young A. Recent developments in contraceptive implants at the Population Council. Contraception, 2002, 65: 113–119. Basic research on endometrial bleeding Gargett C, Rogers PAW. Human endometrial angiogenesis. Reviews in Reproduction, 2001, 121:181–186. Gargett C, Weston G, Rogers PAW. Mechanisms and regulation of endometrial angiogenesis. Reproductive Medicine Review, 2002, 10:45–61. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 48 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 49 Salamonsen LA, Zhang J, Brasted M. Leukocyte networks and human endometrial remodelling. Journal of Reproductive Immu- nology, 2002, 57:95–108. Salamonsen LA, Zhang J, Vincent AJ. New insights into the mechanisms underlying menstruation and abnormal uterine bleeding. In: Maruo T, Barlow D, Mardon H, eds. Proceedings of Kobe Institute symposium “Cell and molecular biology of endometrium in health and disease”. Osaka, SOEISHA, 2002:171–183. Vincent AJ, Zhang J, Ostor A, Rogers PAW, Affandi B, Kovacs G, Salamonsen LA. Decreased tissue inhibitor of metallo- proteinase in the endometrium of women using depot medroxyprogesterone acetate: a role for altered endometrial matrix metalloproteinase/tissue inhibitor of metalloproteinase balance in the pathogenesis of abnormal uterine bleeding? Human Reproduction, 2002, 17(5):1189–1198. Weston G, Lederman F, Vollenhoven B, Rogers PAW. Progesterone effects on uterine vasculature: an in vitro model. IFFS 17th World Congress, Melbourne, Australia, 25–30 November 2001:55. Weston GC, Rogers PAW. Endometrial angiogenesis. In: Smith S, ed. Best Practice and Research Clinical Obstetrics and Gynaecology (part of the Bailliere’s Best Practice and Research Series). Harcourt Publishers, 2000, 14(6):919–936 (ISSN 1521-6934 ). Annex 3b (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 50 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 51 Annex 3c RESEARCH GROUP ON METHODS FOR THE REGULATION OF MALE FERTILITY Publications in 2002 Ellerman DA, Busso D, Cohen DJ, Morgenfeld MM, De Ros VG, Cuasnicú P. Epididymal protein DE and sperm-egg interaction. In Epididymis III, Third International Conference on the Epididymis, Charlottesville, VA, USA, May 29–June 1, 2002, Abstract S13. Gu YQ, Zhang GY. Androgens alone for hormonal male contraception. In: Qian SZ, Handelsman DJ, Waites GMH, eds. Pro- ceedings and programme of the first Asia-Pacific forum on andrology. Asian Journal of Andrology, 2002, 4(Supplement):32–33, Abstract S8-1. Luconi M, Bonaccorsi L, Forti G, Baldi E. Nongenomic progesterone receptors in human spermatozoa. Journal of Andrology, 2002, March/April Supplement Program and Abstracts of 27th Annual Meeting, April 24–27, 2002, Seattle, Washington. Luconi M, Bonaccorsi L, Bini L, Liberatori S, Pallini V, Forti G, Baldi E. Characterization of membrane nongenomic receptors for progesterone in human spermatozoa. Steroids, 2002, 67:505–509. Moeloek N, Pujianto DA, Agustin R, Arsyad KM, Waluyo P, Prihyugiarto Y, Mbizvo MT. Achieving azoospermia by injections of testosterone undecanoate alone or combined with depot medroxyprogesterone acetate in Indonesian men (Jakarta center study). In: Robaire B, Chemes H, Morales CR, eds. Andrology in the 21st century. Proceedings of the VIIth International Con- gress of Andrology. New Jersey, Medimond Publishing Company Inc., 2001:545–550. O’Connor DB, Archer J, Hair WM, Wu FCW. Exogenous testosterone, aggression, and mood in eugonadal and hypogonadal men. Physiology and Behavior, 2002, 75:557–566. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 50 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 51 Annex 3d RESEARCH GROUP ON NATURAL REGULATION OF FERTILITY Publications in 2002 Bhatnagar S for the WHO Task Force on Methods for the Natural Regulation of Fertility. Infant feeding paterns and lactational amenorrhoea in New Delhi. International Journal of Public Health (submitted). Blackwell LF, Brown JB, Vigil P, Gross B, Sufi S, d’Arcangues C. Home definition of the potentially fertile and infertile phases of the human ovulatory cycle by the home Ovarian Monitor, Part I. Correlation of results obtained by the ovarian monitor and those obtained by radioimmunoassay. Steroids (in press). Blackwell LF, Brown JB. Hormonal monitoring of ovarian activity using the Ovarian Monitor, Part II. Characteristics of the normal menstrual cycle (submitted). Blackwell LF, Brown JB, d’Arcangues C, Van Look PFA, Vigil P, Perez A, Gross B. Hormonal monitoring of ovarian activity using the Ovarian Monitor, Part III. Multicentre study of the hormonal definition of the fertile days of the cycle by home hormonal moni- toring for natural family planning. A comparison with the basal body temperature and cervical mucus symptoms (submitted). Cui N for the WHO Task Force on Methods for the Natural Regulation of Fertility. The impact of breastfeeding pattern on the duration of lactational amenorrhoea in Chengdu, China. Reproduction and Contraception, 2002, 13:98–109. Dada OA, Akesode FA, Olanrewaju DM, Olowu OA, Sule-Odu O, Fakoya TA, Oluwole FA, Odunlami BV for the WHO Task Force on Methods for the Natural Regulation of Fertility. Infant feeding and lactational amenorrhea in Sagamu, Nigeria. African Journal of Reproductive Health, 2002, 6:39–50. Gross A, Burger H for the WHO Task Force on Methods for the Natural Regulation of Fertility. Breastfeeding patterns and return to fertility in Australian women. Australian and New Zealand Journal of Obstetrics and Gynaecology, 2002, 42:148–154. Tennekoon KH. Maternal prolactin concentrations and lactation in the early postpartum period in women with lactational amen- orrhoea. Ceylon Medical Journal, 2001, 46:6–10. WHO Working Group on the Growth Reference Protocol and the WHO Task Force on Methods for the Natural Regulation of Fertility. Growth of healthy infants and the timing, type, and frequency of complementary foods. American Journal of Clinical Nutrition, 2002, 76:620–627. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 52 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 53 Annex 3e WHO/ROCKEFELLER FOUNDATION INITIATIVE ON IMPLANTATION RESEARCH Publications in 2002 Borges M, Bose P, Frank HG, Kaufmann P, Pötgens AJG. Differential syncytial fusion behavior, measured by a two-colour fluorescence fusion assay of choriocarcinoma cell lines expressing the genes for syncytin and its putative receptor RDR (sub- mitted). Borthwick, JM, Charnock-Jones DS, Tom BD, Hull ML, Tierney R, Phillips SC, Smith SK. Determination of the transcript profile of human endometrium. Molecular Human Reproduction, 2003, 9:19–33. Chen XL, Gao HJ, Wei P, Song XX, Liu YX. Expression of transforming growth factor-beta and its receptor type-2 and their regulation by IFN gamma in the pregnant corpus luteum of rhesus monkey. Acta Pharmacologica Sinica (in press). Chen XL, Gao HJ, Wei P, Zhang ZH, Liu YX. Expression of Fas/FasL and BcL-2/Bax and their relationship to apoptosis in rat corpus luteum. Science in China (in press). Gao F, Fu GQ, Ma J, Peng W, Feng Q, Hu ZY, Liu YX. Expression of MMP-2, TIMP-1, -3 mRNAs in mouse placenta. Acta Zoologica Sinica, 2002, 48:227–232. Gao F, Pong W, Chen XL, Hu ZY, Liu YX. Apoptosis occurs in early stage of pregnancy. Contraception, 2002, 64:193–200. Gao F, Pong W, Chen XL, Zhang ZH, Liu YX. Relationship between uterine expression of matrix metalloproteinases and their inhibitors and endometrial receptivity. Science in China (Series C), 2002, 45:406–411. Hastings JM, Licence DR, Burton GJ, Charnock-Jones DS, Smith SK. Soluble vascular endothelial growth factor receptor 1 inhibits edema and epithelial proliferation induced by 17-estradiol in the mouse uterus. Endocrinology, 2003, 144:326–334. Hazzard TM, Rohan RM, Molskness TA, Fanton JW, d’Amato RJ, Stouffer RL. Injection of antiangiogenic agents into the macaque preovulatory follicle. Endocrine Reviews, 2002, 17:199–206. Hazzard TM, Xu FH, Stouffer RL. Injection of soluble vascular endothelial growth factor receptor 1 into the preovulatory follicle disrupts ovulation and subsequent luteal function in Rhesus monkeys. Biology of Reproduction, 2002, 67:1305–1312. Martoglio-Schofield A-MM, Miskin JW, Smith SK, MacKay DJC. A decomposition model to track gene expression signatures: preview on observer-independent classification of ovarian cancer. Bioinformatics, 2002, 18:1617–1624. Nie GY, Hampton AL, Fu GQ, Liu YX, Findlay JK, Salamonsen LA. A potential molecular mechanism for regulating pre-mRNA splicing of implantation related genes through unique uterine expression of splicing factor SC35 in women and rhesus mon- keys. Reproduction, 2002, 124:209–217. Nie GY, Hampton YA, Li Y, Findlay JK, Salamonsen LA. Identification and cloning of two isoforms of human HtrA3, characteri- sation of its genomic structure and comparison of its tissue distribution with HtrA1 and HtrA2. Biochemical Journal, 2003, 371: 39–48. Nie GY, Li Y, Minoura H, Findlay JK, Salamonsen LA. Specific and transient up-regulation of proprotein convertase 6 (PC6) at the site of embryo implantation and identification of a unique transcript in mouse uterus during early pregnancy. Biology of Reproduction, 2003, 68:439–447. Nie GY, Li Y. Minoura H, Batten L, Ooi GT, Findlay JK, Salamonsen LA. A novel serine protease of the mammalian HtrA family is up-regulated in mouse uterus coinciding with placentation. Molecular Human Reproduction, 2003, 9:1–11. Pötgens AJG, Schmitz U, Bose P, Versmold A, Kaufmann P, Frank HG. Mechanisms of syncytial fusion: an overview. Placenta, 2002, 23:S107–S113. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 52 A n n u al Tech n ical R ep ort 2002 Development of improved and new methods of fertility regulation 53 Salamonsen LA, Dimitriadis E, Jones RL, Nie GY. Complex regulation of decidualization: a role for cytokines and proteases. Trophoblast Research (in press). Salamonsen LA, Nie GY, Findlay JK. Newly identified endometrial genes of importance for implantation. Journal of Reproduc- tive Immunology, 2002, 53:215–225. Salamonsen LA, Nie GY. Proteases at the endometrial-trophoblast interface: their roles in implantation. Reviews in Endocrine and Metabolic Disorder, 2002, 3:133–143. Sengupta J, Dhawan L, Lalitkumar PGL, Ghosh D. A multiparametric study of the action of mifepristone used in emergency contraception using the rhesus monkey as a primate model. Contraception (in press). Sengupta J, Ghosh D. Blastocyst–endometrium interaction at implantation in the rhesus monkey. Journal of Reproductive Immunology, 2002, 53:227–239. Sengupta J, Ghosh D. Experimental models for human implantation. In: Acosta AA, ed.12th World Congress on In Vitro Fertil- ization and Molecular Reproduction. Monduzzi Editore, S.p.A, International Publications Division, 2002:69–77. Sengupta J, Ghosh D. Experimental models for human implantation. Indian Journal of Physiology and Pharmacology, 2003, 47(1):10–26. Wei P, Zhang ZH, Chen XL, Liu YX. Expression and function of AA98, a newly found vascular endothelial cell related factor, in the maternal-embryonic boundary of rhesus monkey implantation site. Chinese Science Bulletin (in press). Annex 3e (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 54 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 55 Safety and effectiveness of existing methods of fertility regulation T.M.M. Farley and J. Schmidt INTRODUCTION Most of the information on the safety and clinical perform- ance of methods of fertility regulation is generated in developed countries and it is not necessarily appropriate to extrapolate to developing countries. The health and social situations are very different and there may be different inter- actions with endemic conditions. To address these issues, the Programme carries out research on the safety and effec- tiveness of existing methods of fertility regulation by review- ing the existing evidence and building the evidence base on the safety and performance of fertility regulating methods in developing countries. Clinical trials leading to product reg- istration are conducted under ideal conditions with carefully screened and monitored volunteers. These may not reflect what happens when the products are made available to a wider population of users, and observational epidemiologi- cal methods must be used to study safety and effectiveness under actual conditions of use. The evidence forms the basis for the development and promotion of norms, guidelines and training materials for the use of different methods of fertil- ity regulation and for the development of high-quality family planning services. Progress in those areas is summarized in other chapters in the section on Promoting family planning. Objectives The overall objectives of the work on the safety and effec- tiveness of existing methods of fertility regulation are: (i) to collect evidence on the safety and effectiveness of differ- ent methods of contraception among women and men in developing countries; and (ii) to address priority unanswered questions on existing methods of fertility regulation when used in developing countries. RESEARCH ACTIVITIES Progress Breast cancer and breastfeeding The Programme supported The Collaborative Group on Hormo- nal Factors in Breast Cancer in compiling individual patient data from epidemiological studies of breast cancer. The database includes more than 50 000 cases of breast cancer and almost 100 000 women without the disease. The relationships between breast cancer and hormonal contraception, hor- mone replacement therapy and family history have been investigated. A new analysis addressed the impact of breast- feeding and its duration on breast cancer risk. Data on 50 302 women with breast cancer and 96 973 controls from 47 studies in 30 countries were used. Women with breast cancer had, on average, fewer births than con- trols (2·2 vs. 2·6). Furthermore, fewer parous women with cancer than parous controls had ever breastfed (71% vs. 79%), and their average lifetime duration of breastfeed- ing was shorter (9·8 vs. 15·6 months). The relative risk of breast cancer decreased by 4·3% (95% confidence interval 2·9–5·8; p<0·0001) for every 12 months of breastfeeding. There was a decrease of 7·0% (5·0–9·0; p<0·0001) for each birth. The size of the decline in the rela- tive risk of breast cancer associated with breastfeeding did not differ significantly for women in developed and develop- ing countries, and did not vary significantly by age, meno- pausal status, ethnic origin, the number of births a woman had, nor her age when her first child was born. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 54 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 55 It was estimated that the cumulative incidence of breast cancer in developed countries would be reduced by more than half, from 6·3 to 2·7 per 100 women by age 70, if women had the average number of births and lifetime duration of breastfeeding that had been prevalent in developing coun- tries until recently. Breastfeeding could account for almost two-thirds of this estimated reduction in breast cancer inci- dence. The lack of or short lifetime duration of breastfeed- ing typical of women in developed countries makes a major contribution to the high incidence of breast cancer in these countries. Bone mineral density and progestogen-only contraception Worldwide, over 20 million women are estimated to be currently using progestogen-only contraceptives, including injectables, implants, vaginal rings, the levonorgestrel- releasing intrauterine device and oral preparations. Con- cerns have been raised that progestogen-only preparations can decrease bone mineral density and thus increase sub- sequent risk of osteoporotic fracture. It is unclear whether any decrease noted with current use of progestogen-only contraception is transient or persists. Investigators at the Reproductive Health Research Unit, Durban, South Africa, are conducting a prospective study of the impact of progestogen-only contraception among women in the age ranges 15–19 years and 42–49 years. The younger age group covers the period of maximal bone mass acquisition, and any decrease caused by progestogen- only contraception may affect the peak bone mass achieved. In the older age group, a transient decrease in bone mass with progestogen-only contraception may result in a woman starting her menopause-related decline in bone mass from a lower level. The study has completed recruitment of at least 100 women in each of eight subgroups: depot-medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN), combined oral contraceptive (OC), and non-hormonal method users in each of the two age groups. Most young women in South Africa are given the two-monthly injectable NET-EN, so it was difficult to identify young DMPA users. All women are being followed at six monthly intervals up to five years. Among the younger women, body weight increased by about 2% over one year in all groups, with a greater increase among the combined OC users. There was a slight decline in bone mineral density among the OC users and an increase among the other groups. However, the differences were not significant after adjustment for difference in body weight. Interpretation of these data is difficult since there are large ethnic differences in the composi- tion of the hormonal method user groups. Long-term safety and effectiveness of copper intrauterine devices Up to 240 million women worldwide use intrauterine devices (IUDs) as their preferred method of family planning. IUDs have the advantage of being long-acting and relatively easy to remove, with a rapid return of fertility upon removal. The demonstration of their long-term safety and efficacy is an important aspect of the work of the Programme. The long-term follow-up of cohorts of women using the copper-releasing TCu 380A device continued. In the period Figure 1.2. Cumulative intrauterine and ectopic pregnancy rates by device (interim data, cut off July 2002) Intrauterine ML 375 Intrauterine TCu380A Ectopic ML 375 Ectopic TCu380A R at e (% ) Time since insertion (years) A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 56 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 57 1989 to 1998 a total of 5953 women had this device inserted as part of Programme-sponsored randomized trials compar- ing the safety and effectiveness of different devices. The majority of the insertions took place in the period 1990–1991. The first large cohort of users completed 10 years of use at the end of 2001, and over 500 are expected to have com- pleted 12 years of use by the end of 2002. The Programme will continue to follow users up to 15 years from insertion, thus providing unique information on long-term contraceptive safety and efficacy of this device. Previous data from the Pro- gramme’s research have been used to progressively extend the approved life span of the device from the initial three to ten years. It is anticipated that the 12 and 15 year data will be used to extend the approved life span even further. The randomized comparative study of the TCu 380A and the Multiload (ML) 375 copper-releasing device started in the early 1990s, and the interim 10-year results are shown in Table 1.3 Both devices are highly effective in prevent- ing pregnancy and have similar overall continuation rates, although the intrauterine pregnancy rate with the TCu 380A is about half the rate of the ML 375 device at all times since insertion (Figure 1.2). There were few ectopic pregnancies, none of which occurred beyond the fifth year of use. Just over half (54%) the women taking part in the trial are in China. These women had an overall continuation rate of 55 per 100 after 10 years of use compared with only 15 per 100 among women from the other countries (Table 1.4). The pregnancy rates with both devices were higher among women in China than in the other countries, consistent with observations from previous multinational research on IUDs conducted by the Programme. Clinical performance of the levonorgestrel-releasing intrauterine device The clinical performance of the 20 µg/day levonorgestrel (LNG)-releasing IUD (Mirena) compared with the TCu 380A device is being assessed in a multicentre study involving a total of 3815 insertions. The interim results six years after insertion are presented in Table 1.5. The pregnancy rate for the LNG device is significantly lower than for the TCu 380A, but there is a high rate of device removal for menstrual related reasons, in particular amenorrhoea, with the LNG- releasing device. The overall continuation rate at six years was 42.7 per 100 women for the LNG device and 68.5 per 100 women for the TCu 380A. HIV and steroid contraception To assess the impact of different contraceptive methods on the clinical course of human immunodeficiency virus (HIV) infection, the Programme is sponsoring a multicentre study in Brazil, Kenya, Thailand and Zimbabwe. Women with HIV infection are invited to participate in an observational cohort study with six-monthly follow-up visits for four years. Study endpoints include HIV disease progression, the incidence of opportunistic infections, and changes in CD4+ cell counts. These will be analysed according to the contraceptive meth- ods used. By November 2002, 372 women had been enrolled in Bang- kok (Thailand), Harare (Zimbabwe) and Nairobi (Kenya). Recruitment to the study was not possible in Brazil since few patients had CD4+ counts of at least 500 cells/mm3 and antiretroviral therapy (ART) is available nationally for Table 1.3. Cumulative net probabilities (standard error) of discontinuation and continuation rates per 100 women at 10 years of use (interim data, cut off July 2002) TCu 380A Multiload 375 P-value Total pregnancy 3.4 (0.5) 5.3 (0.7) 0.029 - Ectopic pregnancy 0.8 (0.3) 0.1 (0.1) 0.011 - Intrauterine pregnancy 2.7 (0.5) 5.2 (0.7) 0.002 Expulsions 11.2 (1.0) 14.8 (1.2) 0.023 Total medical removals 29.9 (1.4) 28.9 (1.5) 0.80 - Pelvic inflammatory disease 0.4 (0.2) 0.5 (0.2) 0.82 Loss to follow-up 12.7 (1.0) 12.2 (1.1) 0.72 Continuation rate 40.1 (1.3) 37.4 (1.3) 0.14 Woman–years 10,164 10,014 Number of women completing interval 291 271 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 56 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 57 all patients. The majority of women enrolled use hormonal contraception (primarily DMPA in Nairobi and combined OCs in Harare). Non-hormonal methods are used by 25% of the study cohort. Recruitment will continue to the end of 2003. The rates of CD4 decline are much steeper in Bangkok and Harare than in Nairobi (Figure 1.3), possibly reflecting the impact of different HIV subtypes. As a result of increasing access to sustainable ART in the study sites, the protocol is being modified to introduce ART in a structured way to women in the cohort as they become eligible for therapy. This will permit a preliminary assessment of differences in clinical response to ART by type of hormonal contraception. HIV and vaginal epithelium Progestogen-only contraception has been associated with increased susceptibility to HIV infection. In a study in Umeå, Sweden, to assess the impact of different contraceptive methods on the vaginal epithelium, vaginal biopsies were taken from 15 women using combined OCs, DMPA or Norplant, and from 15 women not using hormonal contra- ception. The vaginal epithelium was thicker in all hormonal contraceptive user groups compared with controls and exhibited a distended hyperplastic superficial layer. The fre- quency of intraepithelial vaginal leukocytes was increased in DMPA users compared with controls; a marginal comparitive increase was seen in the Norplant users, and no increase in combined OC users. This difference may reflect a higher frequency of subclinical infections in DMPA users, or behav- ioural differences between women using the different meth- ods. Full results are expected in 2003. New projects initiated during the year Randomized trial of two implantable contraceptives for women The first paper on a progestogen-releasing contraceptive implant was published in 1969. The first implant, Norplant, was approved in 1983 by the Finnish drug regulatory author- ity. Norplant is now registered in over 60 countries, and an estimated 11 million women worldwide have used the method. Several newer implant systems releasing differ- ent synthetic progestogens have been developed or are under development. Because of the increasing importance of implantable contraceptives for women, the Programme convened an expert consultation on these methods in May 2001. The background papers prepared for this consultation were published in 2002, in the journal Contraception (see page 48). The most extensive data on safety and effectiveness cover the six-capsule levonorgestrel-releasing Norplant device. There have been reports of difficult and time-consuming Table 1.4. Cumulative net probabilities (standard error) of discontinuation and continuation rates per 100 women at ten years of use (interim data, cut off July 2002) Chinese centres Non-Chinese centres TCu 380A ML 375 TCu 380A ML 375 Total pregnancy 4.0 (0.7) 6.7 (0.9) 2. 1 (0.6) 2.1 (0.6) - Ectopic pregnancy 0.9 (0.4) 0.1 (0.1) 0.3 (0.2) - - Intrauterine pregnancy 3.1 (0.5) 6.6 (0.9) 1.8 (0.6) 2.1 (0.6) Expulsions 11.4 (1.2) 16.3 (1.4) 9.9 (1.8) 9.8 (1.6) Total medical removals 20.1 (1.5) 17.5 (1.6) 52.0 (3.3) 53.8 (3.3) - Pelvic inflammatory disease - - 1.6 (1.2) 1.6 (0.8) Loss to follow-up 5.9 (0.9) 6.8 (1.1) 25.9 (2.7) 21.8 (2.6) Continuation rate 57.5 (1.7) 52.8 (1.8) 14.9 (1.6) 15.2 (1.6) Woman–years 6780 6672 3365 3343 Number of women completing interval 238 214 53 57 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 58 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 59 removals. Implants with fewer units have been developed, including the two-rod 5-year levonorgestrel-releasing Jadelle and the 3-year single-rod etonogestrel-releasing Implanon. While Jadelle has been compared with Norplant in a moder- ately sized multinational study, and Implanon with Norplant in a single-country study, there have been no formal compari- sons between the two newer devices. The Programme is implementing a multinational randomized comparative trial of Jadelle and Implanon to determine dif- ferences in clinical performance and contraceptive efficacy. Primary endpoints include pregnancy rates, incidence of adverse effects, method acceptability and continuation rates. A total of 2000 women will be enrolled and randomly assigned to use one of the two implants. While non-repro- ductive system complaints such as headache, dizziness, skin alterations and mood changes are commonly associ- ated with progestogen-only implants, their interpretation is difficult. Therefore, in addition to the implant users, an age- matched cohort of 1000 women who use the TCu 380A IUD will be enrolled in parallel with the randomized study. These women will provide data on the incidence of non-reproduc- tive system complaints in users of a non-hormonal method in order to place the observations from the implant users in context. Ten sites in nine countries are participating: Australia, Brazil, Chile, China (Beijing and Shanghai), Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Preparations for the trial are almost complete and recruitment will start in early 2003 and last up to one year. Final results on the key study end- points three years after insertion will be available in early 2007. Structural integrity of female condoms The high cost of the female condom limits its widespread use. Reuse has been reported by women unable to afford or access an adequate supply of female condoms. WHO convened a consultation in January 2002 to review data on the safety and practicality of reuse (see also page 60) during which the question of the impact of different potential lubricants on the structural integrity of the female condom was raised. There is limited choice of lubricants available to female condom users. In studies conducted to date, corn oil has been used to relubricate the condoms but it is not known whether this or other potential lubricants have any deleteri- ous effect on the condoms. A study was undertaken to screen a wide range of potential lubricants, including two often used as sexual lubricants (Vaseline and Baby Oil), eleven com- monly available household oils (sunflower, olive, corn, coco- nut, rape seed, palm, grape seed, mustard, groundnut), two fats (lard and shortening) and Canestan Cream (a vaginal antifungal ointment). Sections of polyurethane film were cut from a single roll and soaked for four days with each lubricant. No samples showed any deterioration in tensile strength compared with controls. The only exception was Canestan Cream, which resulted in a 10% drop in tensile strength, most probably caused by one of the excipients. This decrease is unlikely to affect adversely the female condom in normal use. Table 1.5. Cumulative net probabilities of discontinuation (standard error) per 100 women at six years of use (interim data, cut off August 2002) TCu 380A 20 µg LNG device P-value Total pregnancy 2.0 (0.4) 0.5 (0.2) 0.001 - Ectopic pregnancy 0.1 (0.1) - 0.002 - Intrauterine pregnancy 1.8 (0.4) 0.5 (0.2) 0.162 Expulsions 8.3 (0.8) 7.6 (0.8) 0.52 Pelvic inflammatory disease 0.1 (0.1) 0.3 (0.1) 0.29 Menstrual reasons 11.0 (0.9) 35.8 (1.4) < 0.001 - Amenorrhoea 0.5 (0.3) 23.5 (1.3) < 0.001 - Reduced bleeding 3.1 (0.5) 10.9 (1.0) < 0.001 - Increased bleeding 7.2 (0.7) 5.4 (0.7) 0.085 Total device-related removals 25.6 (1.2) 47.8 (1.3) < 0.001 Loss to follow-up 7.7 (0.7) 5.5. (0.7) 0.029 Woman–years 7334 6308 Number completing interval 580 464 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 58 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 59 Figure 1.3. Decline in CD4+ cell counts (cells/mL) by centre Given the wide range of oils tested it is highly probable that any vegetable oil will be compatible with the female condom and further testing is unnecessary. Of greater concern is the potential for certain lubricants to adversely affect the vagina or penis during intercourse. NORMS AND TOOLS Specifi c objectives and targets Work on the development and dissemination of norms and tools is reported in the chapter on Norms and guidelines for use of methods of fertility regulation, but specifi c activities undertaken under the umbrella of the work on safety and effectiveness of contraceptive methods are reported here. The relationship between hormonal contraceptives and cervical cancer, and the safety of female condom reuse are reviewed. New norms and tools developed Cervical cancer and steroid hormone contraception The question of whether the use of OCs is causally asso- ciated with an increased risk of cervical cancer has been highly controversial. A WHO scientifi c group concluded in 1990, as part of a comprehensive review of hormonal con- traception and cancer, that use of OC for more than 5 years was associated with a modest (1.3- to 1.8-fold) increase in the risk of cervical cancer. However, it was unclear whether that risk refl ected a biological relationship or was attributable to other factors, such as differences in lifestyle between contraceptive method users, or patterns of sexually trans- mitted infections (STIs), particularly with human papilloma virus (HPV). New results published in early 2002 showed that among women who tested positive for HPV infection, those who had used hormonal contraceptives for between 5 and 9 years had a 2.8-fold increased risk of cervical cancer, while women who had used hormonal contraception for 10 or more years had a 4-fold increased risk. In order to put these new results in a public health perspective, and in the context of evidence from other research regarding the relationship between cervical cancer and hormonal contraception, the Programme convened a consultation in March 2002. Persistent infection with specifi c HPV types is now recog- nized to be the underlying cause of cervical cancer. However, since few women with HPV infection (a common, transient viral infection) ever develop cervical cancer, other factors such as smoking and high parity, are also considered impor- tant. Since 1990, studies have shown an increased risk of carcinoma in situ and invasive carcinoma in long-term users of combined OCs. The increased risk appears to be confi ned to women with persistent HPV infection and is thought to be about twice as high after long-term use (5 years or more) of combined OCs. The consultation recommended no changes in contraceptive prescribing practice or use. The number of cervical cancers that result from OC use is likely to be very small. All contra- ceptive methods, including OCs, carry health risks as well as benefi ts. For young, healthy women who do not smoke, the health benefi ts of OCs far exceed the risks. Many cases of cervical cancer are preventable through use of appropriate screening practices. Where screening services are available, OC users should use them in the same way as other women. However, in many settings screening services are not avail- able; pregnancy-associated morbidity and mortality risks are often high in such settings and combined OCs are one of the 700 500 300 Adm 6m 12m 18m Total Nairobi Harare Bangkok Time C D 4+ (c el ls /m L) A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 60 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 61 few contraceptive methods widely available. Furthermore, since parity is a risk factor for cervical cancer, use of OCs may reduce the risk of cervical cancer attributable to parity. The consultation concluded that women should not be denied use of OCs simply because they do not have access to cervi- cal cancer screening services. In such settings the risk asso- ciated with unwanted pregnancy would likely exceed the risk of cervical cancer for the majority of women. Female condom reuse The high cost of the female condom is a barrier to its wide- spread use. Reuse has been reported by women who cannot afford or have inadequate access to female condoms. The Programme has sponsored research on the practicality and safety of reuse practices in order to provide guidance to programme managers and potential users, and convened a consultation on reuse in June 2000. Following this consulta- tion, new research was initiated on whether female condoms could withstand repeated bleach disinfection, washing and drying, on the minimum bleach disinfection required to inactivate STIs, and on the impact on the vagina of reusing disinfected female condoms. The new data were reviewed at a second consultation in January 2002. The 2002 consultation revised and simplified the previous protocol on bleach disinfection, washing and drying, and rec- ommended that used female condoms be soaked for a period of 2–5 minutes in a bleach solution of 1:19 household bleach to water (0.25% sodium hypochlorite solution) before further handling. They also recommended that individual female condoms be used no more than five times. A final reuse pro- tocol was issued for adaptation to local conditions. This pro- tocol must be demonstrated to be understandable and safe to apply before female condom reuse can be recommended and promoted in different settings. In many contexts, reuse of the female condom could expose both the woman and her male partner to more risks, particularly if reuse undermined confidence in female condoms, and/or resulted in less use of male condoms or fresh female condoms. In some contexts, promoting reuse may result in more protected acts of inter- course, while in others a reuse protocol would be impossible to apply safely. Decisions about the utility and risks and benefits of introducing a female condom reuse protocol must ultimately be made at the country or local level. WHO issued a statement in July 20021 on the conclusions of the consultation and is developing guidelines on specific practical issues to be considered by programme managers who intend to evaluate the feasibility and applicability of female condom reuse in particular settings. 1WHO information update: considerations regarding reuse of the female condom. Available online at: http://www.who.int/reproductive- health/rtis/reuse.en.html A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 60 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 61 Annex 1 SPECIALIST PANEL FOR EPIDEMIOLOGICAL RESEARCH IN REPRODUCTIVE HEALTH Members Valerie Beral, Radcliffe Infirmary, Oxford, United Kingdom Michel Boulvain, Hôpital Universitaire de Genève, Geneva, Switzerland Tsungai Chipato, University of Zimbabwe, Harare, Zimbabwe Patricia Claeys, International Centre for Reproductive Health, Ghent, Belgium Maria del Carmen Craviotto, National Institute of Nutrition, Mexico City, Mexico Gao Ersheng, Shanghai Institute of Planned Parenthood Research, Shanghai, China Phil Hannaford, University of Aberdeen, Aberdeen, United Kingdom Carlo La Vecchia, Instituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy Olav Meirik, Instituto Chileno de Medicina Reproductiva, Santiago, Chile Megan Passey, Southern Cross Institute of Health Research, Lismore, Australia David Skegg, University of Otago, Dunedin, New Zealand (Chairman) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 4 36 7 64 11 Women 1 9 3 27 4 from: AFRO 1 9 1 AMRO 2 18 2 EMRO EURO 5 45 5 SEARO WPRO 1 9 2 18 3 Collaborating agency scientists Ann Duerr, Centers for Disease Control and Prevention, Atlanta, GA, USA Silvia Franceschi, International Agency for Research on Cancer, Lyon, France Jennifer Smith, International Agency for Research on Cancer, Lyon, France Robert Spirtas, National Institute of Child Health and Human Development, Bethesda, MD, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 62 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 63 Annex 2 SCIENTISTS IN 2002 Principal investigators Ahmed Abdennadher, Office National de la Famille et de la Population, Tunis, Tunisia Ayşe Akin, Hacettepe University School of Medicine, Ankara, Turkey Simon Alexaniants, Armenian Centre of Maternal and Child Health Protection, Yerevan, Armenia Eliana Amaral, Universidade Estadual de Campinas, Campinas, Brazil Amaury Andrade, Federal University of Juiz de Fora, Juiz de Fora, Brazil Luis Bahamondes, Universidade Estadual de Campinas, Campinas, Brazil György Bártfai, Albert Szent-Györgyi Medical University, Szeged, Hungary Istvan Batár, University Medical School of Debrecen, Debrecen, Hungary Mags Beksinska, Reproductive Health Research Unit, Durban, South Africa Vivian Brache, Profamilia, Santo Domingo, Dominican Republic Cao Xiaoming, Tianjin Municipal Research Institute for Family Planning, Tianjin, China Chen Zhu ping, Ren Ji Hospital, Shanghai, China Cheng Junling, International Peace Maternity and Child Health Hospital, Shanghai, China Cheng Yimin, National Research Institute of Family Planning, Beijing, China Craig Cohen, University of Nairobi Health Science Campus, Nairobi, Kenya Brian Cox, University of Otago, Dunedin, New Zealand Oluwakayode Dada, Centre for Research in Reproductive Health, Sagamu, Nigeria Reinprayoon Damrong, Chulalongkorn Hospital, Bangkok, Thailand Fan Hui-min, Beijing Obstetrics and Gynaecology Hospital, Beijing, China Anibal Faundes, Centre for Research and Control of Maternal and Infant Disease, Campinas, Brazil Glenda Fehler, National Reference Centre for Sexually Transmitted Diseases, Johannesburg, South Africa Feng Zhuan-chong, Shanghai Institute of Planned Parenthood Research, Shanghai, China Marie-Louise Hammarström, Umeå University, Umeå, Sweden Ho Jialiang, Family Planning Institute of Guangdong, Guangzhou, China Jian Li, Beijing Obstetrics & Gynaecology Hospital, Beijing, China Kang Hong, Xuan Wu Hospital, Beijing, China Jonathan Kasule, University of Zimbabwe, Harare, Zimbabwe Orawan Kiriwat, Siriraj Hospital, Bangkok, Thailand Laszlo Kovacs, Albert Szent- Györgyi Medical University, Szeged, Hungary Pablo Lavin, Hospital Ramon Barros Luco-Trudeau, Santiago, Chile Liu Xiaozhang, Family Planning Research Institute of Sichuan, Chengdu, China Luo Lin, Family Planning Research Institute of Sichuan, Chengdu, China Luo Shi-yuan, Family Planning Research Institute of Sichuan, Chengdu, China Elsebeth Lynge, Institute of Public Health, University of Copenhagen, Denmark Alexio Mashu, University of Zimbabwe School of Medicine, Harare, Zimbabwe Rebeca Massai, Instituto Chileno de Medicina Reproductiva, Santiago, Chile Christina Mwachari, Kenya Medical Research Institute, Nairobi, Kenya Peng Dunren, Tianjin Municipal Research Institute, Tianjin, China Ernesto Pizarro, Hospital José Joaquin Aguirre, Santiago, Chile Alenka Pretnar-Darovec, Gynaecological Clinic, Ljubljana, Slovenia Qian Shao-zhen, Jiangsu Family Health Institute, Nanjing, China Atisook Ronachai, Siriraj Family Health Research Centre, Bangkok, Thailand Eyra Ruiz, Centro de Investigación en Reproducción Humana, Panama, Panama Veronica Schiappacasse, Instituto Chileno de Medicina Reproductiva, Santiago, Chile Inga Sjöberg, Umeå University, Umeå, Sweden Jaisamrarn Unnop, Chulalongkorn University, Bangkok, Thailand Patricia Valdes, University of Frontera, Temuco, Chile Wei Yuying, Family Planning Research Institute, Tong-ji Medical University, Wuhan, China Edith Weisberg, Ashfield, New South Wales, Australia Wu Shangchun, National Research Institute for Family Planning, Beijing, China Wu Yu-ming, Peking Union Medical College, Beijing, China Yang Xiulan, International Peace Maternity and Child Health Hospital, Shanghai, China Yuan Wei, Shanghai Institute of Planned Parenthood Research, Shanghai, China Zhang Shaozhen, Xin Hua Hospital, Shanghai, China Zhao Yue Min, Tianjin Municipal Research Institute for Family Planning, Tianjin, China A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 62 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 63 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 45 82 5 9 5 9 55 Women 21 38 1 2 4 7 26 from: AFRO 7 13 7 AMRO 11 20 11 EMRO 1 2 1 EURO 1 2 5 9 3 5 9 SEARO 4 7 4 WPRO 21 38 2 4 23 Annex 2 (continued) Other scientists Mohamed Ali, London School of Hygiene and Tropical Medicine, London, United Kingdom Tsedmaa Baatar, State Research Centre on Maternal and Child Health and Human Reproduction, Ulaanbaatar, Mongolia Ron Ballard, Centers for Disease Control and Prevention, Atlanta, GA, USA Emily Banks, Imperial Cancer Research Fund, Oxford, United Kingdom Queen Cebekhulu, Reproductive Health Research Unit, Durban, South Africa Limmie Chang, Imperial College of Science, Technology and Medicine, London, United Kingdom Chen Gui-ying, National Research Institute for Family Planning, Beijing, China Chen Xiao qin, Family Planning Research Institute of Sichuan, Chengdu, China Chen Yuan qing, Family Planning Research Institute of Sichuan, Chengdu, China Cui Nian, Family Planning Research Institute of Sichuan, Chengdu, China Karen Davis, University of Texas Medical Branch, Galveston, TX, USA Soledad Diaz, Chilean Institute of Reproductive Medicine, Santiago, Chile Berna Dilbaz, SSK Maternity Hospital, Kizilay-Ankara, Turkey Ding Ju-hong, Jiangsu Family Health Institute, Nanjing, China Ding Wan-hua, Jiangsu Family Health Institute, Nanjing, China Fan Guang-sheng, Peking Union Medical College, Beijing, China Fan Xin lin, Family Planning Research Institute of Sichuan, Chengdu, China Fang Hui lan, Tong-ji Medical University, Wuhan, China Fang Li Zhi, Family Planning Research Institute of Sichuan, Chengdu, China Gan Xian qin, International Peace Maternity and Child Health Hospital, Shanghai, China Gao Ya jie, Tianjin Municipal Research Institute for Family Planning, Tianjin, China John Gerofi, Enersol Pty Ltd., Annandale, NSW, Australia Han Li hui, Beijing Obstetrics and Gynaecology Hospital, Beijing, China Jiang Lin-lin, Ren Ji Hospital, Shanghai, China Sirimai Korakot, Siriraj Reproductive Health Research Centre, Mahidol University, Bangkok, Thailand Liu Zhong hua, Family Planning Research Institute of Sichuan, Chengdu, China Györgyi Meszaros, Albert Szent-Györgyi Medical Univerity, Szeged, Hungary Abdel Malek M’Hamdi, Ariana Centre for Human Reproductive Research, Tunis, Tunisia Ni Ming-hong, Ren-Ji Hospital, Shanghai, China Pan Xin-lan, Peking Union Medical College, Beijing, China Mojca Pirc, Gynaecological Clinic, Ljubljana, Slovenia Bill Potter, Stapleford Scientific Services, Cambridge, United Kingdom Neil Poulter, Imperial College School of Medicine, London, United Kingdom Mirjana Puksic, Gynaecological Clinic, Ljubljana, Slovenia Stane Pusenjak, Gynaecological Clinic, Ljubljana, Slovenia Erdenetungalag Radnaabazar, State Research Centre on Maternal and Child Health and Human Reproduction, Ulaanbaatar, Mongolia Primoz Res, Gynaecological Clinic, Ljubljana, Slovenia A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 64 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 65 James Schlesselman, Sylvester Comprehensive Cancer Center, Miami, FL, USA Alejandra Silva, University of Frontera, Temuco, Chile Song Li juan, Tianjin Municipal Research Institute, Tianjin, China Suvanichchati Sukanda, Siriraj Reproductive Health Research Centre, Mahidol University, Bangkok, Thailand Sun Hong-zhu, National Research Institute for Family Planning, Beijing, China Tao Jin-Zhang, Jiangsu Family Health Institute, Nanjing, China Walter Vitor da Fonseca, Institute of Woman and Child Health, Fortaleza, Brazil Gail Walker, Sylvester Comprehensive Cancer Center, Miami, FL, USA Wang Yue-bao, Shanghai Institute of Planned Parenthood Research, Shanghai, China Weng Li-Ju, Peking Union Medical College, Beijing, China Wong Hong, Xin Hua Hospital, Shanghai, China Wu Ming-hu, Beijing Obstetrics and Gynaecology Hospital, Beijing, China Wu Mu-zhen, Peking Union Medical College, Beijing, China Wu Shi Zhong, Sichuan Provincial Family Planning Research Institute, Chengdu, China Wu Yue-zhe, Shanghai Institute of Planned Parenthood Research, Shanghai, China Xiao Ling, Family Planning Research Institute of Sichuan, Chengdu, China Xie Li, Family Planning Research Institute of Sichuan, Chengdu, China Yang Bang yuan, International Peace Maternity and Child Health Hospital, Shanghai, China Yun Ming-ming, Jiangsu Family Health Institute, Nanjing, China Yun Ming rong, Family Planning Research Institute of Sichuan, Chengdu, China Zhang Wen hao, Tianjin Municipal Research Institute, Tianjin, China Zhao Dan ping, Tianjin Municipal Research Institute, Tianjin, China Zhu Xiao-ling, Beijing Obstetrics and Gynaecology Hospital, Beijing, China Zhuang Liu-qi, International Peace Maternity and Child Health Hospital, Shanghai, China Annex 2 (continued) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 46 75 5 8 10 16 61 Women 30 49 2 3 4 7 36 from: AFRO 1 2 1 AMRO 3 5 4 7 7 EMRO 1 2 1 EURO 1 2 5 8 5 8 11 SEARO 2 3 2 WPRO 38 62 1 2 39 A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 64 A n n u al Tech n ical R ep ort 2002 Safety and effectiveness of existing methods of fertility regulation 65 Annex 3 PUBLICATIONS IN 2002 Castellsagué X, Bosch FX, Muñoz N, Meijer CJLM, Shah KV, de Sanjosé S et al. for the International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Male circumcision, penile human papillomavirus infection, and cervical cancer in female partners. New England Journal of Medicine, 2002, 346:1105–1112. Chang CL, Marmot MG, Farley TMM, Poulter NR. The influence of economic development on the association between educa- tion and the risk of acute myocardial infarction and stroke. Journal of Clinical Epidemiology, 2002, 55:741–747. Chang CL, Shipley MJ, Marmot MG, Poulter NR. Can cardiovascular risk factors explain the association between education and cardiovascular disease in young women? Journal of Clinical Epidemiology, 2002, 55:749–755. Collaborative Group on Hormonal Factors in Breast Cancer. Alcohol, tobacco, and breast cancer: collaborative reanalysis of individual data from 53 epidemiological studies, including 58,515 women with breast cancer and 95,067 women without the disease. British Journal of Cancer, 2002, 87:1234–1245. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of indi- vidual data from 47 epidemiological studies in 30 countries, including 50,302 women with breast cancer and 96,973 women without the disease. The Lancet, 2002, 360:187–195. Cox B, Sneyd MJ, Paul C, Delahunt B, Skegg DCG. Vasectomy and risk of prostate cancer. Journal of the American Medical Association, 2002, 287:3110–3115. Donaghy M, Chang CL, Poulter N. Duration, frequency, recency and type of migraine and the risk of ischaemic stroke in women of childbearing age. Journal of Neurology, Neurosurgery & Psychiatry, 2003 (submitted). Farley TMM. Considerations regarding re-use of the female condom. Reproductive Health Matters, 2002, 10:182–186. Farley TMM, Potter W, Gerofi J, Pope M. Structural integrity of the polyurethane female condom after multiple cycles of dis- infection, washing, drying and re-lubrication. XIV International AIDS Conference, Barcelona, Spain, 7–12 July 2002. Abstract No. TuOrD1233. Meriggiola MC, Farley TMM, Mbizvo M. A review of androgen-progestin regimens for male contraception. Human Reproduc- tion, 2003 (in press). Moreno V, Bosch FX, Muñoz N, Meijer CJLM, Shah KV, Walboomers JMM, Herrero R, Franceschi S for the International Agency for Research on Cancer (IARC) Multicentric Cervical Cancer Study Group. Effect of oral contraceptives on risk of cer- vical cancer in women with human papillomavirus infection: the IARC multicentric case-control study. The Lancet, 2002, 359: 1085–1092. Muñoz N, Franceschi S, Bosetti C, Moreno V, Herrero R, Smith JS, Shah KV, Meijer CJLM, Bosch FX for the International Agency for Research on Cancer (IARC) Multicentric Cervical Cancer Study Group. Role of parity and human papillomavirus in cervical cancer: the IARC multicentric case-control study. The Lancet, 2002, 359:1093–1101. Pettifor AE, Beksinska ME, Rees HV, Mqoqi N, Dickson-Tetteh KE. The acceptability of reuse of the female condom among urban South African women. Journal of Urban Health, 2001, 78:647–657. Potter B, Gerofi J, Pope M, Farley TMM. Structural integrity of the polyurethane female condom after multiple cycles of disinfec- tion, washing, drying and re-lubrication. Contraception, 2003, 67:65–72. Thomas DB, Ray RM, Qin Q and the WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Risk factors for progression of squamous cell cervical carcinoma in-situ to invasive cervical cancer: results from a multinational study. Cancer Causes and Control, 2002, 13:683–690. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 66 A n n u al Tech n ical R ep ort 2002 Norms and guidelines for use of methods of fertility regulation 67 World Health Organization. Cervical cancer, oral contraceptives and parity. WHO Weekly Epidemiological Record, 2002, 77: 167–168. World Health Organization. The safety and feasibility of female condom reuse: report of a WHO Consultation. Geneva, World Health Organization, 2002 (available online at: http://www.who.int/reproductive-health/rtis/reuse.en.html#1). Annex 3 (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 66 A n n u al Tech n ical R ep ort 2002 Norms and guidelines for use of methods of fertility regulation 67 Norms and guidelines for use of methods of fertility regulation H.B. Peterson, K. Church, S. Johnson INTRODUCTION Family planning programmes are facing the challenge of finding better ways to deliver high-quality family planning services to the millions of people who would use family plan- ning if they had access to it. However, many family planning programmes have substantial progress to make in improving quality of care. The Department is contributing to these efforts by creating four cornerstones of evidence-based and con- sensus-driven guidance for family planning. This new series includes two guidelines—Improving access to quality care in family planning: medical eligibility criteria for contraceptive use (referred to as Medical eligibility criteria for contraceptive use) and Selected practice recommendations for contracep- tive use. There are also two tools—the Decision-making tool for family planning clients and providers and the Handbook for family planning providers. A system has also been cre- ated to ensure that this global family planning guidance is based on the best available evidence through a continuous, systematic process of identifying, critically appraising, and synthesizing new evidence as it becomes available. The creation of evidence-based guidelines and tools alone, while important, is insufficient to assure that family planning services are improved. The ultimate impact of the Depart- ment’s norms and tools will be contingent on the develop- ment of successful strategies for implementation. OVERALL OBJECTIVE The overall objective of the Department’s work in this area is to create evidence-based and consensus-driven guidance to support the provision of high-quality family planning services globally. This objective will be achieved by: •• establishing the context for norms and tools within a programme of research for promoting family planning; •• developing the four cornerstones of evidence-based guidance for promoting family planning; •• creating a system for developing guidelines based on the best available evidence and ensuring that they are kept up to date; •• developing an implementation strategy for and provid- ing support for countries adopting and adapting WHO’s family planning guidance. Establishing the context The context for developing norms and tools in family plan- ning is based on a framework that links the four major goals of the Department in family planning, namely: •• to develop new and improved methods of contraception (including methods for dual protection); •• to evaluate the safety and effectiveness of existing meth- ods; •• to assess the sociocultural and behavioural determi- nants of successful family planning; and •• to translate available evidence into guidelines that are used successfully at country level. The first three goals are supported by research programmes, and the fourth is based on the findings derived from these A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 68 A n n u al Tech n ical R ep ort 2002 Norms and guidelines for use of methods of fertility regulation 69 programmes and other relevant research. Thus, the findings from both social sciences research and safety and efficacy research feed directly into the evidence base for norms and tools. As new methods are developed and evaluated, safety and efficacy research as well as research on acceptability of these methods are included in the evidence base. Further- more, a feedback loop exists between the guidelines and the research priorities. Key gaps in evidence are identified as available evidence is appraised, synthesized and consid- ered for guidelines and some of these gaps, in turn, become research priorities. The creation of evidence-based guidelines, while important, is insufficient to ensure the delivery of quality services in family planning. The process of dissemination, adaptation and utilization of guidelines is also critical. Thus, the ultimate impact of guidelines will be contingent on the development of strategies for successfully implementing best practices in family planning. The Implementing Best Practices Initiative and the Strategic Approach to the Introduction of Contra- ceptive Technologies, discussed elsewhere in this report, are examples of such strategies and are currently being implemented. The needs of users at the country level will, in turn, help determine priorities for creating and implementing guidelines (Figure 1.4). Developing the four cornerstones of evidence- based guidance for promoting family planning The Medical eligibility criteria for contraceptive use and the Selected practice recommendations for contraceptive use are the first two cornerstones of WHO’s family planning guid- ance. They are intended for policy-makers, family planning programme managers and the scientific community, and aim to assist in the preparation of guidelines for service delivery, thus providing guidance for guides. The Medical eligibility criteria for contraceptive use provides guidance regarding who can safely use contraceptive methods. Appropriate medical eligibility criteria are determined for women with over 50 conditions. The Selected practice recommendations for contraceptive use provides guidance regarding how to use contraceptive methods safely and effectively. Recom- mendations include instructions on when and how to start contraceptives and what to do in problem situations. These two guidelines will be updated with recommendations from working group meetings in 2003 and 2004, and published by the end of 2004. The Decision-making tool for family planning clients and pro- viders and the Handbook for family planning providers are the third and fourth cornerstones of WHO’s family planning Figure 1.4. Schematic presentation of the role of different areas in the development of norms and tools to promote family planning A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 68 A n n u al Tech n ical R ep ort 2002 Norms and guidelines for use of methods of fertility regulation 69 guidance, and will be derived primarily from the Medical eligi- bility criteria for contraceptive use and the Selected practice recommendations for contraceptive use, but also include best evidence from social science research on how to meet the needs of the family planning client. They are intended to be used during the family planning encounter to improve the quality of care, thus providing ‘guidance for health care providers’. These two tools will also be accompanied by an adaptation guide, training package, and client materials. Creating a system The Medical eligibility criteria for contraceptive use and the Selected practice recommendations for contraceptive use are evidence-based and consensus-driven guidelines. They provide recommendations made by an expert working group based on an appraisal of relevant evidence. They are reviewed and updated in a timely manner. A system has been developed to assure that this global family planning guidance is created—and maintained— based on the best available evidence (Figure 1.5). This system includes a continuous and comprehensive process of identifying, critically appraising, and synthesizing new evidence as it becomes available. The system is a col- laborative effort between the Department, the Johns Hopkins University Bloomberg School of Public Health’s Center for Communication Programs (JHU/CCP) and the Centers for Disease Control and Prevention/WHO Collaborating Centre for Reproductive Health (CDC/WHOCC). The initial activity of the system will be conducted by JHU/ CCP, and will consist of an ongoing, comprehensive bib- liographic search using the POPLINE database to identify studies that may be of relevance to the guidance. This will be achieved by: (i) screening input to the POPLINE data- base (averaging 850 records per month) to identify research reports that may be relevant; (ii) posting bibliographic infor- mation to a database; and (iii) categorizing the bibliographic data according to the research issue it addresses. The second activity of the system will be conducted by CDC, and will consist of: (i) determining which new pieces of evi- dence are relevant; (ii) critically appraising new evidence; (iii) sending critical appraisals for peer review and subsequently creating final appraisals; and (iv) conducting systematic reviews. CDC will also assist WHO in determining whether the newly synthesized evidence is sufficient to warrant an update of existing recommendations. The third activity of the system will be conducted by WHO, and will consist of activities i–iv above for CDC, as well as determining whether an update of the guidance is warranted pending the next expert working group meeting to update the Medical eligibility criteria for contraceptive use and the Selected practice recommendations for contraceptive use. Updates will be provided electronically pending the next printing of the guidance. The system was piloted in September and October 2002 and was in full operation by November 2002. Figure 1.5. The four cornerstones of evidence-based guidance and the system to ensure that the guidance remains up to date and based on the best available science Medical eligibility criteria for contraceptive use Selected practice recommendations for contraceptive use Decision-making tool for family planning clients and providers Handbook for family planning providers Guidance for guides Guidance for providers and clients Process for keeping the guidance up-to-date A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 70 A n n u al Tech n ical R ep ort 2002 Norms and guidelines for use of methods of fertility regulation 71 Developing an implementation strategy To be sure that the guidance has impact on the delivery of services in family planning, the Department needs to provide technical assistance and support for effective implementa- tion, including adaptation of the guidance for local context and training in its use. The Department is therefore commit- ted to strengthening the technical link between the creation and the implementation of its guidance, working with regional and country offices and global partners to assure maximum impact. While evidence-based guidelines such as the Medical eligi- bility criteria for contraceptive use and the Selected practice recommendations for contraceptive use may require minimal adaptation to be useful at country level, tools such as the Decision-making tool for family planning clients and provid- ers invariably require adaptation prior to adoption and use. During 2002, the Department initiated field-testing of the Decision-making tool for family planning clients and provid- ers in Indonesia, Mexico, South Africa, and Trinidad and Tobago. Based on this experience, training and adaptation guides for implementation are being developed. NEW NORMS/TOOLS DEVELOPED: SELECTED PRACTICE RECOMMENDATIONS FOR CONTRACEPTIVE USE The document Selected practice recommendations for contraceptive use, published in 2002, is one of the two key evidence-based, consensus guidelines produced by the Department for improving quality of care in family planning service delivery. Its counterpart, the Medical eligibility criteria for contraceptive use addresses who can safely and effec- tively use contraceptive methods, identifying the medical appropriateness of contraceptive choices for women with certain medical conditions, whereas the Selected practice recommendations for contraceptive use address how to use contraceptive methods safely and effectively. Practical guidance is provided on common clinical issues, for exam- ple, what a woman should do if she misses oral contracep- tive (OC) pills. Both of these guidelines are developed and revised using a system that ensures an ongoing review of new relevant evidence. When new evidence warrants change, the guidelines are updated electronically pending expert working group meetings and subsequent printed revi- sions. The Selected practice recommendations for contraceptive use document summarizes the main recommendations of a scientific working group meeting held in London, United Kingdom, on 3–6 October 2001. The working group brought together 33 participants from 16 countries, including repre- sentatives of several agencies and organizations. It reviewed new evidence obtained primarily from a systematic detailed review of the most recent literature contained in the MEDLINE database. The purpose of the review was to identify direct evidence addressing key common clinical challenges repre- sented by the questions listed below. Indirect evidence or theoretical considerations were not reviewed. Programmatic implications of the recommendations were also considered by the working group. The questions addressed by the work- ing group were as follows: •• When can a woman start combined OCs? •• What can a woman do if she misses combined OCs? •• What can a woman do if she vomits and/or has severe diarrhoea while using combined OCs or progestogen- only pills? •• When can a woman start combined injectable contra- ceptives? •• When can a woman have repeat combined injectable contraceptive injections? •• When can a woman start progestogen-only pills? •• What can a woman do if she misses progestogen-only pills? •• What can a woman do if she vomits after taking emer- gency contraceptive pills? •• When can a woman start the progestogen-only inject- ables depot-medroxyprogesterone acetate (DMPA) or norethisterone enanthate (NET-EN)? •• When can a woman have repeat DMPA or NET-EN? •• What can be done if a woman has menstrual abnormali- ties when using DMPA or NET-EN? •• When can a woman start using an implant? •• What can be done if a woman experiences menstrual abnormalities using implants? A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 70 A n n u al Tech n ical R ep ort 2002 Norms and guidelines for use of methods of fertility regulation 71 •• When can a copper-bearing intrauterine device (IUD) be inserted? •• What can be done if a woman experiences menstrual abnormalities when using a copper-bearing IUD? •• What should be done if a woman using a copper-bearing IUD is diagnosed with pelvic inflammatory disease? •• What should be done if a woman using a copper-bearing IUD is found to be pregnant? •• Should prophylactic antibiotics be provided for copper- bearing IUD insertion? •• What can a Standard Days Method user do if she has menstrual cycles outside the 26–32 day range? •• What examinations or tests should be done routinely before providing a method of contraception? •• How many pill packs (combined or progestogen-only pills) should be given at initial and return visits? •• What follow-up is appropriate for combined OC, proges- togen-only pill, implant and IUD users? •• How can one be reasonably sure that a woman is not pregnant? The companion to this document, the Medical eligibility criteria for contraceptive use, has been published in nine languages and used in dozens of countries in the prepara- tion and revision of national service delivery guidelines for family planning. The Selected practice recommendations for contraceptive use is expected to have an equally far-reach- ing impact. The Clinical Effectiveness Committee of the Faculty of Family Planning and Reproductive Health Care of the Royal College of Obstetricians and Gynaecologists, London, United Kingdom, has already met to consider these recommendations and to determine how best to update their current guidance. These recommendations are meant to be adapted as needed for local circumstances prior to adoption. When feasible and appropriate, the Department will provide technical assistance in this process. NEW WORK UNDERTAKEN ON NORMS/TOOLS UNDER DEVELOPMENT: THE DECISION-MAKING TOOL FOR FAMILY PLANNING CLIENTS AND PROVIDERS The Decision-making tool for family planning clients and pro- viders and the Handbook for family planning providers are two tools that are part of WHO’s evidence-based guidance for family planning. These tools are designed to be used during the family planning encounter to support both the provider and the client. The Decision-making tool will be derived from and supported by the Medical eligibility criteria for contraceptive use and the Selected practice recommendations for contraceptive use. In addition, training and educational materials for clients and providers, and an adaptation guide will be developed to sup- port the tool. The primary objectives of the Decision-making tool are: •• to promote the client’s informed choice and role in family planning service delivery; •• to enable providers to apply evidence-based best prac- tices in the client–provider interaction during delivery of family planning services; •• to provide the technical information necessary for opti- mal delivery of non-surgical contraceptive methods; and •• to encourage providers and health systems to promote best practices in client-provider interaction as an integral part of service delivery. The guiding principles supporting these objectives are to ensure that: •• the process for family planning decision-making is client- driven and interactive; •• the client’s needs as expressed by the client are met to the greatest possible extent; •• evidence-based best practices in client–provider com- munication are used; •• technical information needed for appropriate choice and for safe and effective use of family planning methods is provided; •• the discussion and the process are tailored to the needs of the individual client with provider’s statements or actions depending, as much as possible, on the client’s previous answer or statement; and that •• the client is enabled to express her/his purposes quickly in the encounter and the provider to respond appropri- ately. The Decision-making tool has been developed in partnership with JHU/CCP, with technical input from many other experts in reproductive health and health communication. It has undergone expert reviews on the counselling/communication component, as well as the technical information it contains. A field-testing draft was finalized in September 2002 and Phase I field-testing began the following month. Phase I field-testing involves meetings with providers to get initial feedback on the usability of the tool. Phase II will include A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 72 A n n u al Tech n ical R ep ort 2002 73 initial adaptation or translation, and involve feedback from both the client and the provider. Phase III will include impact evaluation of the use of the tool and be conducted once the tool has been adapted and adopted. Phase I testing has been undertaken with partner organiza- tions in Indonesia (Sustaining Technical Achievements in Reproductive Health [STARH] Project of JHU/CCP), Mexico (Population Council and JHU/CCP), South Africa (Reproduc- tive Health Research Unit of the University of Witwatersrand), and Trinidad and Tobago (International Planned Parenthood Federation). Phase II began in January 2003 in Indonesia and Mexico. Feedback on the tool from both clients and providers will be obtained using observational techniques, interviews and focus group discussions. NEW NORMS/TOOLS INITIATED: THE HANDBOOK FOR FAMILY PLANNING PROVIDERS The Handbook for family planning providers will be a compan- ion to the Decision-making tool for family planning clients and providers, intended to give in-depth and detailed information for providers on the provision of high-quality family planning services. It will include a comprehensive overview of coun- selling approaches and messages, and technical information needed not only for family planning, but also for dual protec- tion against pregnancy and HIV/ STIs. The handbook will be based on the Essentials of contraceptive technology of JHU/ CCP, and will be developed through a consensus process led by WHO and the Implementing Best Practices Consortium. This process will bring together experts in the field to review evidence and to achieve consensus. The group will address, in particular, key controversies and inconsistencies in current guidance to enhance the likelihood that providers are given sound and consistent messages. This handbook is in the initial planning stages. It will be com- pleted by the end of 2004 and incorporate the latest WHO recommendations from the updates of the Medical eligibility criteria for contraceptive use and the Selected practice rec- ommendations for contraceptive use. A n n u al T ec h n ic al R ep or t 2 00 2 Section 1 - Promoting family planning 72 A n n u al Tech n ical R ep ort 2002 73 Section 2 Making pregnancy safer A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 74 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 75 Generating new evidence for maternal and perinatal health J. Villar, M. Gülmezoglu, M. Merialdi INTRODUCTION There is widespread agreement that, although health serv- ices could incorporate effective treatments and emergency medical and surgical strategies to reduce maternal and peri- natal mortality, many effective interventions remain underu- tilized (a gap between evidence and practice). In addition, there is still a lack of preventive action for pregnancy-specific conditions, particularly the leading causes of severe morbid- ity and mortality (a gap between preventive and curative care). This is in contrast to the major progress made in other areas of medicine in the last decade, such as the mapping of the human genome. The 1998–2003 programme of work was oriented to provide evidence for mapping the best maternal and perinatal health practices. The Department’s Scientific and Technical Advisory Group (STAG), supported by the WHO Maternal and Perinatal Health Research Com- mittee, identified maternal health priority research areas, taking into account WHO’s advantages such as its credibility and neutrality at country level and its network of collaborating institutions in developing countries. STAG approved a Programme of Work for Maternal Health Research to be implemented between 1998 and 2003, which is now almost completed (Table 2.1). A detailed description of the progress made in each specific area is presented in the following sections. RESEARCH ACTIVITIES Specific objectives of research The goal of this programme of work is to reduce maternal morbidity and mortality through the development of accept- able and affordable evidence-based health programmes. Implementation of the maternal health research strategic component is achieved by: (i) evaluating effectiveness of practices; (ii) improving understanding of sociocultural factors influencing maternal health care; (iii) reviewing methodologi- cal issues related to maternal health research; (iv) conducting follow-up studies of the populations included in pregnancy- related research; (v) evaluating the implementation strategies of research results; and (vi) stimulating fundamental research on outstanding obstetric problems of global importance. Progress Evaluation of effectiveness of practices The WHO randomized controlled trial for the evaluation of a new antenatal care programme The Programme completed this large multicentre randomized controlled trial in 1999, in collaboration with four institutions in developing countries (Argentina, Cuba, Saudi Arabia and Thailand). The new WHO antenatal care (ANC) model limits the tests, clinical procedures and follow-up actions to those scientifically demonstrated to be effective in improving mater- nal and newborn outcomes. The selected ANC activities are distributed over four visits during the course of pregnancy. The trial included 53 antenatal care units (24 678 women) randomly allocated to provide either the new programme of antenatal care or the traditional programme in use at that time. The new ANC model was found to be as effective as the standard model, could be implemented without major resist- ance from women and providers, and may reduce cost. In 2002, an extensive dissemination effort of the results was conducted, including presentations at several international meetings and symposia and at special regional and country A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 74 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 75 meetings. The manual for the implementation of the new WHO ANC model was published also in 2002 with other supporting materials and included in a document to be used as a tool for incorporating the results of this research project into services. The WHO multicentre randomized trial of misoprostol in the management of the third stage of labour This multicentre, double-blind, randomized controlled trial compared the efficacy of a single oral dose of 600 μg of misoprostol to an intramuscular or intravenous 10 IU dose of oxytocin in the context of active management of the third stage of labour. Overall trial coordination was done by the Programme with collaborating centres in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Viet Nam. The results of this trial demonstrate that 10 IU oxytocin (intra- venous or intramuscular) is preferable to 600 μg misoprostol taken orally in the active management of the third stage of labour in hospital settings where active management of the third stage of labour is the norm. Reports on effective- ness, side-effects, pharmacokinetics, milk concentration of misoprostol and the systematic review of all evidence from randomized controlled trials were published. During 2002, dissemination of effective strategies to pre- vent postpartum haemorrhage was carried out. It is now considered that WHO has covered all the research gaps in this area and that a complete set of evidence is now avail- able for implementing programmes for the prevention of postpartum haemorrhage. However, the identification of the best treatments for this condition remains a challenge to be addressed. The Latin American randomized controlled trial of man- datory second opinion for the reduction of the rate of caesarean section Within the framework of a cluster randomization model, the trial evaluated an intervention that consisted of a mandatory second opinion, based on the best available evidence about effective and safe management of childbirth, to be requested before every non-emergency caesarean section. Thirty-four hospitals from five Latin American countries par- ticipated in the trial: Argentina (18), Brazil (6), Cuba (4), Gua- temala (2) and Mexico (4). The trial failed to demonstrate a clinically significant reduction in caesarean section rate asso- ciated with the intervention in these hospitals. The negative result of the trial has contributed to a delay in the publication of the main results, as is often the case, but efforts are being made to avoid this publication bias. Data have been collected and analysed regarding the pri- mary outcomes, and women’s and providers’ opinions about the mode of delivery and the social context of caesarean section in Latin America. Several reports have been submit- ted for publication in 2002. Table 2.1. Maternal health interventions with leading participation of the Programme, evaluated up to 2002 Countries Women Status Antenatal care 4 24 678 Published Postpartum haemorrhage (prevention) 9 18 530 Published Treatment of pre-eclampsia* 31 10 141 Published Caesarean section 5 149 276 Publications submitted Reproductive Health Library evaluation 2 76 053 Ongoing (evaluation phase) Prevention of pre-eclampsia (calcium) 6 8500 Ongoing (final recruitment phase) Prevention of pre-eclampsia (treatment of hypertension) 5 1600 In preparation Screening and treatment of urinary tract infection 4 18 000 In preparation Postpartum haemorrhage (treatment) 4 1000 In preparation TOTAL 25** 307 778 * The Programme was not responsible for the management of this trial. Hence the countries involved are not part of the total. * * Some countries have been involved in more than one study. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 76 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 77 The trial of magnesium sulfate for the prevention of eclampsia: reducing the human and health service burden of pre-eclampsia (MAGPIE Trial) This trial compared magnesium sulfate with placebo for the treatment of women with pre-eclampsia. Primary outcome measures were eclampsia and the death of mother or baby. The effects on other measures of serious maternal and neonatal morbidity were also assessed, as was the use of health service resources. Recruitment to the study began in July 1998 and involved women and clinicians from 150 hospitals in 31 countries. It was stopped in November 2001 after 10 141 women had been recruited, on the recommen- dation of the Data and Safety Management Committee who considered that the effectiveness of magnesium sulfate in preventing eclampsia and in reducing maternal mortality had been proved. The trial was the largest ever conducted of anticonvulsants for the treatment of pre-eclampsia, support- ing the effectiveness of magnesium sulfate. The results were published in The Lancet in June 2002 and disseminated worldwide, including in an editorial jointly published in the British Medical Journal by WHO, the International Federation of Gynecology and Obstetrics (FIGO) and the International Society for the Study of Hypertension. The WHO randomized double-blind controlled trial of calcium supplementation during pregnancy provided to deficient calcium intake women for the prevention of pre-eclampsia The protective effect of calcium supplementation during pregnancy provided to low calcium intake women has been proposed as a promising preventive strategy for pre- eclampsia. It is now being evaluated by the Programme in an adequately sized trial in populations with low calcium intake, the most likely to benefit from such a nutritional intervention (1.5 g of calcium a day). The primary objective of the trial is the reduction of pre-eclampsia. The trial is being conducted in Argentina, Egypt, India, Peru, South Africa and Viet Nam. A baseline survey of calcium intake of the pregnant populations served by the selected clinics and hospitals in these countries included over 500 women, and demonstrated that the mean calcium intake is less than 600 mg/day, or approximately 50% of the 1200 mg/day dose recommended for pregnant women. The total sample size of the trial is expected to be 8500 women. By December 2002, almost 6500 women had been recruited, of whom approximately 2500 have already delivered. It is expected that the trial will be completed in 2003. Systematic reviews Systematic reviews are conducted within the framework of the WHO Programme to Map Best Reproductive Health Practices (for details, see the chapter on Implementing best practices). Review topics are selected on the basis of their importance for developing countries and scientists from these countries take the responsibility for preparing and maintain- ing the reviews. In the area of maternal health care interven- tions, seven systematic reviews have been updated, and three full reviews and two review protocols have been pub- lished following The Cochrane Library requirements, by staff of the Programme or by scientists from developing countries with support from the Programme. These systematic reviews were published in the 2002 issues of The Cochrane Library, and will be included in the forthcoming issues of The WHO Reproductive Health Library (RHL). The reviews addressed prophylactic antibiotics during pregnancy; prevention of postpartum haemorrhage by prostaglandins; nutritional interventions (calcium, vitamin A); and care during and after caesarean section (fluids, antibiotics). Overview of evidence of effectiveness The Programme was invited to participate in the Wellcome Trust/United States Agency for International Development (USAID) initiative, Nutrition as Prevention Strategy Against Adverse Maternal Pregnancy Outcomes, and to prepare, as background documents, two overviews of systematic reviews of nutritional interventions during pregnancy to prevent and treat maternal morbidity, mortality, preterm delivery and intrauterine growth impairment. The meeting was intended to produce the guidelines for future strategies in maternal health to be implemented by those agencies. The two over- views have been accepted for publication in the Journal of Nutrition in 2003: Nutritional interventions during pregnancy for the prevention or treatment of maternal morbidity and preterm delivery: an overview of randomized controlled trials; and Nutritional interventions during pregnancy for the prevention or treatment of impaired fetal growth: an overview of randomized controlled trials. Improvements in the understanding of sociocultural and economic factors influencing maternal health care Women’s and providers’ perceptions of the quality of antenatal care Women’s and providers’ perceptions of the quality of antena- tal care were assessed alongside the WHO Antenatal Care Trial in collaboration with the Latin American office of The Population Council, and the National Perinatal Epidemiology Unit, Oxford University, Oxford, United Kingdom. A sample of 1600 pregnant women and all antenatal care providers par- ticipating in the trial were included. The two main papers of this component were published in 2002. The results showed that clients and providers generally accepted the new WHO antenatal care model. These publications have been incor- porated in the full set of documents of the WHO Antenatal Care Trial and are now being disseminated. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 76 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 77 The economic evaluation of a rational package for ANC conducted alongside a multicentre randomized control- led trial This economic evaluation was completed in collaboration with the University of East Anglia, Norwich, United Kingdom and the London School of Hygiene and Tropical Medicine, London, United Kingdom. Its overall aim was to assess whether the new programme of ANC tested in the WHO Antenatal Care Trial was more cost-effective than the exist- ing level of service, both for women using the service and for health care providers. A further aim was to examine the factors that may lead to differences in the cost–effectiveness estimates for the coun- tries that took part in the economic study, and to assess the transferability of the results. To this end, data were also col- lected in an additional centre in KwaZulu Natal, South Africa, and combined with data from the WHO trial centres. Individual reports from each participating centre were pub- lished during 2001–2002. A paper reporting the main findings was submitted for publication to a leading health economics journal and results were distributed to the participating insti- tutions for implementation of the recommendations. Review of research methodology related to maternal health Heterogeneity in meta-analyses of randomized control- led trials An evaluation of the statistical tests used to evaluate hetero- geneity of trial results in meta-analyses was initiated in 2002. Results of this unique research work in statistical sciences will be available in 2003. Methodological considerations for the design, analysis and meta-analysis of cluster randomization trials This activity was conducted in collaboration with the Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. Utilizing the experience gained in the WHO Antenatal Care Trial, work continued on statistical issues related to trial design, sample size and power calculations. One methodological paper was accepted for publication and will be published in 2003. Clinical trials methodology The WHO multicentre randomized controlled trial to evaluate the use of misoprostol in the management of the third stage of labour (see above) presented special methodological challenges. The methods of sequence generation, allocation concealment and blinding used in this trial were described in a paper that also describes how the possible existence of ascertainment bias in the main outcomes was assessed. The method of allocation concealment used in the trial offers a practical and convenient mechanism of drug administration in a hospital delivery ward that can be used even in remote developing country settings. A similar strategy is going to be used in the multicentre trial evaluating treatment for asymptomatic bacteriuria in pregnancy. All trials planned are inspired by the principle that it is better to collect 10 times less data in 10 times more patients. Methodology for meta-analysis of observational studies Work is being done on the methodology of meta-analysis of observational studies, to be applied in the systematic review of mapping the magnitude of maternal ill-health (see below). Programme staff participated in two workshops on Meta- analysis of Observational Studies organized by l’Institut de la Santé et de la Recherche Médicale (INSERM) in France. Two methodological papers are to be published in 2003. Follow-up studies of populations included in pregnancy-related research The possibility of intrauterine programming of diseases that appear later in life, including various chronic conditions, continues to attract considerable interest. The hypothesis arose from the results of observational studies, most of them conducted among populations from developed countries. However, there are concerns about the methodological limitations of these epidemiological studies, which used data from hospital records from decades ago and included only small numbers of intrauterine growth-retarded newborns. There are also concerns over inconsistencies in the results. The Programme is exploring some of these issues using perinatal and childhood/adolescent data, prospectively col- lected in large cohorts of children. The effect of high calcium exposure in utero on blood pressure during late childhood: long-term follow-up of subjects enrolled in a randomized controlled trial This is a prospective follow-up study of 600 pre-adolescent children born to women enrolled in a previously conducted double-blind randomized placebo-controlled trial of calcium supplementation during pregnancy. It explores the long-term effect of calcium supplementation during pregnancy on the offspring’s blood pressure during pre-adolescence, particu- larly among children with high body-mass index. Standard- ized blood pressure, clinical anthropometric measures, and morbidity history were obtained at follow-up for the children and their mothers. The study was completed in late 2001 with a loss of follow-up of less than 10% of eligible children, 12 years after the children were born. Contrary to the results of previous follow-up studies, no effect on blood pressure as related to calcium supplements was observed. These obser- vations are in agreement with a recent systematic review and reflect the inconsistency in results which has affected this research based on the Barker’s hypothesis or Fetal Origins of Adult Disease hypothesis. A paper has been submitted for publication. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 78 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 79 Follow-up of the “MAGPIE” trial study population This is a follow-up study of children born to mothers enrolled in the “MAGPIE” trial up to two years of age. Growth, devel- opment and morbidity will be evaluated. External funding has been obtained from the United Kingdom Medical Research Council and other donors and this will be complemented by the Programme’s support to three collaborating centres in developing countries (Colombia, Cuba, and Nigeria). Evaluation of the implementation strategies of research results A randomized controlled trial to evaluate a programme promoting evidence-based medicine based on RHL In order to evaluate the uptake of information from RHL and subsequent changes in health care practices, a randomized controlled trial of an educational outreach strategy is being undertaken, using maternal care practices as indicators (for details, see the chapter on Implementing best practices). Implementation of the new ANC model The new WHO ANC model uptake has been positive with independent implementation under way in several countries. In Thailand, the implementation of this model will be moni- tored and evaluated in Khon Kaen after one year of imple- mentation to assess the scale of success and any barriers to implementation. Stimulation of fundamental research on outstanding obstetric problems of global importance There are two highly prevalent maternal morbidities in developing countries for which there is very little knowledge of pathophysiology on which to base preventive and thera- peutic interventions: hypertensive disorders of pregnancy and impaired fetal growth. Currently available interventions consist largely of symptomatic treatment for the mother and intensive care of a preterm or growth-impaired infant. It is unlikely that morbidity and costs can be reduced with- out identifying effective preventive measures. Moreover, because severe pre-eclampsia and impaired fetal growth are relatively rare in developed countries, research in these areas has been neglected. Considerable efforts will be needed in implementing basic research aimed at understanding their pathophysiological processes, in order to identify new pre- ventive strategies. Therefore, in collaboration with a network of institutions in both developing and developed countries, a new compre- hensive research and service programme entitled “Global Programme to Conquer Pre-eclampsia–Eclampsia”, based on the concept of systematic reviews and priority research areas, was launched. Implementation started in 2002. The initial phase includes the preparation of systematic reviews on screening of pre-eclamspia, promising etiologi- cal and pathophysiological hypotheses to be tested in future research, and treatment recommendations, including rec- ommendations to treat impaired fetal growth. One of these reviews was conducted during 2002 and the results are cur- rently being summarized and prepared for publication. The second systematic review will be initiated during 2003. To address the issues of impaired fetal growth, a conference is being organized to consider a multinational effort to gener- ate international reference fetal growth standards. A proposal has been submitted to The Rockefeller Foundation and a protocol prepared. This will be a WHO inter-cluster research effort and will involve the Department, the Department of Nutrition for Health and Development, and the Department of Noncommunicable Diseases Prevention and Health Pro- motion. Mapping the magnitude of maternal ill-health The systematic review of epidemiological evidence for maternal morbidity and mortality The Department’s activities in maternal health research are concentrated on the prevention of maternal mortality and its leading causes. In addition, a systematic review of epidemio- logical data, that became available between 1997 and 2002, is being conducted (for details, see the chapter on Monitor- ing and evaluation). This unique systematic review will be completed during 2003. Global monitoring system of maternal and perinatal health This project aims to create a network of randomly selected institutions that will monitor maternal and perinatal health services worldwide, using a simplified data collection instru- ment. These surveys will focus on one issue at a time and will be repeated periodically, e.g. every two years. The first survey will be conducted in 2003 and will focus on the relationship between the mode of delivery and perinatal out- comes. Radiation and reproductive health: assessment of repro- ductive health in relation to radiation exposure around the nuclear test site in Semipalatinsk Radiation has the potential to influence reproductive outcome negatively in three ways. Direct irradiation of the embryo or the fetus could influence the outcome of the pregnancy and/or the health of the baby and could have carcinogenic effects which become manifest in later life. Irradiation of the gonads can lead to genetic effects, which in turn could affect the health of the offspring. Irradiation of the gonads can also affect fertility, through radiation-induced death of germinal cells. However, very few data are available on this subject which has important implications for the reproductive health of people with occupational or accidental exposure to radia- tion. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 78 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 79 The Programme, the Institute for Cancer Research in the United Kingdom and the Research Institute for Radiation Medicine and Ecology in Kazakhstan collaborated on a major research effort, launched in 2001 with financial support of UNFPA, to investigate the consequences for reproductive health of exposure to radiation in the area of Semipalatinsk in Kazakhstan. This study is a retrospective comparative assessment of reproduction-related health effects caused by exposure to radioactive fallout from nuclear weapons testing in the Semipalatinsk region. This area was a nuclear weapons testing site from 1947 to 1989, which resulted in considerable radioactive contamination of large territories, and in radiation exposure to the inhabitants of Semipalatinsk. Identification of source documents and data collection were initiated in 2002. The study focuses on outcomes of three time windows of exposure that are of particular concern with regard to repro- ductive health: fertility and birth outcomes in relation to radia- tion exposure before or during reproductive age; infant and child mortality in relation to exposure in utero and in early life; and infant and child mortality in unexposed children from exposed parents (genetic effects). It is a longitudinal inves- tigation of an unselected group of people in exposed and control settlements who were alive at the time of the highest exposure levels (i.e. when potential radiation-induced repro- ductive health effects would have been most severe). It stud- ies various reproductive health measures and will provide analyses of these measures according to individual radia- tion doses. It is one of the largest studies yet undertaken on reproductive health in relation to exposure to nuclear fallout. From research to action Concern has been expressed at the difficulties of transform- ing research results into improved practice. In this context a project was initiated, called “From Research to Action”, that includes active large-scale dissemination at local level of the main results of the research projects conducted by WHO and the operational or other research methodologies needed to facilitate or evaluate the implementation processes. In 2002, for example, efforts to introduce the new WHO ANC model began in Argentina, Brazil, Chile, Cuba, Ethiopia, Haiti, Italy, Oman, Pakistan, Spain, Syrian Arab Republic, Thailand and Zambia. In seven of these countries (Brazil, Chile, Ethiopia, Haiti, Oman, Syrian Arab Republic and Zambia) the request to initiate local implementation came spontaneously from ministry officials or health care managers after they learned about the new model from the scientific literature. The new WHO ANC model has been formally introduced to all national offices of FIGO and the Royal College of Obstetricians and Gynaecologists in the United Kingdom. A formal online interactive course for training staff worldwide in the introduction of the new WHO ANC model is under preparation in collaboration with experts from the Boston University School of Medicine, Boston, MA, USA, and will be implemented during 2003. It is planned that this on-line approach will also be applied to the dissemination of the research results of the “MAGPIE” and misoprostol/oxytocin trials during 2003. New projects initiated in 2002 A randomized controlled trial evaluating strategies for the treatment of postpartum haemorrhage In developing countries, as many as 40 maternal deaths per 100 000 births in rural areas are caused by postpartum haemorrhage. Preliminary studies have suggested that a promising strategy of drug treatment for this complication would be misoprostol used together with oxytocin. Centres from Africa that are part of the WHO collaborative network of research institutions, and the Medical Research Council of the United Kingdom, are developing a protocol for a compre- hensive programme to address the issues of effectiveness, risks, and optimal dosage of misoprostol in the treatment of postpartum haemorrhage. Systematic reviews of rand- omized and non-randomized trials have been prepared. A multicentre randomized trial to evaluate the effectiveness of misoprostol for the treatment of postpartum haemorrhage is being prepared for implementation in Gambia, Nigeria, South Africa, and Zambia. The trial will be coordinated by local institutions with technical support and funding from the Programme. A randomized controlled trial evaluating strategies for the routine screening and treatment of urinary tract infection during pregnancy With technical and financial support from the Programme, activities are being developed by a collaborating centre in Thailand to implement a comprehensive programme for evaluating the most effective strategies for screening, laboratory procedures and treating urinary tract infection during pregnancy. The research programme will include all the methodological steps from the systematic review of pub- lications evaluating screening techniques, which has now been completed, to the implementation of a clinical trial and health service research (including cost analysis) of different screening and treatment modalities. Preparatory activities were initiated during 2002 and the trial will be implemented during 2003. Ancillary and explanatory studies to the WHO trial of calcium supplementation in low calcium intake women for the prevention of pre-eclampsia The Steering Committee of the WHO trial of calcium supple- mentation approved three ancillary studies that will provide important data to explain the results of the main trial. These studies will be conducted as independent initiatives of the collaborating centres, with consultants from the Baylor Col- lege of Medicine, Texas, USA, the University of Cincinnati, Ohio, USA, and the Universidad Catolica de Chile, Santiago, Chile, taking part. The studies will focus on the relationship A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 80 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 81 between calcium supplementation and fetal growth, fetopla- cental blood flow and markers of pre-eclampsia and calcium metabolism. All of the studies are funded mainly by external agencies through competitive grant proposal mechanisms. The future The Programme and its network of collaborating centres completed in 2002 most of the maternal health research approved by STAG for the 1998–2003 period. The first challenge for 2003 is to complete this programme fully and satisfactorily, including some of the medium-priority areas for which funding was not initially available. The second challenge remains how to transfer this knowl- edge into practice in many developing countries. The proc- ess of dissemination of knowledge and increasing service coverage to all pregnant women remains a major challenge of the interphase between research and practice. The third challenge is to implement and maintain long-term capacity building efforts in maternal health research, allowing countries both to conduct their own priority research and to be part of global initiatives. Initial efforts began in 2002. The fourth challenge is to complete, and incorporate into RHL, the maternal morbidity and other systematic reviews of observational data begun in 2002. This requires identify- ing and tabulating available information, applying the best statistical techniques for pooling observational studies, and disseminating the results through RHL. The fifth challenge is even more formidable. There is still a considerable gap in the understanding of most of the specific pregnancy-related conditions, which hinders the implemen- tation of effective prevention programmes. One example is the case of pre-eclampsia/eclampsia. The pathophysiology of this disease remains largely unknown and there are no effective preventive and curative strategies other than deliv- ery. Large numbers of pregnant women are treated with antihypertensive drugs for moderate hypertension during pregnancy, although the effectiveness of this therapy is unclear. The “Global Programme to Conquer Pre-eclampsia- Eclampsia” is aimed at this gap. The sixth challenge—severe morbidity, such as chronic anaemia, fistulae, gynaecological infections, pyelonephri- tis, chronic renal diseases, chronic pelvic pain and uterine prolapse—affects large numbers of women. Some of these conditions can be prevented or treated effectively, while for others considerable epidemiological, etiologic, therapeutic and health service research is needed. There are no effective preventive measures for preterm labour and prelabour rup- ture of membranes, pregnancy-specific conditions that are leading causes of newborn morbidity and mortality. These conditions (associated with up to 24% of all neonatal deaths) are related to infections in most epidemiological studies. Yet randomized controlled trials have failed to demonstrate the effectiveness of maternal antibiotic treatment in their preven- tion in the general pregnant population or among those with laboratory evidence of infection. Finally, recent evidence from developed and developing countries suggests intra- and inter-generational effects of pregnancy-related events. For example, there is evidence of an association between obstructed labour and short stature, as well as fetal malnutrition and chronic diseases in adult life. The latter effects, if confirmed in populations from developing countries, could have great importance for those countries in their epidemiological transition, where ischaemic heart dis- ease is already the second most common cause of death. This short review demonstrates that although health services at all levels can now incorporate effective treatments and emergency medical and surgical strategies to reduce mater- nal mortality and severe morbidity, there is still an alarming lack of scientific understanding of pregnancy-specific condi- tions. This is particularly true for conditions related to the prevention of leading causes of morbidity and mortality. The review also points to the lack of a good understanding of the epidemiology of these conditions in developing countries. In summary, the challenges that are expected to be faced in the next mid-term programme of work are: •• to identify gaps in knowledge by means of systematic reviews and to conduct the required research; •• to evaluate alternative mechanisms for changing medi- cal practices which could contribute to closing the gap between evidence and practice; •• to initiate long-term research capacity building focused on maternal and perinatal issues; •• to implement the global epidemiological surveillance system of maternal and perinatal morbidity in developing countries; and •• to contribute to the scientific effort of moving from pallia- tive care to prevention of pregnancy-related conditions, which is the goal of public health. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 80 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 81 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 3 33 6 66 9 Women 1 11 4 44 5 from: AFRO 2 22 2 AMRO 1 11 1 11 2 EMRO EURO 3 33 3 SEARO WPRO 2 22 2 Annex 1 RESEARCH GROUP ON MATERNAL AND PERINATAL HEALTH IN 2002 Members Andres De Francisco, Global Forum for Health Research, Geneva, Switzerland Jo Garcia, Institute of Health Sciences, Oxford, United Kingdom Ellen Hodnett, University of Toronto, Toronto, Canada (Chairwoman) Mark Keirse, The Flinders University of South Australia, Adelaide, Australia Pius Ngassa, WHO Centre for Research in Human Reproduction, Yaoundé, Cameroon Pius Okong, Nsambya Hospital, Kampala, Uganda Silvina Ramos, Centro de Estado y Societad, Buenos Aires, Argentina Marisa Rebagliato, University Miguel Hernández, Valencia, Spain Fiona Stanley, Telethon Institute for Child Health, Perth, Australia A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 82 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 83 Annex 2 SCIENTISTS IN 2002 Principal investigators Hany Abdel-Aleem, Assiut University Hospital, Assiut, Egypt Olayiwola Adetoro, Ogun State University, Sagamu, Nigeria Yaccob Al-Mazrou, Ministry of Health, Riyadh, Saudi Arabia Muneera Al-Osimi, Ministry of Health, Jeddah, Saudi Arabia Hassan Ba’aqueel, King Khalid National Guard Hospital, Jeddah, Saudi Arabia Leiv Bakketeig, Odense University, Odense, Denmark Per Bergsjø, University of Bergen, Bergen, Norway Liana Campodonico, Centro Rosarino de Estudios Perinatales, Rosario, Argentina Guillermo Carroli, Centro Rosarino de Estudios Perinatales, Rosario, Argentina Linan Cheng, International Peace Maternity and Child Health Hospital, Shanghai, China Russell Deter, Baylor College of Medicine, Houston, TX, USA Allan Donner, University of Western Ontario, London, Ontario, Canada Lelia Duley, Institute of Health Sciences, Oxford, United Kingdom Diana Elbourne, London School of Hygiene and Tropical Medicine, London, United Kingdom Ubaldo Farnot, Hospital Gineco-Obstetrico “America Arias”, Havana, Cuba Julia Fox-Rushby, London School of Hygiene and Tropical Medicine, London, United Kingdom Rogelio Gonzalez, Universidad Catolica de Chile, Santiago, Chile Justus Hofmeyr, University of Witwatersrand, Johannesburg, South Africa Chusri Kuchaisit, Khon Kaen University, Khon Kaen, Thailand Ana Langer, The Population Council, Mexico DF, Mexico Pisake Lumbiganon, Khon Kaen University, Khon Kaen, Thailand Giancarlo Mari, University of Cincinnati, Cincinnati, OH, USA Matthews Mathai, The Christian Medical College and Hospital, Vellore, India Miranda Mugford, University of East Anglia, Norwich, United Kingdom Nguyen Thi Nhu Ngoc, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam Kimberly O’Brien, The Johns Hopkins University, Baltimore, MD, USA Manorama Purwar, The Government Medical College and Hospital, Nagpur, India Georgina Rojas, Hospital Gineco-Obstetrico “America Arias”, Havana, Cuba Maria Ximena Rojas, Universidad Javeriana, Bogota, Colombia Mariana Romero, Centro Rosarino de Estudios Perinatales, Rosario, Argentina Anthony Swerdlow, Centre for Cancer Research, London, United Kingdom Nelly Zavaleta, Instituto de Investigacion Nutricional, Lima, Peru Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 21 66 11 34 32 Women 11 34 5 16 16 from: AFRO 2 6 2 AMRO 9 28 4 13 13 EMRO 4 13 4 EURO 7 22 7 SEARO 4 13 4 WPRO 2 6 2 A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 82 A n n u al Tech n ical R ep ort 2002 Generating new evidence for maternal and perinatal health 83 Annex 3 PUBLICATIONS IN 2002 Abalos E, Villar J, Carroli G. Pregnancy, pre-eclampsia and diet. In: Caballero B, ed. Encyclopedia of food sciences and nutri- tion. London, Academic Press, 2002. Abdel-Aleem H, Villar J, Gülmezoglu M, Mostafa S, Youssef A, Shokry M, Watzer B. The pharmocokinetics of the prostaglandin E1 analogue misoprostol in plasma and colostrum after postpartum oral administration. European Journal of Obstetrics and Gynecology, and Reproductive Biology, 2003, 108:25–28. Donner A, Piaggio G, Villar J. Meta-analyses of cluster randomization trials: power considerations. Evaluation & the Health Professions, 2003 (in press). Duley L, Villar J. Big is still beautiful: why we continue to need large simple trials for identifying best practices. In: Duley L, ed. Clinical trials: into the new millennium. London, British Medical Journal Publications, 2002:42–56. Gülmezoglu M, Villar J. Evidence-based emergency obstetric care in developing countries. Archives of Ibadan Medicine, 2002, 3:20–22. Langer A, Villar J, Romero M, Nigenda G, Piaggio G, Kuchaisit C et al. Are women and providers satisfied with antenatal care? Views on a standard and a simplified, evidence-based, model of care in four developing countries. BioMed Central Women’s Health, 2002, 2:7. Langer A, Villar J. Promoting evidence-based practice in maternal care would keep the knife away. British Medical Journal, 2002, 324:928–929. Lumbiganon P, Piaggio G, Villar J, Pinol A, Bakketeig L, Bergsjo P, Al-Mazrou Y, Ba’aqeel H, Belizan JM, Farnot U, Carroli G, Berendes H for the WHO Antenatal Care Trial Research Group. The epidemiology of syphilis in pregnancy. International Jour- nal of STD and AIDS, 2002, 13:486–494. Lumbiganon P, Villar J, Piaggio G, Gülmezoglu M, Adetoro L, Carroli G. Side effects of oral misoprostol during the first 24 hours after administration in the third stage of labour. British Journal of Obstetrics and Gynaecology, 2002, 109:1222–1226. Merialdi M, Carroli G, Villar J, Abalos E, Gülmezoglu M, Kulier R, de Onis M. Nutritional interventions for the prevention or treat- ment of impaired fetal growth. Journal of Nutrition, 2003 (in press). Nigenda G, Langer A, Kuchaisit C, Romero M, Rojas G, Al-Osimy M et al. for the WHO Antenatal Care Research Trial. Wom- en’s opinions in antenatal care in developing countries: results of a study in Cuba, Thailand, Saudi Arabia and Argentina. BioMed Central Public Health, 2003, 3:17. Piaggio G, Elbourne D, Schulz KF, Villar J, Pinol APY, Gülmezoglu AM for the WHO Research Group to Evaluate Misoprostol in the Management of the Third Stage of Labour. Methods for randomisation, concealment and blinding in the WHO misoprostol third stage of labour trial. Controlled Clinical Trials, 2002, 23:39s–40s. Roberts J, Villar J, Arulkumaran S. Preventing and treating eclampsia seizures. British Medical Journal, 2002, 325:609–610. Romero M, Ramos S, Szulik D. Preferencias de las mujeres acerca del tipo de parto. Revista de la Sociedad de Obstetricia y Ginecologia de Buenos Aires, 2002, 81:27–28. Villar J, Betran A, Gülmezoglu M, Say L. Systematic reviews and meta-analysis of observational studies (letter). International Journal of Epidemiology, 2003 (in press). Villar J, Duley L. The need for large and simple randomised trials in reproductive health. The WHO Reproductive Health Library No. 6. Geneva, World Health Organization, 2003. Villar J, Gülmezoglu AM, Carroli G, Schulz KF, Lumbiganon P, Mittal S, Hofmeyr GJ, Langer A, Cheng L. Is it time to do away A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 84 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 85 with conclusions in systematic reviews? The WHO Reproductive Health Library No. 5. Geneva, World Health Organization, 2002. Villar J, Gülmezoglu M, Hofmeyr J, Cheng L, Elbourne D. Use of misoprostol in third stage of labour. The Lancet, 2002, 359: 709–710. Villar J, Gülmezoglu M, Hofmeyr J, Forna F. Systematic review of randomised controlled trials of misoprostol to prevent post- partum hemorrhage. Obstetrics & Gynecology, 2002, 100:1301–1312. Villar J, Merialdi M, Gülmezoglu M, Abalos E, Carroli G, Kulier R, de Onis M. Nutritional interventions for the prevention or treat- ment of maternal morbidity and preterm delivery. Journal of Nutrition, 2003 (in press). SYSTEMATIC REVIEWS PUBLISHED IN THE COCHRANE LIBRARY IN 2002 New reviews 1. Thinkhamrop J, Hofmeyr GJ, Adetoro O, Lumbiganon P. Prophylactic antibiotic administration in pregnancy to prevent infec- tious morbidity and mortality (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 2. van den Broek N, Kulier R, Gülmezoglu AM, Villar J. Vitamin A supplementation during pregnancy (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 3. Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after Caesarean section (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. Updated reviews 1. Smaill F, Hofmeyr GJ. Antibiotic prophylaxis for Caesarean section (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 2. Gülmezoglu AM. Interventions for trichomoniasis in pregnancy (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 3. Gülmezoglu AM, Forna F, Villar J, Hofmeyr GJ. Prostaglandins for prevention of postpartum haemorrhage (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 4. Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 5. Hofmeyr GJ. Amnioinfusion for meconium-stained liquor in labour (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 6. Hofmeyr GJ, Atallah AN, Duley L. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 7. Hofmeyr GJ, Gülmezoglu AM. Maternal hydration for increasing amniotic fluid volume in oligohydramnios and normal amni- otic fluid volume (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. Protocols 1. Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after Caesarean section (Protocol for a Cochrane Review). In: The Cochrane Library, Issue 1, 2002. Oxford: Update Software. 2. Abalos E, Carroli G. Bed rest with or without hospitalisation for hypertension during pregnancy (Protocol for a Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 84 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 85 Implementation of evidence-based programmes B. Diallo, L.M. de Bernis, H. Fogstad, R. Kabra, O. Lincetto, A. Portela, A. Martin Hilber, D.R. Sherratt, J. Zupan INTRODUCTION The Making Pregnancy Safer (MPR) initiative represents WHO’s strengthened contribution to the global safe mother- hood movement. It emphasizes the importance of improving health systems in order to attain long-term sustainable and affordable results in improving the well-being of women and newborns. In line with the United Nations Millennium Devel- opment Goals (MDGs), the goal of MPR is to contribute to the improvement of maternal and newborn health. The specific targets are to contribute towards the reduction of the maternal mortality ratio by three-quarters between 1990 and 2015, and to contribute to the reduction, by two-thirds, of under-five mortality by 2015, through reduction in the number of newborn deaths. Work in MPR consists of: (i) conducting research to map effective interventions and improve the quality of services; and (ii) providing normative guidance and technical support to countries for the development, implementation and evalu- ation of cost-effective interventions to reduce maternal and newborn morbidity and mortality. This latter component is called Implementation of evidence-based programmes. Work is being undertaken at both WHO headquarters and country level through WHO regional and country offices, in close collaboration with partners. During the past year, Implementation of evidence-based programmes, the sub- ject of this document, has involved: (i) developing tools and guidelines based on research findings; (ii) assisting countries in introducing them to achieve a genuine shift from outdated approaches to best practices; (iii) developing appropriate strategies for working with women, their families and com- munities; and (iv) providing technical support to build institu- tional capacity at both national and regional levels to develop and effectively manage gender-sensitive programmes that are responsive to the countries’ needs. STRATEGIC FOCUS During the past year, the MPR team continued to develop and refine further the overall strategy and vision of the Making Pregnancy Safer initiative. The Making pregnancy safer—strategy paper for discussion will be finalized in 2003, reflecting the areas of focus described below. Global action for skilled attendants for pregnancy, childbirth and the newborn In 2002, MPR prepared an advocacy document proposing a global movement for increasing access to skilled attendants during pregnancy, childbirth and the postpartum period for which five strategies and five stakeholders have been identi- fied: the 5+5 strategy (Figure 2.1). The availability of skilled staff to provide effective cover- age both overall as well as for the more disadvantaged and under-resourced populations is the most challenging issue for developing countries and one where support is needed. A joint document on skilled attendants, being developed with the International Federation of Gynecology and Obstetrics (FIGO) and the International Confederation of Midwives (ICM), will be published in early 2003. Contacts have also been established with the private sector and philanthropic organizations to explore their interest and possible commit- ment towards championing a global movement for enhanc- ing levels of skilled care for pregnant women and their newborns. Individual, family and community issues in maternal and neonatal health In 2002, a concept and strategy paper, Working with individu- als, families and communities (IFC) to improve maternal and A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 86 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 87 newborn health, was produced by the MPR global team and key partners. The aim of working at the IFC level is to contrib- ute to the empowerment of women, men, families and com- munities to improve maternal and neonatal health, as well as to increase access to and utilization of quality skilled care. Strategies have been identified that target the factors known to contribute to health inequities and poor maternal and neo- natal health, as have been a set of promising interventions, as identified from the literature and field experiences. This area of work will be incorporated into the larger MPR strategy and workplan, and related concepts integrated into MPR research as well as norms and tools. In 2003, discussions will continue with regions and countries to strengthen their efforts in this area. Maternal and neonatal health and poverty Work began to better understand and delineate the relation- ship between maternal and neonatal health and poverty. The findings of this work will be formulated into a policy that aims to ensure the wider coverage of maternal and neonatal health to include marginal and poorer segments of society. It will also identify cost-effective interventions and strategies, as well as delineate the benefits of investing in maternal and neonatal health, especially as a supporting activity in the overall framework of poverty reduction strategies. Collabora- tion is being established with the World Bank and the United Nations Population Fund (UNFPA). A report and policy briefs will be developed in 2003, drawing from approximately 12 background papers. Cost–effectiveness studies of maternal and neonatal health interventions The MPR team is currently working in collaboration with the WHO Effectiveness, Quality and Costs (EQC) team within the Department of Global Programme on Evidence for Health Policy in reviewing and conducting cost–effectiveness studies of maternal and neonatal health interventions listed in The WHO Reproductive Health Library (RHL) (both those that are cost-effective and those that are expensive with small or negative effects on health). This work is intended to provide policy-makers with information on the cost–effec- tiveness of maternal and neonatal health services that will enhance decision-making and improve planning of services. The EQC team is currently compiling data on costs and effectiveness from 17 subregions in the world that have been grouped on the basis of epidemiology, infrastructure and economic situation. It has been decided to begin by conduct- ing cost–effectiveness studies of a set of 12 marker interven- tions for making pregnancy safer (Table 2.2). These marker interventions have been drawn from the list of interventions in RHL for which there is the highest level of evidence and without which it will not be possible to ensure the health and survival of mothers and newborns; additionally, the marker interventions can be measured through most health informa- tion systems. The underlying assumption in choosing these interventions as markers is that, if these interventions are in place, other beneficial forms of care are also likely to be available. Conversely, if these marker interventions are not in place, the level of care offered will most likely be inadequate. This work will continue in 2003. Maternal and neonatal health in the context of health sector reform—case studies There is a need to share lessons and develop an experi- ence-based framework on successfully integrating maternal and neonatal health issues into health sector reform efforts. Through the development of case studies, MPR intends to see if and how maternal and neonatal health issues have been adequately included in the design and implementa- tion of health sector reforms. This document will include vignettes (constraints, lessons learnt and success stories) from selected countries, and will highlight policy and/or operational issues to be considered when designing, devel- oping, implementing and evaluating health sector reforms for making pregnancy safer. The literature review and selection of countries to be included in the case studies was com- pleted in 2002. The case studies, as well as the report and policy briefs, will be finalized in 2003. Developing health systems profiles The MPR initiative is making efforts to increase the knowl- edge base and understanding of key elements of health sys- Figure 2.1. Global action for skilled attendants for pregnant women: the 5+5 strategy A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 86 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 87 tems, such as laws, policies, socioeconomic, sociocultural and demographic parameters, before developing and imple- menting maternal and neonatal health programmes. MPR is developing health system profiles in order to lay the basis for monitoring progress later and evaluating achievements as needed. Health system profiles will also enable easier comparison within and among countries using appropriate parameters and procedures. In 2002, work commenced on Ethiopia, Indonesia, Mozambique and Nigeria. The health system profile template will be finalized for adaptation and use for planning purposes by other countries in 2003. It is also planned to make the health system profiles available on the MPR web site. Mapping midwifery services in the world The MPR team began efforts in 2002 to compile data on midwifery services worldwide. This work will enable more detailed analysis of service coverage, equipment and staff- ing patterns of health facilities, adequacy of policies and reg- ulations regarding midwifery, and quality of data. It will assist in identifying gaps that may exist and inform decisions on models of care needed to provide quality midwifery services. It is expected that the work will help in the benchmarking of numbers of skilled attendants at birth, as well as indicating countries where more in-depth analysis related to midwifery services is needed. The work in this area will be conducted in close collaboration with countries, WHO regional offices and country offices and other WHO departments, such as Health Service Provision, as well as partners such as ICM, the International Council of Nurses (ICN), FIGO and relevant nongovernmental organi- zations (NGOs). The database will be established and a draft report will be completed by the end of 2003. NORMATIVE TOOLS AND GUIDELINES Based on available evidence, the MPR team has, in close collaboration with partners, developed a number of norma- tive tools and guidelines. These are meant for countries to use to improve quality of care. They include clinical, train- ing and managerial tools and other materials, as described below. Table 2.2. The 12 marker interventions for making pregnancy safer Intervention 1. Women have social support during labour and birth 2. Breastfeeding is initiated within one hour after birth 3. Every newborn is immediately dried and kept warm to protect against hypothermia 4. The WHO antenatal care package is used for all pregnant women 5. Magnesium sulfate is used to treat severe pre-eclampsia and eclampsia 6. A partogram is used to identify obstructed labour 7. Oxytocin is used for all women as part of the active management of third stage of labour 8. Antibiotic prophylaxis is used for women undergoing caesarean delivery 9. Manual vacuum aspiration is used for management of incomplete abortion and induced abortion up to 12 weeks of amenorrhoea (in circumstances where it is not against the law) 10. The kangaroo mother care of skin-to-skin contact is used for all low birth weight babies 11. Assisted delivery (including caesarean section) is performed in cases of obstructed labour Where malaria is endemic or HIV-prevalence is high, other markers may be added: 12a All pregnant women receive Intermittent Preventive Treatment for malaria during pregnancy 12b All pregnant and postnatal women and newborns sleep under insecticide-treated bed nets 12c All pregnant women are offered voluntary counselling and testing for HIV. Women who are HIV-positive are provided with specific interventions to reduce HIV transmission to their infant and relevant care and support. Women who are HIV-negative are counselled on how to remain uninfected. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 88 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 89 Clinical tools and standards Managing complications in pregnancy and childbirth: a guide for midwives and doctors This manual was published in 2001 to give skilled providers at the referral level knowledge on managing complications in pregnancy and childbirth, and to assist them in making rapid clinical assessments and decisions. United Nations agencies and professional organizations have endorsed the document. Worldwide distribution continued in 2002 with translations into French, Indonesian, Laotian, Russian and Spanish. The Arabic and Chinese translations will be com- pleted in 2003. Several regional workshops have been held in order to plan introduction of the manual at country level with governments and professional organizations. The plans also contemplate the revision of national standards of care and monitoring of changes in providers’ practice. Additional workshops are planned for 2003. Managing newborn problems: a guide for doctors, nurses and midwives This manual provides protocols to assist health care provid- ers at the district hospital in making rapid clinical assess- ments and decisions, and implementing effective clinical interventions for preterm newborn infants including those with life-threatening conditions. It was prepared in col- laboration with Maternal and Newborn Health/Johns Hop- kins Program of International Education in Gynecology and Obstetrics (JHPIEGO). Consultation and review with experts from more than 30 countries were held throughout the devel- opment process during 2002. Printing and distribution is expected in early 2003. Pregnancy, childbirth and newborn care: a guide for essential practice This is a practice guide for clinical decision-making and also for preventive measures at home and in the community. It sets out WHO recommendations for essential routine and emergency care for women and newborns during pregnancy, childbirth and the postnatal period, as well as for post-abor- tion care. It also integrates the management of malaria, HIV, anaemia and tuberculosis in connection with maternal and neonatal health care. It is intended for skilled attendants at all levels of health care, with a special focus on the primary care level. The guide is also foreseen to be useful to trainers and educators for integrating essential care into national curricula and in-service training programmes. In 2002, reviews were completed and finalized. The layout and navigation tools to facilitate its use have been improved. Workshop materials for introduction of the tool were also developed and tested with providers in pilot areas. A draft adaptation guide has also been developed to assist countries in adapting the tool to country needs and circumstances. The tool will be published in mid 2003. Handbook for communicating and counselling for pregnancy, childbirth and newborn care The aim of this handbook is to assist health care providers to communicate effectively and counsel for decision-making on the key information from the Pregnancy, childbirth and newborn care: a guide for essential care. A first draft was developed in 2002 emphasizing a self-learning approach for communication and counselling. The document is to be field-tested in early 2003, and will be reviewed by regional representatives and other experts in the field. A final version will be available by December 2003. Standards for maternal and neonatal care The Standards for maternal and neonatal care is a generic guideline aimed at establishing evidence-based standards of care during pregnancy, childbirth and the postpartum period. The document, developed in collaboration and consulta- tion with a number of departments, regions and experts, is intended for policy-makers and programme managers at national, district and facility levels. It will help countries to define their own standards for maternal and neonatal care. In addition to discussing clinical standards, the document has been expanded to include a set of health service delivery standards. Issues related to the role of individuals, families and communities and the interface between health services and the community will also be strengthened. Internal and external advisers reviewed the document in 2002. Publication is expected for 2003. Subsequently, tech- nical assistance will be provided to countries in adapting and implementing the standards, including, where appropriate, incremental adaptation. The standards will be updated regu- larly as new evidence becomes available. Kangaroo mother care (KMC): a practical guide This guide was developed in 2002, drawing on the experience gained over the last 20 years. It provides practical advice on when and how the KMC method can best be applied. It is intended for health professionals caring for low-birth-weight and preterm newborn babies in first referral hospitals with limited resources. It also provides decision-makers and planners at the national and local levels with essential infor- mation for deciding on the appropriateness of KMC for their health system and identifying what is required to implement it successfully. The finalized version of the guide has been printed and a limited number of copies were distributed in 2002. Broader dissemination is planned for early 2003. Guideline on prevention and control of maternal and congenital syphilis An existing Guideline on prevention and control of maternal and congenital syphilis presents the magnitude of the syphi- lis problem worldwide, and guidance on its prevention and A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 88 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 89 control in pregnancy. The recommendations of this guideline are included in the other MPR norms and tools. During 2002, under the leadership of the Department’s team on “Controlling sexually transmitted and reproductive tract infections”, a consultation was held in Geneva, Switzerland, to review several articles on maternal and congenital syphi- lis that are to be published in a special issue of the Bulletin of the World Health Organization. The guideline was also reviewed and it was decided that a shorter and updated ver- sion should be produced in 2003 (for details, see the chapter on Controlling sexually transmitted and reproductive tract infections). Clinical guidelines for management of pregnant women with HIV During 2002, the MPR team worked in close collaboration with the Controlling sexually transmitted and reproductive tract infections team to finalize the Clinical guidelines for management of pregnant women with HIV. The objective of these guidelines is to facilitate the integration of the pre- vention of mother-to-child transmission (MTCT) of HIV into countries’ existing health care systems. The guide was field- tested in 2002 and will be published in mid 2003. HIV inventory and reference guide on HIV During 2002, the MPR team collaborated with the Depart- ment of HIV/AIDS on the development of a guide provision- ally entitled: Reference guide on HIV-related care: treatment and support for HIV-infected women and their children. This guide focuses on formal global recommendations developed and endorsed by WHO and the US Center for Disease Con- trol and Prevention (CDC). It will be published in 2003. Strategic framework for malaria control during pregnancy in the WHO African Region During 2002, the MPR team worked in close collaboration with the WHO Roll Back Malaria (Malaria in Pregnancy) team and the WHO Regional Office for Africa (AFRO) to finalize the Strategic framework for malaria control during pregnancy in the WHO African Region. The framework aims to contrib- ute to the achievement of the Abuja goal of 60% coverage of pregnancies with Intermittent Preventive Treatment and insecticide-treated nets by 2005. The tool provides policy- makers and national programme managers with guidance on prevention and case management of malaria in pregnant women, still the main adult target group in Africa. An English version was finalized in 2002 and will be published in early 2003. Translation into French and Portuguese is expected in 2003. Also, detailed guidelines will be developed as a com- panion document during 2003. MPR will also collaborate to develop a framework on Moni- toring and evaluation of malaria during pregnancy at the health facility level. This tool will be pilot-tested in 2003. Surgical care at the district hospital During 2002, the MPR team worked in close collaboration with the Department of Blood Safety and Clinical Technology to develop a manual on Surgical care at the district hospi- tal. This manual provides practical guidance on surgical procedures that are commonly performed by non-specialist clinicians working in first-level referral hospitals with limited resources. The objective of this manual is to improve the quality of surgical care, particularly in essential procedures in surgery, obstetrics, gynaecology, orthopaedics, anaesthesia and trauma. Field-testing of the manual will begin in 2003. Training tools The revised WHO midwifery education modules This set of manuals was initially designed to assist teach- ers to improve the skills of midwives in dealing with major obstetric problems as well as to strengthen their skills for working with the community. The set has been updated to be in line with new evidence, to better integrate issues related to HIV prevention and to ensure consistency with the MCPC manual. A new module on Management of incomplete abor- tion—education material for teachers of midwifery has also been developed to complete the set. The completed revised set will be available in the early part of 2003. Strengthening midwifery toolkit In addition to the above revised WHO midwifery education modules, MPR has developed a toolkit for assisting policy- makers and decision-makers at the national level in dealing with wider aspects of strengthening midwifery. The toolkit consists of six separate guidance documents, each dealing with a different aspect of work that is critical for strengthening midwifery. There is also a simple needs assessment tool for helping users to prioritize actions. The full toolkit includes: • Strengthening midwifery: a background paper including an appendix containing a simple needs assessment tool • Legislation and regulation: making safe motherhood possible • Competencies for midwifery practices • Developing standards to assist practitioners provide quality midwifery care • Guidelines for the development of midwifery education programmes • Competencies for midwifery practice guidelines for the development of programmes for the education of mid- wife teachers. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 90 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 91 The kit will be available for dissemination and use in the first half of 2003. MPR education and training strategy and tools MPR is developing a strategy for improving health practition- ers’ performance. The framework underpinning this strategy is being developed with the Child and Adolescent Health and Development Department with input from other departments within WHO and from JHPIEGO. In addition, MPR is collaborating with the Department of Child and Adolescent Health and Development in the production of a set of tools for strengthening the capacity of teachers of health practitioners. They are intended for national capacity building workshops, especially in areas of training. This tool set will be available in mid-2003 as a printed publication and in a CD-ROM package. Management tools The MPR team continues to work in active collaboration with partners to develop management tools and approaches to assist countries in ensuring that health programmes respond to the needs of women and newborns, especially the poor and vulnerable. Building on existing materials and efforts related to health systems development, this work will con- tinue in 2003 and culminate in a series of tools. Beyond the numbers: reviewing maternal deaths and complications for making pregnancy safer In 2002, work began to revise and update a draft guide- line on investigating maternal deaths and complications of pregnancy. The revised document, Beyond the numbers: reviewing maternal deaths and complications for making pregnancy safer, is for health planners, managers and other health professionals. The specific objectives of the guide are: (i) to describe a range of approaches to the investiga- tion of maternal deaths, and (ii) to provide guidance on the selection of appropriate approaches to different settings and circumstances. The ultimate aim of these approaches is to increase awareness and knowledge of the causes of maternal mortality and pregnancy complications so that appropriate action can be taken in terms of improved quality clinical care, increased access to services, improved service management, etc. The approaches can be applied at com- munity, facility, district or national level. Case studies from a wide range of countries are also provided as examples. The guide has undergone extensive review in 2002 and will be published in 2003. MPR planning guide The MPR planning guide is intended to assist health manag- ers and planners to better plan and implement key interven- tions for maternal and newborn health. It will help them to select the most relevant processes, methods and tools and adapt these to their own capacities, resources and local con- text. The guide will address health systems requirements, in line with the WHO health systems performance framework, and will complement the clinical tools of the Department. It will describe the planning processes including budgeting, monitoring and evaluation. A first draft of the guide will be completed and field-tested in 2003. MPR planning workshop manual The MPR planning workshop manual will assist district man- agers and planners to conduct a workshop for the develop- ment of an operational district maternal and neonatal health health plan. The manual is intended to be user-friendly and comprises a pre-workshop manual as well as a workshop guide that includes materials for the participants. A first draft was completed, technically reviewed and field-tested during 2002. It will be used as accompanying material to the MPR planning guide. Both documents will be field-tested together during 2003. MPR—essential health technology package The MPR—essential health technology package builds on the Mother-baby package: costing spreadsheet, and is being developed in close collaboration with the Department of Organization of Health Service Delivery and the WHO Col- laborating Centre for Essential Technologies for Health in Cape Town, South Africa. It is a CD-ROM software package for resource planning of the maternal and neonatal health interventions recommended in the Essential care practice guide and the Standards for maternal and neonatal care. The package is designed to assist resource planning through simulations of needs assessment analysis, procurement, technology management, and cross-departmental planning. Field tests of a simplified generic version began in 2002. The package will be technically reviewed by experts and final- ized in 2003, with country adaptation in several of the MPR spotlight countries. Health and human rights assessment tool for maternal and neonatal health Under the leadership of the Department’s Gender and Reproductive Rights (GRR) team, the MPR team has collab- orated in the development of a tool that uses a rights-based approach to assessing and addressing the legal, policy, regulatory and practice aspects that influence maternal and neonatal health. A focus for technical support to countries will be on capacity building to use human rights as a frame- work for integrating maternal and neonatal health issues in national development plans. Field-testing of the tool has begun in Switzerland and will begin in Mozambique in 2003 (for details, see the chapter on Gender and reproductive rights in reproductive health). A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 90 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 91 TECHNICAL SUPPORT TO COUNTRIES A major thrust of the work of MPR is to provide technical and policy support to countries for the development, implementa- tion and evaluation of national plans to improve maternal and neonatal health and thereby reduce maternal and newborn morbidity and mortality. Activities continued in the 10 MPR spotlight countries, and have been increasingly implemented in other countries. These activities build on existing in-coun- try efforts to improve maternal and newborn health. This section summarizes progress and achievements made through the provision of support by the MPR teams (in WHO Headquarters, regional and country offices) at the policy and strategy level, as well as at the programme development and implementation level. Policy and strategy At the policy and strategy level, support provided to coun- tries has: (i) contributed to increased political commitment for maternal and neonatal health in national health and development plans and; (ii) reviewed/established national and regional policies and strategies to ensure that issues related to maternal and neonatal health are adequately and strategically addressed. In this regard: •• In addition to official government declarations reaffirming the priority of making pregnancy safer in national health plans, assessments of laws, policies and regulations have commenced to identify barriers to priority maternal and neonatal health services in all ten MPR spotlight countries (Bolivia, Ethiopia, Indonesia, Lao People’s Democratic Republic, Mauritania, Mozambique, Nigeria, Republic of Moldova, Sudan, and Uganda), as well as in such countries as Albania, Kazakhstan, Turkmenistan and Uzbekistan. In the latter four countries, efforts have been made to change policy in order to ensure free emergency obstetric care. In the Republic of Moldova, following the revision of the legal framework for the provi- sion of post-abortion care, a decision was made to issue additional regulation in order to ensure the wide use of manual vacuum aspiration. This is in addition to ensur- ing that maternal and neonatal health services become part of the basic package of services in the compulsory health insurance scheme provided by the Government. •• In Indonesia, groups of village midwives, “Bidan Di Desa” (BDD) were trained, mainly with support from the World Bank. During the period under review (2002), sup- port has been provided to review the staffing situation of maternity facilities and identify gaps, and introduce the IMPAC tools in order to update the skills of trained village midwives. As a result of policy dialogue initiated at the country level with MPR support, a presidential decree (No. 77/2000) allowed the three-year BDD contracts to be renewed twice, rather than only once, effectively postponing a decision concerning the future of BDD. One immediate consequence of this decree has been that about 50 000 BDD have been placed so far in vil- lages. Recently, the policy was revised again to allow BDD to renew their contracts without limit, provided the Government deems their performance to be adequate. This will aid the Government’s efforts to integrate village midwives into the public, government-paid health care system. The objective set by this country and by Sudan is to achieve a coverage of one midwife for every village by the year 2006. •• National and sub-national Reproductive Health/Safe Motherhood strategies have been reviewed, developed and are currently being implemented in countries such as Albania, Bolivia, Cambodia, China, Djibouti, Ethio- pia, Indonesia, Kazakhstan, Lao People’s Democratic Republic, Mauritania, Mongolia, Morocco, Mozambique, Nigeria, Papua New Guinea, Philippines, Republic of Moldova, Sudan, Tunisia, Uganda, Uzbekistan, Viet Nam and Yemen. Efforts are also under way in AFRO and in the WHO Regional Offices for Europe (EURO) and the Western Pacific (WPRO) to develop adolescent sexual and reproductive health strategies. •• Fruitful dialogue with the Council of Europe has led to the development of a draft document on maternal morbidity in which it is recommended that countries in the European Region implement MPR as a key strategy to enhance maternal and neonatal health, and reduce maternal-newborn mortality and morbidity. AFRO has developed an advocacy tool for MPR in 2002, using the REDUCE model, that includes policy briefs, leaflets, videos and presentation slides. The tool is targeted at policy-makers and decision-makers to raise awareness and resources for maternal and neonatal health in coun- tries. It has been further adapted for national use in Mau- ritania, Mozambique, Nigeria and Uganda. The WHO Regional Office for South-East Asia (SEARO) published policy guidance and information kits. In the Eastern Mediterranean Region, Sudan conducted a series of workshops for policy-makers at national level and in pilot states/districts. Technical workshops for policy-makers from 11 countries in the Region of the Americas have been held on effective maternal and neonatal health interventions, including that of essential obstetric and neonatal care, and on the importance of increasing the proportion of births attended by skilled attendants. Strengthening of maternal and neonatal health programmes MPR team efforts have contributed to the extension of safe motherhood programmes beyond the 10 MPR spot- light countries, the strengthening of existing maternal and neonatal health programmes and, in many countries, the expansion of national geographic coverage of maternal and neonatal health services. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 92 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 93 •• National Programme Officers or Focal Points for MPR have been established at the ministries of health in the following countries to ensure improved coordination and accelerated implementation of maternal and neonatal health plans: Bolivia, Ethiopia, Kazakhstan, Lao People’s Democratic Republic, Mauritania, Mozambique, Nigeria, Republic of Moldova, Sudan, Uganda and Uzbekistan. •• Support has been provided to increase the numbers of skilled attendants in several countries: (i) in Haiti, the WHO Regional Office for the Americas (AMRO) assisted with the reopening of the School of Midwifery; (ii) in Sudan, student intake in the long-term national training plan for midwives has increased from 300 to 1755 per year; (iii) revision or strengthening of midwifery curricula has been ongoing in 2002 in Bangladesh, Lao People’s Democratic Republic, Mozambique and Sudan; (iv) in the Syrian Arab Republic, efforts have been ongoing to improve the skills of health workers in neonatal resus- citation, control of newborn infections and health care of newborns in critical conditions; and (v) EURO and AFRO conducted MPR training of trainers workshops in essential obstetric care and life-saving skills in several countries. •• Efforts have begun to disseminate, adapt and use IMPAC tools (such as Managing complications of pregnancy and childbirth and Essential care practice guide) in several countries in 2002. This has required the review of national norms, standards and protocols in Albania, Bangladesh, Bolivia, Cambodia, China, Indone- sia, Kazakhstan, Kyrgyzstan, Lao People’s Democratic Republic, Mongolia, Nepal, Nigeria, Philippines, Repub- lic of Moldova, Sudan, Tajikistan, Uganda, Uzbekistan and Viet Nam. •• Assessments of provider performance and quality of services have been conducted in Bolivia, Republic of Moldova and Sudan. Plans to enhance provider skills were developed in these countries in 2002. EURO has also developed assessment follow-up tools for training, which have been field-tested in the Russian Federation, while building regional capacity through the participa- tion of seven other countries in the use of these tools. In Afghanistan and Djibouti, activities have focused on improving health staff skills in emergency and standard obstetric case management, particularly in rural areas. •• Training on maternal death audits has been imple- mented in Cambodia, China and Mongolia to improve management and provision of maternal and newborn services. SEARO held a regional consultation on investi- gating maternal deaths with the representation of policy- makers and planners from different countries. •• In the European Region, technical support and regional courses have been provided to strengthen national capacity to improve crucial aspects of health systems, such as the availability of equipment, supplies and facili- ties. This has taken place in Albania, Armenia, Georgia, Kazakhstan, Lithuania, Republic of Moldova, Russian Federation, Tajikistan and Uzbekistan. A regional course for top-level clinicians and decision-makers on evi- dence-based maternal and neonatal health care has been developed in 2002. Training on quality of care was conducted in Georgia and the Republic of Moldova. Audit of quality of care has been conducted in the latter country during 2002. Recommendations for follow-up were presented to the Ministry of Health and implemen- tation has started. An MPR documentation centre has also been established in the Republic of Moldova. •• In the Eastern Mediterranean Region, collaboration has been ongoing since 1999 with CDC in developing managerial skills at district and peripheral levels through integrating total quality management approaches in maternal and perinatal health care. The initiative was field-tested in 2002 and will be disseminated in early 2003. •• An emergency health care plan for the northern Cau- casus was developed in 2002, which includes MPR, “Promoting Effective Perinatal Care” and “Integrated Management of Childhood Illnesses”. •• In the African Region, efforts were made to accelerate the development of national reproductive health sub- programmes with the assistance of UNFPA, the United Nations Children’s Fund (UNICEF) and the World Bank, among others. •• Regional consultations were organized by AFRO, SEARO and WPRO to select a minimum package of indicators for the monitoring and evaluation of maternal and neonatal health programmes including MPR inter- ventions in the respective regions. •• The WHO Regional Office for the Eastern Mediterra- nean (EMRO) has, in collaboration with CDC, developed training materials on the use of data for decision-making in maternal and perinatal health care. These materi- als were disseminated to all the Member States in the region in 2002. Family health surveys are being con- ducted in Djibouti and Yemen to update the database on maternal and neonatal health and strengthen the national programmes on the protection and promotion of maternal and perinatal health in these countries. Efforts are currently in place within some states of Sudan to improve data on service utilization in hospitals, as well as to pilot a community-based information system. •• The MPR team has collaborated in the preparation of protocols for a multicountry study in the African Region to look at community and facility interventions to reduce the “three delays”. Community-level interventions will aim at increasing involvement and support for maternal A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 92 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 93 and neonatal health from individuals (including males), families and the community as a whole. •• Technical and policy support was provided to enhance the role of women, men, families and communities in improving maternal and neonatal health. In Sudan, the Sudanese Women’s Union was included in the develop- ment and implementation of skilled attendant plans in the communities; in Bolivia, workshops were conducted to equip community leaders, women’s groups and peas- ants’ associations with skills for promoting the use of health care services during pregnancy, childbirth and the postnatal period; in the African Region, a framework is being developed to support community actions that have an impact on the health of pregnant women and their newborns; in EURO, an initial inventory of information, education and communication materials in reproduc- tive health and making pregnancy safer has been con- ducted. •• MPR/Safe Motherhood ministerial committees, task- forces or partners coordination committees at national level have been established or revitalised and are meet- ing to a greater extent on a routine basis in all of the regions, namely within the following countries: Albania, Bangladesh, Bolivia, Ethiopia, India, Indonesia, Myan- mar, Nepal, Nigeria, Mauritania, Mozambique, Republic of Moldova, Sudan, Uganda and Uzbekistan. •• Partner collaboration with UN agencies and NGOs has been established at global, regional and country levels in efforts to reduce maternal-newborn morbidity and mor- tality in line with the MDGs. A joint consensus document, entitled Regional strategy for maternal mortality and morbidity reduction, has been developed and approved by AMRO, UNICEF, UNFPA, the Inter-American Devel- opment Bank, the World Bank, and Family Care Interna- tional, and Member States, to be distributed soon in the Region of the Americas. In the Eastern Mediterranean Region, a joint plan of action for making pregnancy safer has been developed in 2002 to be implemented jointly by EMRO and UNICEF’s Middle East and North Africa Regional Office (MENARO). A joint UNICEF and WHO strategy for the European Region has been established for the prevention of MTCT of HIV. The MPR initiative, and the programmes of HIV/AIDS and Child and Ado- lescent Health and Development within UNICEF and WHO will implement the strategy in 2003. Collaboration has been established with UNICEF and other partners (including CDC) to adopt international definitions of peri- natal and infant mortality in the European Region. OTHER ACTIVITIES •• The MPR web site has been further developed during 2002 and can be accessed at: http://www.who.int/ reproductive-health/MNBH/index.htm. •• The Safe motherhood newsletter serves as a platform for information sharing and continued dialogue among partners. Each edition is centred on a specific theme. The most recent issue published in 2002, for example, focused on the need for skilled attendants. The newslet- ter will continue to be produced twice a year beginning in 2003. •• MPR contributed to the development of the WHO document Strategic directions for improving child and adolescent health. The document includes reference to the importance of maternal health and care for child and adolescent health. It will be presented at the World Health Assembly in 2003. •• The MPR team has worked with the Department of Nutri- tion for Health and Development in developing an Infant and young child feeding strategy, which was presented at the World Health Assembly in 2002. Practical implica- tions of the strategy have been included in MPR norms and tools, and MPR will thus play an important role in supporting the implementation of the strategy in coun- tries. •• MPR participated in the preparatory meeting (convened in Stockholm, Sweden in 2002), for the United Nations Special Session on Children, held in New York, NY, USA, in May 2002, and in the Special Session itself (New York, NY, USA, May 2002). At these events, MPR contributed to a special session on the newborn, followed the Ad Hoc Committee deliberations and advocated, at all opportunities, for action to support the need for skilled attendants to ensure a healthy start in life. •• The MPR team has contributed to the development of a global framework and plan of action for the Strate- gic directions for strengthening nursing and midwifery services, developed in response to the World Health Assembly resolution 54.12 adopted in May 2001. This work has been spearheaded by the Department of Health Services Provision. As an integral part of this work, MPR participated in the Global Advisory Group Meeting for Nursing and Midwifery in October 2002. MPR is working closely with the Department of Health Services Provision to ensure that aspects of this plan of action are integrated in all relevant areas of work in MPR. •• MPR has collaborated with the Human Resources team in the Department of Health Services Provision on Human resources and national health systems: shaping the agenda for action. The MPR team contributed to the development of a background document and took part in a workshop in December 2002. As a result of this work- shop, it has been suggested that the Human Resources for Health (HRH) framework, intended to diagnose human resources problems, be tested by applying it to maternal and neonatal health and to plan appropriate A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 94 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 95 human resources interventions to achieve the related MDGs. Collaboration in this area will also include work- ing with the World Bank in 2003 on relevant HRH policy issues. •• MPR collaborated with the Department of Communicable Disease Surveillance and Response, with the Depart- ment of HIV/AIDS and with other teams in the Depart- ment to prepare a lecture on “The role of surveillance in preventing consequences of transmissible diseases during pregnancy” in an international course organized by the Swiss Tropical Institute, Basel, Switzerland. Col- laboration with the Swiss Tropical Institute continues to support and strengthen studies related to surveillance of transmissible diseases during pregnancy. •• MPR has collaborated with the Department of Child and Adolescent Health and Development in the formation of a working group on adolescents and pregnancy. A back- ground document has been prepared and a consultant hired to review the literature on Strategies for ensuring adequate access and good quality of care for pregnant adolescents. • MPR worked with the Departments of HIV/AIDS and Roll Back Malaria to develop a framework for integrat- ing activities for the prevention of HIV among infants and young children and malaria control among pregnant women within existing maternal and newborn health services (i.e. antenatal care, delivery care and postnatal care). MPR will play an important role in supporting the implementation of the proposed framework in selected African countries. This is expected to provide key knowl- edge for integrating these activities in other countries. •• MPR has also collaborated with the Department of Com- municable Disease Control, Prevention and Eradication on the development of the WHO strategy on Use of pra- ziquantel during pregnancy. THE WAY FORWARD Building on current work, achievements, constraints and lessons learnt, MPR will continue to focus on areas of work which are critical for the success of the initiative in contribut- ing to progress towards the MDGs. This section highlights MPR’s strategic direction and areas of work for the future. As pointed out below, it is foreseen that MPR will move forward with a strengthened global MPR team (headquarters, regions and countries) and in close collaboration with other UN agen- cies and partners in maternal and neonatal health. •• Reviewing and updating the Making pregnancy safer discussion paper. MPR plans to review the Making pregnancy safer discussion paper in 2003, in line with the strategic focus of the initiative and lessons learnt so far at global, regional and country levels. •• Developing and implementing evidence-based norms and tools. Attention will continue to be given to the development and implementation of evidence-based norms, guidelines, standards and tools for maternal and neonatal health clinical services. However, an increased emphasis will be placed on providing support to coun- tries on adaptation and use of these norms and tools in order to ensure effective implementation of best prac- tices for maternal and neonatal health interventions. In addition to clinical norms, guidelines on strengthening the management, leadership and negotiation skills of maternal and neonatal health managers and planners will also be developed and made available for adapta- tion and use in national programmes for the delivery of effective, equitable and efficient maternal and neonatal health programmes. Guidance will also be developed for improving the interface between the health delivery system and communities as well as for increasing the capacities of women, families and communities for improved maternal and neonatal health. Guidance on maternal and neonatal health policies, laws and regula- tions that are gender-sensitive, respect cultural diversity and are responsive to the needs of the people will also be developed. •• Expanding and strengthening maternal and neonatal health programmes through technical support. MPR will increasingly provide technical and policy support to strengthen national capacity to plan, design and imple- ment effective evidence-based maternal and neonatal health programmes, including service delivery, manage- ment and community interventions. Special focus will be placed on providing technical support to strengthen the leadership and negotiation capacity of health teams at national and district levels to help them develop mater- nal and neonatal health programmes. Current national Poverty Reduction Strategy Papers (PRSPs), Sector- wide Approaches (SWAPs) and Health Sector Reforms (HSRs) will be reviewed in order to develop strategies for improving access to maternal and neonatal health services, especially among the poor and other vulner- able groups. Emphasis will also be placed on providing guidance to countries on human resource development policies and the strategies necessary to achieve the MDG indicator on the proportion of births attended by skilled health personnel. Technical support will be scaled up to include additional countries as selected by the regional offices. •• Increasing political commitment for maternal and neonatal health through advocacy. MPR will continue to seek support among interested parties at global, regional and country levels, to increase resources, promote consistent, equitable and evidence-based policies, and ensure that safe motherhood is kept high on the agenda. Special efforts will be made to increase and maintain political commitment and priority focus to maternal and neonatal health in national development A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 94 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 95 plans with a focus on increased access for the poor, and a strong emphasis on the availability and acces- sibility of skilled attendants. There will be an associated need to develop and equip partners, governments and senior management with advocacy tools, skills and evidence-based advocacy materials to focus on priority interventions and strategies for making pregnancy safer at country, regional and international levels. •• Partnership building and improved collaboration. MPR will galvanize dynamic partnerships and collabora- tions at global, regional and country levels among United Nations agencies, bilateral and lending agencies, pro- fessional associations, public, private and civil society to strengthen and improve commitment to and coordina- tion of maternal and neonatal health plans and activities. There will be an emphasis on ensuring that safe mother- hood, including skilled attendants for maternal and neo- natal health, is kept high on the health and development agenda. At country level, MPR will contribute towards the effective coordination of maternal and neonatal health work and toward the integration of maternal and neona- tal health in national policies, for instance PRSPs and HSRs, United Nations Development Assistance Frame- works (UNDAFs), SWAPs, etc. Furthermore, efforts will be intensified to enhance effective coordination of work within the MPR global team in 2003. Mechanisms will be put in place to improve communication and sharing of information in order to improve coordination of all MPR work. •• Providing guidance on improving data sets and data collection systems for monitoring maternal and neonatal health. MPR will continue to conduct global monitoring of maternal and perinatal health indicators in order to monitor progress towards universally agreed goals and milestone, e.g. MDGs and ICPD targets. MPR will also monitor and evaluate implementation of the work supported by the initiative, including assessment of maternal and neonatal health programmes at country level in order to document progress and lessons learnt. The initiative will also provide technical guidance to countries on improving monitoring of maternal and peri- natal health outcomes as well as monitoring of maternal and neonatal health programmes and services. A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 96 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 97 Annex 1a MATERNAL AND NEONATAL HEALTH STRATEGIC COMMITTEE IN 2002 Yusuf Ahmed, Department of Obstetrics and Gynaecology, School of Medicine, Lusaka, Zambia Mohammed Ali Baldo, Ministry of Health, Riyadh, Saudi Arabia Nicola Hyam Bashour, Damascus University, Damascus, Syria Bruno Dujardin, Ecole de Santé Publique, Brussels, Belgium Teresa Gonzalez-Cossio, Universidad No. 665, Cuernavaca, Mexico Ellen Hodnett, University of Toronto, Ontario, Canada Kanshana Siripon, Ministry of Public Health, Nothaburi, Thailand Mandiaye Loume, Direction de la Sante, Dakar, Senegal Festin Mario, Department of Obstetrics and Gynaecology, University of the Philippines, Manila, Philippines Jack Moodley, Nelson R Mandela School of Medicine, Congella, South Africa Margret Peters, Victoria, Australia Siddarth Ramiji, Mulana Azad Medical College, New Delhi, India Mary Renfrew, Mother and Infant Research Unit, University of Leeds, Leeds, United Kingdom Xu Qian, School of Public Health, Fudan University, Shanghai, China Collaborating agency scientists Guiseppe Benagiano, FIGO, London, United Kingdom Collin Bullough, IMMPACT, University of Aberdeen, Aberdeen, United Kingdom Marilen Danguilan, UNICEF, New York, NY, USA Fadel Diadhiou, African Society for Gynaecologists-Obstetricians, Dakar, Senegal France Donnay, UNFPA, New York, NY, USA Wendy Graham, IMMPACT, University of Aberdeen, Aberdeen, United Kingdom Frances Granges, Save the Children, Washington, DC, USA Judith Oulton, International Council of Nurses, Geneva, Switzerland Khama Rogo, The World Bank, Washington, DC, USA Allan Rosenfield, Columbia University, New York, NY, USA Barry Scheer, International Association of Paediatrics, London, United Kingdom Petra Ten Hoope-Bender, International Confederation of Midwives, The Hague, Netherlands Anne Tinker, Save the Children, Washington, DC, USA Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 11 79 3 21 14 Women 1 7 3 21 4 from: AFRO 3 21 3 AMRO 1 7 1 7 2 EMRO 2 14 2 EURO 2 14 2 SEARO 2 14 2 WPRO 2 14 1 7 3 A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 96 A n n u al Tech n ical R ep ort 2002 Implementation of evidence-based programmes 97 Annex 1b MATERNAL–NEWBORN HEALTH AND POVERTY ADVISORY GROUP IN 2002 Members Marge Berer, Reproductive Health Matters, United Kingdom John Cairns, IMMPACT, University of Aberdeen, Aberdeen, Scotland, United Kingdom Bjorn Ekman, Lund University Centre for Health, Lund, Sweden Lynn Freedman, Millennium Development Goals Task Force No. 4 on Maternal and Child Health, New York, NY, USA Frances Ganges, Save the Children, Washington, DC, USA Montasser Kamal, Canadian International Development Agency, Quebec, Canada Jerker Liljestrand, Lund University Centre for Health, Lund, Sweden Rosina Lipyoga, Muhimbili National Hospital, Dar Es Salam, United Republic of Tanzania Deborah Maine, Averting Maternal Death and Disabilities, Columbia University, New York, NY, USA Dileep Mavalankar, Averting Maternal Death and Disabilities, Indian Institute of Management, Vastrapur, India Vinod Kumar Paul, All India Institute of Medical Sciences, Ansari Nagar, India Jane Pepperall, Department for International Development, London, United Kingdom Petra Ten Hoope-Bender, International Federation of Midwives, The Hague, Netherlands David Woodward, Development Economist, Geneva, Switzerland Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 3 21 11 79 14 Women 1 7 6 42 7 from: AFRO 1 21 1 AMRO 4 28 4 EMRO EURO 7 49 7 SEARO 2 14 2 WPRO Collaborating agency scientists Marilen Danguilan, UNICEF, New York, NY, USA France Donnay, UNFPA, New York, USA Abdel El Abassi, UNICEF, Geneva, Switzerland Vincent Fauveau, UNFPA, Geneva, Switzerland Elisabeth Lule, The World Bank, Washington, DC, USA Evy Messell, International Labour Office, Geneva, Switzerland Khama Rogo, The World Bank, Washington, DC, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 98 A n n u al Tech n ical R ep ort 2002 99 A n n u al T ec h n ic al R ep or t 2 00 2 Section 2 - Making Pregnancy Safer 98 A n n u al Tech n ical R ep ort 2002 99 Section 3 Controlling sexually transmitted and reproductive tract infections A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 100 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 101 Controlling sexually transmitted and reproductive tract infections T.M.M. Farley, F. Ndowa, N. Broutet, B. Deperthes, I. de Vincenzi, S. Dludlu, A. Dzokoto, J. Mandala, I.M. Malonza, D. Mugditchian, J. Samuelson INTRODUCTION Sexually transmitted and reproductive tract infections (STIs and RTIs) are responsible for a considerable burden of reproductive ill-health worldwide, both directly and through their ability to enhance the risk of transmission or acquisi- tion of the human immunodeficiency virus (HIV). Some 340 million curable STIs are estimated to occur worldwide each year, and many millions of incurable viral STIs occur annu- ally, including an estimated 5 million new HIV infections. WHO’s role in contributing to the reduction of the disease burden associated with STIs and RTIs extends across all WHO core functions: advocacy, information management, research and evidence, technical cooperation and policy support, setting norms and standards, and developing new technologies, tools and guidelines. In May 2002, the Department assumed responsibility for all WHO’s STI and RTI work with the transfer of the Unit for STI from the HIV/AIDS Department. This has provided the opportunity to take a coherent view of WHO’s strategies and policies for STI control, including global advocacy, country support and technical issues (research, guideline develop- ment and normative functions) with the overall aim of pre- vention and care of STIs, RTIs and their complications. The Department has identified the need to position STI control as a separate, though overlapping, component of a compre- hensive approach to sexual and reproductive health and HIV control (Figure 3.1). In the 1960s and 1970s, STIs were mainly considered from the point of view of infertility and stigmatized on other fronts—STI control was a component of family planning and reproductive health programmes. In the 1980s, the manage- ment of STIs was identified as one of the key approaches to controlling the HIV pandemic, but the focus of many HIV/ AIDS programmes has since turned to other issues such as expansion and sustainability of antiretroviral therapies and care, overshadowing the importance of STIs. The revised mandate of the Control of Sexually Transmitted and Reproductive Tract Infections Team in the Department is to promote and develop guidelines and tools for STI and RTI policy, programme planning and implementation; to estab- lish the evidence for new and improved STI and RTI control strategies; to conduct research on the prevention of mother- to-child transmission (MTCT) of HIV and other STIs; and to advocate for and conduct research on the development and deployment of safe and effective microbicides. In order to fulfil this mission, the Team collaborates with a number of partners within the Organization, WHO country and regional offices, international agencies, research networks and non- governmental organizations (NGOs). Figure 3.1. Components and areas of work in a com- prehensive model of sexual and reproduc- tive health and HIV control STI HIV Reproductive Health A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 100 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 101 RESEARCH ACTIVITIES Female condoms Objective and rationale The female condom provides a means of protection for women when male condoms are not available or not accept- able. The method is under the control of the woman and requires no, or less, cooperation from her male partner. WHO’s female condom research addresses whether female condoms provide equivalent protection against pregnancy and STIs as male condoms. Progress A contraceptive effectiveness study is being conducted in Chengdu (China), Durban (South Africa), Panama City (Panama) and Sagamu (Nigeria). Five hundred women choos- ing the female condom for contraception will be enrolled, and compared with a similar number of male condom users. The study participants will be followed monthly for six months and two-monthly thereafter to one year. The main phase started in August 2002. By the end of November 2002, 528 women had been admitted, 68% of whom chose to use the female condom. After one week, 75% of novice female condom users decided to continue using the device. The remaining 25% switched to male condoms. Recruitment of women to use female condoms for contraception in Panama and South Africa is expected to take longer since many potential volunteers already use male condoms or hormonal contraception. The first-month follow-up visit was completed by 409 women (159 and 250 in the male and female condom groups, respec- tively). Fifty-seven women (51 in the female condom group) withdrew after the first week training period, mainly because of partner objection or discomfort during intercourse. Three- quarters reported difficulties using fingers to insert the device, leading to discomfort from incorrect positioning. Twenty requests for emergency contraception—9 in the male and 11 in the female condom group—have occurred, the main reasons being breakage (male condom group) or slippage or incorrect insertion (female condom group). No pregnancies have been reported. In China, more female condom users will be recruited because of the high discontinuation rate. In Nigeria, poten- tial volunteers are more interested in the female than male condom and identifying a matching number of male condom users may be difficult. Biological markers are an extremely sensitive method of assessing whether condoms prevent exposure to semen or STIs during intercourse. Postcoital Prostate Specific Antigen (PSA) levels have been used to compare the efficacy of male and female condoms in preventing exposure to semen. WHO extended the concept to detect whether any exposure to sexually transmitted pathogens occurs following inter- course with an infected partner. A study will be conducted in sex workers in South Africa using self-administered vaginal swabs before and after inter- course, and the used condom will be assessed for signs of infection in the ejaculate. Pilot projects to assess the accept- ability and practicality of the study will start in 2003. The first study will assess whether volunteers are willing to participate in the study, the frequency of intercourse, and the STI preva- lence among their male clients. The second study will assess the performance of self-collected vaginal swabs compared with swabs collected by a clinician in the detection of sexu- ally transmitted pathogens. This information will be used to plan the main study. Prevalence of STIs and RTIs Objective and rationale The data currently available to describe the etiology and prevalence of important RTIs remain limited, especially in resource-constrained settings. The capacity of researchers in such settings needs strengthening so that countries can conduct high-quality research to target programmatic inter- ventions. The Department provides technical and financial support to studies on RTI prevalence in the Asia-Pacific region, identified as a priority topic by the Department’s Asia- Pacific Regional Advisory Panel. Progress Three studies assessing the prevalence of STIs and RTIs have been or are nearly completed and the final papers are being prepared. In Viet Nam, a multicentre, cross-sectional study on the prevalence of lower genital tract infections in 1000 women aged 18–44 years attending maternal and child health and family planning clinics in Hanoi during 1998 was completed. Results showed a 4.4% prevalence for Chlamydia trachoma- tis (C. trachomatis), 1.3% for Trichomonas vaginalis (T. vagi- nalis), 11% for Candida species, 3.5% for bacterial vaginosis (BV). No gonococcal infections were identified. Lower genital tract infection was not associated with reported symptoms of vaginal discharge. A study in Mongolia on mothers’ knowledge, perception and health-seeking behaviours related to their prepubertal daughters’ vaginal discharge is nearly completed. This study was undertaken because high proportions of prepubescent girls were diagnosed with abnormal discharge at the State Research Centre on Mother and Child Health and Human Reproduction, Ulaanbataar. Seven hundred prepubertal girls, accompanied by their mothers, who attended the centre with a complaint of vaginal discharge, were enrolled in the study. Final analyses will include knowledge and per- A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 102 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 103 ceptions among the mothers regarding their daughters’ vagi- nal discharge, contributing factors to perceived high rates of vaginal discharge in this age group, and factors influencing health-seeking behaviours. A study in Vientiane, Lao People’s Democratic Republic, on the prevalence of RTIs in antenatal clinic patients in two central hospitals is near completion, with final analyses expected in 2003. Five hundred pregnant women of 20 or fewer weeks gestation attending their first antenatal care visit were included, 250 from the Mother and Child Hospital and 250 from Sethathirath Hospital. A new study on the prevalence of lower genital tract infec- tions in rural women in Sichuan province, China, will start in 2003. Two thousand rural married women between 20 and 49 years of age will be recruited. The prevalence of and risk factors for C. trachomatis, Neisseria gonorrhoeae (N. gonorrhoeae), syphilis, human papilloma virus, herpes simplex virus 2 (HSV2), T. vaginalis and bacterial vaginosis will be assessed. Demographic characteristics and marital, obstetric, contraceptive, sexual and medical history will be obtained from a structured interview prior to physical exami- nation. Study participants will be recruited in 2003, with analysis of the results in 2004. A similar cross-sectional study will be conducted on the prevalence of RTIs in 700 women aged 15–49 years attend- ing the family planning clinic at Central Women’s Hospital in Yangon, Myanmar. Demographic, contraceptive, sexual, obstetric and medical histories will be collected and followed by physical examination and laboratory diagnostics to assess the prevalence of T. vaginalis, candida, bacterial vaginosis, N. gonorrhoeae, C. trachomatis, syphilis and HSV2. This study will enrol participants in 2003, with completion in 2004. Pelvic inflammatory disease following induced abortion Objective and rationale A multicentre nested case-control study on the incidence and risk factors for pelvic inflammatory disease (PID) following induced abortion will be embedded in a study on surgical abortion which will evaluate the effect of vaginal administra- tion of 400 μg of misoprostol prior to vacuum aspiration abor- tion on complications. The misoprostol study is a randomized double-blind controlled trial among women seeking termina- tion of pregnancy before 12 completed weeks of gestation. Five thousand women will be recruited in 14 centres in nine countries, and followed-up 7 and 14 days after abortion. The risk of post-abortion upper genital tract infection resulting from pre-existing RTIs will be assessed in the nested study, which will also explore the effectiveness of different screen- ing or antimicrobial administration strategies prior to induced abortion to prevent infections. Progress One hundred eighty cases with four controls per case are expected. The study will be implemented in 2003 together with the misoprostol trial. Antiretroviral therapy, MTCT and mother’s health Objective and rationale Despite recent advances in ways of reducing the risk of MTCT of HIV, and an expansion of programmes using single-dose nevirapine to reach more pregnant women, transmission rates remain persistently higher in developing than developed countries, and acceptability remains low. The acceptability, safety and effectiveness of triple-combination antiretroviral (ARV) prophylaxis to reduce MTCT are being addressed in research conducted by the Department. Progress The protocol to study the impact of Highly Active Antiretrovi- ral Therapy (HAART) on MTCT and mother’s health was fur- ther developed in 2002. The main objective is to assess the efficacy, tolerability and acceptability of a triple antiretroviral combination containing zidovudine (ZDV), lamivudine (3TC) and nevirapine (NVP) given for at least seven months (from 34 weeks gestation to 6 months postpartum) to HIV-positive pregnant women with CD4+ cell counts below 500 cells/mm3, compared to ZDV plus NVP prophylaxis for one month. The specific objectives are: • to prevent MTCT in populations where breastfeeding is the predominant mode of infant feeding despite offer of free breast-milk substitute; • to reduce HIV-related morbidity and increase two-year survival among HIV-positive mothers; and • to reduce two-year morbidity and increase survival among children born to HIV-positive mothers. The study will offer a comprehensive approach to MTCT prevention, but the intervention and study objectives differ according to the clinical stage of disease in the mother. Thus the study includes: • An observational study describing health outcomes among women with WHO clinical stage 4 or CD4+ count <200 cells/mm3 receiving the triple combination regimen and their newborns. Such women will be offered life-long ARV therapy. • A multicentre randomized controlled clinical trial com- paring the short ZDV plus NVP regimen given from 34 weeks pregnancy to delivery with the triple combination regimen given from 34 weeks pregnancy to 6 months postpartum, associated with rapid weaning of the child A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 102 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 103 at 6 months, among women with CD4+ counts between 200 and 500 cells/mm3 (and clinical stage lower than 4). • An observational study assessing the effectiveness of the MTCT-prevention package including the short ZDV plus NVP regimen, among women with more than 500 CD4+ cells/mm3 (and clinical stage lower than 4). Principal investigators and collaborating research agencies met in November 2002 to review draft study instruments and issues related to study implementation. It is expected that study instruments will be ready by March 2003 and enrol- ment will begin in May or June 2003. Sites identified for the study include: The Network of AIDS Research of Southern and Eastern Africa study clinic in Nairobi, Kenya, with financial support from the Centers for Disease Control and Prevention (CDC) and the US National Institutes of Health (NIH); The Coast General Hospital, in partnership with the International Centre for Reproductive Health, both in Mombasa, Kenya, with partial financial sup- port from the Belgian Directorate General for International Cooperation; The Kilimanjaro Christian Medical Centre in Moshi, United Republic of Tanzania; the Centre Muraz in Bobo-Dioulasso, Burkina Faso, with support for research expected from the French Agence Nationale de Recherche sur le SIDA, although additional funds are required to accel- erate and expand the MTCT-prevention facilities. These four sites will enrol 1500 HIV-positive women, while 2500 are required to achieve the study objectives. Addi- tional sites in Cotonou (Benin), Harare (Zimbabwe), Kigali (Rwanda), and Kinshasa (Democratic Republic of the Congo) are under consideration. Safety of antiretroviral regimens to prevent MTCT of HIV Objective and rationale Transient emergence of resistant HIV strains has been reported following short prophylactic regimens to prevent MTCT, particularly with single-dose nevirapine. The objec- tive is to discover whether this resistance has any negative impact on the efficacy of therapeutic antiretroviral regimens when such treatment is initiated months or years later. Progress A study protocol to assess the clinical response of women initiating combination antiretroviral therapy has been drafted. The study will be conducted in sites where MTCT-preven- tion interventions have been available for several years and standard ARV therapies are being offered to women who require treatment. Identification of potential study sites and principal investigators, together with further development of detailed study procedures and instruments will be under- taken in early 2003. Safety of cellulose sulfate Objective and rationale There is a need to expand the range of available female-con- trolled methods to prevent STIs including HIV. Microbicides, used in the vagina or rectum, offer such a possibility. Approxi- mately 50 promising candidate products are under develop- ment, 15 of them in clinical research. In partnership with CONRAD, WHO is implementing a three-centre randomized double-blind Phase I study of the safety and acceptability of cellulose sulfate gel compared with K-Y Jelly among healthy women volunteers in Kampala (Uganda), Mumbai (India), and Sagamu (Nigeria). The products are applied in 3.5 ml doses twice daily for 7 days, in a cohort of 30 women in each centre not having sexual intercourse (cohort I), followed by a similar cohort of women having intercourse (cohort II). The study endpoints are symptoms and signs of irritation of the external genitalia, cervix, and vagina, and epithelial disrup- tion as seen on colposcopy. Progress Recruitment of volunteers for cohorts I and II was completed in Kampala in September 2002. Two volunteers were lost to follow-up; two discontinued due to onset of menses, and one discontinued gel application complaining of vaginal itch- ing. In Sagamu, cohort I was completed in July 2002 with no premature discontinuations and 22 volunteers had been enrolled in cohort II by mid-November. In Mumbai, the study started in July and 19 volunteers had been recruited into cohort I by November. No serious adverse events have been reported. Some of the mild adverse events reported include vaginal itching, vaginal discharge and vaginal bleeding (not considered to be associated with gel application). The study is expected to be completed by April 2003. NORMS AND TOOLS Specific objectives/targets The objectives of the norms and tools developed by the Department are to increase the availability of high-quality, culture- and gender-sensitive and non-stigmatizing services for the prevention, care and management of STIs/RTIs and their complications, to broaden the range of safe, effective and affordable methods of preventing and managing STIs/ RTIs and MTCT of HIV and other STIs, and to contribute towards the strengthening of national health system capacity to deliver these services. New norms/tools developed During 2002, the Team continued the development and assessment of tools and guidelines for the prevention and management of STIs and RTIs. A wide range of guides and guidelines have been developed and others are in progress or under discussion for 2003. A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 104 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 105 Conceptual framework of STI/RTI control for programme managers To provide an overall picture of STI control strategies of proven effectiveness, WHO is developing a conceptual framework of STI/RTI control for programme managers. This guide, currently in draft form, covers the basic elements of an STI/RTI control strategy, together with a summary of the tools and guides available. It will help managers in planning devel- opment and implementation of a control strategy adapted to the particular social and epidemiological conditions of the country or setting in question. The draft framework will be ready in early 2003 for external review by experts and pro- gramme managers before being fi nalized and disseminated to programme managers during 2003. STI/RTI programme guidance tool This decision-making tool is an adaptation of the Strategic Approach for contraceptive technology introduction (found in the WHO document, Making decisions about contraceptive introduction [WHO/RHR/02.11]) to the problems of STI and RTI control and management. It considers a broad range of programmatic interventions and assists programme manag- ers in identifying information required to make decisions on the interventions most appropriate to their national context. With the experience gained in fi eld trials in Brazil, Cambodia, Ghana and Latvia, the STI/RTI programme guidance tool has been rewritten in a simplifi ed, more user-friendly way for distribution in 2003. It is currently being piloted in selected provinces in China to identify and implement appropriate interventions for STI/RTI control. STI/RTI management in reproductive health care settings: a guide for essential practice (ECPG) Clients presenting to reproductive health facilities such as family planning, antenatal care or some other primary health care services have different patterns of risk factors for, and prevalence of, STIs and RTIs from patients presenting with STI complaints to specifi c STI services. The ECPG for STI/RTI provides a comprehensive approach to STIs and RTIs (including counselling, preven- tion, screening, case-fi nding, and management) adapted to the needs of such clients. The guide is compatible with other guides and tools devel- oped by the Department, including the essential practice guide for pregnancy and childbirth, that for family planning, as well as the syndromic approach to STI management which is specifi - cally targeted at the needs of patients presenting with complaints and/or symptoms of acute STI. The ECPG for STI/RTI includes three docu- ments: 1—a practical guideline for health care providers (narrative document and pocket guide); 2—an implementation and adaptation guideline for programme managers; and 3—training guidelines for health care providers. The health care providers’ practical guide is ready for fi eld-testing in Brazil, China, India, Jamaica, Kenya, and Latvia. The programme managers’ guideline will help programme man- agers to identify and interpret national and local data on STIs/RTIs and behaviours determining their epidemiology. The programme managers’ guideline will be developed and fi eld-tested in Figure 3.2. Prevalence of positive syphilis serology (RPR) by year of study in South Africa1 Figure 3.3. Prevalence of chancroid and genital herpes by year of study in South Africa1 1 Htun Y, Ballard R. Management of genital ulcer diseases (GUD) in South Africa: aeti- ology of GUD among mine workers in South Africa (1986 to 1998). Presented at the WHO Consultation on Improving the Management of Sexually Transmitted Infections, 28–30 November 2001 (unpublished). Prevalence (%) 35 30 25 20 15 10 5 0 1986 1990 1994 1998 CHANCROID GENITAL HERPES 80 70 60 50 40 30 20 10 0 Prevalence (%) 1986 1990 1994 1998 1 Htun Y, Ballard R. Management of genital ulcer diseases (GUD) in South Africa: aeti- ology of GUD among mine workers in South Africa (1986 to 1998). Presented at the WHO Consultation on Improving the Management of Sexually Transmitted Infections, 28–30 November 2001 (unpublished). A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 104 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 105 2003 together with the training manual to complement other STI/RTI manuals. Updated STI management guidelines The syndromic approach developed by WHO has been a key element in STI management in resource-limited set- tings. New data on genital ulcer disease (GUD) epidemiol- ogy and experience with management of vaginal discharge syndromes were reviewed at a consultation of STI experts to update the WHO Guidelines for the management of sexually transmitted infections. Recent data point to a worldwide increase in the prevalence of sexually transmitted HSV2 which is a major cause of GUD, especially in the developing world. This is substantiated by data from China, South Africa, Sri Lanka, and Uganda. In South Africa the contribution of syphilis and chancroid to GUD have declined while HSV2 has increased (Figures 3.2 & 3.3). HSV2 is the major cause of GUD in men and women attend- ing STI clinics in Sri Lanka (Figure 3.4), while syphilis consti- tutes only 3% of pathogens in men and none in women, and no chancroid was detected in men or women. Syphilis was highly prevalent in the setting studied in China, and HSV2 was responsible for 31% of ulcers alone or con- comitantly with syphilis (Figure 3.5). The main change to the GUD management flowchart included in the Guidelines for the management of sexually transmitted infections was to include HSV2 treatment where seroprevalence is 30% or higher. This treatment provides symptomatic relief, decreases viral shedding and decreases the duration of symptoms. WHO was urged to advocate for access to affordable STI drugs, including the HSV2 antiviral drug, acyclovir. Similarly, WHO was asked to facilitate devel- opment of rapid diagnostic tests for HSV2 to help countries assess prevalence in various populations. Despite the difficulty of distinguishing vaginal and cervical infections in women presenting with vaginal discharge, the consultation agreed that syndromic management remains the recommended STI case-management approach, espe- cially in resource-constrained settings. To avoid high levels of over-treatment for cervical infection in women with vagi- nal discharge, decisions on treatment for gonorrhoea and Chlamydia should be based on the prevalence of these infections. WHO was urged to develop guidelines and tools to assist programme managers calculate the prevalence of infection below which syndromic management is not cost- effective. The consultation recommended: (i) that azithromycin be removed as treatment for gonococcal infections follow- ing some early reports of resistance, but that it should be continued for treatment of chlamydial infections; and (ii) that training and supervision were critical components of STI management. STI management guidelines adapted to meet the needs of adolescents and of children were developed in collaboration with the WHO Department of Child and Adolescent Health and Development. Training modules for the management of STIs To improve the quality of STI care at country level, WHO developed workbooks and tools for countries to use or adapt, and to train health personnel in STI management. Following a survey of the use and adaptation of the training modules and the new elements in STI epidemiology and manage- ment strategies, Ashford Open Learning, United Kingdom, was contracted in May 2001 to produce seven modules and a trainers’ guide, including hard copies, a CD-ROM version and an interactive CD-ROM-based e-learning version. The tool, provisionally entitled Training modules for the manage- ment of sexually transmitted infections, will be available in the first quarter of 2003. Assessment of cost–effectiveness tool In 2002, the Department finalized and sponsored the assess- ment in Thailand of a cost–effectiveness tool for MTCT-pre- vention. The tool had been prepared for the Joint United Nations Programme for HIV/AIDS (UNAIDS). The assess- ment concluded that the tool was well-defined, user-friendly and could be used by a non-health economist. Clinical guides for the management of pregnant women with HIV infection The Department developed a set of Clinical guides for the management of pregnant women with HIV infection, consist- ing of four separate but complementary booklets, namely: Voluntary counselling and testing for HIV in pregnant women; Antenatal care for HIV-infected women; Labour and delivery care for HIV-infected women; and Post-pregnancy care of HIV-infected mothers and their infants. The target audience ranges from policy-makers to health care providers in central or peripheral health facilities in resource-limited settings. The guides help providers implement programmes to prevent MTCT of HIV and provide appropriate care and support for HIV-positive mothers. In 2001 and 2002, the guides were field-tested in urban and rural areas in the Bahamas, Ethiopia, Guyana, Kenya, and Thailand. The field-testing revealed the need for adaptation of some WHO policies and guides (e.g. on feeding options and immunization schedules for infants born to HIV-positive mothers). The adapted policies and the field-testing experi- ence were consolidated into the final version of the guides in 2002 in collaboration with the WHO Regional Office for Africa (AFRO) and experts from the Chris Hani Baragwanath A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 106 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 107 Hospital, Johannesburg, South Africa. The English version will be ready for distribution in mid 2003. It is anticipated that the guides will be translated into French, Spanish and Portuguese and disseminated to many coun- tries. The guides will be reviewed and updated as new infor- mation on the prevention of MTCT of HIV becomes available and new WHO policies and principles are issued. Psychosocial support for HIV-positive mothers and families Psychosocial support is a fundamental need for people diagnosed with HIV, but is seldom considered in MTCT- prevention programmes. The Department commissioned a systematic review of psychosocial support for HIV-positive mothers and their families, which revealed large gaps in scientific and programmatic knowledge. A psychosocial support demonstration project was established in Chitungwiza, near Harare, Zimbabwe, by the Zimbabwe AIDS Prevention and Support Organisation and AFRO, with support from the Department and Italian funds. The project was evaluated in November 2002. Conclusions will be presented in Harare in early 2003 and the key elements will be used as a model for replication in other countries. A guid- ance tool on how to pro- vide psychosocial support for HIV-positive mothers will be developed and field-tested in two coun- tries in 2003. New work undertaken on norms/tools under development Bulletin of the World Health Organization special issue on maternal and congenital syphilis Three case studies on maternal and congenital syphilis conducted between 1999 and 2001 in Bolivia, Kenya, and South Africa showed that national congenital syphilis con- trol programmes were hampered by difficulties in opera- tions, policy and financing. Key issues included: • the magnitude of the problem; • the failure of policy and programme implementation, including lack of financial, technical and operational support to programmes at country level; • whether congenital and maternal syphilis were per- ceived as a problem considering that pregnant women and their newborn infants tended to be followed by different health care providers, that the social impli- cations of syphilis infections were severe, and that patient motivation was poor; Figure 3.4. Genital ulcer profile: Sri Lanka1 P er ce nt ag e Figure 3.5. Main causes of GUD in a sample of STI patients in China1 1 Wang QQ, Mabey D, Peeling RW, Tan ML, Jian DM, Yang P, Zhong MY, Wang GJ. Validation of syndromic algorithm for the manage- ment of genital ulcer diseases in China. International Journal of STD and AIDS, 2002, 13:469–474. 1 Abeyewickreme I. Genital ulcer syndrome: Sri Lanka experience. Presented at the WHO Consultation on Improving the Management of Sexually Transmitted Infections, 28–30 November 2001 (unpub- lished). A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 106 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 107 • whether the tools available were adapted to the objec- tives of the programmes; and • the effectiveness and robustness of diagnostic tools and the effectiveness of treatment. Seven articles addressing the failures and challenges of syphilis control and elimination have been submitted for a special issue of the Bulletin of the World Health Organiza- tion. A 2000 draft guideline, Maternal and congenital syphilis: an outline for prevention and control, was reviewed by an expert meeting in October. The document will be shortened, updated and revised as a reference document, the key ele- ments of which will be incorporated into relevant tools and guidelines being developed by the Department. New norms/tools initiated Development of a global strategy for STI prevention and control WHO works with national governments, international donors, implementing agencies and other UN agencies to implement effective STI control policies and guidelines at country level. To facilitate dissemination, adaptation and adoption of the recommended policies and strategies, WHO is developing an updated global STI strategy that reflects recent evidence and experience in STI control and its impact on the HIV epidemic accumulated at national, regional and global levels. The pre- vious global strategy covered the period 1997 to 2001. The updated strategy will include elements for countries to con- sider as part of their national strategy as well as an assess- ment of the role WHO should adopt to best support national and international STI control measures in partnership with countries and other agencies. The process for updating the strategy commenced with compilation of new elements and issues in the area of STI prevention, control and care. A series of consultations with WHO regional offices, interna- tional partners and selected country programme managers will be undertaken in 2003. The updated draft strategy will be available in late 2003. Country adaptation of global STI management protocols The WHO Guidelines for the management of sexually trans- mitted infections and the ECPG for STI/RTI reflect global recommendations for the management and control of STIs in different health care settings. Countries are encouraged to adapt these guidelines and develop national guidelines based on available evidence and cultural norms for their country or setting. To facilitate this process, AFRO and the Department are collaborating with the London School of Hygiene and Tropical Medicine, London, United Kingdom, and Family Health International, Research Triangle Park, NC, USA, to develop guidance for countries embarking on the adaptation and implementation process. At the same time, work has begun on a decision tree to help managers decide whether syndromic management of women with vaginal discharge will be cost-effective in their setting, balancing the costs of treatment against the costs of STI sequelae prevented (including PID, infertility, or ectopic pregnancy). This decision-tree will provide managers with a rationale for adaptation, especially for the syndromic management of cervical infection in women presenting with vaginal discharge. Male latex condom specification and guidelines for procurement In January 2002, the Department held a meeting with the United Nations Population Fund (UNFPA), the United States Agency for International Development (USAID), the United Nations Children’s Fund (UNICEF), CDC, the Program for Appropriate Technology in Health (PATH) and John Snow Inc. to update publications on male latex condoms. Three tech- nical papers were prepared reviewing evidence on condom size, safety and efficacy, and the technical basis for the WHO male latex condom specifications. These background materi- als were discussed at an Informal Technical Consultation to update the Male latex condom: specification and guidelines for procurement, convened in May 2002 in Johannesburg, South Africa, in collaboration with AFRO, UNFPA, UNAIDS, Family Health International and the Reproductive Health and Research Unit, Chris Hani Baragwanath Hospital, Johan- nesburg. Thirty-four participants from four regions and 13 countries took part, representing donor and international agencies, NGOs and social marketing organizations, manu- facturers, bulk procurement agencies, testing laboratories, national regulatory boards, research institutes and country programme managers. In July 2002, with support from the Secretariat of the International Standardisation Organization Technical Committee 157 and the Malaysian National Regu- latory Board, the Department convened a meeting for a final review of the document which is widely used by both private and public sectors throughout the world. In 2003, the Department will continue to work with collaborat- ing agencies on the development of technical materials and a dissemination strategy to support the adaptation and use of guidelines at national level. An Internet-based helpline for programme managers will also be initiated. Strategies to increase access to affordable STI drugs and commodities Drugs The global interest in increasing access to affordable medi- cines and the recent initiatives within the World Trade Organ- ization provide the opportunity to improve access to effective A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 108 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 109 medicines and commodities for STI care and prevention. The Team has adopted a three-step process to increase access to STI drugs. The first step is the inclusion of greater choice of STI medi- cines in the WHO Model list of essential medicines. The initial proposal is to include azithromycin for the treatment of uncomplicated genital C. trachomatis infection and val- aciclovir for the treatment of genital herpes. Médecins Sans Frontières have also submitted a proposal for the use of azi- thromycin to cover Chlamydia infection and trachoma. Azithromycin is an azalide macrolide with an oral bioavail- ability that provides sustained high antibacterial levels in a wide range of tissues, including the urogenital tract in both men and women. Because of its long half-life (68 hours) its tissue concentration is maintained for several days. It has been shown to be as effective as doxycycline in the man- agement of C. trachomatis and equally well tolerated. The high-efficacy single-dose therapy and limited side-effects of azithromycin mean that the drug can be used for the man- agement of STIs, especially in populations where compli- ance and follow-up may pose problems. For HSV2 treatment valaciclovir may be taken in a twice- daily dosage regimen in contrast to aciclovir which must be administered at four- to six-hourly intervals. The efficacy of valaciclovir is similar to that of aciclovir, and there is no sig- nificant difference in adverse events between the two drugs. The second step is the development of a position paper on STI drugs, which discusses issues and concerns relating to the global provision of effective drugs, in particular questions of availability, affordability, equity and the use of generic drugs. The third step is to develop and disseminate a guidance tool on how to increase access to, and sustainability of, STI drugs at country level. These tools will provide countries with information to assist in the procurement of affordable, high-quality STI drugs, an essential element of an effective STI control strategy. Commodities In response to requests from the Inter-Agency Group on Commodity Security, the Department has been working in collaboration with UNFPA and the Unit of Policy, Access and Rational Use in WHO’s Department of Essential Drugs and Medicines Policy (EDM) to develop an Essential list of repro- ductive health medicines and commodities. Work has been undertaken to define the technical basis for such a list, which will then be incorporated into the WHO Model list of essen- tial medicines. The Department is also discussing with EDM and PATH the development of guidelines to increase access and sustainability of all essential reproductive health drugs and commodities through the development of information resource centres, guidelines and tools that help countries to procure affordable, high-quality regulated reproductive health drugs and commodities. The position paper on STI drugs and the experience gained in developing specifications and qual- ity assurance measures for the male latex condom will feed into the development of these materials and tools. STI/RTI prevalence tool to adapt guidelines in country Risk assessment methods based on socioeconomic, demo- graphic, clinical, and behavioural indicators lack the sensitiv- ity and specificity to predict which STI clients are at high risk of STI/RTI infection and therefore in greater need of testing and treatment. In high-risk populations, many clients will be considered high risk according to the risk assessment algo- rithms, resulting in unnecessary treatment of many women. Studies have shown that risk assessment is of limited benefit in low-risk populations, such as among family planning and antenatal clinic attendees. In view of the low validity of this risk-assessment method- ology, objective data on STI/RTI prevalence at the health facility level are needed, to estimate the likelihood that an individual patient is infected. This will permit management guidelines to be adapted and used appropriately. A review of the protocols for STI/RTI prevalence studies has been undertaken and will be assessed at a consultation before being finalized and published in 2004. Cost–effectiveness of syndromic management of STIs in women Effective STI control programmes are essential in resource- limited countries, both to reduce the burden of STIs and their sequelae, as well as to prevent HIV transmission. Currently, gold standard methods for the diagnosis and treatment of STIs are neither practical nor possible in most clinical set- tings in resource-limited countries. Syndromic management offers an alternative approach. However, over-treatment of women for STIs when a non-sexually transmitted endog- enous infection (or some other cause) is the cause of their symptoms remains a problem in many settings where the syndromic management algorithm has been evaluated. Hawkes et al. (The Lancet, 1999, 354(9192):1776–1781) found that the proportion of cost spent on over-treatment was extremely high in a setting of low STI prevalence (<1% N. gonorrhoeae and Chlamydia and <2% Trichomonas, in women presenting with vaginal discharge) in rural Bangla- desh. In addition to wasting resources, over-treatment is poorly accepted by health service providers and individual patients. Particularly controversial is the syndromic manage- ment of women complaining of genital discharge syndromes in settings of low STI prevalence. In order to inform rational policy making, WHO is compiling a review of the published evidence on the use of the syndromic approach in resource- limited settings. The review and tools will be published and disseminated in early 2003. A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 108 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 109 TECHNICAL COOPERATION WITH COUNTRIES Implementation of the programme guidance tool The STI/RTI Programme guidance tool (see page 104) was developed, tested and applied in Brazil, Cambodia, Ghana and Latvia. During 2002, work focused on implementing the recommendations identified in each country. An evaluation of the process started in Cambodia. Implementation of the tool in China started in Guandong and Yunnan Provinces in April 2002, and the first assessment workshop will be held in February 2003. Further requests to implement the tool have been received from Kosovo (Serbia and Montenegro) and South Africa. Prevalence of STIs and RTIs in reproductive health settings Technical and financial assistance has been provided (in col- laboration with the Technical Support to Countries Team) to institutions in resource-constrained settings to estimate the prevalence of STIs and RTIs among women attending repro- ductive health care services, such as family planning clinics, general gynaecological services and antenatal care settings (for details of completed and ongoing projects, see the sec- tion on research activities, above). Current data describing the etiology and prevalence of important RTIs remain limited, especially in resource-constrained settings. The capacity of researchers in such settings needs strengthening in order for countries to conduct high-quality research to target programmatic interventions, as well as monitor the impact of programmes. Adaptation of the ECPG for STI/RTI under development (see the section on norms and tools, above) is based on such prevalence and etiological data. The Team has provided technical and financial support to RTI preva- lence studies in the Asia-Pacific region, identified as a priority theme by the Regional Advisory Panel. New studies requiring technical support are being planned in China, Mongolia, Myanmar and Viet Nam. The objectives of the studies vary, but include assessment of the association between C. trachomatis and ectopic pregnancy in Mongolia and Myanmar, and assessment of the infectious etiology of post-abortion complications in China. Another study in Mongolia is linked with a plan to introduce national coverage of syphilis serological screening among pregnant women in antenatal clinics. There is a need to monitor the progress of the coverage and the effectiveness of this campaign. The results of this study will be used to develop a health policy aimed at reducing congenital syphilis and complications of syphilis with the cooperation of the Ministry of Health of Mon- golia. Two studies in Ho Chi Minh City, Viet Nam, propose to assess the prevalence of RTIs and STIs among family plan- ning attendees and pregnant women seeking antenatal care. The final protocols will be developed during 2003. Assessment of integration of STI services into reproductive health The Ministry of Health in Botswana embarked, in the early 1990s, on integration of STI prevention and management with reproductive health services. A joint mission between the Department and AFRO to Botswana was conducted to assess national policies and actual levels of integration, focusing particularly on the syndromic approach to STI man- agement and dual protection. Recommendations from the mission included: the need to review national STI management guidelines with special reference to genital ulcer desease; a review of the national policy on anti-herpes drugs; finalization of national policies on integration of STI services with reproductive health serv- ices; dissemination of policy guidelines and service stand- ards for sexual and reproductive health to all levels of the health service and to stakeholders; and a regular review of national maternal and child health and family planning serv- ices, as well as of the prevalence and incidence of STIs in order to facilitate prompt review of national policies and pro- grammes. The Department will continue to provide technical support to AFRO to conduct evaluations in other countries in the region, as well as to assist countries to implement the recommendations. Technical and financial support to the Masaka trial in Uganda WHO provided partial technical and financial support to the Masaka community intervention trial in Uganda from its inception in 1994 to its conclusion in 2001. This community- based study aimed to evaluate the impact on HIV incidence of a standardized and replicable information, education and counselling behavioural intervention, with and without improved management and syndromic treatment of STIs. The trial demonstrated a significant reduction in syphilis incidence and prevalence of gonococcal infections in the intervention arms of the trial, but these reductions did not translate into a reduced HIV incidence. The trial comple- ments the results from the previous STI intervention trial in Rakai, Uganda, during 1994–1998 which also demonstrated an impact on a curable STI (high titre syphilis) with no reduc- tion in HIV incidence. By contrast, the Mwanza trial conducted in the United Repub- lic of Tanzania in 1991–1995 demonstrated an impact on HIV incidence, as well as syphilis incidence. The apparently con- flicting results from the three east African community inter- vention trials are explained by the different stages of the HIV epidemic and different sexual behaviours in the two countries when the studies were conducted. In Uganda, behaviour change and safer sexual practices had largely occurred before the study interventions were implemented. Although HIV prevalence was higher in Uganda, the proportion of men and women with multiple sexual partners was lower than in A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 110 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 111 the United Republic of Tanzania. Similarly, the proportions of men and women reporting condom use were 10 times higher in the Uganda sites than in the United Republic of Tanzania. The HIV epidemic in the latter country was rapidly expand- ing, fuelled by unsafe sexual behaviour and a high incidence of curable STIs. By contrast, the incidence of HIV and STIs in Uganda was lower, thus providing less opportunity for an aggressive STI control strategy to have an impact on the HIV epidemic. While such STI control strategies appear to have greatest impact in settings where there are high rates of curable STIs and an expanding HIV epidemic, STI control remains critical where the incidence is low so that the epi- demic can be contained. A greater impact on further reduc- ing HIV incidence in low-incidence settings may be achieved through other interventions, such as encouraging partner testing and disclosure, or promoting dual protection within stable relationships and among regular partners. The interpretation of the results from the east African inter- vention trials is complex and the STI Team is working closely with the research groups to facilitate dissemination of their results and appropriate assessment of the programmatic implications at country level. Strengthening capacity for microbicide research There are few sites in developing countries with adequate clinical trial capacity to implement safety and effectiveness studies on microbicides. In collaboration with the Technical Support to Countries Team, clinical and laboratory facilities are being upgraded and staff trained in research methodol- ogy, Good Clinical Practice requirements, clinical trial design and implementation, and STI diagnostics. The centres involved in the Phase I safety trial of 6% Cel- lulose Sulfate in India, Nigeria and Uganda were evaluated in 2002 with a view to expanding their capacity to implement more complex microbicide research protocols. Several new clinical sites were identified in 2002, and their interest and capacity to participate in microbicide research assessed. The Department of Obstetrics and Gynaecology, University of Addis Ababa, Addis Ababa, Ethiopia, was visited in March 2002, and a preliminary plan for staff training, and upgrading clinical and laboratory facilities was developed. Swaziland was visited in September 2002, and there is potential to build capacity at the University of Swaziland and through the Ministry of Health and Social Welfare, for microbicide and reproductive health research in the country. Two research centres in Mozambique were assessed in November 2002: the Maputo Central Hospital Department of Obstetrics and Gynaecology and the Regional Centre for Health Develop- ment. Strengthening national capacity for microbicide research and registration Research, development, and safety and effectiveness assessment of microbicides pose particular scientific, ethi- cal and regulatory problems. There are important differences between the assessment and approval of products to treat conditions and those intended to prevent disease. In addi- tion, all HIV prevention work is highly complex in ethical and social terms owing to the stigma surrounding the condition, the lack of cure and the extreme inequities between rich and poor. National Regulatory Authorities (NRAs) in many coun- tries where new microbicidal products are likely to be most valuable do not have the capacity to oversee and assess the research and then register the product. In 2002, the Depart- ment initiated discussions with scientists, advocates and representatives from NRAs and local Institutional Review Boards (IRBs) on mechanisms and procedures to facilitate microbicide development, assessment of safety and effec- tiveness, and registration. The Department, in conjunction with CONRAD and the Alliance for Microbicide Development, convened an inter- national consultation in March 2002 in Villars-sur-Ollon, Switzerland, on the Scientific Basis for Regulatory Decisions on Microbicides. The meeting brought together 42 repre- sentatives from 16 developed and developing countries, bringing expertise from academic institutions, clinical trial centres, national and international regulatory authorities, biopharmaceutical companies, and non-profit research and advocacy organizations. The meeting identified areas of con- sensus on the scientific basis for proceeding systematically through the different stages of pre-clinical testing, Phase I safety trials, expanded safety studies and efficacy trials. Questions were raised regarding the progressive expansion from well-screened and low-risk volunteers involved in the Phase I safety trials, to higher-risk volunteers more typical of the intended eventual users of the products, before proceed- ing to full-scale efficacy trials. Bridging studies to broaden the basis for safety recommendations among intended even- tual users were recommended. The meeting was unable to reach a consensus on a number of issues, including whether colposcopy was necessary in all volunteers in efficacy trials, and on the minimum standards of care required in order to implement studies in an ethical and scientifically sound manner. The meeting revealed close parallels between the scientific and regulatory considerations for HIV vaccines and those for microbicides. As a follow-up to the March meeting, a Southern African Regional Workshop was held in Gaborone, Botswana, in November 2002, with members of NRAs and IRBs from 16 countries in the southern African region. The purpose was to disseminate the report and recommendations from the March meeting, facilitate discussions on the parallels and differences between HIV vaccines and microbicides, and identify ways in which WHO could best support and strengthen NRAs and IRBs to oversee such research. A key recommendation from the workshop was for WHO to estab- lish a Microbicide Scientific and Ethical Advisory Committee which would be able to address the scientific and ethical concerns in microbicide safety and efficacy trials, as well as provide technical, scientific and ethical comment and advice in response to particular questions raised by NRAs. A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 110 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 111 Global distance learning network on the prevention of MTCT In 2002, the Department convened a series of video con- ferences for countries to exchange information and experi- ences in implementing MTCT-prevention interventions, using the World Bank Global Distance Learning Network and the PMTCT Gateway, a web site where participants pursued electronic discussions and posted reading materials for exchange of information. Ten sessions were conducted, each bringing together approximately 60 participants to dis- cuss a specific topic on MTCT prevention. There were four sessions for Asian countries (Cambodia, China, Sri Lanka, Thailand and Viet Nam), three sessions for English-speak- ing African countries (Ethiopia, Ghana, Malawi, Uganda and Zambia), and three sessions for French-speaking African countries (Burkina Faso, Cameroon, Côte d’Ivoire, Rwanda and Senegal) making a total of 15 countries. This work was executed as part of WHO’s contribution to UNAIDS/WHO/ UNICEF/World Bank Inter Agency Task Team on MTCT. Two additional sessions are planned, to be followed by an evalu- ation in 2003. A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 112 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 113 Annex 1a STRATEGIC COMMITTEE ON CONTROL OF SEXUALLY TRANSMITTED AND REPRODUCTIVE TRACT INFECTIONS Members Kamal Alami, STD/AIDS Control Programme Manager, Rabat, Morocco Anita Albau, EASE International, Copenhagen, Denmark Christopher Allison, Health System Consultant, Exeter, United Kingdom Chitwarakorn Anupong, Department of Disease Control, Ministry of Public Health, Nothanburi, Thailand Michael Chirenje, Senior Lecturer, University of Zimbabwe, Harare, Zimbabwe Sinead Delaney, Reproductive Health Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa Sarah Hawkes, Population Council South and East Asia Regional Office, New Delhi, India Monica Iris Jasis, Centro Mujeres A.C., Mexico City, Mexico Anatoli Kamali, Medical Research Council, Kampala, Uganda Philippe Mayaud, London School of Hygiene and Tropical Medicine, London, United Kingdom (Co-chair) Ibra Ndoye, National STI/HIV/AIDS Programme, Dakar, Senegal Sunanda Ray, Southern Africa HIV/AIDS Information Dissemination Service (SAFAIDS), Harare, Zimbabwe Adele Schwartz Benzaken, Instituto de Dermatogia Tropical e Venereologia “A”, Cachoeirinha, Manaus, Brazil Rachel Snow, University of Heidelberg Medical School, Heidelberg, Germany (Co-chair) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 10 71 4 29 14 Women 4 29 2 14 6 from: AFRO 5 36 5 AMRO 2 14 2 EMRO 1 7 1 EURO 4 29 4 SEARO 2 14 2 WPRO Collaborating agency scientists Sevgi Aral, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA Gina Dallabetta, Family Health International, Research Triangle Park, NC, USA France Donnay, UNFPA, New York, NY, USA Caroline Ryan, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA Johannes van Dam, Horizons, Population Council, New York, NY, USA Lut Van Damme, CONRAD, Arlington, VA, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 112 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 113 Annex 2a CONTROL OF SEXUALLY TRANSMITTED AND REPRODUCTIVE TRACT INFECTIONS Scientists in 2002 Principal investigators Simon Aleksanyants, Armenian Research Centre of Maternal and Child Health Protection, Yerevan, Armenia Manuel Gomez Alzugaray, National Institute of Endocrinology, Cmdte. Fajardo Hospital, Havana, Cuba Oyunbileg Amindavaa, State Research Centre on Human Reproduction and Maternal Child Health, Ulaanbaatar, Mongolia Phan Kim Anh, Institute for Protection of Mother and Newborn, Hanoi, Viet Nam Mohommad Dahlan Darip, West Indonesia Reproductive Health Development Centre, Medan, Indonesia Dong Zhaowen, National Research Institute for Family Planning, Beijing, China Aucky Hinting, Airlangga University, Reproductive Health Research Centre, Surabaya, Indonesia Thi Ngoc Khanh, Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam Hendrik Koornof, National Health Laboratory Service, Johannesburg, South Africa Gunta Lazdane, Department of Obstetrics and Gynaecology, Medical Academy of Latvia, Riga, Latvia Hans Lumintang, Reproductive Health Research Centre, Airlangga University, Surabaya, Indonesia Ohn Mar, Department of Medical Research, Yangon, Myanmar Suneeta Mittal, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India Nguyen Thi Ngoc Phuong, Tu Du Hospital, Ho Chi Minh City, Viet Nam Nguyen Thi Nhu Ngoc, Family Planning Unit, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam Khin Nwe Oo, Department of Medical Research, Yangon, Myanmar Alenka Pretnar-Darovec, University Department of Obsterics and Gynaecology, Ljubljana, Slovenia Telma Queiroz, Instituto de Saude e Desenvolvimento Social, Cearà, Brazil Erdenetungalag Radnaabazar, State Research Centre on Maternal and Child Health and Human Reproduction, Ulaanbaatar, Mongolia Helen Rees, Chris Hani Baragwanath Hospital, Johannesburg, South Africa Augustin Rosca, East European Institute of Reproductive Health, Cluj Napoca, Romania Seng Sutwantha, National Centre for HIV/AIDS, Dermotology and STD, Phnom Penh, Cambodia Tang Yong-jun, Family Planning Research Institute, Chengdu, China Placede Tapsoba, Population Council, Dakar, Senegal Sivixay Thammalangsy, Mother and Child Health Institute, Ministry of Health, Vientiane, Lao People’s Democratic Republic Le Than Thuy, Hanoi Obstetrics and Gynaecology Hospital, Hanoi, Viet Nam Wu Shang-chun, National Research Institute for Family Planning, Beijing, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 23 85 4 15 27 Women 13 48 13 from: AFRO 3 11 3 AMRO 2 7.5 2 EMRO EURO 4 15 4 SEARO 6 22 6 WPRO 12 44 12 A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 114 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 115 Annex 2a (continued) Other scientists Improving management of sexually transmitted infections Iyanthi Abeyewickreme, National STD/AIDS Control Programme, Colombo, Sri Lanka Kamal Alami, STD/AIDS Control Programme, Ministry of Public Health, Rabat, Morocco Michel Alary, Unité de Recherche en Santé des Populations, St-Sacrement Hospital, Quebec, Canada Georg M. Antal, International Union Against Sexually Transmitted Infections, Geneva, Switzerland Chitwarakorn Anupong, Venereal Disease Division, Department of Communicable Diseases Control, Ministry of Public Health, Nonthaburi, Thailand Chen Xiang-Sheng, National Centre for STD and Leprosy Control, Institute of Dermatology, Nanjing, China Kate Flore, Department of Health Management and Policy, School of Public Health, The University of Michigan, Ann Arbor, MI, USA Gérard Gresenguet, Centre national de Référence des MST/SIDA, Bangui, République Centrafricaine Pushpa Gupta, Department of Preventive and Social Medicine, University College of Medical Sciences, Shahadara, India Sarah Hawkes, Population Council South and East Asia Regional Office, New Delhi, India Anatoli Kamali, Medical Research Council (MRC), Research Programme on AIDS, Entebbe, Uganda Fred Kambugu, STD Control Unit, STD/AIDS Control Programme, Ministry of Health, Kampala, Uganda Gunta Lazdane, Department Obstetrics and Gynaecology, Medical Academy of Latvia, Riga, Latvia A.B.M. Mafizur Rahman, STD Programme, Gaborone West, Botswana Keba B. Manneh, Disease Control, Department of State of Health and Social Welfare, Medical Headquarters, Banjul, Gambia Philippe Mayaud, Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom André Z. Meheus, Epidemiology and Community Medicine, University of Antwerp, Belgium Phal Sano, NCHADS STD Unit National Centre for HIV/AIDS Dermatology and STD, Phnom Penh, Cambodia Adele Schwartz Banzaken, Governo do Anmazonas, Instituto de Dermatogia Tropical e Venereologia, Manaus, Brazil Pachara Sirivongrangson, Venereal Disease Division, Ministry of Public Health, Bangkok, Thailand Bea Vuylsteke, STI Unit Projet RETRO-CI, Abidjan, Côte d’Ivoire Wang Qian-Qiu, National Centre for STD and Leprosy Control, Nanjing, China Beryl West, MRC Laboratories, Banjul, The Republic of the Gambia Htun Ye, Reference Centre for STD Department of Clinical Microbiology and Infectious Diseases, Institute for Medical Research, Johannesburg, South Africa Kwaku Yeboah, National AIDS Control Programme, Accra, Ghana HSV2 vaccines Anne Buvé, STD/HIV Research and Intervention Unit, Institute of Tropical Medicine, Antwerp, Belgium Geoffrey Peter Garnett, Department of Infectious Disease Epidemiology, Imperial College, London, United Kingdom Judith Glynn, London School of Hygiene and Tropical Medicine, London, United Kingdom Richard Hayes, Epidemiology and International Health, London School of Hygiene and Tropical Medicine, London, United Kingdom Kate Orroth, Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom Peter Smith, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom Lawrence R. Stanberry, Sealy Center for Vaccine Development, University of Texas Medical Branch, Galveston, TX, USA Philippe Van de Perre, Department of Bacteriology-Virology, University Teaching Hospital, Montpellier, France Essential care practice guide for reproductive tract infections Kamal Alami, STD/AIDS National Control, Ministry of Health, Rabat, Morocco Chitwarakorn Anupong, STI/HIV/AIDS, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand Lalit K. Bhutani, Sita Ram Bhartia Institute for Science and Research, New Delhi, India Maria Elena Casanova, Consultant, Mexico City, Mexico Patricia Claeys, International Centre for Reproductive Health, Ghent University, Ghent, Belgium Moshira El-Shafei, South to South Cairo Technical Office, Cairo, Egypt Patricia J. Garcia, School of Public Health, Universidad Peruana Cayetano Heredia, San Martin de Porres, Lima, Peru Sarah Hawkes, Population Council South and East Asia Regional Office, New Delhi, India Young Mi Kim, Johns Hopkins University, Baltimore, MD, USA André Meheus, Epidemiology and Community Medicine, University of Antwerp, Antwerp, Belgium Rosalind Parkes, Specialist Registrar, St Mary’s Hospital, London, United Kingdom Telma Queiroz, Instituto de Projetos e Investigações em Saúde, Fundaçao Nacional de Saúde, Fortaleza, Brazil Adrian Renton, Imperial College School of Medicine, London, United Kingdom Carine Ronsmans, London School of Hygiene and Tropical Medicine, London, United Kingdom A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 114 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 115 Annex 2a (continued) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 28 54 1 2 22 42 52 Women 12 23 1 2 10 19 23 from: AFRO 10 19 10 AMRO 5 10 6 12 11 EMRO 2 4 2 EURO 1 2 18 35 19 SEARO 6 12 6 WPRO 4 8 4 Guida Silva, National Coordinator STIs/AIDS, Ministry of Health, Brasilia, Brazil Jeffrey Smith, JHPIEGO Corporation, Baltimore, MD, USA Richard Steen, Durham, NC, USA Giorgio Tamburlini, Instituto di ricovero e cura a carattere scientifico (IRCCS), Trieste, Italy Marleen Temmerman, International Centre for Reproductive Health, Ghent University, Ghent, Belgium Eddy Van Dyck, Department of Microbiology, Institute of Tropical Medicine, Antwerp, Belgium Kathia Van Egmond, International Centre for Reproductive Health, Ghent University, Ghent, Belgium Zeng Guang, Institute of Epidemiology & Microbiology, Chinese Academy of Preventive Medicine, Beijing, China Introduction and field evaluation of essential care practice guides Maria Elena Casanova, Mexico City, Mexico Patricia Claeys, International Centre for Reproductive Health, Ghent University, Ghent, Belgium Young Mi Kim, Johns Hopkins University, Baltimore, MD, USA Carine Ronsmans, London School of Hygiene and Tropical Medicine, London, United Kingdom Jeffrey Smith, JHPIEGO Corporation, Baltimore, MD, USA Giorgio Tamburlini, Instituto di ricovero e cura a carattere scientifico (IRCCS), Burlo Garofolo, Trieste, Italy Prevention and control of maternal syphilis André Meheus, Epidemiology and Community Medicine, University of Antwerp, Antwerp, Belgium Saiqa Mullick, Reproductive Health Research Unit, Durban, South Africa Rosalind Parkes, St Mary’s Hospital, London, United Kingdom Marleen Temmerman, International Centre for Reproductive Health, Ghent University, Ghent, Belgium Eddy Van Dyck, Department of Microbiology, Institute of Tropical Medicine, Antwerp, Belgium Collaborating agency scientists Sevgi Aral, Centers for Disease Control and Prevention, Atlanta, GA, USA Ian Askew, FRONTIERS, Population Council, Nairobi, Kenya Ron Ballard, Centers for Disease Control and Prevention, Atlanta, GA, USA Stuart M. Berman, Centers for Disease Control and Prevention, Atlanta, GA, USA Paul Brown, North Atlantic Treaty Organization Kosovo Force, British Contingent in Kosovo (Yugoslavia) Florence Carayon, Family Health International, Research Triangle Park, NC, USA Gina Dallabetta, Technical Support/Prevention, Family Health International, Arlington, VA, USA Heiner Grosskurth, HIV/STI Prevention and Care, Population Council, New Delhi, India Isme Humolli, MOH, Institute of Public Health, Pristina, Kosovo (Yugoslavia) Saiqa Mullick, Population Council, Johannesburg, South Africa Baker Ndugga Maggwa, Regional Office for Population Activities, Family Health International, Nairobi, Kenya Julitta Onabanjo, UNFPA, New York, NY, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 116 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 117 Annex 2a (continued) Robert Rice, Family Health International, Research Triangle Park, NC, USA Caroline Ryan, Centers for Disease Control and Prevention, Atlanta, GA, USA Jane Schuler-Repp, UNFPA Kosovo, Pristina, Kosovo (Yugoslavia) Serap Sener, WHO, Pristina, Kosovo (Yugoslavia) Jennifer Smith, International Agency for Research on Cancer, Lyon, France John Stanback, Family Health International, Research Triangle Park, NC, USA Johannes Van Dam, HORIZONS, Population Council, Washington, DC, USA Theodora Elvira Wi, Family Health International/Philippines, Philippine National AIDS Council Secretariat, Department of Health, Manila, Philippines Irina Yacobson, Family Health International, Research Triangle Park, NC, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 116 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 117 Annex 2b RESEARCH GROUP ON MICROBICIDES Scientists in 2002 Principal investigators Kai Dada, Centre for Research in Reproductive Health, Ogun State University, Sagamu, Nigeria Florence Mirembe, Department of Reproductive Health, Makerere University, Kampala, Uganda Chander Puri, National Institute for Research in Reproductive Health, Mumbai, India Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 3 100 3 Women 1 33 1 from: AFRO 2 67 2 AMRO EMRO EURO SEARO 1 33 1 WPRO Other scientists Sanjay L. Chauhan, National Institute for Research in Reproductive Health, Mumbai, India Shanta Chitlange, National Institute for Research in Reproductive Health, Mumbai, India Kim Dickson, University of Witwatersrand, Johannesburg, South Africa Kamal Hazari, National Institute for Research in Reproductive Health, Mumbai, India Frank Kaharuza, Centers for Disease Control, Entebbe, Uganda Zufan Lakew, Addis Ababa University, Addis Ababa, Ethiopia Clemensia Nakabiito, Makerere University, Kampala, Uganda Yomi Ogun, Ogun State University, Sagamu, Nigeria Bina Pande, Makerere University, Kampala, Uganda Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 9 100 9 Women 6 67 6 from: AFRO 6 67 6 AMRO EMRO EURO SEARO 3 33 3 WPRO A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 118 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 119 Annex 2b (continued) Collaborating agency scientists Marianne Callahan, CONRAD, Arlington, VA, USA Lut Van Damme, CONRAD, Arlington, VA, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 118 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 119 Annex 2c RESEARCH GROUP ON PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV Scientists in 2002 Principal investigators Mark Hawken, International Centre for Reproductive Health, Mombasa, Kenya Siripon Kanshana, Ministry of Health, Nonthaburi, Thailand Nicolas Meda, Centre MURAZ, Bobo-Dioulasso, Burkina-Faso Ruth Nduati, University of Nairobi, Nairobi, Kenya Dorothy Mbori-Ngacha, University of Nairobi, Nairobi, Kenya John Shao, Kilimanjaro Christian Medical Center, Moshi, United Republic of Tanzania Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 6 100 6 Women 3 50 3 from: AFRO 5 83 5 AMRO EMRO EURO SEARO 1 17 1 WPRO Other scientists Isidore Adeyanju, National AIDS Programme, Cotonou, Benin Deqa Ali, Médecins du Monde, Bukoba, United Republic of Tanzania Inam Chitsike, National MTCT Technical Group, Harare, Zimbabwe François Dabis, Université Victor Segalen, Bordeaux, France Hugo de Vuyst, International Centre for Reproductive Health, Mombasa, Kenya Marie-Christine Defer, Centre MURAZ, Bobo-Dioulasso, Burkina Faso Serge Diagbouga, Centre MURAZ, Bobo-Dioulasso, Burkina Faso Esther Getambu, Provincial AIDS Control, Mombasa, Kenya Glenda Gray, University of Witwatersrand, Johannesburg, South Africa Geert Haverkamp, National AIDS Therapy and Evaluation Centre, University of Amsterdam, Amsterdam, Netherlands Grace John-Stewart, University of Nairobi, Nairobi, Kenya M.B. Katole, Bukoba Hospital, Bukoba, United Republic of Tanzania James Kiarie, University of Nairobi, Nairobi, Kenya Liz Lindsey, University of Victoria, Sidney, Canada Barbara Lohman, University of Washington, Seattle, WA, USA Kishor Mandaliya, Coast Provincial General Hospital, Mombasa, Kenya James McIntyre, University of Witwatersrand, Johannesburg, South Africa Andolo S. Miheso, Division of Child Health/Ministry of Health, Nairobi, Kenya Frank Mosha, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania Jane Mutambirwa, University of Zimbabwe, Harare, Zimbabwe Fabian Mwanyumba, Provincial Medical Office, Mombasa, Kenya Teresia Mwikali, National AIDS Control Programme, Nairobi, Kenya Ephantus Njagi, University of Nairobi, Nairobi, Kenya Olola Oneko, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania Donata Origo, Zimbabwean AIDS Prevention and Support Organization, Harare, Zimbabwe Jane Othigo, Coast Provincial General Hospital, Mombasa, Kenya A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 120 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 121 Annex 2c (continued) Evelyne Serima, Zimbabwean AIDS Prevention and Support Organization, Harare, Zimbabwe Shahnaaz Kassam Sharif, Medical Services, Mombasa, Kenya Lorraine Sherr, Royal Free and University College Medical School, London, United Kingdom K.S. Shikely, Coast Provincial General Hospital, Mombasa, Kenya Byera Shwekerela, Bukoba Hospital, Bukoba, United Republic of Tanzania Marleen Temmerman, International Centre for Reproductive Health, Ghent, Belgium Philippe Van de Perre, Centre Hospitalier Regional Arnaud de Villeneuve, Montpellier, France Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 26 78 7 22 33 Women 11 33 4 12 15 from: AFRO 26 78 26 AMRO 2 6 2 EMRO EURO 5 15 5 SEARO WPRO Collaborating agency scientists Brigitte Bazin, Agence Nationale de Recherche sur la SIDA, Paris, France Anne Duerr, Centers for Disease Control and Prevention, Atlanta, GA, USA Mary Glenn Fowler, Centers for Disease Control and Prevention, Atlanta, GA, USA Denise Jamieson, Centers for Disease Control and Prevention, Atlanta, GA, USA Lynne Mofenson, National Institutes of Health, Rockville, MD, USA Jennifer Read, Pediatric, Adolescent and Maternal AIDS Branch, Center for Research for Mothers and Children, National Institutes of Health, Bethesda, MD, USA Avina Sarna, HORIZONS, Population Council, New Delhi, India Mukadi Ya Diul, Family Health International, Arlington, VA, USA A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 120 A n n u al Tech n ical R ep ort 2002 Controlling sexually transmitted and reproductive tract infections 121 Annex 3 PUBLICATIONS IN 2002 Anh PH, Khanh NTN, Ha DH, Chien DT, Thuc PH, Luong PH et al. Prevalence of lower genital tract infections among women attending maternal and child health and family planning clinics in Hanoi, Viet Nam. South East Asian Journal of Public Health (submitted). Beksinska ME, Mullick S, Kunene B, Rees H, Deperthes B. A case study of antenatal syphilis screening in South Africa: suc- cesses and challenges. Sexually Transmitted Diseases, 2002, 29(1):32–37. Berman S. Pathophysiology and treatment of fetal infection during pregnancy: the importance of science in understanding and improving public health programs. Bulletin of the World Health Organization (submitted). Calmy A, Ciaffi L, Pedrique B, de Vincenzi I, Michon C, Andrieux-Meyer I. From pilot projects to extended ARV programs; an MSF experience. XIV International AIDS Conference. Barcelona, 7–12 July, 2002. Abstract No. ThOrF1519. de Vincenzi I, Gaillard P, Farley T. Impact of Highly Active Anti-Retroviral Treatment (HAART) during pregnancy and breastfeed- ing on Mother-to-Child HIV Transmission (MTCT) and mother’s health in developing countries. XIV International AIDS Confer- ence, Barcelona, 7–12 July, 2002. Abstract No. WePeB5953. Deperthes B, O’Reilly K, Meheus A, Broutet, N. Maternal syphilis: the way forward. Bulletin of the World Health Organization (submitted). Essential care practice guide for sexually transmitted and reproductive tract infections. Geneva, World Health Organization, 2003 (forthcoming). Gaillard P, O’Reilly K, Dao H, Sint TT, de Zoysa I. Reduction of HIV infection in infants: WHO strategic approaches. XIV Inter- national AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. TuPeF5415. Hawkes S, Miller S, Reichenbach L, Nayyar A, Buse K. Antenatal syphilis control: people, programmes, policies and politics. Bulletin of the World Health Organization (submitted). Hawkes S, O’Reilly K, Broutet N, Van Dam J, Bun Leng H, Lazdane G, Yeboah K, Quieroz T. Evaluation of a nationally-led programme guidance tool for RTI programmes. XIV International AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. MoPeG4197. Hawkes SJ, O’Reilly K, Van Dam J, Deperthes B, Broutet N, Leng HB, Lazdane G, Queiroz T. Development of a program guidance tool for reproductive tract infection program managers: results from 4 countries. XIV International AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. MoPeG4197. Herpes simplex virus type 2. Programmatic and research priorities in developing countries. Geneva, World Health Organiza- tion, 2001 (WHO/HIV–AIDS/2001.05 UNAIDS/01.89E). Hoff E, Mandala Kol J, McIntyre J, Van Look P. Clinical guides for management of pregnant women with HIV infection. XIV International AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. WePeF6733. Inion I, Gaillard P, Mandaliya K, Fonck K, Mungalo A, Kenga W et al. Voluntary counselling and testing for HIV integrated in a public health setting, Mombasa, Kenya. XIV International AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. TuPeD4965. Inion I, Mwanyumba F, Gaillard P, Chohan V, Verhofstede C, Claeys P, Mandaliya K, Van Marck E, Temmerman M. Placental malaria and perinatal transmission of HIV1. XIV International AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. ThOrC1490. Mandala Kol J, Hoff E, McIntyre J, Farley T. Experience of field-testing clinical guides on prevention of mother-to-child transmis- sion of HIV. XIV International AIDS Conference, Barcelona, 7–12 July, 2002. Abstract No. WePeF6719. A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 122 A n n u al Tech n ical R ep ort 2002 123 Müllick S, Htun Y, Temmerman M, Ndowa F, Broutet N. Maternal syphilis: a public health problem. Bulletin of the World Health Organization (submitted). O’Reilly K, Temmerman M. Syphilis (editorial). Bulletin of the World Health Organization (submitted). Peeling R, Htun Y, van Dyck E. Are there appropriate tools for the prevention and control of maternal and congenital syphilis? Bulletin of the World Health Organization (submitted). Saloojee H, Velaphi S, Goga Y, Afadapa N, Steen R, Lincetto O. Prevention and management of congenital syphilis. Bulletin of the World Health Organization (submitted). Schmid G. Economic and programmatic aspects of screening for syphilis during pregnancy: improving effectiveness of pro- grammes. Bulletin of the World Health Organization (submitted). Technical Consultation on Nonoxynol-9. WHO/CONRAD summary report. Geneva, World Health Organization (WHO/RHR/ 03.08) (forthcoming). Van Damme L, Ramjee G, Alary M, Vuylsteke B, Chandeying V, Rees H et al. Effectiveness of Col-1492, a nonoxynol-9 vaginal gel, on HIV transmission among female sex workers: a randomized controlled trial. The Lancet, 2002, 360:971–977. Wilkinson D. Nonoxynol-9 fails to prevent STDs, but microbicide research continues. The Lancet, 2002, 360:962–963. Annex 3 (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 3 - Controlling sexually transmitted and reproductive tract infections 122 A n n u al Tech n ical R ep ort 2002 123 Section 4 Preventing unsafe abortion A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 124 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 125 Preventing unsafe abortion I.H. Shah, H. von Hertzen, J. Cottingham, E. Ezcurra, P. Fajans, M. Gülmezoglu, E. Aahman INTRODUCTION The guiding document for the Department’s work on abor- tion is the Programme of Action adopted at the International Conference on Population and Development (ICPD) held in Cairo, Egypt, in 1994, which urges countries and organiza- tions to address the health consequences of unsafe abor- tion and to ensure that, in circumstances where abortion is not restricted by law, the provision of abortion is safe. It is estimated that 46 million abortions are performed annually of which 19 million are unsafe. Unsafe abortion is defined by WHO as a procedure for terminating an unintended preg- nancy either by persons lacking the necessary skills or in an environment lacking the minimal medical standards, or both. The consequences of unsafe abortion are many. It has been estimated that in addition to some 80 000 women who die each year as a consequence of unsafe abortion, a further 5 million suffer temporary or permanent disability. The overall strategy of the Department’s work on preventing unsafe abortion is to generate scientifically sound evidence on abortion prevalence and practices, to improve technolo- gies and interventions to make abortion safer, to translate evidence into norms, tools and guidelines, and to assist in the development of programmes and policies to reduce unsafe abortion. The Department’s activities address pri- orities identified by two consultations on abortion, held in August and September 2000, and by the 2002 meeting of the Scientific and Technical Advisory Group (STAG). RESEARCH ACTIVITIES Specific objectives of research The specific objectives of research by the Programme include, but are not limited to, providing evidence on the inci- dence of unsafe abortion and its related morbidity and mor- tality; assessing safety of abortion technologies; developing evidence-based norms, tools and guidelines; and assisting countries in implementing best practices for high-quality abortion services and post-abortion care. The Department conducts research to document the global dimensions of unsafe abortion by compiling and maintaining data on the incidence of unsafe abortion and abortion-related mortality and morbidity. It also conducts research on the determinants and consequences of unsafe abortion, including access to qualified providers and post-abortion care. Since its inception the Programme has carried out research for developing safe and effective non-surgical methods for early termination of pregnancy. This research was important for the registration, in 1988, of the first non-surgical method of early abortion, the sequential regimen of mifepristone fol- lowed, two days later, by a suitable prostaglandin. Subse- quent research led to a simplified regimen, and investigated ways to shorten the duration of post-abortion bleeding. Two consultations on abortion in 2000 recommended that the Programme should develop effective, safe and acceptable misoprostol-only regimens for early first trimester as well as second trimester abortions. Two multicentre studies have been launched to address these recommendations. The ben- efits of routine priming of the cervix with misoprostol are also being investigated in a new study to determine whether the safety of the vacuum aspiration procedure can be improved further. Another new area of research is aimed at developing A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 124 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 125 an effective non-surgical method for a non-viable pregnancy (missed abortion). The research generated by the Programme is used for developing norms, tools and guidelines as well as assisting countries in implementing best practices. One example of such interface is the Technical and policy guidance docu- ment completed in 2002. Progress Updating global and regional data on the incidence of unsafe abortion The number of unsafe abortions and other abortion-related indicators are among the most difficult reproductive health data to estimate. As part of the Department’s commitment to maintain up-to-date data on unsafe abortion globally and by region, new estimates of unsafe abortion became available in 2002. These data, updated every five years, provide global and regional estimates of the incidence of unsafe abortion, the ratio of unsafe abortions to 100 live births and the number of unsafe abortions per 1000 women aged 15 to 49 years, and of maternal mortality due to unsafe abortion. Overall, 19 mil- lion unsafe abortions are estimated to take place each year, corresponding to one in ten pregnancies ending in an unsafe abortion or one unsafe abortion to approximately seven live births. In Latin America and the Caribbean, the ratio of unsafe abortion is one to every three live births. Important regional differentials are found in the incidence, ratio and rate of unsafe abortion (Table 4.1). This update shows that despite a major increase in contraceptive use and in spite of Estimated number of unsafe abortions (000s) Incidence ratio (unsafe abortions to 100 live births) Incidence rate (unsafe abortions per 1000 women aged 15–49) World 19 000 14 12 More developed regions1 500 4 2 Less developed regions 18 500 15 15 Africa 4 200 14 22 Eastern Africa 1 700 16 29 Middle Africa 400 9 20 Northern Africa 700 15 15 Southern Africa 200 16 16 Western Africa 1 200 13 24 Asia 1 10 500 14 11 Eastern Asia 1 — 2 — 2 — 2 South-central Asia 7 200 18 20 South-eastern Asia 2 700 23 19 Western Asia 500 10 11 Europe 500 7 3 Eastern Europe 400 14 5 Northern Europe 10 1 1 Southern Europe 100 7 3 Western Europe — 2 — 2 — 2 Latin America and Caribbean 3 700 32 26 Caribbean 110 15 11 Central America 680 20 19 South America 2 900 39 30 Oceania 1 30 12 15 N.B. Figures may not add up to totals due to rounding. 1 Japan, Australia and New Zealand have been excluded from the regional estimates, but are included in the total for developed countries. 2 No estimates are shown for regions where the incidence is negligible. Table 4.1. Global and regional annual estimates of incidence of unsafe abortion by United Nations region, for the year 2000 A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 126 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 127 the fact that unsafe abortions are entirely preventable, they continue to prevail in all developing regions. Abortion and the Global Burden of Disease (GBD) The Department also contributed to WHO’s work on the GBD 2000, specifically, the global burden of abortion. Estimated incidence of unsafe abortion, together with unsafe abortion- related mortality and infertility, were used to estimate the global burden of disease caused by unsafe abortion in 2000. Comparisons with earlier estimates for 1990 show that the magnitude of the burden remains broadly unchanged. Mor- tality owing to unsafe abortion is estimated at 4 per 100 000 women of reproductive age and case fatality at 0.3 per 100 unsafe abortions. The infertility caused by unsafe abortion is estimated to be 1.4 per 1000 women of reproductive age, while the importance of the burden caused by post-abortion pelvic inflammatory disease (PID) has only recently been recognized and will be included in the final calculations for the GBD 2000. This will provide a more complete account of the worldwide health impact of unsafe abortions. The total disability-adjusted life–years (DALYs) loss due to unsafe abortion is currently estimated at over 5 million. The informa- tion on the burden of unsafe abortion is included together with other important aspects of health in the updated GBD 2000. Fertility decline and the role of abortion An ongoing study in Togo is assessing the role of abortion in the context of western Africa where fertility has declined but increases in contraceptive prevalence are too small to account for the change. Togo is a country where recourse to abortion is thought to be high, and the study is both documenting the incidence of abortion and investigating pathways to abortion. It includes a survey of 4500 women of reproductive age (15–49 years) to measure the prevalence of abortion and its impact on fertility levels in Lomé, Togo, and uses qualitative interviews and focus group discussions to explore the pathways to abortion among women living in Lomé. Currently, legislation in Togo permits abortion only in cases where it is performed to save the woman’s life. Results are expected at the end of 2003. Assessing the safety and efficacy of abortions performed by mid-level providers Obtaining access to safe abortion services is a challenge for many women in developing countries facing an unwanted pregnancy. In countries where abortion is legal, the law generally restricts the provision of abortion to physicians and in some cases requires additional training and certification. For a variety of reasons, millions of women turn to mid-level providers or non-physicians, such as midwives, paramedics, and traditional birth attendants, who may not be clinically trained in abortion techniques. An ongoing randomized trial is investigating the safety of abortions—assessed from com- plications—provided by medically trained and government- certified mid-level providers compared to physicians in South Africa and Viet Nam, where first trimester abortions are cur- rently legally performed by both physicians and non-physi- cians. Approximately 20 providers in four clinics and 1400 women will participate in the study in each country. Results are expected at the end of 2003. Medical abortion clinical trials The results of several clinical trials were published in 2002. Findings from a study testing whether repeated administra- tion of oral misoprostol following mifepristone pretreatment improves clinical efficacy, will be published in the British Journal of Obstetrics and Gynaecology. Studies addressing acceptability show that many women prefer oral administra- tion of drugs, but a previous study clearly demonstrated that 0.4 mg of oral misoprostol after pretreatment with mifepristone was not effective enough in pregnancies with gestational age longer than seven weeks (Ho PC, British Journal of Obstetrics and Gynaecology, 2000, 107:524–530). Side-effects and the impact of this regimen on the duration and amount of post-abortion bleeding were also evaluated, as well as women’s perceptions of the treatments. This ran- domized, double-blind study involved three misoprostol regi- mens, administered 48 hours after 200 mg of mifepristone: (i) an initial oral dose of 0.8 mg continued with an oral dose of 0.4 mg twice daily for 7 days; (ii) an initial vaginal dose of 0.8 mg continued with an oral dose of 0.4 mg twice daily for 7 days; and (iii) a vaginal dose of 0.8 mg. The recruitment target was 2250 women, in 3 groups of 750 women each, with duration of amenorrhoea of: (i) up to 49 days; (ii) 50–56 days; and (iii) 57–63 days. A total of 2219 women were recruited for the study in 15 centres worldwide. In addition to assessing efficacy and side-effects, a brief questionnaire was included in the study to collect data on women’s opin- ions of the regimen, their assessment of whether they would feel confident using the regimen at home, and whether they would prefer home use should they be given the choice. The complete abortion rate was 92.3% in the oral plus con- tinued oral misoprostol group (O/O); in the vaginal-only group (V) it was 93.5%; and in the vaginal group that continued with oral misoprostol (V/O) it was 94.7%. Undetermined outcome cases were considered as failures. Among women with amenorrhoea for 57 days or more, the risk of failure of com- plete abortion was almost three times higher in the O/O group (RR=2.8, 95% confidence interval [CI] 1.3–5.8) and more than twice as high in the V-group (RR=2.2, 95% CI 1.0–4.7) when compared to the V/O group. Among women with shorter duration of amenorrhoea, the differences were not significant. Nausea, vomiting and diarrhoea were more frequent with oral than with vaginal misoprostol. Timing of expulsion and dura- tion of bleeding were similar in the three groups with about 25% of the women bleeding for more than 17 days. The study suggests that the vaginal route of misoprostol is more effective than the oral route to achieve complete abor- tion among women with 57–63 days of amenorrhoea, and A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 126 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 127 that continuing prostaglandin for one week improves the effi- cacy of the method significantly, but does not influence the duration of post-abortion bleeding. Findings from several single-centre studies were also pub- lished in 2002. In connection with the study discussed above, the participating centre in Hong Kong Special Administrative Region of China (Hong Kong SAR) measured actual blood loss in the three treatment groups and found no statistically significant difference. In a separate study, the pharmacokinet- ics of sublingual administration of misoprostol were studied by collaborators in Hong Kong SAR; the results suggested great potential for the sublingual route to be developed into a method of medical abortion. Subsequently, a uterine contrac- tility study was carried out in Stockholm, Sweden, comparing the sublingual and vaginal administration of misoprostol. Findings indicated that uterine contractility and uterine tonus were both significantly greater two to four hours after sublin- gual intake of misoprostol when compared to either vaginal or oral administration of the drug. New projects initiated during the year Research on men and abortion Work is under way at the Centro de Estudios de Población, Buenos Aires, Argentina, to produce a review paper on Men and abortion: their knowledge, attitudes, perspectives and roles. The report will be based in part on a bibliographic review of studies and a synthesis of findings. Various topics will be analysed, including: (i) men’s attitudes and their perceived roles and responsibilities toward unintended pregnancy; (ii) men’s attitudes and perspectives regarding abortion including grounds for being in favour of or against abortion; (iii) the perceived psychosocial consequences for men whose partner has an abortion as well as their opinion of the consequences for their partner; (iv) men’s perspec- tives on male involvement in abortion decision-making, on support during the abortion process (emotional, economic), and on post-abortion care, as well as on post-abortion con- traceptive use; and (v) models for male involvement in abor- tion and post-abortion. The review will also incorporate findings from the analysis of data from the World Values Survey describing overall patterns of attitudes towards abortion and their variation by age and sex. This analysis will evaluate the extent to which attitudes towards abortion vary across countries and identify those countries in which men and women show the great- est (and least) differences in their views on abortion. The availability of data from different points in time for selected countries will also allow examination of the extent to which attitudes towards abortion have changed over the past dec- ades in those countries and whether men and women have experienced similar patterns of attitudinal change. The paper will also include a critical assessment of the strengths and limitations of the studies reviewed, and the extent to which the evidence is ambiguous. On the basis of the review and the assessment, the paper will propose a strategy to address policy-relevant gaps in knowledge through research in the area of men and abortion. Research on quality of care for post-abortion services Although abortion is restricted by law in Argentina, health services there are beginning to address the reproductive health care needs of women with abortion complications. A new study was launched to assess the quality of post-abor- tion care and to evaluate a strategy for improving such care in a public hospital in Buenos Aires. Specifically, the investi- gators propose to assess pre- and post-intervention levels of professional competence, user satisfaction, and availability of technical resources. They will develop, implement and evaluate a model intervention that will include training health professionals in manual vacuum aspiration (MVA), pain man- agement, diagnosis and treatment of complications, use of antibiotics, post-MVA care, post-abortion contraceptive coun- selling, and ethical, psychological and social aspects of the doctor-patient relationship. The issue is important for the field of reproductive health and for the field of reproductive rights. Although similar work has been done in other countries, this kind of research has not been done in Argentina, where abor- tion policies are restrictive. The research design and instru- ments build on similar work conducted in Mexico. Non-surgical abortion with misoprostol alone The wide availability and reasonably low price of misopr- ostol compared to other prostaglandin analogues have contributed to its use and to a renaissance of research into a prostaglandin-only method of pregnancy termination with this compound in countries where mifepristone has not been available. However, no systematic research had been carried out to determine the best regimen for this indication. To this end a randomized multicentre trial was launched involving 11 centres in Armenia, Cuba, Georgia, India, Mongolia and Viet Nam. The aim is to recruit 2100 pregnant women (up to 63 days of gestation) requesting legal termination of pregnancy: eligible women who wish to join the study are allocated randomly to four treatment groups. All women receive three doses of 0.8 mg of misoprostol, which will be administered either sublingually or vaginally, at intervals of 3 or 12 hours. The four regimens will be compared in respect of their effec- tiveness for inducing complete abortion, induction-to-abor- tion interval, acceptability and occurrence of side-effects. The clinical phase of the study is expected to last one year and the results should be available by the end of 2003. Non-surgical abortion using a sequential regimen Another study of medical abortion is comparing two doses of mifepristone, 100 mg and 200 mg, followed by 0.8 mg of vaginal misoprostol either 24 hours or 48 hours later, when used for the termination of early pregnancy in women with amenorrhoea of up to 63 days from last menstrual period. A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 128 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 129 The four regimens are to be compared with respect to the following main outcomes: effectiveness of induced complete abortion relative to the length of gestation, frequency of side- effects, and duration of bleeding. This study includes 2100 women in 14 centres in China, Hungary, Mongolia, Romania, Serbia and Montenegro, Slovenia, South Africa, Sweden, Viet Nam and Zambia. It is anticipated that the clinical phase of this study will last one year. Routine priming of the cervix with misoprostol A randomized, double-blind multicentre study is ongoing to test whether routine pre-operative treatment with 0.4 mg of vaginal misoprostol administered three hours prior to vacuum aspiration reduces complications, such as cervical injury, uterine perforation, severe haemorrhage, incomplete evacuation, pelvic infection, etc. This study includes a total of 5000 women up to 12 weeks of pregnancy, who are being recruited for the study in 14 centres in Armenia, China, Cuba, Hungary, India, Mongolia, Romania, Slovenia and Viet Nam. The centres estimate that recruitment of volunteers for this study will take one year. Misoprostol-alone regimens for second trimester abortion The two consultations on the Department’s activities in the area of unsafe abortion recommended that effective regi- mens should also be developed for second trimester preg- nancy termination. To this end, a randomized, double-blind multicentre study was launched which involves 680 pregnant women requesting legal termination of pregnancy during the second trimester of pregnancy (14–20 weeks amenorrhoea). Women are randomized to receive 0.4 mg misoprostol either vaginally or sublingually every 3 hours for up to 5 doses. Twelve centres are participating in this study from Armenia, Georgia, Hungary, India, Slovenia, South Africa, Viet Nam and Zambia. The recruitment for the study is expected to take six months and results should be available in 2003. Sublingual/vaginal administration of misoprostol after mifepristone Two randomized double-blind studies, one in the first tri- mester and the other in the second trimester, are ongoing in Hong Kong SAR to compare the efficacy, side-effects and acceptability of sublingual administration of misoprostol compared to vaginal administration after mifepristone pre- treatment. The results of these studies are expected to be available in late 2003. NORMS AND TOOLS Specific objectives/targets The norms and tools developed for preventing unsafe abor- tion, and for accessing safe abortion and post-abortion care are designed to provide policy-makers and medical practi- tioners with guidelines for improving the quality of care. Technical and policy guidance on safe abortion During 2002 a document entitled Safe abortion: technical and policy guidance for health systems was revised and finessed by a group of clinical, legal and health systems experts. The document is ready for publication and will be available in English in early 2003. Over the next year, translations into French, Russian and Spanish, and possibly Portuguese and Romanian, are plannned. The rationale for the document is the ICPD+5 government agreement that “in circumstances where abortion is not against the law, health systems should train and equip health service providers and should take other measures to ensure that such abortion is safe and accessible. Additional meas- ures should be taken to safeguard women’s health” (Key actions for the further implementation of the Programme of Action of the International Conference on Population and Development. New York, United Nations, 1999). The document consists of four chapters covering: (i) the public health challenge of safe abortion; (ii) clinical care for women undergoing abortion; (iii) putting services in place; and (iv) legal and policy considerations. It includes a number of annexes relating to further reading, post-abortion contra- ception, and international agreements on abortion services. The following sections summarise the main recommenda- tions from the document. The public health challenge In developing countries, the risk of death following complica- tions from an unsafe abortion procedure is several hundred A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 128 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 129 times higher than that of an abortion performed professionally under safe conditions. Complications resulting from unsafe abortion, including infertility, contribute to serious sequelae for women’s health. Since no contraceptive is 100% effec- tive, there will continue to be unwanted pregnancies which women may seek to end by induced abortion. In almost all countries the law permits abortion to save the woman’s life and in most countries abortion is allowed to preserve the physical and mental health of the woman (Figure 4.1). For women to have rapid access to safe abortion services as provided by law, these services need to be available, pro- vided by well-trained health personnel, supported by policies and regulations, and supported by health systems infrastruc- ture, including equipment and supplies. Clinical care for women undergoing abortion Determining the length of pregnancy is a critical factor in selecting the most appropriate abortion method. Bimanual pelvic examination and recognition of other symptoms of pregnancy is usually adequate although laboratory or ultra- sound testing may be used for confirmation. In areas where anaemia is prevalent, measuring haemaglobin or haemat- ocrit levels will enable prompt response in case of complica- tions requiring blood transfusion. Routine use of antibiotics at the time of abortion reduces the post-procedural risk of infection. Complete, accurate and easy-to-understand infor- mation about the procedure and what to expect during and afterwards must be given to the woman, as well as voluntary counselling about options available to her to help her make informed decisions. Preferred methods for early abortion (first trimester) are: (i) manual or electric vacuum aspiration, for up to 12 completed weeks since the woman’s last menstrual period, and (ii) medical methods of abortion consisting of a combination of mifepristone followed by a prostaglandin such as misoprostol Figure 4.1. Percentages of countries by legally permitted grounds for abortion Source: United Nations Population Division, 1999. or gemeprost, for up to 9 completed weeks since last men- strual period. Misoprostol is the prostaglandin of choice for most settings since it is relatively inexpensive and does not require refrigeration. For pregnancies of more than 12 completed weeks since the woman’s last menstrual period, the preferred methods are: (i) dilatation and evacuation (D&E), using vacuum aspiration and forceps; (ii) mifepristone followed by repeated doses of a prostaglandin such as misoprostol or gemeprost; and (iii) prostaglandins alone (misoprostol or gemeprost), in repeated doses. Medication for pain management should always be offered. Universal precautions for infection control should be used, as with the care of all patients at all times, to reduce the risk of transmission of bloodborne infections including HIV. Before they leave the health care facility, all women should receive information on contraception and, for those who want them, contraceptives or referral to contraceptive services should be provided. Women should receive oral and written instructions about how to care for themselves after leaving the health care facility, about how much bleeding to expect, and about recognizing complications and how to seek help for them. Putting services in place Planning and managing abortion services requires consider- ation of a number of factors which are applicable irrespective of the circumstances under which abortion is legal, or who has responsibility for decision-making and implementation within the health system. They apply whether services are public, private or nongovernmental and include the following: (i) assessment of the current situation regarding laws and regulations, extent, level and quality of services currently provided, characteristics of users, and attitudes and knowl- edge of health care providers; (ii) establishment of national norms and standards governing the provision of quality A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 130 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 131 abortion care, including essential equipment and supplies, referral mechanisms, respect for women’s informed deci- sion-making, attention to the special needs of adolescents, and special provisions for women who have suffered rape; (iii) definition of provider skills, training, supervision and certification processes; (iv) monitoring and evaluation of services; and (v) financing. Legal and policy considerations As Figure 4.1 shows, in almost all countries abortion is allowed at least when there is a threat to the woman’s life. The majority of national laws also allow abortion when pregnancy poses a threat to the woman’s physical or mental health; many allow it when pregnancy is the result of rape or incest or when there is fetal impairment; and several allow it for socioeconomic reasons and on request by the woman. Very often, administrative barriers exist which hinder women from accessing the services to which they are legally eligible. An enabling policy environment is needed to ensure that every woman legally eligible has ready access to high-qual- ity abortion services. Policies should be geared to achieving positive health outcomes for women, to providing good-qual- ity family planning information and services, and to meet- ing the particular needs of groups such as poor women, adolescents, rape survivors and HIV-infected women. Poli- cies and programmes should aim to remove barriers to the timely provision of services such as lack of knowledge of the law, lengthy judicial processes for rape victims, third-party authorization or notification clauses, unnecessary condi- tions or procedures such as waiting periods, and excessive restrictions on the kinds of health professionals or institutions licensed to provide abortion. New work and progress on systematic reviews of abortion In 2002, two new Cochrane systematic reviews addressing safe abortion were published in the Cochrane Library. One of these reviews compares different surgical methods for first trimester termination of pregnancy. The review found the evidence inadequate for comparing surgical methods in terms of rare outcomes, women’s satisfaction, the need for pain relief, and providers’ preferences. The second review compares medical and surgical methods for first trimester termination of pregnancy. Although based on evidence from small trials, the results of this review suggest that prostag- landins alone are less effective and more painful than surgi- cal methods. There is inadequate evidence to compare the acceptability and side-effects of the two methods. Another Cochrane review comparing medical methods for first trimes- ter termination of pregnancy is currently under way and will be ready for publication in the Cochrane Library in 2003. TECHNICAL COOPERATION WITH COUNTRIES Improving abortion care in Viet Nam: policy and practice In 1997, the Programme supported a national strategic assessment of issues related to abortion and abortion serv- ices in Viet Nam. This assessment recommended a variety of actions to reduce recourse to abortion and to improve the quality of abortion services, including the introduction of post-abortion family planning. In response to the assess- ment, the Vietnamese Ministry of Health began a series of activities to implement the recommendations made, and included strategies for reducing recourse to abortion and for improving the quality of abortion services in its National Reproductive Health Strategy for 2001–2010, which has just been published. In late 2001, the Ministry of Health began a project known as the Comprehensive Abortion Care (CAC) Project which is developing and testing a high-quality, client-centred abor- tion care model to be replicated at all levels of the health system in Viet Nam. The project is being implemented in collaboration with the Institute for the Protection of Mothers and Newborns, Hanoi and Tu Du Obstetrics and Gynaecol- ogy Hospital, Ho Chi Minh City. The project is being jointly funded by The Ford Foundation, Ipas, and WHO with techni- cal assistance provided by Ipas and WHO. In the first phase of the project in 2002, WHO and Ipas sup- ported the development of Vietnamese national standards and guidelines for abortion service delivery and the develop- ment of a service delivery package for improving the quality of comprehensive abortion care based on these standards and guidelines. The guidelines and service delivery protocols are being tested at the two national tertiary referral hospitals responsible for national training in reproductive health, prior to being revised and disseminated. The Programme will include training for their utilization at more peripheral levels of service delivery. Although the new national standards and guidelines included the provision of medical abortion, the initial service delivery guidelines being tested did not include introduction of medi- cal abortion protocols, focusing instead on improving the provision of existing surgical abortion services. The project is currently assisting in the development of service delivery protocols for the introduction of first trimester medical abor- tion into project activities. Improving abortion care in Romania: policy and practice In November 2001, the Programme assisted the Ministry of Health of Romania to conduct a strategic assessment of issues related to abortion, in order to identify appropri- ate research and programme interventions to reduce the recourse to abortion and to improve the quality of abor- A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 130 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 131 tion services in the public and private health care sectors. A national conference to disseminate the findings of the assessment was convened in Bucharest in April 2002 and included a wide range of stakeholders from across the coun- try. Core members of the assessment team began imple- menting some of the key recommendations immediately following the conference. The first policy recommendation addressed was the need to develop national standards and guidelines for abortion care. Staff from the Ministry of Health and Family, the National College of Physicians, and the Society of Obstetrics and Gynaecology are developing draft guidelines which will be circulated for review to a broader technical committee, as well as to the team that carried out the strategic assessment. Completed guidelines will be disseminated in a proposed dissemination conference in early 2003. In response to other assessment recommendations, the Directorate of Maternal and Child Health recently expanded the eligibility criteria for free contraception to include not only students and the unemployed, but also all women residing in rural areas and all those undergoing abortion in the public sector. For the first time, the Ministry has earmarked its own funds for the purchase of contraceptives for eligible women. In addition, oral and injectable contraceptives were placed on the list of drugs to be subsidized by the National Health Insur- ance House. A related new policy now requires all obstet- rics-gynaecology departments to provide safe, high-quality abortion services, including post-abortion contraception, at an affordable price which is set by the Ministry of Health and Family. Further policy outcomes of the assessment have included the signing of an agreement between the Ministry of Health and Family and the Ministry of Education for the man- datory introduction of health education in Romanian schools in 2003, as well as plans to begin an information, education and communication campaign utilizing mass media to inform women about the availability of free contraceptives, following the introduction of the new, expanded eligibility criteria. In November 2002, the East European Institute of Reproduc- tive Health began work on a project to introduce high-quality post-abortion family planning counselling and modern con- traceptives as part of comprehensive reproductive health care. The project will run for four years and complement planned work to improve abortion care in Romania. Members of the assessment team are currently preparing a proposal for a three-year project which will develop a model for comprehensive abortion and post-abortion care services in Romania, based on the recommendations of the assess- ment and the new standards and guidelines. This model will be tested at referral and district level hospital services in two regions of Romania, prior to being scaled up throughout the country. It will focus on improving the quality of existing services and will include the introduction of MVA and medical abortion. A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 132 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 133 Annex 1 SPECIALIST PANEL FOR SOCIAL SCIENCE AND OPERATIONS RESEARCH IN REPRODUCTIVE HEALTH IN 2002 AND RESEARCH GROUP ON POST-OVULATORY METHODS OF FERTILITY REGULATION IN 2002 See Section 1 on Promoting Family Planning. A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 132 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 133 Annex 2a RESEARCH GROUP ON SOCIAL SCIENCE AND OPERATIONS RESEARCH SCIENTISTS IN 2002 Principal investigators Kodjopatapa Amergee, University of Lomé, Lomé, Togo Catalin Andrei, Health Services Management Institute, Bucharest, Romania Radu Belloiu, National College of Physicians, Bucharest, Romania Cosmina Blaj, East European Institute of Reproductive Health, Targu Mures, Romania Ionela Cozos, East European Institute of Reproductive Health, Targu Mures, Romania Nguyen Dinh Loan, Maternal and Child Health/Family Planning, Ministry of Health, Hanoi, Viet Nam Daniela Draghici, NGO Coalition for Reproductive Health, Bucharest, Romania Monica Dunarintu, Marie Stopes Foundation, Bucharest, Romania Nguyen Duy Khe, Maternal and Child Health/Family Planning, Ministry of Health, Hanoi, Viet Nam Piyadasa Hewage, University of Ruhuna, Matara, Ruhuna, Sri Lanka Margaret Hoffman, Medical School University of Cape Town, Cape Town, South Africa Mihai Horga, Ministry of Health and Family, Bucharest, Romania Virginia Ionescu, Marie Stopes Foundation, Bucharest, Romania Borbala Koo, Society for Education on Contraception and Sexuality, Bucharest, Romania Dan Aurelian Lazarescu, National College of Physicians, Bucharest, Romania Luminita Marcu, Institute for Mother and Child Care, Bucharest, Romania Doina Ocnaru, National Health Insurance House, Bucharest, Romania Mihaela Zoe Poenariu, East European Institute of Reproductive Health, Targu Mures, Romania Cristian Posea, Romanian Society of Obstetrics and Gynaecology, Bucharest, Romania Silviu Predoi, Ministry of Health and Family, Bucharest, Romania Florina Prundaru, East European Institute of Reproductive Health, Targu Mures, Romania Lia Rugan, NGO Coalition for Reproductive Health, Bucharest, Romania Entela Shehu, Ipas, Bucharest, Romania Raluca Teodoru, Youth for Youth Foundation, Bucharest, Romania Nguyen Thi My Huong, Institute for the Protection of the Mother and Newborn, Hanoi, Viet Nam Adrian Vaduva, Romanian Society of Obstetrics and Gynaecology, Bucharest, Romania Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 26 100 26 Women 15 86 15 from: AFRO 2 8 2 AMRO EMRO EURO 20 77 20 SEARO 1 4 1 WPRO 3 12 3 A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 134 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 135 Annex 2b RESEARCH GROUP ON POST-OVULATORY METHODS FOR FERTILITY REGULATION SCIENTISTS IN 2002 Principal investigators Simon Aleksaniants, Armenian Research Centre of Maternal and Child Health Protection, Yerevan, Armenia Karine Arustamian, Armenian Research Centre of Maternal and Child Health Protection, Yerevan, Armenia György Bártfai, Albert Szent-Györgyi Medical University, Szeged, Hungary Marc Bygdeman, Karolinska Institute, Stockholm, Sweden Evelio Cabezas Cruz, Hospital Docente Gineco-Obstetrico “Eusebio Hernandez”, Havana, Cuba Carina Chan chi wai, University of Hong Kong, Hong Kong Special Administrative Region of China Cheng Linan, Shanghai Institute of Family Planning Technical Instruction, Shanghai, China Kim Dickson-Tetteh, Chris Hani Baragwanath Hospital, Johannesburg, South Africa Nguyen Duc Hinh, Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam Nguyen Duc Vy, Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam Fang Aihua, International Peace Maternity and Child Health Hospital, Shanghai, China Kristina Gemzell-Danielsson, Karolinska Institute, Stockholm, Sweden Manuel Gomez Alzugaray, National Institute of Endocrinology, Cmdte. Fajardo Hospital, Havana, Cuba Sarala Gopalan, Postgraduate Institute of Medical Education and Research, Chandigarh, India Ho Pak Chung, University of Hong Kong, Hong Kong Special Administrative Region of China Helena Honkanen, Helsinki University Central Hospital, Helsinki, Finland Mihai Horga, Medical Research Centre, Targu Mures, Romania Nguyen Huy Bao, Hanoi Obstetric and Gynaecology Hospital, Hanoi, Viet Nam Fridtjof Jerve, Ulleval Hospital, Oslo, Norway Aleksandra Kapamadzija, Clinical Centre Novi Sad, Novi Sad, Serbia and Montenegro Christine Kaseba, University Teaching Hospital, School of Medicine, Lusaka, Zambia Archil Khomassuridze, Zhordania Institute of Human Reproduction, Tbilisi, Georgia Laszlo Kovacs, Albert Szent-Györgyi Medical University, Szeged, Hungary Liu Yinkun, Liver Cancer Institute, Zhong Shan Hospital, Shanghai, China To Minh Huong, Hanoi Obstetric and Gynaecology Hospital, Hanoi, Viet Nam Suneeta Mittal, All India Institute of Medical Sciences, New Delhi, India George Okeov, Armenian Research Centre of Maternal and Child Health Protection, Yerevan, Armenia R.N.V. Prasad, National University of Singapore, Singapore Alenka Pretnar-Darovec, University Medical Centre, Ljubljana, Slovenia Erdenetungalag Radnaabazar, State Research Centre on Human Reproduction and Maternal and Child Health, Ulaanbaatar, Mongolia Nair Rajasekharan, S.A.T. Hospital, Trivandrum, India Augustin Rosca, East European Institute of Reproductive Health, Cluj Napoca, Romania Rashmi Shah, Institute for Research in Reproduction, Mumbai, India Song Si, Shanghai Institute of Planned Parenthood Research, Shanghai, China Biu Suong, Hanoi Obstetric and Gynaecology Hospital, Hanoi, Viet Nam Tang Oi-shan, University of Hong Kong, Hong Kong Special Administrative Region of China Le Than Thuy, Hanoi Obstetric and Gynaecology Hospital, Hanoi, Viet Nam Nguyen Thi Ngoc Phuong, Tu Du Hospital, Ho Chi Minh City, Viet Nam Nguyen Thi Nhu Ngoc, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam Ngo Van Tai, Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam Wu Shang-chun, National Research Institute for Family Planning, Beijing, China A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 134 A n n u al Tech n ical R ep ort 2002 Preventing unsafe abortion 135 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 27 66 10 24 4 10 41 Women 15 37 3 7 2 5 20 from: AFRO 2 5 2 AMRO 2 5 2 EMRO EURO 10 24 4 10 14 SEARO 4 10 4 WPRO 19 46 19 Other scientists Constantin Enciulescu, Centre of Public Health Targu-Mures, Targu-Mures, Romania Attila Kereszturi, Albert Szent-György Medical University, Szeged, Hungary Miroslava Mirkovic, Clinical Centre Novi Sad, Novi Sad, Serbia and Montenegro Mihaela Zoe Peonariu, East European Institute of Reproductive Health, Cluj Napoca, Romania Qiao Gen-mei, National Research Institute for Family Planning, Beijing, China Helen Rees, Chris Hani Baragwanath Hospital, Johannesburg, South Africa Janette Rodriguez, Hospital Docente Gineco-Obstetrico “Eusebio Hernandez”, Havana, Cuba Eric Schaff, University of Rochester, New York, NY, USA Allan Templeton, University of Aberdeen, Aberdeen, United Kingdom Hoang Thi Diem Tuyet, Tu Du Hospital, Ho Chi Minh City, Viet Nam Nguyen Thi Ngoc Khanh, Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam George Tsertsvadze, Zhordania Institute of Human Reproduction, Tbilisi, Georgia Tamar Tsoreteli, Zhordania Institute of Human Reproduction, Tbilisi, Georgia Alezandro Velazco, Hospital Docente Gineco-Obstetrico “Eusebio Hernandez”, Havana, Cuba Pham Viet Thanh, Tu Du Hospital, Ho Chi Minh City, Viet Nam Claire von Mollendorf, Chris Hani Baragwanath Hospital, Johannesburg, South Africa Jelka Vukelic, Clinical Centre Novi Sad, Novi Sad, Serbia and Montenegro Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 8 47 7 41 2 12 17 Women 5 29 3 18 8 from: AFRO 2 12 2 AMRO 2 12 1 6 3 EMRO EURO 7 41 1 6 8 SEARO WPRO 4 24 4 Annex 2b (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 136 A n n u al Tech n ical R ep ort 2002 137 Annex 3 PUBLICATIONS IN 2002 Åhman E, Shah I. Unsafe abortion: worldwide estimates for 2000. Reproductive Health Matters, 2002, 10(19):13–17. Åhman E, Dolea C, Shah I. Global burden of abortion in the year 2000. In: Global Burden of Disease 2000. Geneva, World Health Organization (forthcoming). Åhman E, Abou-Zahr C, Shah I. Unsafe abortion: the persistence of a preventable public health problem. Bulletin of the World Health Organization (submitted). Aronsson A, Bygdeman M, Gemzell-Danielsson K. Sublingual administration of misoprostol: effect on uterine contractility. Obstetrics and Gynecology (submitted). Ganatra B, Hirve S. Induced abortion among adolescent women in rural Maharashtra, India. Reproductive Health Matters, 2002, 10(19):76–85. Gogna M, Petracci M, Romero M, Ramos S, Szulik D. Abortion in a restrictive legal context: the views of obstetrician-gynae- cologists in Buenos Aires, Argentina. Reproductive Health Matters, 2002, 10(19):128–137. Hewage P. Cases of induced abortion reported to the health professionals in Colombo district. Journal of the Faculty of Humani- ties & Social Sciences, Vol. 3. Colombo, University of Ruhuna, 2002:10–18. Honkanen H, von Hertzen H. Acceptability of medical abortion in Finland. Contraception, 2002, 65:419–423. Tang OS, Lee SWH, Ho PC. A prospective randomized study on the measured blood loss in medical termination of early pregnancy by three different misoprostol regimens after pretreatment with mifepristone. Human Reproduction, 2002, 17: 2865–2868. Tang OS, Lee SWH, Ho PC. The effect of contraceptive pills on the measured blood loss in medical termination of pregnancy by mifepristone and misoprostol: a randomized placebo controlled trial. Human Reproduction, 2002, 17:99–102. Tang OS, Schweer H, Seyberta HW, Lee SW, Ho PC. Pharmacokinetics and different routes of administration of misoprostol. Human Reproduction, 2002, 17:332–336. UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduc- tion, Research Group on Post-ovulatory Methods for Fertility Regulation. WHO multinational study of three misoprostol regi- mens after mifepristone for early medical abortion: I Efficacy. British Journal of Obstetrics and Gynaecology (in press). Van Look PFA, Cottingham JC. Unsafe abortion: an avoidable tragedy. Best Practice & Research Clinical Obstetrics and Gynaecology, 2002, 16(2):205–220. A n n u al T ec h n ic al R ep or t 2 00 2 Section 4 - Preventing unsafe abortion 136 A n n u al Tech n ical R ep ort 2002 137 Section 5 Promoting sexual and reproductive health of adolescents A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 138 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 139 Promoting sexual and reproductive health of adolescents S. Jejeebhoy, H. Bathija, I.H. Shah, I.K. Warriner INTRODUCTION Adolescence is a time of transition from childhood to adult- hood, during which young people experience changes fol- lowing puberty, but do not immediately assume the roles, privileges and responsibilities of adulthood. Experiences of adolescence vary by age, sex, marital status, socioeconomic status, region and cultural context. Addressing the needs of young people in the context of rapid and profound social, economic and political change in the developing world is undoubtedly challenging. Behaviours of young people may also change faster than societal values, a disjuncture that has implications for the development of sound policies and programmes, such as appropriate family planning services for young people. These changes have enormous implica- tions for adolescents’ education, employment, marriage and childbearing, but also for their sexual and reproductive health and behaviour. As a group, adolescents have sexual and reproductive health needs that differ from those of adults in important ways, and which remain poorly understood or served in much of the world. The 1994 International Conference on Population and Development (ICPD) highlighted these issues and noted that “the reproductive health needs of adolescents as a group have been largely ignored to date by existing reproductive health services” (ICPD Programme of Action, paragraph 7.41. New York, United Nations, 1995). Neglect of this popu- lation has major implications for the future, since sexual and reproductive behaviours during adolescence have far-reach- ing consequences for people’s lives as they develop into adulthood. The Department’s work on promoting adolescent sexual and reproductive health concentrates on addressing these gaps, with the objective of enabling the experience of healthy sexual development and maturation, and enhancing the capacity for equitable and responsible relationships. The main focus is on supporting research that addresses issues relevant to policy-making and enhances the evidence base on the sexual and reproductive health situation and needs of adolescents, including intervention research on the optimal provision of health and information services. Related to this work are activities intended to strengthen research capac- ity and to disseminate findings. At the same time, technical and managerial tools and advocacy materials developed by the Department for reproductive health in the population at large are also tailored to address the unique needs of ado- lescents. RESEARCH ACTIVITIES Specific objectives of research The aim is to support research that addresses factors that contribute to positive sexual and reproductive health out- comes, especially those that can be influenced by appropri- ate interventions in developing countries. The focus is on behavioural research, both social science and operations, largely supported by the ongoing social science research initiative on the topic. Progress Trends in sexual and reproductive behaviour among young never-married women: a case study of Colombia and Peru, 1985–1999 In collaboration with staff of the University of London School of Hygiene and Tropical Medicine, London, United Kingdom, a study was completed that documented yearly trends in sexual activity, contraceptive use, and subsequent reproduc- A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 138 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 139 tive outcomes among never-married women aged 15–24 in Colombia and Peru. Using ‘calendar’ data from successive Demographic and Health Surveys (DHS), the study reveals that over the period 1985–1999, young single women in both settings became sexually active at increasingly younger ages (Figure 5.1). Contraceptive use, and especially the use of condoms, did increase (Figure 5.2), but this increase did not fully offset the rise in sexual activity. The evidence sug- gests, therefore, an increase in the incidence of unplanned pregnancies and abortions among young single women. The results have three major implications for programmes and policies. First, the clear trend towards sexual activ- ity—for many, unprotected—at early ages among adolescent females calls for programmes and policies that reinforce efforts to provide appropriate information and services to the unmarried. Second, contraceptive services and choices must be made available to youth, condoms must be pro- moted vigorously and made widely available, and efforts made to reduce failure associated with periodic abstinence and withdrawal. Third, a more comprehensive strategy may be warranted to address the various dimensions of young women’s sexual and reproductive lives. This strategy would need to go beyond the focus on contraceptive use to address the ever-increasing number of abortions and unwanted chil- dren born out of wedlock. Estimating unsafe abortion among young women As part of the Department’s work on estimating the incidence of unsafe abortion, data by age were used to estimate the magnitude of unsafe abortion among women aged 15–19 and 20–24 years. Overall, 40% of all unsafe abortions in the developing world occur among women aged 15–24 years, resulting in 7.3 million unsafe abortions in this age group each year. In Africa, nearly 59% of all unsafe abortions occur among women aged 15–24 years (Table 5.1). Figure 5.2. Contraceptive protection through condom use, never-married women of 15–24 years, Colombia and Peru Source: Ali et al, forthcoming Figure 5.1. Never-married women, 15–24 years, in specifi c exposure states, Colombia and Peru. Source: Ali et al, forthcoming Colombia Peru Naturally protected Protected Unprotected Virgin A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 140 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 141 Social science research initiative on adolescent sexual and reproductive health The year 2002 witnessed the continuation, in 28 countries, of 41 research projects approved in 2001 or earlier, address- ing social and behavioural aspects of adolescent sexual and reproductive health in different developing country settings. As described in earlier reports, the studies address sexual risk behaviours, their correlates and consequences, and health-seeking behaviour, quality of care and provider per- spectives. Since late 2001, 36 papers have been published, present- ing results and policy implications; these have highlighted the extent, patterns and consequences of risky sexual behaviours, contraception and condom use, and abortion. They have also shed light on underlying factors that place youth at greater risk of, or protect them from, unsafe sexual and reproductive experiences. These include the roles and perspectives of parents and providers; exposure to sexuality education programmes; health-seeking behaviour and the quality of services; and gender attitudes and roles. Many studies focus on filling evidence gaps relating to the sexual and reproductive health needs of the particularly disadvan- taged, such as out-of-school and migrant adolescents. Here we summarize findings from three studies addressing the particularly disadvantaged in diverse settings. A study conducted in a slum setting in Jakarta, Indonesia, focused on young men aged 15–24, using a participatory approach and qualitative techniques. The majority of study participants had some education, but were out-of-school and unemployed. Premarital sex among young men in this set- ting was reported to be “common” and “taken for granted”. Sexual relations with sex workers were frequently reported and often described as a group activity, usually spontane- ous and largely dependent on the availability of cash. As other studies in this age group have noted, condom use was largely dismissed and a sense of invulnerability prevailed. Examples of statements recorded include: “No condom, boys do not use condom… if you use condom, it is not sex. Sex is skin to skin. With protection it is not pleasant” (in-depth interview, unemployed man aged 23); and “I do not think that far…I do not bother” (focus group discussion [FGD], unemployed group). Neither infection nor pregnancy are necessarily perceived as likely adverse consequences of sexual relations: “I go to the brothel… if we got a disease… it is fate… have thought about it but never got it” (FGD, unemployed group). Infection is perceived as easily treatable: “… One time I got a disease but taking ampicillin [antibiotics] 500, after three days recov- ered… just drink herbs, you won’t get [sexually transmitted] disease, you can be sure of traditional herbals” (in-depth interview, temporarily employed parking-lot attendant aged 23). Pregnancy and abortion were not uncommon, but some- times used as a strategy for forcing parents to consent to an early marriage: “Many [unwanted pregnancy] happen here… It happens because of the parent factor, because parents don’t permit it, they just do it [sex, become pregnant]” (FGD, unemployed group). Several programmatic implications were recommended as a result of this study. First, misconceptions and lack of aware- ness about sexual risk behaviours need to be addressed in ways that are acceptable to peer networks; messages concerning condom use in particular must be reinforced. Second, study participants themselves acknowledged the need for counselling—preferably through mentoring relation- ships—and for opportunities to discuss and seek information and advice on sexual and reproductive health. Third, the findings suggested the need to modify current approaches to youth to address the special service delivery needs of low- income and out-of-school young men and women. Table 5.1. Unsafe abortions worldwide by age group and region Age group Region 15–19 years 20–24 years 15–24 years % of all unsafe abortions No. of unsafe abortions % of all unsafe abortions No. of unsafe abortions % of all unsafe abortions No. of unsafe abortions Developing countries 14 2 500 000 26 4 800 000 40 7 300 000 Africa 26 1 100 000 33 1 400 000 59 2 500 000 Asia 8 900 000 22 2 300 000 31 3 200 000 Latin America & Caribbean 15 500 000 29 1 100 000 44 1 600 000 A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 140 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 141 A study of the sexual risk behaviours of adolescent girls and boys in a low-income setting in New Delhi, India, also reveals risky sexual behaviours: 5% and 15% of adolescent girls and boys, respectively, reported sexual activity. As in Jakarta, many sexually active young men reported relations with sex workers, yet a considerable percentage reported relations with girls residing in the community. Study findings under- score wide gender disparities in socialization and a false confidence among parents that withholding information from adolescents and closely regulating the activities of daughters will protect them from risky sexual encounters. Findings sug- gest that despite strict regulation of daughters, sexual rela- tions are not unknown: “There are a lot of constraints on girls’ movements. But they continue to meet their male friends stealthily. When parents learn of these cases they generally forcibly get them married off elsewhere after an abortion or agree to get them married to the same boy” (adolescent girls, 17–19, slum resident); and, “There are some cases of preg- nancies among unmarried girls, we do have girls of this kind in our area. We do not know them well” (adolescent girls, 15–17, resettlement colony). The findings from this study highlight the need for interven- tions that: (i) recognize and address misperceptions held by parents; (ii) apprise parents of existing conditions and of the need to communicate with their adolescent children in order to inform them about sexual and reproductive health issues, to protect them from unsafe and unwanted sex; and (iii) con- vince parents of the need to focus on enhancing informed choice among adolescents rather than imposing tight regu- lation, because it is a more effective strategy of ensuring sexual and reproductive well-being. The findings also suggest the need for programmes that pro- vide extensive sexuality education for both young females and males, that facilitate communication between adoles- cent partners and between adolescents and their parents on sexual matters, and that seek to redress gender imbal- ances and double standards influencing adolescents’ own autonomy and ability to exercise informed choice. Finally, programmes are needed that reorient adult gatekeepers, and particularly providers, away from traditional and judge- mental attitudes to premarital sexual activity and towards the provision of services that enable safe sexual relations among young people. A qualitative study of young migrant females to five cities in China (Beijing, Guangzhou, Guiyang, Shanghai and Taiy- uan) underscores the risky sexual behaviour characterizing this population. The findings also show that there are many obstacles to negotiation with partner(s) on sexual matters as well as to the access of contraception and services. Major industrial cities in China attract a large number (between 70 and 80 million) of internal temporary or seasonal migrant workers—called “floating population”—mostly from rural areas. On short-term employment contracts and without per- manent household residence, these migrants do not receive the health and welfare benefits available to registered resi- dents. Women comprise over a third of this population, and about half of these women are under 25 years and unmar- ried; most work in small factories or in the service industry. The study revealed that while premarital sex was perceived as acceptable, young female migrants deeply feared dis- closure of their sexual activity status to their families at home. While they expressed concern about the social con- sequences of an unintended pregnancy, several obstacles inhibited them from practicing contraception. Most sexually active young women believed that family planning distribu- tion centres were for married women only. Most had never used contraception, few knew where to obtain it, and many preferred to risk pregnancy (calling it “just bad luck”) than the embarrassment of acquiring contraceptives and risking dis- closure of their sexual activity status. Providers reported that migrant women were more likely than non-migrants to delay seeking abortion and to experience multiple abortions. They were also more likely to resort to private—usually unquali- fied—providers, believing that confidentiality would be better protected. The researchers made several programmatic recommenda- tions based on the evidence: that registration offices and employers of migrant workers should provide information to new arrivals regarding family planning and the location of services; that reproductive health services for migrants be made available in medical clinics attached to the workplace; and finally, that service delivery strategies be adapted to address the needs of migrant young women, for example through visits by urban family planning workers to migrant workplaces and residences. Findings of this study were dis- seminated through a WHO Social science policy brief and a paper in Reproductive Health Matters (Zheng et al., 2001). Network activities A network of researchers supported by the social science research initiative on adolescent sexual and reproductive health was established in 2000 to initiate a forum for the exchange of ideas and information. The network is also a means of providing technical support to researchers. Net- work activities include: (i) regular updating of both the syn- opsis of ongoing research supported by the initiative and the annotated bibliography of relevant materials; (ii) the main- tenance of a limited documentation centre and facilities to provide researchers with materials they are unable to access otherwise; (iii) the provision of core instruments (FGD guide- lines, in-depth interview guides and a survey questionnaire) for the study of adolescent sexual risk behaviours, that are intended for researchers to adapt to the thematic focus of their research and to the local context; and (iv) site visits to investigators in selected countries. Dissemination In addition to publication in peer-reviewed journals (see Annex 3), findings from several projects supported by this A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 142 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 143 research initiative have been disseminated at seminars and conferences. Highlights include: •• The International Union for the Scientific Study of Popu- lation (IUSSP) Population Conference: Southeast Asia’s Population in a Changing Asian Context, Bangkok, Thai- land, June 2002. A session on “Adolescent sexual and reproductive health: the new Asian scenario” was organ- ised by the Department, and four papers by participating investigators were presented. •• The 6th Asia-Pacific Social Science and Medicine Con- ference, Kunming, China, October 2002. The Depart- ment sponsored five sessions at the conference, dealing with issues related to adolescent sexual and reproduc- tive health. Eleven papers by investigators participating in the initiative were presented. •• A volume submitted for publication with syntheses of 45 major presentations and panel discussions from an international conference held at Mumbai, India in 2000, entitled Adolescent Reproductive Health: Evidence and Programme Implications for South Asia. Operations research on improving reproductive health services for adolescents in French-speaking African countries As described in previous reports, an operations research project to evaluate and improve reproductive health serv- ices for adolescents has been ongoing in several French- speaking sub-Saharan countries. The project includes three phases: (i) a baseline survey of adolescents using health services, and of the quality of services offered; (ii) an intervention, informed by findings from the baseline survey, to address the information needs of adolescents, training of service providers or modification of existing services to enhance their youth-friendliness; and (iii) a post-intervention survey to evaluate the effectiveness of the intervention. The Programme facilitates and coordinates this regional initiative and provides support for research capacity strengthening, but funding for each country project is raised locally. In Benin and Côte d’Ivoire, the survey was completed in 2000, findings were disseminated at local and national levels and interventions have been under preparation but not yet implemented because of a lack of funding. In Senegal, the evaluation has been completed and analysis is ongoing. In 2002, research activities were initiated in Cameroon and the baseline survey commenced in December. In Guinea, the evaluation phase will be initiated in early 2003. With the Programme’s collaboration, the centre in Senegal was included in the USAID-funded project FRONTIERS in Reproductive Health (along with centres in Bangladesh, Kenya and Mexico), in a study of reproductive health serv- ices for youth. Selected findings have been presented in earlier reports. The project has also contributed to the development of tools, including a training manual for health professionals on ado- lescent health and development. These tools are now avail- able for French-speaking countries. Regional research initiative on adolescent migrants and reproductive health in the Greater Mekong region A regional research initiative is ongoing in one major city in each of five countries of the Greater Mekong region, namely China (Yunnan Province), the Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam. The objective is to assess the reproductive health needs of a growing but vul- nerable and marginalized sub-population, young migrants. At the same time, the initiative aims to strengthen research capacity through intraregional networking. Using qualitative research methods, the study explores risky and health-seek- ing behaviours, and service and information needs. In 2002, an investigators’ meeting was held at the Institute of Population and Social Research (IPSR), Mahidol Univer- sity, Bangkok, Thailand, to develop study instruments and implementation plans. Preliminary findings from Thailand are available and suggest that young migrants perceive them- selves as healthy; as far as health seeking is concerned, neighbourhood pharmacies are commonly mentioned sources of treatment for minor ailments, and government hospitals are sought for delivery care or immunization of children. However, reproductive health knowledge and use of reproductive health services is limited. For example, while unmarried adolescents are aware of HIV/AIDS, they tend to lack information about sexually transmitted infections; use of government health services is limited, and condoms, if used, are more likely to be purchased from pharmacies than obtained from government facilities. Data from all settings will become available in early 2003 and investigators will meet to discuss analysis in March at a workshop to be held in Kunming, China, and organized by the Institute of Sociology, Yunnan Academy of Social Sci- ences, China. Results from the initiative will be disseminated at the World Congress of the International Institute of Sociol- ogy in Beijing, China, on 7–11 July 2003. Research on pre-adolescent girls reporting vaginal symptoms Studies are under way in Mongolia in response to reports from providers of unusually high levels of lower genital tract infection among pre-adolescents. Symptoms may have been observed by adolescents themselves or by their mothers. One study explores the perceptions of about 500 mothers of these pre-adolescents concerning vaginal discharge in general and their daughter’s complaint in particular. A second will examine about 500 pre-adolescents for the presence of discharge and any signs of lower genital tract infection, and screen speci- mens for Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Candida spp. and anaerobes. A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 142 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 143 Study on bone mass and hormonal contraception An ongoing study in Durban, South Africa, explores the extent to which use of hormonal contraception at ages 16– 20—a period critical for bone mass acquisition—depresses peak bone mass achieved and puts young women at greater risk of osteoporosis in later life. This is a five-year longitudi- nal study in young (16–20 years) and older (45–49 years) women of the impact of depot medroxyprogesterone acetate (DMPA), norethisterone enantate (NET-EN) and combined oral contraceptives on bone mass density, with a comparison group of women not using any hormonal contraception. Pre- liminary results were presented at a meeting in September in South Africa (for further details, see the chapter on Safety and effectiveness of existing methods). New projects initiated during the year Social science research initiative on adolescent sexual and reproductive health Two new projects were approved in 2002. The first, “Inter- active sex education program on the Internet”, provides an exciting and youth-friendly opportunity to address young people’s sexual and reproductive health concerns and information needs. The study, to be undertaken in selected schools in Shanghai, China, will (i) design and implement a sex education web site for adolescents; and (ii) evaluate this intervention in terms of changes in knowledge and attitudes, and also in terms of young people’s own assessments about its usefulness. The second study, “Condom use among tem- porary migrants in urban China”, aims to understand the per- spectives of young male migrants with regard to condoms: their awareness, attitudes and practices. More specifically, it will identify condom use patterns and explore constraints to condom use among young temporary migrants. Find- ings should help identify acceptable strategies to increase condom use among young migrants in China. Plans for future work Although there is increasing evidence of risky consensual sex among young people in developing countries, non-con- sensual sexual experiences among them have rarely been studied. Moreover, few interventions exist that are intended to protect adolescents from unwanted sexual experiences. In this context, the Programme intends to take steps, jointly with YouthNet and the Population Council, to consolidate avail- able evidence and identify and fill research gaps in the area of non-consensual sexual experiences of young people. The World report on violence and health (World Health Organization, 2002) has increased awareness of the issue of forced sexual debut among young people; similarly, an ongoing study, coordinated by WHO, of physical and sexual domestic violence experienced by women in six countries, sheds light on sexual violence experienced by young women, and raises important questions. A more dedicated investigation of their situation and needs is required. For the most part, however, while the non-consensual sexual experi- ences of young people are highlighted in studies of sexual violence in general, few studies focus exclusively on the experiences and particular circumstances of young people. Rape is the most extreme form of non-consensual sex, but it is not the only form that youth experience and the available evidence demonstrates the existence of unwanted touch, coerced sex through threats, deception and use of force, and sex in exchange for gifts and money in diverse sociocultural settings. Yet these issues remain poorly studied and insights into the context in which these experiences occur and the risks they pose to a healthy transition to adulthood remain limited. To raise awareness of this neglected issue and arrive at a global consensus on concepts, ethical issues, and measure- ment issues and appropriate design, the Programme will collaborate with the Population Council and YouthNet in a phased initiative intended to promote dialogue and enhance the evidence base on non-consensual sexual experiences of young people. In its first phase, scheduled for late 2003, a consultative meeting is proposed that will consolidate the available evidence and raise awareness of the issue, outline outstanding gaps in evidence, identify scientifically and ethi- cally sound research approaches to fill these gaps, and lay the foundation for evidence-based direction for programmes intended to protect young people from non-consensual sexual advances. NORMS AND TOOLS Specific objectives Because adolescents are more likely than adults to experi- ence risky outcomes and to require different approaches in terms of service and care provision, norms and tools intended to enhance the reproductive health of individuals in general must be adapted to the particular situation and needs of adolescents. These issues are highlighted in guide- lines and other tools for programming and capacity building developed by the Department. Other norms and tools relat- ing to adolescent sexual and reproductive health needs are developed by the Department of Child and Adolescent Health and Development. Tools developed Included in every tool developed by the Department for the promotion of reproductive health is a special section devoted to the unique needs of adolescents. For example: •• The Pregnancy, childbirth and newborn care: a guide for essential practice, and the ECPG for RTI/STIs, give special attention to the needs of adolescents and the special considerations that should be accorded when dealing with adolescents. Further information on these A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 144 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 145 two tools can be found in the chapters on Implementa- tion of evidence-based programes in Section 2: Making Pregnancy Safer and in Section 3: Controlling sexually transmitted and reproductive tract infections. •• Guidelines on medical eligibility criteria for family plan- ning provide guidance on issues specific to adolescents, as do other tools including the Decision making tool for family planning clients and providers, advocacy materials and guidelines on the prevention of unwanted pregnan- cies and unsafe abortions, and technical and managerial guidelines on management of abortion complications. •• The Department also developed specification and pro- curement guidelines for the male latex condom and is working with the United Nations Population Fund (UNFPA) and the Inter Agency Task Force Team on Prevention of HIV to develop condom programming guidelines, giving special consideration to the needs and situation of adolescents. •• The training curriculum, Transforming health systems: gender and rights in reproductive health, provides sup- port for programming at national level for adolescent sexual and reproductive health in several ways, includ- ing through the presentation of case examples of ado- lescent sexual and reproductive health issues intended to sensitize participants to address adolescent needs within their programmes and services. •• Following the publication in 2001 of Advancing safe motherhood through human rights, a shorter version for use by policy-makers and programme managers is now under development. This pocket guide is intended to assist national level managers address key rights issues for adolescents and other special groups. • In January 2002, a Technical Consultation on Sexual Health was held, which addressed both adolescent and adult sexual health issues. The consultation report will be published in early 2003, together with a selection of the background papers, including one focusing particu- larly on healthy sexual development. LINKS WITH THE DEPARTMENT OF CHILD AND ADOLESCENT HEALTH AND DEVELOPMENT The Department continues to collaborate with the Depart- ment of Child and Adolescent Health and Development (CAH) in several activities. Staff members actively participate in the working groups on HIV/AIDS and young people and on adolescent pregnancy. Staff members also participated in a meeting on Monitoring & Evaluation of HIV/AIDS in Young People, jointly organized by WHO, the United Nations Children’s Fund (UNICEF), and the Joint United Nations Pro- gramme on HIV/AIDS (UNAIDS), to take a significant step towards developing a guide for the monitoring and evaluation of HIV/AIDS programmes for young people. Staff members also participated in a workshop on the role of “regulation” on adolescent behaviour organized by CAH, and in a meeting on adolescent pregnancy organized by CAH to obtain the perspectives of all relevant WHO departments. They also continued to provide extensive comments and suggestions on documents produced on adolescent sexual and reproduc- tive health issues. A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 144 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 145 Annex 1 SPECIALIST PANEL FOR SOCIAL SCIENCE AND OPERATIONS RESEARCH ON REPRODUCTIVE HEALTH IN 2002 See Section 1 on Promoting Family Planning. A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 146 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 147 Annex 2 SCIENTISTS IN 2002 Principal investigators Akosua Adomako Ampofo, Institute of African Studies, University of Ghana, Legon, Ghana Ademola Ajuwon, African Regional Health Education Centre, University of Ibadan, Ibadan, Nigeria Ayse Akin, Hacettepe University Medical Faculty, Ankara, Turkey Luisa Alvarez Vazquez, National Institute of Endocrinology, Havana, Cuba Mariame Ba, University Hospital “Le Dantec”, Dakar, Senegal Patsy Bailey, Family Health International, Research Triangle Park, NC, USA Mamadou Baldé, University Hospital “Donka”, Conakry, Guinea Ibrahima Barry, Dakar, Senegal Dominique Behague, Universidade Federal de Pelotas, Rio Grande do Sul, Brazil Zenilda Vieira Bruno, Maternidade Escola Assis Chateaubriand, Fortaleza, Brazil Cui Nian, Sichuan Family Planning Research Institute, Chengdu, China Manuela de la Pena Vega, Asociacion Multidiscipliniaria de Investigacion y Docencia en Poblacion (AMIDEP), Lima, Peru Danuta Duch, Research Unit on Women and Family, Polish Academy of Sciences, Warsaw, Poland Gao Ersheng, Shanghai Institute of Planned Parenthood Research, Shanghai, China José Carlos Gomes dos Anjos, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil Helen Goncalves, Universidade Federal de Pelotas, Rio Grande do Sul, Brazil Diomandé Gondo, National Institute of Public Health, Abidjan, Côte d’Ivoire Viviana Gonzalez de la Cruz, Medical School of Sancti Spiritus, Havana, Cuba Ana Cristina Gonzalez Velez, SISMA-MUJER, Bogota, Colombia Caridad Teresita Gracia-Alvarez, National Institute of Endocrinology, Hospital “Cmdte Fajardo”, Havana, Cuba Abigail Harrison, South African Medical Research Council, Durban, South Africa Amir Hodzic, Centre for Education and Counselling of Women, Zagreb, Croatia Ko Ko Zaw, Department of Medical Research, Yangon, Myanmar Chaohua Lou, Shanghai Institute of Planned Parenthood Research, Shanghai, China Cecilia McCallum, Federal University of Bahia, Salvador, Brazil Maung Maung Toe, Department of Medical Research, Yangon, Myanmar Robinson Mbu, University of Yaoundé 1, Yaoundé, Cameroon Sunil Mehra, Mamta Health Institute for Mother and Child, New Delhi, India Patricia Merlo, Instituto Mexicano de Investigacion de Familia y Poblacion, AC, Mexico, DF, Mexico Laurike Moeliono, Centre for Societal Development Studies (CSDS), Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia Mohammad Mohammadi, National Research Centre of Medical Sciences, Tehran, Islamic Republic of Iran Alejandro Andres Moyano, Centro de Estudios de Poblacion (CENEP), Buenos Aires, Argentina Soori Nnko, National Institute for Medical Research, Mwanza, United Republic of Tanzania Wanda Nowicka, Federation for Women and Family Planning, Warsaw, Poland Charles Nzioka, University of Nairobi, Nairobi, Kenya Sevkat Bahar Ozvans, Hacettepe University Medical Faculty, Ankara, Turkey Vikram Patel, The Sangath Society for Child Development and Family Guidance, Goa, India Cristian Pereda Feliu, University of Chile, Santiago, Chile Susan Pick, Instituto Mexicano de Investigacion de Familia y Poblacion, AC, Mexico, DF, Mexico Laurie Ramiro, College of Arts and Sciences and Clinical Epidemiology Unit, University of the Philippines, Manila, Philippines Sabina Rashid, Bangladesh Rural Advancement Committee, Dhaka, Bangladesh Marcela Sanchez Buitrago, PROFAMILIA, Bogota, Colombia R. Savithri, Mamta Health Institute for Mother and Child, New Delhi, India Claudio Stern, Centro de Estudios Sociologicos, El Colegio de Mexico, Mexico City, Mexico Vanphanom Sychareun, National University of Laos, Vientiane, Lao People’s Democratic Republic Negussie Taffa, African Population and Health Research Centre, Nairobi, Kenya Anand Tamang, Centre for Research on Environmental Health and Population Activities (CREHPA), Kathmandu, Nepal Arunrat Tangmunkongvorakul, Centre for Public Health Research, Chiang Mai University, Chiang Mai, Thailand Nilar Tin, Department of Health, Ministry of Health, Yangon, Myanmar Anna Titkow, Research Unit on Women and Family, Polish Academy of Sciences, Warsaw, Poland Tu Xiaowen, Shanghai Institute of Planned Parenthood Research, Shanghai, China Sahdia Wannous, Ministry of Health, Damascus, Syrian Arab Republic Supra Wimbarti, Dr Sardjito General Hospital, Gadjah Mada University, Yogyakarta, Indonesia Ariel Mino Worobiej, Centro de Estudios Rurales Interdisciplinarios (CERI), Asuncion, Paraguay Wu Shi-Zhong, Sichuan Family Planning Research Institute, Chengdu, China Zhang Liying, National Research Institute for Family Planning, Beijing, China Zheng Zhenzhen, Institute of Population Research, Peking University, Beijing, China Zhou Yun, Institute of Population Research, Peking University, Beijing, China A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 146 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 147 Annex 2 (continued) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 53 91 4 7 1 2 58 Women 33 57 3 5 1 2 37 from: AFRO 11 19 11 AMRO 17 29 1 2 18 EMRO 2 3 2 EURO 2 3 4 7 6 SEARO 11 19 11 WPRO 10 17 10 Other scientists Sarah Bott, Los Angeles, CA, USA Carlos Caceres, REDESS Jovenes, Lima, Peru John Cleland, London School of Hygiene and Tropical Medicine, London, United Kingdom Rebecca Cook, University of Toronto, Toronto, Canada Nafissatou Diop, FRONTIERS in Reproductive Health, Dakar, Senegal Bela Ganatra, Ipas, Pune, India Gu Baochang, China Family Planning Association, Beijing, China Philip Guest, The Population Council, Bangkok, Thailand Roger Ingham, University of Southampton, Southampton, United Kingdom Shireen Jejeebhoy, The Population Council, New Delhi, India Evert Ketting, Zeist, Netherlands Malika Ladjali, UNESCO, Paris, France Gottlieb Mpangile, Dar es Salaam, United Republic of Tanzania Judith Senderowitz, Pathfinder International, Watertown, MA, USA Susheela Singh, The Alan Guttmacher Institute, New York, NY, USA Ivonne Szasz, Centro de Estudios Demograficos y de Desarrollo Urbano, El Colegio de Mexico, Mexico, DF, Mexico Shyam Thapa, YouthNet, Arlington, VA, USA Wang Yifei, Shanghai Second Medical University, Shanghai, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 9 50 9 50 18 Women 3 17 5 28 8 from: AFRO 2 11 2 AMRO 2 11 5 28 7 EMRO EURO 4 22 4 SEARO 3 17 3 WPRO 2 11 2 A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 148 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 149 Annex 3 PUBLICATIONS IN 2002 Ali MA, Cleland JG, Shah IH. Trends in sexual and reproductive behaviour of young unmarried women in Colombia and Peru. Demography (forthcoming). Bayley P, Bruno Z, Bezerra M, Queiroz I, Oliveira C. Adolescents’ decision-making and attitudes towards abortion in NE Brazil. Journal of Biosocial Science (in press). Bojelic N. Power and young women’s gender identities in the context of sexual relations. Journal for Literature and Culture, and Social Issues, 2002, 14:102–111 (in Bosnian). Cui N, Li M, Gao E. How the Chinese parents view the provision of contraception services to unmarried young adults. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:276–281. Cui N, Li M, Gao E. Views of Chinese parents on the provision of contraception to unmarried youth. Chinese Journal of Family Planning, 2001, 9(3):167–170. Cui N, Li M, Tian A. Sexual perspectives and needs of the unmarried young adults in Sichuan. Population and Family Planning, 2001, 2:45–46. Gan S, Xu X, Chang M, Bo L, Hu S, Zhang P, Chang M. The qualitative study on reproductive health service among unmarried young adults in Henan province. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:168–173. Gao E, Lou C, Liu Y. Underreported rate of first sexual behaviour survey data and the influencing factors. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:314–322. Hodzic A. Gender does matter: framing risk sexual behaviours among Croatian adolescents. Journal for Literature and Culture, and Social Issues, 2002, 67(13):273–286. Jiang H, Sun D, Chen A. The investigation on provision barriers for sexual and reproductive health services for unmarried young adults. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:174–176. Li H, Tong Q, Tan Z. Attitude of family planning workers toward unmarried young adults’ needs for reproductive health. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:161–163. Lou C, Wang B, Tu X, Gao E. Family planning workers’ opinion on reproductive health matters among unmarried young people. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:136–140. Lou C, Peng M, Tu X, Gao E. Premarital contraceptive use and its influencing factors. Reproduction and Contraception, 2002, 22(4):226–230. Mehra S, Savithri R, Coutinho L. Gender double standards and power imbalances: adolescent partnerships in Delhi, India. In: Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science and Medicine Conference. Kunming, Institute of Health Sci- ences (in press). Moeliono L. Sexual risk behaviour of out-of-school young males in an urban slum: a case study in Duri Utara, Jakarta. In: Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science and Medicine Conference. Kunming, Institute of Health Sciences (in press). A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 148 A n n u al Tech n ical R ep ort 2002 Promoting sexual and reproductive health of adolescents 149 Schufer ML. Sexual relations among young people in developing countries: evidence from WHO case studies (book review). Medicina y Sociedad, 2001, 24(3-4):184–185. Tong Q, Li H, Tan Z. Understanding of parents perspectives on providing knowledge of sex, contraception and STDs to their unmarried young kids in rural areas in China. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:282–285. Tu X, Peng M, Lou C, Gao E. Attitudes of family planning workers toward providing contraceptive services for unmarried young adults in 8 settings in China. Population Information, 2001, 3(116):24–29. Tu X, Lou C, Gao E. Study on needs in sex and reproductive health education among young unmarried people. China Public Health, 2002, 18(11):1353–1355. Tu X, Yu Yi, Lou C, Gao E. Attitude of family planning workers to providing knowledge and information on sex and reproductive health for unmarried young adults. China Public Health, 2002, 18(7):863–866. Tu X, Peng M, Lou C, Gao E. Attitude of family planning workers towards providing contraceptive services for unmarried young adults in 8 centers in China. Reproduction & Contraception, 2002, 22(3):169–175. Tu X, Liu Y, Lou C, Gao E. Attitudes of family planning workers to setting up special counselling stations for unmarried young adults. Chinese Journal of Family Planning, 2002, 10(2):101–104. Tu X, Liu Y, Lou C, Gao E. Attitudes of family planning workers to setting up special counselling stations for unmarried young adults. Reproduction & Contraception, 2001, 12(2):93–101. Tu X, Peng M, Lou C, Gao E. Attitude of family planning workers towards providing contraceptive services for unmarried young adults in 8 centers in China. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:141–149. Tu X, Liu Y, Lou C, Gao E. Attitudes of family planning workers to setting up special counselling stations for unmarried young adults. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strat- egies. Shanghai, Publishing House of Second Military Medical University, 2002:156–160. Tu X, Lou C, Gao E. Sexual debut among unmarried men and women in Shanghai. Fudan University Journal of Medical Sci- ence, 2002, 29(2):109–112. Wang B, Zhong Y, Gao E. Analysis on contraceptive choices among unmarried youth. China Public Health, 2002, 18(7): 869–870. Wang B, Lou C, Gao E, Tu X. Sexual and reproductive health (SRH) problems among the unmarried youths in sub-urban Shanghai: needs for RH education and services. Reproduction and Contraception (English version), 2001, 12(2):110–126. Wang B, Lou C, Shen Yan, Gao E, Tu X. Sexual behaviour and contraceptive use among unmarried youths in sub-urban Shanghai. Reproduction and Contraception (Chinese version), 2002, 22(2):99–106. Wang B, Lou C, Tu X, Gao E. Family planning workers’ attitude toward and opinion on premarital sexual behavior and induced abortion. Population Information, 2001, 1(114):19–25. Wang B, Lou Chaohua, Tu X, Gao E. The perspectives and attitudes of family planning workers to premarital sex, induced abortion and its consequences on health among unmarried young adults. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medi- cal University, 2002:129–135, 149. Yu J, Zhang Y, Qi H. Attitudes of family planning workers towards providing reproductive health services to unmarried youth. Chinese Journal of Family Planning (in press). A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 150 A n n u al Tech n ical R ep ort 2002 151 Zhang Y, Yu J, Qi H, Cong H. The investigation on the needs of reproductive health services among unmarried young adults in Hebei province. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:164–167. Zhao S, Lou C, Tu X, Gao E. Attitude toward premarital sex behavior and its influencing factors among people seeking premari- tal medical examination. China Public Health, 2002, 18(1):61–64. Zheng Z. Reproductive health service use among unmarried young female migratory workers in urban China. In: Zhang K, ed. Proceedings of the 6th Asia-Pacific Social Science and Medicine Conference. Kunming, Institute of Health Sciences (in press). Zhou L, Wang B, Tu X, Gao E. Analysis on the attitude of the family planning workers about the contraception service delivery to the unmarried youth. Chinese Journal of Family Planning, 2001, 9(4):223–225. Zhou L, Wang B, Tu X, Gao E. Analysis on the attitudes of family planning staff toward the contraceptive service delivery to the unmarried youth. Reproduction & Contraception, 2001, 12(2):102–109. Zhou L, Wang B, Tu X, Gao E. Analysis on the attitudes of family planning staff toward the contraceptive service delivery to the unmarried youth. In: Gao E, Lou C, Tu X, Shah I, eds. Adolescent and unmarried youth reproductive health: status, perspective and strategies. Shanghai, Publishing House of Second Military Medical University, 2002:150–155. A n n u al T ec h n ic al R ep or t 2 00 2 Section 5 - Promoting sexual and reproductive health of adolescents 150 A n n u al Tech n ical R ep ort 2002 151 Section 6 Gender and reproductive rights in reproductive health A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 152 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 153 Gender and reproductive rights in reproductive health J. Cottingham, A. Martin Hilber, M. Colombini, E. Kismodi INTRODUCTION The International Conference on Population and Develop- ment (ICPD, Cairo, 1994) and the Fourth World Conference on Women (FWCW, Beijing, 1995) both clearly emphasized the need to promote gender equity and equality in reproduc- tive health policies and programmes, and to promote and protect human rights. These agreements were reinforced in the five-year reviews of both conferences, held in 1999 and 2000, respectively. Among the key issues to be given greater attention following the recommendations of the reviews were: measures aimed at promoting and achieving gender equality and equity in a systematic and comprehensive manner (ICPD+5, paragraph 39); the incorporation of issues related to sexual and reproductive health in the work of rel- evant United Nations bodies on indicators for the promotion and protection of the human rights of women (ICPD+5, para- graph 40); and the protection and promotion of human rights by ensuring that all health services and workers conform to ethical, professional and gender-sensitive standards in the delivery of women’s health services, including through the establishment or strengthening of regulatory and enforce- ment mechanisms (Beijing+5, paragraph 107 g). In order to contribute to these goals, the Department carries out a number of specific projects to promote gender equity and reproductive rights. Objectives The work of the Department in this area aims: •• to identify, develop and evaluate strategies and mecha- nisms for promoting gender equality and human rights in reproductive health research, programming and techni- cal support; •• to support countries to ensure that reproductive pro- grammes and policies respect, protect and fulfil human rights and promote gender equity and equality; and •• to ensure that the promotion of gender equity and equal- ity and human rights principles are integrated into the Department’s work. The Department is guided in this work by the Gender Advi- sory Panel (GAP), a group of independent, external experts from different disciplines and regions. INTEGRATING A RIGHTS-BASED APPROACH INTO SEXUAL AND REPRODUCTIVE HEALTH Specific objectives The respect, protection and fulfilment of human rights related to sexual and reproductive health can only be achieved if national laws and policies reflect a recognition of these rights, either implicitly or explicitly. There is evidence to show that laws which violate human rights have a negative impact on health. This can be by the specific restriction of access to health services which only women need, for example those relating to pregnancy and childbirth, thus violating their right to non-discrimination. The absence of laws and policies which protect human rights, such as those which prohibit female genital mutilation, and the lack of punishment and social con- demnation of perpetrators of violence against women, have also been shown to contribute to negative health outcomes. Thus, taking concrete action to ensure that people’s rights are protected through the laws and policies surrounding whatever public health intervention is being proposed, could be expected to have a positive impact on health. The Depart- ment is therefore working both at the country and the interna- A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 152 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 153 tional level to integrate human rights and examine laws and policies related to different aspects of reproductive health, in order to help identify areas where such laws and policies might be adapted to improve reproductive and sexual health. The objectives of this area of work are: •• to elaborate and implement a methodology for integrat- ing human rights into aspects of reproductive health interventions, through country pilot projects; and •• to develop evaluation mechanisms, including indicators for measuring the impact of integrating human rights. Over the past year, the Department has continued to work on the development of a human rights framework for maternal and neonatal health, and has been defining new work in the areas of sexual health broadly and sexual and reproductive health of refugees specifically. Progress Health and human rights framework and prioritising tool for maternal and newborn health The framework and tool, initially elaborated for WHO’s Making Pregnancy Safer initiative, is designed to facilitate a multidisciplinary analysis of the determinants of maternal and neonatal mortality and morbidity and the interventions to address them. Organized around rights related to safe moth- erhood, the tool links a government’s commitments to inter- national human rights treaties, conventions and consensus document targets, to the national legal and policy environ- ment, and health processes and outcomes associated with maternal and newborn health. It helps countries to review clearly, and appraise systematically, the range of rights, their accepted meanings, and consequent obligations in terms of government law, policy and practices. This in turn permits an identification and assessment of those laws, policies and practices that are facilitating the reduction of maternal and neonatal mortality and morbidity, and those that are hindering such a reduction. By bringing different perspectives to bear, the tool and the analysis process will result in recommended areas for action based on multidisciplinary, multistakeholder consensus on what is urgently needed to improve maternal and newborn health. Through this rights-based process and use of the tool, the Department will contribute to govern- ments’ efforts to become more accountable for their inter- national commitments to promote and protect their citizens’ rights to maternal and neonatal health care. With the continued assistance of the Francois-Xavier Bag- noud Center for Health and Human Rights at the Harvard School of Public Health, Boston, MA, USA, the Department finalized the framework in 2002 and presented it to the Department’s Scientific and Ethical Review Group (SERG) for comment. It was agreed that the more detailed tool, when further elaborated and validated, could be submitted for fur- ther review in early 2003. The Department commissioned the Swiss Institute for Social and Preventive Medicine in Basel, Switzerland, to instrumen- talize and validate the tool. The results and recommenda- tions of the study will inform the finalization of the process and tool before it is field-tested in Mozambique in 2003. In response to the recommendations of GAP and SERG, a user’s guide has been developed to explain terminology, and the purpose and intent of the data collection, analysis, and reporting sections of the tool. It also explains the participa- tory methodology that must accompany the tool’s use at dif- ferent stages of the process. The user’s guide is also part of the validation study. Critical for the implementation of such a process and tool in countries is the collaboration and partnership of government, WHO regional offices, partner agencies such as the United Nations Population Fund (UNFPA) and the United Nations Children’s Fund (UNICEF), and other key partners in the field such as the Averting Maternal Death and Disability (AMDD) network coordinated by Columbia University, New York, NY, USA, and other nongovernmental organization (NGO) actors such as the Center for Reproductive Law and Policy (CRLP) and the International Planned Parenthood Federation (IPPF). In 2002, various meetings were held with these partners to share approaches to addressing maternal and perinatal mor- tality reduction efforts using a rights-based approach. If the planned field test in Mozambique is successful, the Department, as recommended by GAP in 2002, plans to support the use of the tool and process in two other coun- tries with high maternal and neonatal mortality and morbid- ity. The countries will be selected on the GAP-suggested criteria of: (i) government commitment to applying a human rights approach; (ii) a basic public health infrastructure being already in place; and (iii) capacity to undertake the process, A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 154 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 155 including the involvement of nongovernmental partners, especially women’s health and rights groups and human rights committees. Indicators for measuring fulfilment of rights At its January 2002 meeting, GAP recommended that the Department continue to work on a framework for rights indi- cators, focusing on laws and their application, already exist- ing reproductive health process and outcome indicators, and on finding a way to capture a state’s accountability. Progress in this area has been slow, partly because priority was given to other areas of work, and partly because elaboration of “rights” indicators is being discussed at a broader, Organi- zational level, coordinated by the Health and Human Rights Unit in the Director-General’s Office. In the second part of 2002, an informal meeting was held with two members of the Committee for Economic, Social and Cultural Rights (for details, see below), whose covenant contains the right to the highest attainable standard of health. The committee has specifically requested WHO to elaborate indicators that can be used to monitor the right to health, as laid out in its General Comment No.14, adopted in August 2000. Discussion at this meeting clarified that a “rights” indicator may very well be a “health” indicator, but it must be tracked back to a human rights norm and can be used to hold duty-bearers to account. Such an indicator might be, for instance, the maternal mortality ratio which can be tracked back to the right to life, for which governments could be held accountable if they have not trained and equipped health services to provide women with comprehensive essential obstetric care or if no such services are available. Importantly, these health indicators which are also “rights” indicators, can be linked to the UN Millennium Development Goals. The Department’s work on the Health and Human Rights Framework (described above) will help flesh out this work on rights indicators, because it is organized in such a way that health indicators are grouped under specific rights to which they have relevance. The Department will continue to con- tribute to the overall development of rights indicators, with a specific contribution to sexual and reproductive health areas. A more formal meeting with health indicator and human rights experts is foreseen for 2003, for the Organization as a whole, to which the Department will substantially contribute. Sexual health In late 2000, WHO headquarters agreed to review definitions and work related specifically to sexual health. With the sup- port of a grant from The Ford Foundation, the Department was able to engage all WHO regional offices in the prepara- tory process during 2001 and in the international Technical Consultation on Sexual Health which took place in January 2002. Preparatory work for the consultation included com- missioning background papers from consultants in China, Egypt, Guinea, India, Indonesia, Jamaica, Latvia, Lebanon, Morocco, the Philippines, the Russian Federation, South Africa, Thailand, Turkey and Zimbabwe, as well as conven- ing four regional roundtable discussions. This was done with the assistance of staff from the Pan American Health Organization in close collaboration with representatives of the World Association of Sexology. The Technical Consultation on Sexual Health was organized in collaboration with the Departments of HIV/AIDS and of Child and Adolescent Health and Development. The meeting was attended by 60 participants from all regions of the world and from a variety of disciplinary fields (e.g. HIV epidemiol- ogy, sexuality and behaviour research, family planning and reproductive health service provision, sexology, anthro- pology, mental health). During the meeting, participants reviewed the burden of illness related to sexual ill-health, discussed background determinants (including legal and policy issues), shared regional, social and cultural barriers and opportunities for addressing sexual health, and began to build international consensus around new definitions. The report of the meeting, which includes the revised definitions and a selection of the background papers, will be published in early 2003. One of the results of the consultation has been interest, in both regional offices and headquarters, and the commitment to better address sexual health and rights as a topic. The Regional Office for the Eastern Mediterranean (EMRO), for instance, is planning to sponsor a regional meeting on sexual health in 2003, while the Regional Office for the Americas (AMRO) cosponsored a meeting on the sexual health of indigenous populations in October 2002, in Venezuela. Following the Technical Consultation, the Department’s Scientific and Technical Advisory Group (STAG) recom- mended that sexual health be developed as an area of work for the period 2004–2009. This recommendation resulted in the convening of an international Strategic Committee on Sexual Health in early October 2002, with the purpose of setting new priorities in the area of sexual health and rights, which will form part of the overall work plan for the Depart- ment for the next three biennia. The committee consisted of representatives from all regions, from a variety of disciplinary backgrounds. In preparation for this meeting, the Department commis- sioned two reviews to inform the discussion: Integration of sexual health into reproductive health services: needs, evidence and implications (Royal Tropical Institute of the Netherlands, Amsterdam, Netherlands); and Searching for sex: a systematic literature review of international research related to sexuality and sexual behaviour (La Trobe Uni- versity, Melbourne, Australia). The reviews focused on previously unaddressed dimensions of sexual health and sexuality that could form the basis of the Department’s future work in sexual health, as GAP has recommended in January 2002. As a result, the priorities developed by the Strategic Committee on Sexual Health reflect many unaddressed and A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 154 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 155 under-addressed issues such as the service delivery needs of sex workers, migrants and refugees, and topics such as pleasure, harmful sexual practices, and the construction of masculinity and femininity and how these affect sexual health and well-being. These reviews are currently being revised for possible publication in 2003. Informed consent research In 2002, the final report from a study in Mexico on informed consent procedures in sterilization services, carried out by the Mexican Institute of Social Security, with support from the Programme and technical assistance from EngenderHealth, became available. This descriptive, qualitative study was done through observations of client-provider interaction and in-depth interviews with users, providers and managers. The study examined postpartum and interval tubal occlusion for women and vasectomy for men. It found that the preopera- tive information given to many women undergoing postpar- tum sterilization was often inadequate. Generally speaking, women undergoing interval sterilization received more complete information than those accepting a postpartum procedure. Men were generally better informed than either group of women, and they tended to ask for more information before and during the counselling than did the women. Perceptions of the significance of the informed consent form varied considerably. Providers and managers generally felt that signing the form indicated that clients had understood the procedure they were about to undergo. However, many of the women did not feel they had received adequate infor- mation and yet believed that the informed consent form constituted legal protection for themselves. To most vasec- tomy acceptors, signing the informed consent form implied a shared responsibility between them and the health workers. As a result of the study findings, the Mexican Institute of Social Security is proposing to implement training of health workers to improve counselling for informed decision-making and to foster understanding of sexual and reproductive rights. They also intend to develop a protocol for counselling pregnant women about sterilization so that information given postpartum is better understood, and they will make informa- tion about the right to free and informed decision-making for clients widely available. Following the pilot studies on informed consent in research, conducted in Brazil and Chile in 1998–1999, the Department will conduct further research in the coming year to examine the informed decision-making process. A suitable multicoun- try study needs to be identified, on which to “piggy-back” the study. Sexual and reproductive health of refugees The Department is currently exploring the possibility of expanding its work to the reproductive health and rights of migrants, including refugees. In November 2002, staff from the Department participated in an international expert meet- ing, organized by the International Centre for Reproductive Health, Ghent University, Ghent, Belgium, on sexual and reproductive needs and rights of women displaced by war and armed conflict. In 2003, the Department will work fur- ther with its partners on ways to improve the protection of reproductive rights of refugees and improve the reproductive health services provided. Technical and policy guidance on safe abortion During 2002, the Department finalized the guidance docu- ment on safe abortion, under the coordination of Gender and Reproductive Rights Group. The document will be published at the beginning of 2003. Details are given in the section on Preventing unsafe abortion. NORMS AND TOOLS FOR ADDRESSING GENDER AND RIGHTS IN REPRODUCTIVE HEALTH Specific objectives/targets The Gender and Reproductive Rights Group aims to inte- grate gender and rights considerations throughout the Department’s normative work. While the Group’s guidance documents focus on the gender and human rights aspects of sexual and reproductive health, particularly as highlighted in the legal and policy environment, the Group also works with other Departmental teams to ensure that those considera- tions are integrated into other guidance documents. In 2002, the Group thus focused on addressing legal, policy, regula- tory and practice barriers related to maternal and newborn health, and on expanding its work with the Human Rights Treaty Bodies to bring greater attention to the human rights related to sexual and reproductive health. Norms/tools under development Policy and rights in maternal and newborn standards of care In order to assist colleagues within the Department to better address gender and rights issues within specific thematic areas, staff of the Gender and Reproductive Rights Group participated as part of the Making Pregnancy Safer core team on issues related to gender and rights. In 2002, the Group’s contribution has focused on developing a health and human rights assessment framework and tool for reviewing legal, policy and practice related to maternal and newborn health (see above) and on reviewing and incorporating gender and rights considerations into the maternal and newborn health standards of care. Working as part of the health systems group within the Making Pregnancy Safer team, the Gender and Reproductive Rights Group has contributed a policy standard, policy recommendations for many of the clinical and other health system standards, and specific references to gender and rights issues within each standard. The stand- A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 156 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 157 ards of care are currently under review and are scheduled to be published in mid-2003. Advancing safe motherhood through human rights: users’ guide In 2001, the Department published Advancing safe moth- erhood through human rights as an occasional paper. The purpose of the document is to explore how human rights, long established in national constitutional laws and other national laws, and international human rights treaties, can be applied to advance safe motherhood. The Document’s aim is to contribute to national initiatives to promote compliance with human rights principles, and national and international dialogues on how a human rights approach to advance safe motherhood might be developed and applied. The document summarizes case law and examples of how governments can and do respect, protect and fulfil their obligation to safe motherhood. Since the document is very comprehensive, the Department has developed a summarized version (users’ guide) to facilitate its use by a variety of actors. The users’ guide is currently being reviewed to see whether it should be published independently or as a part of the Making preg- nancy safer planning guide which is under development. Human Rights Treaty Bodies—collaboration to support norms and standards within the human rights framework Over the past two to three years, greater emphasis has been given within WHO as a whole to integrating human rights into technical areas of work. This reflects the mandate given by the United Nations Secretary-General five years ago for human rights to be integrated as an approach across the United Nations Organization and its various agencies. Within WHO, the Health and Human Rights Unit in the Director- General’s Office is coordinating, among other things, the var- ious departments’ technical contributions to the UN Human Rights Treaty Monitoring Bodies, in which the Department has been taking an active role. All countries have ratified at least one, and sometimes sev- eral of the human rights treaties. The most well known of these treaties at the international level are: the International Covenant on Civil and Political Rights (monitored by the Human Rights Committee [HRC]); the International Cov- enant on Economic, Social and Cultural Rights (monitored by the Committee on Economic, Social and Cultural Rights [CESCR]); the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW); and the Conven- tion on the Rights of the Child (CRC), both of whose monitor- ing committees have the same acronym as the Convention. Each of these committees meets twice or three times per year to examine between five and eight country reports which indicate the extent to which these countries are making progress (or not) in the respect, protection and fulfilment of the various human rights laid out in the covenant or conven- tion. After examining a country’s report, and those submit- ted by intergovernmental agencies and nongovernmental organizations, the committee makes concluding observa- tions which are recommendations the country is expected to act upon before its next report in 3–5 years’ time. Because these treaties have the force of law, countries are legally bound to work towards implementing the recom- mendations of the committees. In the area of sexual and reproductive health, for instance, a concluding observation which requests a country to give greater support to ensuring access for all women to emergency obstetric care, in order to fulfil the right to health (and the right to non-discrimination on the basis of sex), will need to be taken very seriously by the country. WHO’s work with the treaty bodies can there- fore help the committees to understand a particular health issue in a country (by presenting sound data), and to include specific recommendations relating to that health issue in its concluding observations. These concluding observations can then be used by WHO and its partners in a country to strengthen the work that they are already carrying out—or about to carry out—on, for instance, making pregnancy safer. In other words, working with the treaty bodies provides an opportunity to use the human rights mechanisms as an additional tool for promoting and supporting country-level policies and programmes in sexual and reproductive health. As recommended by GAP in January 2002, over the next year the Department plans to make reports to all four treaty bodies mentioned above on four or five countries per treaty body, and to work with at least one country on ensuring the implementation of the concluding observations. The Depart- ment will continue to contribute to the coordination of this work across different departments as well as with WHO Regional Offices, and an evaluation will be carried out after one year on the usefulness of the exercise. The Department is embarking on more intensive work in this area over the next 1–2 years. In 2002, for example, a report was submitted to the HRC on the maternal health situation in the Republic of Moldova, one of the Making Pregnancy Safer spotlight countries. The Department worked with the WHO Regional Office for Europe and the country office to obtain the latest data available. The HRC included reference to deteriorating health services and the need to improve these for women’s health in its concluding observations on the Republic of Moldova. These will be used by the Making Pregnancy Safer team in work with the country. In October 2002, a human rights adviser joined the Gender and Reproductive Rights Group to work more specifically on collaboration with the treaty bodies. As a result, the Depart- ment has been working closely with the Department of Child and Adolescent Health and Development to ensure the pro- vision of data on adolescent sexual and reproductive health in the reports to the CRC on Bangladesh, Jamaica, Morocco and Sri Lanka. As recommended by GAP, the Department has also been involved in discussing the proposed General Comment on adolescent health and development, which is likely to be finalized next year. A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 156 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 157 For the CESCR it was decided to focus particularly on those reporting countries where the improvement of reproductive and sexual health issues is especially crucial (Guatemala, Republic of Moldova, Russian Federation and Slovakia in 2002). The compiling of all these reports—which are usually limited to a maximum of five pages including recommenda- tions—is done in close consultation with country and regional offices. The Department is also working with UNFPA on the preparation of some reports. TECHNICAL COOPERATION WITH COUNTRIES Training on gender and rights in reproductive health The Department has played a key role in coordinating a multicountry, multi-institutional effort to elaborate a training curriculum to integrate gender and rights in reproductive health. Of the five institutions which have run the course, two—the Key Centre for Women’s Health in Society (Australia) and the Centre for African Studies (Kenya)—ran the course for the fourth time each in 2002. The Women’s Health Project at the University of Witwatersrand (South Africa) ran its sixth course in October 2002. All three courses were well received. The Centre for the Study of State and Society (CEDES, Argentina) and the Yunnan Reproductive Health Research Association (YRHRA, China) both expect to run the course again in 2003, on completion of the translated versions of the curriculum (see below). Much of the contin- ued work on the course was carried out with support from The Ford Foundation. Expansion of the training to other regions To support the further expansion of the course to other regions, the Department supported four trainers to attend the South African course in October 2002 in a training of train- ers capacity: three people from the Kazakhstan School of Public Health and one from the University of Sains Malaysia. In all cases their participation was guided by trainers from the Women’s Health Project with a view to their adapting and running the course in their region in the future. In particular, these two training centres have expressed interest in running a training course using the curriculum in 2003. Training of trainers courses on gender and rights in reproductive health Over recent years, the Department has been increasingly solicited to give technical support to shorter courses of two to five days, focusing specifically on rights, or on gender and rights. Therefore, the Department ran a three-day training of trainers workshop on the Rights Module from the curriculum to provide additional training to the five regional centres (in Argentina, Australia, China, Kenya and South Africa) that are already running the course. The aim was to train experienced trainers in running a two- to three-day module on human rights and reproductive health within their region, as well as to reinforce those centres’ capacity to teach the Rights Module as part of the three-week training course. The evalu- ation by participants was very positive and some of those trained have already run the module in the context of the full training course. Short courses and adaptation of key sessions for use in other courses and curricula In September 2002, the Sakhi Women’s Resource Centre in Trivandrum, India, which coordinates a state-level network of women’s development organizations working with sexual and reproductive rights, adapted parts of the modules on Gender, Social Determinants and Policy for a two-week course on Gender, Health and Development. Part of this short course is also integrated into the Gender and Health Course of the Masters of Public Health Programme offered by Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, in Trivandrum, India, and is also going to be run in 2003. In the field of medical education, a number of medical schools and those involved in elaborating medical cur- ricula have approached WHO for guidance in integrating gender and rights into these curricula. Canada and India in particular are pursuing the adaptation of certain parts of the WHO training curriculum on gender and rights in repro- ductive health, for use in the broader curriculum. The Sree Chitra Tirunal Institute for Medical Sciences and Technology is taking the lead in a process of national sensitization for medical educators, health service managers, policy-makers and others, by designing a syllabus for a course on gender and medical education. The Department is collaborating with WHO’s Department of Gender and Women’s Health and the Regional Office for South-East Asia (SEARO) to give techni- cal support to this endeavour, and to support representatives from other countries in the region to participate in an adapta- tion workshop to be held in July 2003. Promotion of the training curriculum Dissemination of the curriculum has been carried out in a targeted way through regional offices, collaborating agencies and centres and other training institutions that expressed an interest in response to a brochure published and distributed earlier in 2002. As part of the dissemination strategy, the curriculum has been promoted at several international meet- ings. Presentations of the curriculum were also organized at WHO headquarters and at EMRO (July 2002), the Regional Office for the Western Pacific (WPRO) (August 2002), AMRO (September 2002) and SEARO (September 2002). All these events brought regional WHO staff together with representa- tives of governmental organizations and NGOs, collaborat- ing agencies, universities and medical and nursing schools. A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 158 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 159 A CD-ROM version of the curriculum in English has been prepared, and 3000 copies were available for distribution at the end of December 2002. CD-ROM versions in other lan- guages will be prepared as the texts become available. The production of an interactive electronic version for use on the Web is being considered. The Spanish translation of the training manual has been completed by CEDES and will be published in 2003. The Chinese translation, prepared by YRHRA, will be finalized in March 2003. Both these centres will continue to run the course in their regions in 2003. The possibility of producing a French version is being explored with several centres in Africa. Future plans Over the next biennium, the Department plans: (i) to encourage and give technical support to the centres in Kazakhstan and Malaysia to run the course for countries in their region; (ii) to give continued technical support to those centres already running the course, as requested; and (iii) to give guidance and technical support to develop short- course adaptations for use with specific countries or organizations. A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 158 A n n u al Tech n ical R ep ort 2002 Gender and reproductive rights in reproductive health 159 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 9 90 1 10 10 Women 6 60 1 10 7 from: AFRO 1 10 1 AMRO 3 30 1 10 4 EMRO 1 10 1 EURO SEARO 2 20 2 WPRO 2 20 2 Annex 1 GENDER ADVISORY PANEL (GAP) IN 2002 Members Babatunde Ahonsi, The Ford Foundation, Lagos, Nigeria Soledad Diaz, Chilean Institute of Reproductive Medicine (ICMER), Santiago, Chile Amal El-Hadi, New Woman Research Centre, Cairo, Egypt Thein Thein Htay, Ministry of Health, Yangon, Myanmar Sharad Iyengar, Action Research and Training for Health (ARTH), Udaipur, India Maria Isabel Plata, PROFAMILIA, Bogota, Colombia (Chairwoman) Raffaela Schiavon, The Population Council, Mexico, DF, Mexico Angeline Faye Schrater, Florence, MA, USA Rashidah Shuib, University of Sains Malaysia, Kelantan, Malaysia Zhang Kaining, Yunnan Reproductive Health Research Association, Kunming, China Temporary advisers In 2002 Marge Berer, Reproductive Health Matters, London, United Kingdom Borbala Koo, Society for Education on Contraception and Sexuality, Bucharest, Romania Karen Newman, International Planned Parenthood Federation, London, United Kingdom Wanda Nowicka, Federation for Women and Family Planning, Warsaw, Poland Sheila Tlou, University of Botswana, Gaborone, Botswana Makhosazana Xaba, Ipas, Johannesburg, South Africa A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 160 A n n u al Tech n ical R ep ort 2002 161 Annex 2 SCIENTISTS IN 2002 Korrie de Koning, Royal Tropical Institute (KIT), Amsterdam, the Netherlands Gary Dowsett, Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, Australia Sofia Gruskin, François Xavier Center for Health and Human Rights, Harvard School of Public Health, Boston, MA, USA Marian Pitts, Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, Australia Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 4 100 4 Women 3 75 3 from: AFRO AMRO 1 25 1 EMRO 1 25 1 EURO SEARO WPRO 2 50 2 A n n u al T ec h n ic al R ep or t 2 00 2 Section 6 - Gender and reproductive rights in reproductive health 160 A n n u al Tech n ical R ep ort 2002 161 Section 7 Technical cooperation with countries A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 162 A n n u al Tech n ical R ep ort 2002 Overview of activities—interregional activities and collaboration with regional offices 163 Overview of activities—interregional activities and collaboration with regional offices A. Ntabona, M. Mbizvo INTRODUCTION The Department continued to cooperate with WHO regional and country offices, governments, nongovernmental organi- zations (NGOs) and other partners, with the objective of addressing reproductive health needs through intraregional and national research, and through research and technical capacity strengthening. HIGHLIGHTS OF PROGRESS IN INTERREGIONAL ACTIVITIES DURING 2002 Publication of brochures on research capacity strengthening grants Following the recommendations made by the in-depth evalu- ation of research capacity strengthening by the Programme, the Department published brochures outlining key compo- nents for each research capacity strengthening grant. The brochures were complemented by a description of each grant on the Department web site. Included with each bro- chure are revised application and reporting forms, the grant objectives, key elements for grant award, and criteria for selection of centres and monitoring the performance of cen- tres. Where applicable, indicators for impact and efficiency are also included. Meeting of Regional Advisers in Reproductive Health on impact of health sector reforms The 2002 meeting of Regional Advisers and staff of the headquarters Technical Support to Countries Team reviewed experiences and lessons learnt when implementing health reforms. Participants exchanged information and shared regional experiences, including research findings, of the impact of health sector reforms on reproductive health pro- grammes and outcomes. They recommended that further research be conducted to establish the extent to which health sector reforms have facilitated or impeded the delivery of quality reproductive health services. There was a need to monitor the implementation of various reforms using defined process indicators. Inter-agency workshop on Effective Partnerships for Accelerating the Implementation of Reproductive Health Programmes The World Bank, the United Nations Population Fund (UNFPA), the United Nations Children’s Fund (UNICEF) and the Department jointly convened a workshop aimed at enhancing understanding of key reproductive health issues in the context of development modalities such as Sector-wide Approaches (SWAPs), United Nations Development Assist- ance Frameworks (UNDAFs) and Poverty Reduction Strat- egy Papers (PSRPs). The workshop reviewed strategies for accelerating the implementation of reproductive health pro- grammes through effective partnerships. Participants agreed on defining benchmarks towards building national capacities in reproductive health and underscored the need for improv- ing reproductive health services to serve effectively as entry points for HIV prevention and care. Enhancing WHO and UNFPA collaboration in reproductive health Senior technical staff from UNFPA and WHO met to outline areas of collaboration and refine modalities for such coop- eration. The bilateral technical consultation preceded a high- level meeting of the executive heads of UNFPA and WHO. The meetings emphasized the need to reinforce comple- mentarity in the implementation of activities of mutual inter- est and to accelerate actions towards the achievement of the A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 162 A n n u al Tech n ical R ep ort 2002 Overview of activities—interregional activities and collaboration with regional offices 163 development goals of the United Nations Millennium Decla- ration and other international development goals and targets related to reproductive health. As part of agencies’ common efforts to improve sexual and reproductive health, it was rec- ommended that all staff in the respective agencies should articulate consistent, ethical and evidence-based messages on best practices. In addition, the meeting outlined areas of possible collaboration within the UNFPA-funded Strategic Partnership Programme, which is set to replace the Techni- cal Advisory Specialist System at the headquarters of agen- cies participating in the Technical Advisory Programme. Collaboration with WHO regional offices Collaborative activities were undertaken with each of the WHO regional offices, in line with joint plans of action devel- oped in 2001 or early 2002. Table 7.1 provides highlights of collaborative activities with WHO regional offices in 2002. WHO collaborating centres in reproductive health In 2002, there were 55 officially designated WHO Collabo- rating Centres for Research and Technical Cooperation in Human Reproduction/Reproductive Health and two new centres had completed the screening process for designa- tion. In addition, there was cooperation with 26 centres which are not officially designated. PLANNED ACTIVITIES Meetings were held in 2002 with Family Health International (FHI), the Population Council FRONTIERS Project and other partners to plan a technical consultation in 2003 where guidelines will be drawn up for the translation of reproductive health research findings into policy and programmes. The Department will collaborate with the United States Agency for International Development (USAID) and the Program for Applied Technology in Health (PATH) towards convening a global conference on Reaching Men to Improve Sexual and Reproductive Health for All. The Interregional Consultation with Regional Advisers in 2003 will be based on the theme of Pregnancy in Adoles- cents, and will be hosted by the WHO Regional Office for the Western Pacific in Manila, Philippines. WHO Regions Collaborative activity Africa • Organisation of a meeting of investigators to finalize the protocol and develop instruments for the proposed intraregional study on community and facility interventions to improve maternal health. • Organisation of the first meeting of a Regional Reproductive Health Task Force whose mandate includes, among other things, providing guidance to AFRO on issues relevant to Member States in the implementation of the region’s Reproductive Health Strategy, advising on programmatic directions most likely to impact positively on service delivery, and mobilizing resources. • Collaboration in identifying centres and areas of cooperation within the proposed grants to Service Guidance Centres. Americas • Collaborative activities embraced the areas of improving maternal and perinatal health, introducing emergency contraception, defining programmes for male involvement, improving adolescent sexual and reproductive health, and the application of the Strategic Approach to increase access to quality reproductive health services. Eastern Mediterranean • Initiation of the development of a reproductive health research directory (five countries). • Continuation of the research study on adolescent reproductive health (three centres). • Organization of a workshop on ethics in reproductive health research (Oman). Europe • Providing support to training courses in reproductive medicine, operations research and reproductive biology. South-East Asia and the Western Pacific • Systematic introduction of Essential care practice guides. Table 7.1. Collaboration with WHO Regional Offices, 2002 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 164 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 165 Annex 1 PUBLICATIONS IN 2002 UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Repro- duction. A framework to assist countries in the development and strengthening of national and district health plans and pro- grammes in reproductive health. A report based on the meeting of WHO Regional Advisers in Reproductive Health, World Health Organization, Geneva, Switzerland, 21–24 August 2000 (WHO/FCH/RHR/02.2). UNDP/UNFPA/WHO World Bank Special UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. Programming for male involvement in reproductive health. A report based on the meeting of WHO Regional Advisers in Reproductive Health, Regional Office for the Americas (PAHO), Washington, DC, USA, 5–7 September 2001 (WHO/FCH/RHR/02.3). UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduc- tion. Report on the in-depth review of research capacity strengthening by HRP/WHO. Geneva, World Health Organization (WHO/FCH/RHR/02.4). A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 164 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 165 The WHO Regions of Africa and the Eastern Mediterranean H. Bathija, D. Chikamata, A. Fahmy INTRODUCTION The main objective of the Department’s activities in this area is to pursue the strengthening of research capacity of institutions in the WHO Regions of Africa and the Eastern Mediterranean in order to enhance their potential to imple- ment reproductive health research relevant to national and regional needs, and to facilitate their participation in the global research effort. The strategy continued to focus on the strengthening of selected institutions and the stimulation of interest in repro- ductive health research in various countries. The main elements of the strategy are as follows: 1. development of subregional centres of excellence, which are capable of assisting weaker centres, espe- cially those in least developed countries (LDCs); 2. promotion of networks through South to South and South to North links; 3. improvement of research protocol development, research management and scientific writing; 4. promotion of intraregional training; 5. stimulation of interest in sexual and reproductive health issues in LDCs, French-speaking Africa and the Eastern Mediterranean Region; 6. promotion of resource mobilization for research capabil- ity strengthening activities in the two regions; 7. strengthening of research skills in the social sciences; and 8. promotion of “targeted” research on major reproductive health problems and on the needs of LDCs. RESEARCH ACTIVITIES Overall research output The nine centres supported with Long-term Institutional Development (LID) grants or Resource Maintenance Grants (RMGs) are involved in projects which address regional and national reproductive health priorities. From the total number of 71 studies, nine projects (13%) were implemented with support from the Programme. Twenty-six projects (37%) were carried out at the centres with support from national sources. The participation of the regional centres in the global research effort is exemplified by the eight projects (11%) conducted in these collaborating institutions with support from the various teams of the Department. Like- wise, the institutional strengthening efforts deployed by the Programme in these regional centres have enhanced their capacities for fundraising from other international agencies, to address topics of global or local relevance: 36 projects (51%) carried out in these centres received support from international agencies other than WHO. Some 31% of the projects were mainly in the area of epide- miology or social sciences and a similar percentage (38%) were on clinical research. Eleven projects (15%) were basic science studies and eight (11%) used operations research designs with several methodologies. All thematic areas were A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 166 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 167 studied, but the highest number of projects dealt with mater- nal health (21), family planning (13) and HIV/AIDS (9). Many projects were dealing with several thematic areas concur- rently. Regional research initiatives Research on female genital mutilation (FGM) Current work on FGM supported by the Programme focuses on the obstetric sequelae of FGM, as well as the socio- cultural context of the practice. The objective of this work is to increase knowledge, particularly on the frequency of the reproductive health consequences of FGM, in order to improve advocacy and programming as well as to develop, test and disseminate tools for research into various aspects of FGM. The research on obstetric sequelae of FGM is being under- taken as a multicountry, multicentre prospective cohort study, based at maternity units and obstetrics departments in Burkina Faso, Ghana, Kenya, Nigeria, Senegal and Sudan. It aims to provide reliable information regarding the health consequences of FGM and has the primary objectives of estimating the incidence of obstetric complications among women with FGM giving birth in hospital, and evaluating the relationship between different types of FGM and obstetric complications. A subsidiary objective is to obtain clinical information relevant to the prevention and treatment of obstetric complications in women with FGM. All women with singleton pregnancies admitted to the par- ticipating centres for delivery are approached for possible recruitment into the study. Those who volunteer undergo an examination to determine their FGM status prior to delivery. Women admitted to the study are followed through labour and delivery up until six weeks after their discharge from hos- pital. Information is also obtained regarding the health and anthropometric measures of infants born to these women. The study is observational in nature, with no active interven- tions expected on the part of the staff, apart from examining women and gathering information. The pilot phase of the study was carried out between Decem- ber 2000 and the end of February 2001. The main phase is being conducted in the same six countries as the pilot study: Burkina Faso (5 sites), Ghana (3 sites), Kenya (3 sites), Nigeria (6 sites), Senegal (13) and Sudan (3 sites). At the end of November 2002, a total of 22 440 questionnaires had been received from participating centres. Data collection for the main phase has ended in Kenya, Ghana and Nigeria and will continue in the remaining sites until March 2003. Since FGM type III is concentrated in Burkina Faso and Sudan, it was decided that centres in these countries should recruit 9000 and 6000 subjects, respectively, to ensure sufficient cases of FGM type III. The first results are expected in the second half of 2003. Although there is growing information on the sociocultural aspects of FGM, much of it is fragmentary and obtained from secondary sources. There is, therefore, a need for an in-depth study to understand the sociocultural diversity and complexity of FGM and its consequences, in order to design culturally meaningful and workable programmes towards advocacy and intervention strategies. A call for proposals for studies examining these aspects was prepared in 2001 and sent out in 2002 to more than 200 persons, groups or institutions. The following were among the priorities highlighted in the call for proposals: Understanding factors underlying the persistence of the practice The determinants of marriageability; how FGM may affect directly or indirectly a woman’s fertility; how childbearing is linked to the practice; and how the kinship system (type of society, lineage systems, inheritance, gender roles and iden- tity) influence the preservation of the practice. Understanding the decision-making process for FGM Gender power relationship, women’s status and the social organization; the power differential between the different actors involved in the FGM decision-making process; the effects of the power differentials on outcomes such as the continuation, abandonment or introduction of change in the nature of the practice. Understanding the links between gender relations and sexual constructs, and FGM How gender identity is constructed in relation to the practice of FGM; the social values and functions of the initiation cer- emonies; the significance of the physical act of cutting and how the act of cutting influences a woman’s identity and sexuality; male and female perspectives on male sexual preferences in relation to FGM. Assessing the changes in the practice of FGM The ways in which people reach the decision to reject or change the tradition; how people figure out how to put their decisions into practice, the support that allows them to stick to their decisions, and the extent to which they are able to share their experience with others; the implications of their decisions for their daughters’ marriages, maintenance of marital unions, and impact on their own and their daugh- ters’ social and economic status; the relationship between changes in women’s status and conditions and changes in the practice; the consequences of changes in the practice on individual women’s and community’s perceptions of women’s role, identity and sexuality; and the reasons behind the adop- tion of FGM by non-practising communities. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 166 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 167 A total of 30 responses were received to the call for propos- als. An FGM research group was set up and met in July 2002 to review them. Nine projects were selected for further devel- opment and eventual funding. These studies are expected to start in 2003. Operations research on improving reproductive health services for adolescents In 2002, the operations research project to evaluate and improve reproductive health services for adolescents contin- ued in five French-speaking sub-Saharan countries: Benin, Cameroon, Côte d’Ivoire, Guinea and Senegal. The Pro- gramme is facilitating and coordinating this regional initiative and is providing support for research capacity strengthening aspects of the project, but funding for most country projects is being raised locally. The WHO Country Office for Benin funded the first phase of the study, and in Cameroon the Programme contributed to the financing of the first phase. A characteristic feature of the project is the implementation by multidisciplinary research teams and the active participation of youth representatives in each team. In Senegal, the Programme is collaborating with the FRON- TIERS in Reproductive Health Project funded by the United States Agency for International Development (USAID). The FRONTIERS Project has assumed the funding for the forma- tive research and interventions in Senegal, while the Pro- gramme contributed financially to the evaluation phase that was completed in 2002. Adolescent reproductive health in the Eastern Mediter- ranean Region In response to the recommendations of the intercountry workshop on “Adolescents’ Needs and Perspectives in Reproductive Health in the Eastern Mediterranean Region”, held in Tunisia in 1999, the Department, in collaboration with the Regional Office for the Eastern Mediterranean Region (EMRO) has, since 2000, given technical support for the development of research proposals in the Islamic Republic of Iran, Oman and the Syrian Arab Republic. These studies are in progress and explore the reproductive knowledge, attitudes and behaviour of 15–18 year old boys in Tehran, Islamic Republic of Iran, and of adolescents in secondary schools in Oman and the Syrian Arab Republic. Operations research on community and facility interventions towards improving maternal-newborn health The Regional Advisory Panel (RAP) for the WHO Regions of Africa and the Eastern Mediterranean agreed, in its meetings in 1998 and 1999, that a multicountry operations research study on maternal health should be initiated to examine the ways pregnant women, communities and health personnel perceive pregnancy complications and react to them. The aim was to develop appropriate strategies for action, includ- ing the use of antenatal care visits to prepare birth plans for pregnant women and explore ways of assuring skilled attendance at delivery. It had also been agreed that a special feature of the study would be to look at the role of men in maternal health care. The issue of community involvement in maternal health was identified in the February 2000 and March 2002 joint planning meetings between the Regional Office for Africa (AFRO) and WHO headquarters as one of the projects of common interest that should be developed. In June 2002, a meeting of principal investigators was held in Geneva, Switzerland, to review a prototype protocol that had been prepared by the Department in collaboration with African researchers. At this meeting it was decided that a more detailed protocol specifically for the assessment phase should be developed. This protocol was reviewed by RAP in October 2002, and together with the overall prototype pro- tocol that includes assessment, intervention and evaluation phases, it will be reviewed in 2003 by the Specialist Panel for Social Science and Operations Research on Reproduc- tive Health. These protocols will be adapted to individual country needs in Ethiopia, Nigeria, South Africa and Uganda, and it is hoped the projects will start in 2003. A randomized, double-blind study to compare two regimens of levonorgestrel in emergency contraception in Nigeria The Programme has carried out research in the area of emergency contraception to find agents that are more effec- tive and/or have fewer side-effects than the hormonal meth- ods used at present. The objective of the present project is to compare the efficacy and side-effects of two treatments: (i) levonorgestrel administered in two doses of 0.75 mg at 24-hour interval; and (ii) levonorgestrel administered in one dose of 1.5 mg. It would be a major practical advantage if levonorgestrel could be given in a single dose in emergency contraception up to 120 hours after unprotected intercourse, because this would simplify the treatment and increase com- pliance and acceptability. The project will also serve as train- ing in clinical research carried out according to Good Clinical Practice and it will play a role in developing a network of cen- tres that can be used for clinical research in Nigeria. Finally, the project will contribute to making emergency contracep- tion known in parts of Nigeria where it is unknown at present and to collecting national data on the use of levonorgestrel for emergency contraception. The study will be carried out in seven family planning clinics in collaborating centres and will include 3150 women (450 for each centre). The study will be coordinated by the Centre for Reproductive Health Research in Sagamu. Project implementation commenced with an inception meet- ing held on 10–13 October 2001 in Sagamu, which was attended by the principal investigator and family planning provider (nurse/midwife) from each of the seven network centres. Study materials and funds were despatched to all A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 168 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 169 study centres at the end of August 2002, allowing recruitment of volunteers to begin. It was originally planned that the coordinating centre would receive all forms, undertake data entry and verification and conduct the data analysis. However, because of the depar- ture of staff from the coordinating centre, it has now been agreed that all study data would be sent to the Clinical Trials and Informatics Support Unit in Geneva for data manage- ment. The Unit will assist in further capacity building of data management staff at the Sagamu Centre during the course of the project for future undertakings. DEVELOPMENT OF HUMAN RESOURCES Workshops and short courses WHO-sponsored international semenology workshop Since 1997, the Department of Obstetrics and Gynaecol- ogy in Tygerberg Hospital, Cape Town, South Africa, has organized semenology workshops for health care service providers in conjunction with WHO. The sixth WHO-spon- sored semenology workshop, held in December 2002, was attended by eight participants from the University of Nairobi (Kenya), Makerere University (Uganda), University of Zambia (Zambia) and University of Pretoria and Stellen- bosch (South Africa). All participants successfully completed both the theoretical and practical examinations. To date, 72 individuals have been trained and enrolled in the quality control programme for sperm morphology. The programme has allowed the establishment of satellite laboratories in various centres such as those in Kampala (Uganda), Lusaka (Zambia), Nairobi (Kenya) and Sagamu (Nigeria). Research projects in these centres such as the studies in Kenya on the potential of the primate zona pellucida as a target for contraception, have benefited. Satellite laboratories, such as the Centre for Research in Reproductive Health in Sagamu, Nigeria, have initiated local training and provided guidance to multiple individuals in the area. Regional training course for French-speaking countries in Africa An evaluation of more than 120 health professionals from French-speaking Africa who had taken a research method- ology course organized by the Programme, suggested the need for the training of trainers who could replicate train- ing at the national level. However, this approach has been constrained by the lack of a standardized training manual in French, among other reasons. Thus, efforts continued to develop a standardized training manual in French for research methodologies which are useful and important in studying reproductive health. The modules developed for the manual were tested in various courses during 2000 and 2001. Each module includes text, teaching aids, exercises, responses to the exercises, and handouts for the student. A working group of French-speaking experts from Africa and Europe was set up in 2002 to finalize the manual. This work will continue in 2003 since it is likely that more testing will be needed. Courses on gender and reproductive health These courses were conducted in Kenya and South Africa. Details of the courses are given in the chapter on Gender and reproductive rights in reproductive health. Workshops on ethical issues in research in reproductive health As a follow-up to the regional workshops held in Cairo (Egypt) and Kadona (Zimbabwe), the Programme sup- ported three workshops on ethical issues in research in reproductive health in Ibadan (Nigeria), Karachi (Pakistan) and Muscat (Oman). The meeting in Karachi was organized by the National Research Institute for Fertility Care and was attended by 47 participants from research organizations in Karachi. These workshops were conducted in response to the recommendation by the Programme’s Scientific and Ethi- cal Review Group (SERG) that the Programme should organ- ize regional workshops devoted to the principles and practice of ethics in research on human subjects in the field of human reproduction for participants from centres collaborating with the Programme. The general purpose of the workshops has been to stimulate discussion on, and encourage ethical prac- tices in, reproductive health research. Reproductive health research in this context includes biomedical, social science and epidemiological research involving human subjects, covering such areas as maternal health, fertility regulation, infertility, sexual behaviour, sexually transmitted infections (STIs) and HIV infection. One regional ethics workshop is planned for French-speak- ing Africa for late 2003 and another for north African coun- tries. Regional workshop on infertility management Since infertility is a priority issue in the WHO Regions of Africa and the Eastern Mediterranean, RAP recommended that a workshop be organized to develop a multicountry study of operational research on infertility management at the primary and secondary levels of health care. Thus a workshop on management of infertility was held in February 2002 in Nairobi, Kenya. Its objectives were to: •• define best practices and formulate solutions to the man- agement of infertility in a limited-resource setting at both primary and secondary levels; •• review past experiences, identify best practices, outline perspectives for the future and draw up a blueprint for the improved management of infertility in countries with limited resources; A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 168 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 169 •• formulate a preventive strategy of infertility in the two regions. A total of 24 participants from eight African countries (Cam- eroon, Democratic Republic of Congo, Ethiopia, Kenya, Nigeria, Senegal, South Africa and Uganda) and from four of the Eastern Mediterranean Region countries (Egypt, Oman, Sudan and the Syrian Arab Republic) attended. The regional offices were represented by the Regional Reproduc- tive Health Adviser from AFRO and a consultant for EMRO. The first part of the workshop focused on sharing experience and learning from the countries in the two regions. For the second part of the workshop, the participants divided into four groups to discuss four issue areas: social aspects of infertility; prevention of infertility; management of infertility at primary and secondary health care levels; and advocacy and quality of care. The information from regional and country presentations was used in the second part of the workshop, in which discussions concentrated on development of a prevention strategy and guidelines for the management of infertility at primary and secondary levels of health care using an algorithm. The recommendations from the workshop were as follows: (i) Services should be provided at all levels of health care for the prevention and management of STIs, unsafe abortion and traditional delivery practices and their complications, such as infertility. (ii) The use of practice guides would facilitate the improvement of quality of infertility services at the primary and secondary levels of health care. Therefore, the practice guides (algorithms) developed by colleagues in South Africa in collaboration with the Department, should be completed and field-tested. (iii) Since treatment of infertility caused by tubal damage is commonly unsuccessful, and in recognition of the limited resources available in the countries in the Afri- can and Eastern Mediterranean Regions, the development of a low-cost Assisted Reproduction Technologies (ART) protocol and establishment of low-cost ART services in a few centres in these regions should be considered. An algorithm guide, Prevention and management of infertil- ity: a guide for reproductive health workers, describing man- agement of infertility in poor resource settings will be revised and field-tested in two centres, one in the African Region and the other in the Eastern Mediterranean Region, in 2003. Operations research training Recognizing the need for programmatically-focused research that complements normative and basic research, the Department, USAID, and the FRONTIERS Project signed a Memorandum of Understanding (MOU) in 2001 to collaborate in operations research (OR) activities. Improving the capacity of developing countries to conduct and utilize operations research has become an important part of this collaboration. One of the main concerns of capacity build- ing efforts has been to institutionalize training in universities and research organizations in developing countries in order to ensure capacity to produce better-trained managers and researchers. FRONTIERS, USAID and the Department have agreed that bringing together specialists in reproductive health research and programme management from international agencies with existing and potential training centres will contribute to improving the availability and quality of training in operations research. In turn, this will stimulate the increased use of operations research and lead to improved programme effec- tiveness, including quality and efficiency. In 2002, the Programme supported 12 researchers from five collaborating centres to attend operations research training courses in Cairo (Egypt) and Dhaka (Bangladesh). Seven of the researchers selected were from the centres participating in the project “Operations research on community and facility interventions towards improving maternal-newborn health in Ethiopia, South Africa and Uganda”. A special initiative for developing an operations research training centre for French-speaking Africa was planned in collaboration with FRONTIERS and AFRO. Five institu- tions were first selected and invited to send in a proposal for an operations research training programme for the period 2003–2005. The selection, based on strict criteria and a site visit, ended in favour of the Centre de Recherche sur la Population et Développement (CERPOD) in Bamako (Mali). Training activities will start in 2003 and will involve 10 French-speaking countries (to be selected). Youth training As a consequence of the operations research projects on improving adolescent reproductive health in French-speak- ing countries, a youth research network was formed by the youth representatives in 2000. This network became an affili- ate of the African Network for Reproductive Health Research (RESAR). In 2002, with the support of the Programme, RESAR held a research methodology training course in Abid- jan (Côte d’Ivoire) that brought together young persons from eight countries. During the course the participants developed concept papers and draft protocols for four multicountry stud- ies on themes such as “Behaviour of young people in the face of sexually transmitted infections (STIs) and HIV in rural areas”, and “Sexual behaviour and use of health services by young girls who work as sex workers”. Reproductive Health Research Methodology Course in South Africa This course has been conducted annually in the Repro- ductive Health Research Unit, Chris Hani Baragwanath Hospital, Johannesburg, South Africa, since 1997. The main aim of the course is to support and improve reproductive health policy and programme planning in Africa by building capacity in reproductive health research skills and interven- tion strategies. In 2002, the course was held on 29 July–23 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 170 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 171 August with 23 participants from eight countries. Funding was received from WHO, The Population Council, The Well- come Trust, The Ford Foundation, the United Kingdom’s Department for International Development (DFID) and the United Nations Population Fund (UNFPA). Over the previous five years, 169 participants from 15 coun- tries in sub-Saharan Africa have attended this course. Of these, 106 were females and 63 males. The majority of par- ticipants were from government and research institutions. Research training grants In 2002, six researchers were studying with funding from the Programme: one from Nigeria and one from Uganda at the London School of Tropical Medicine and Hygiene, London, United Kingdom, for a Master’s course in reproductive and sexual health research; two from Côte d’Ivoire at the Free University of Brussels, Brussels, Belgium, for a course on health systems research and applied statistics; one from Nigeria at the University of Edinburgh, Edinburgh, United Kingdom, for studies in andrology; and one from Cameroon for a Master’s Course in biostatistics at the University of Ibadan, Nigeria. Other grants were approved for courses to be held in 2003. M.Sc. course in biostatistics, University of Ibadan, Ibadan, Nigeria Since 1998, the Programme has provided support to an M.Sc. course in biostatistics at the University of Ibadan, Ibadan, Nigeria. The course is organized by the Department of Epi- demiology, Medical Statistics and Environmental Health, College of Medicine, University of Ibadan. This course trains professional biostatisticians to provide statistical expertise to biomedical research groups in Africa. The Programme’s sup- port to this course includes building capacity to strengthen the academic staff and enhancing computer facilities and library resources. In the academic year 2000–2001, all eight students who had registered successfully completed the programme. Since its inception, the course has trained 42 professional biostatisticians and epidemiologists. Of these, only five were foreign students, all others were Nigerians. However, the course now attracts students from other African countries and 10 foreign students were accepted for the fourth course held during the 2001–2002 academic year. Training provided by the centres Training abroad of staff from centres supported by the Pro- gramme was complemented by training programmes organ- ized by the centres themselves for professional and technical staff from national institutions, including service providers. The nine centres receiving research capacity strengthening support (LID grants or RMGs) provided individual training to 12 staff from other institutions. Forty-five fellows participated in formal courses and 1414 persons attended short, group- learning activities such as seminars and workshops organ- ized by these centres. DISSEMINATION OF RESEARCH FINDINGS The dissemination of relevant research findings is a pre- requisite to their adaptation, adoption and utilization by reproductive health programmes and services. Research results have to be shared with and validated by international and local scientific communities, and the most direct way to achieve this is by means of publications in peer-reviewed journals and presentations at scientific events. The Programme collaborated with the Francophone Regional Committee for Post-abortion Care Initiative in organizing a congress on post-abortion care in Dakar, Senegal, in March 2002. This initiative had been launched by a consortium of 12 USAID cooperating agencies. The objective of the initiative is to promote a better access to and quality of services for post-abortion care in French-speaking Africa. The congress brought together over 200 participants from 17 countries. Delegations from 12 countries prepared action plans for expansion or introduction of post-abortion care services in their respective countries at the congress. During the reporting period, a total number of 57 research articles (42 original papers and 15 review articles) were pub- lished and 13 books or book chapters were authored by staff from the nine centres receiving research capacity strength- ening support. Likewise, 46 presentations were made in national, regional or international scientific events. SUMMARY OF COUNTRY ACTIVITIES During 2002, the Department collaborated with 36 institutions or research groups in 23 countries of the African and East- ern Mediterranean Regions. A brief description of the main developments at country level is given in Table 7.2 below. OTHER ACTIVITIES Regional directories of reproductive health Data collection for a reproductive health research directory for the French-speaking African countries was completed in 2002 by RESAR as a follow-up to the training workshop held in November 2000 in Ouagadougou, Burkina Faso, for participants of 12 French-speaking African countries. The purpose of this initiative is twofold: (i) to improve dissemina- tion of research findings; and (ii) to promote networking. This directory will be widely disseminated through the Internet and as a CD-ROM. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 170 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 171 Country Grants, institutions and activities Benin Operations research on adolescents1 Small grant—The Centre for Research in Human Reproduction and Demography (CERRHUD) of the Department of Obstetrics and Gynaecology, University of Benin, Cotonou: • Provides statistical support to adolescent study in other countries1 Burkina Faso Obstetric sequelae of female genital mutilation (FGM)1 - Centre Hospitalier National Yalgado Oue- draogo, Ouagadougou Cameroon Operations research on adolescents1 The African Reproductive Health Research Network (RESAR): organizes research methodology courses and develops manuals for French-speaking countries1 Côte d’Ivoire Operations research on adolescents1 LID grant 1998–2002—National Research Cellule on Reproductive Health in the National Institute of Public Health in Abidjan, a member of RESAR: • Collaborates actively with many national agencies on issues such as validating research proto- cols, planning courses on reproductive health, and participated in organization of an international symposium on “Gender, population and development in Africa” Egypt LID grant 1992–2002—The Egyptian Fertility Care Society (EFCS), an affiliate of the Egyptian Medical Association. Its research network includes all university and Ministry of Health teaching hospitals: • Completed research on clinic-based assessment of incidence of reproductive tract infections in women as well as on effectiveness and side-effects of progestogen-only injectable contraceptives as perceived by users • Continued research on improving post-abortion care • Initiated a project on long-term side-effects of FGM • Conducted a training of trainers workshop in curriculum development, teaching methods and evaluation of teaching in reproductive health and family planning for 28 core university faculty members from 14 universities of Egypt • Held a communication training workshop for researchers and policy-makers. • Translated into Arabic and edited the textbook The essentials of contraceptive technology— A handbook for clinic staff (Hatcher et al., Baltimore, MD, John Hopkins University/Population Information Program, 1997) • Prepared a policy briefing and a mass media advocacy plan for efforts aiming at the eradication of FGM in Egypt • In collaboration with EMRO, provided technical assistance to Yemen for expanding the contracep- tive method mix Ethiopia LID grant 1990–1994. New LID grant approved for 2003–2007—Department of Obstetrics and Gynaecology, University of Addis Ababa, Addis Ababa: • Two researchers attended operations research course1 • Planning participation in project “Operations research on community and facility interventions towards improving maternal and newborn health”1 Ghana Obstetric sequelae of FGM1—Rural Help Integrated, Bolgatanga Guinea Operations research on adolescents1 LID grant approved for 2003–2007—The Reproductive Health Research Cellule (Cellule de Recher- che en Santé de la Reproduction en Guinée, CERREGUI), part of RESAR 1 Activity reported in detail elsewhere in the report. . Table 7.2. Summary of country activities in the WHO Regions of Africa and Eastern Mediterranean A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 172 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 173 Islamic Republic of Iran Small grant—National Research Centre for Reproductive Health of Deputy Ministry for Research Affairs, Ministry of Health and Medical Education, Tehran Research on adolescent reproductive health: Ministry of Health1 Kenya Obstetric sequelae of FGM1—Kenyatta National Hospital, Nairobi Small grants—National Centre for Research in Reproduction (NCRR) composed of four units: the Department of Obstetrics and Gynaecology, University of Nairobi; the Reproductive Biology Unit in the Department of Animal Physiology, University of Nairobi; the Institute of Primate Research of the National Museums of Kenya; and the Reproductive Health Research Unit (RHRU) of the Kenya Medi- cal Research Institute (KEMRI). The Department of Obstetrics and Gynaecology, University of Nairobi, organized on behalf of the Programme the regional workshop on “Management of infertility in devel- oping countries”. Re-entry grant for research project “Production and characterization of monoclonal antibodies against BaEV and retroviral-related antigens expressed in baboon placental villous tissue”, Institute of Primate Research (IPR), Nairobi Mali Operations research training—CERPOD: • Selected to host an operations research training programme for french-speaking countries, 2003–2005 Mozambique LID grant from 1989 to 1999—Department of Obstetrics and Gynaecology, National University of Maputo, Maputo: • In January 2001, an in-depth evaluation of the centre was conducted: a significant number of professional staff has been trained and the centre has had an impact on the reproductive health programmes of the Ministry of Health; a number of important research activities in reproductive health utilizing a “twinning” arrangement with a counterpart department in Uppsala University, Uppsala, Sweden have taken place Nigeria Obstetric sequelae of FGM 1—National Hospital for Women and Children, Abuja, and University of Benin City Hospital, Benin City Small grants—Department of Obstetrics and Gynaecology, University of Ibadan, Ibadan; Depart- ment of Obstetrics and Gynaecology, University of Benin, Benin City; Department of Obstetrics and Gynaecology, University of Jos, Jos; Department of Obstetrics and Gynaecology, University of Lagos, Lagos LID grant 1999–2003—Centre for Research in Reproductive Health, College of Health Sciences, Ogun State University Teaching Hospital, Sagamu: • Conducts community-based research in reproductive health • Coordinates a national multicentre study to compare two doses of levonorgestrel for emergency contraception • Organized training on ethical issues in reproductive health for 75 staff members Centres in Jos and Benin City planning participation in project “Operations research on community and facility interventions towards improving maternal and newborn health”1 M.Sc. course in Biostatistics1—Ibadan Department of Epidemiology, Medical Statistics and Environ- mental Health Emergency contraception study1—The seven collaborating centres are the Departments of Obstetrics and Gynaecology in the university teaching hospitals in Benin City, Enugu, Ibadan, Jos, Lagos, Port Harcourt and Sagamu Support to the workshop on ethical issues in reproductive health1, Department of Obstetrics and Gynaecology, University College Hospital, Ibadan Oman Support for research on adolescent reproductive health, Ministry of Health, Muscat1 Support to the workshop on ethical issues in reproductive health held by Ministry of Health, Muscat1 1 Activity reported in detail elsewhere in the report. Table 7.2. Summary of country activities in the WHO Regions of Africa and Eastern Mediterranean (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 172 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 173 Pakistan Small grants—National Research Institute of Fertility Care (NRIFC), Ministry of Population Welfare, Government of Pakistan, Karachi; Reproductive Physiology Laboratory, Department of Biological Sciences, Quaid-I-Azam University, Islamabad Support to workshop on ethical issues in reproductive health held in NRIFC, Karachi1 Senegal Operations research on adolescents1 Obstetric sequelae of FGM1—Université Cheick Anta Diop, Dakar LID grant for 1999–2003—Department of Obstetrics and Gynaecology at Le Dantec Hospital, Univer- sity of Dakar, Dakar, and the International Centre for Training and Research in Reproductive Health (CEFOREP), which is attached to the Department: • Continued research on post-abortion care and on natural family planning • Organized a research methodology course and a scientific writing workshop for the Department’s staff • Two researchers from the Department of Obstetrics and Gynaecology at Le Dantec Hospital, Uni- versity of Dakar, Dakar attended operations research course in Cairo1 South Africa Small grant—Reproductive Health Research Unit (RHRU), Chris Hani Baragwanath Hospital, Johannesburg Research methodology course1—RHRU, Johannesburg Semenology course1—University of Stellenbosch, Cape Town • Planning participation in “Operations research on community and facility interventions towards improving maternal and newborn health”1—RHRU, Durban LID grant for 2001–2005—Effective Care Research Unit (ECRU) in the Department of Obstetrics and Gynaecology of the East London Hospital complex, which consists of Cecilia Makiwane Hospital in Mdantsane, and Frere Hospital in East London: • Objectives: to generate, implement and disseminate research-based evidence of the effectiveness of clinical and health system interventions, appropriate to the needs, customs and constraints of low-income country population; to develop the capacity of developing country health personnel in research and implementation of effective, affordable care; and to develop its research capacity through research traineeships • Focus on clinical trials designed to answer questions of relevance to reproductive health • Organized a workshop on “Practical research methods” Sudan Resource Maintenance Grant—Department of Obstetrics and Gynaecology, University of Khartoum, Khartoum: • Has an active endocrinology/microbiology laboratory • Conducted community-based research on FGM; published a book on the findings in collaboration with UNFPA • Conducted two research methodology courses Obstetric sequelae of FGM1—University of Khartoum, Khartoum Syrian Arab Republic Support for research on adolescent reproductive health, Ministry of Health1 1 Activity reported in detail elsewhere in the report. Table 7.2. Summary of country activities in the WHO Regions of Africa and Eastern Mediterranean (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 174 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 175 Tunisia LID grant for 1998–2002—Centre for Research in Human Reproduction, National Office of Family and Population (ONFP), Tunis: • Initiated a national reproductive health research network • Held a workshop on research methodology for the research network members • Coordinates a study on the diagnosis and prevention of STIs in Morocco and Tunisia with the objective of developing a regional strategy and setting-up a regional reference laboratory for STIs • One staff member served as faculty for the international course on epidemiology and statistics held in Dakar, Senegal Uganda Resource Maintenance Grant—Department of Obstetrics and Gynaecology, Makerere University, Kampala: • Collaborated extensively with many institutions at international level • Completed a randomized clinical trial demonstrating the efficacy of nevirapine in prevention of mother-to-child transmission (MTCT) of HIV; the results of the study have been widely dissemi- nated and continuously discussed at national as well as at international levels leading to the plan- ning of national MTCT prevention strategies; members of the Ugandan research team are being invited by other African countries to assist them • Held a scientific writing workshop • Two researchers from the Department of Obstetrics and Gynaecology, Mulago Hospital, Kampala, attended operations research course1 • Planning participation in project “Operations research on community and facility interventions towards improving maternal and newborn health”1—Department of Obstetrics and Gynaecology, Mulago Hospital, Kampala Zambia Small grant—Department of Obstetrics and Gynaecology of the University of Zambia, based in the Teaching Hospital in Lusaka : • Two researchers from the Department of Obstetrics and Gynaecology, University Teaching Hospi- tal, Lusaka, attended operations research course1 Zimbabwe Resource Maintenance Grant—Department of Obstetrics and Gynaecology, University of Zimbabwe, Harare: • 23 ongoing research projects and 22 publications • Developed a proposal for multicountry project on cervical cancer screening by visual inspection with acetic acid 1 Activity reported in detail elsewhere in the report. Table 7.2. Summary of country activities in the WHO Regions of Africa and Eastern Mediterranean (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 174 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 175 Informal consultation for a reproductive health research directory in the Eastern Mediterranean Region was held at EMRO in August 2001. It was attended by the country coor- dinators of Egypt, Islamic Republic of Iran, Lebanon, Saudi Arabia and Syrian Arab Republic, a representative of UNFPA and the WHO secretariat from EMRO and headquarters. Data collection and the follow-up activities have been ham- pered by the insufficiency of funds. Other funding sources have been explored in 2002 and it is hoped that the activities can be carried out in 2003. The African Reproductive Health Research and Training Network A feasibility study conducted in 2001 found that there was a need to establish an African Reproductive Health Research and Training Network (ARHRTN). ARHRTN will serve as an umbrella network linking, coordinating and strengthen- ing existing reproductive health research networks for the purpose of setting regional reproductive health priorities and improving reproductive health status in Africa. An important step towards the establishment of ARHRTN was a meeting organized by RHRU, Johannesburg, South Africa, in August 2002, where an interim steering committee of African experts in the field of reproductive health wrote a constitution and a three-year workplan. ARHRTN is seen as an important networking link for countries, networks and research institutions to scale up research across the conti- nent and as a means of facilitating and forging links with the international reproductive health community. It is expected that ARHRTN, through its networking and knowledge Department Thematic Group or collaborating agency Activity Countries participating in the activity Controlling STIs/RTIs Capacity strengthening in microbicide research Ethiopia, Nigeria and Uganda Expanded safety and acceptability study of 6% cellulose sulfate Nigeria Multicentre study on impact of HAART on mother’s health and MTCT of HIV Burkina Faso, United Republic of Tanzania Making Pregnancy Safer Making Pregnancy Safer activities in spotlight countries Ethiopia, Mauritania, Mozambique, Nigeria, Uganda and Sudan Use of misoprostol in the third stage of labour Egypt, Nigeria, South Africa Follow-up study of children whose mothers participated in the trial on magnesium sulfate for management of pre-eclampsia (MAGPIE) Nigeria WHO Country Focus Initiative Planning of Country Cooperation Strategies (CCS) African and Eastern Mediterranean Regions Planning and programming in collaboration with AFRO A training initiative in evidence-based reproductive health care African Region Technical cooperation with countries Participation in the evaluation of the reproductive health components of UNFPA-funded national population programmes Sao Tome Strategic approach to reproductive health: Phase I, II and III Ethiopia, South Africa, Zambia Anglophone Africa Regional Workshop to Disseminate Information on the WHO Strategic Approach to Improving the Quality of Care of Reproductive Health Services English-speaking African countries Table 7.3. Activities carried out in collaboration with other partners within the Department or other international agencies A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 176 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 177 exchange activities, will facilitate the process of address- ing the reproductive health research priorities of Africa. The steering committee noted that ARHRTN will provide a forum for discussions and negotiations and play a strong advocacy role. It will provide an opportunity for networks in Africa to cooperate and strengthen each other, involving all stakehold- ers including policy-makers in reproductive health research. There is a need to finalize the constitution, produce a direc- tory, elect a steering committee, engage in fund raising and link up with the African Research Forum which met in Arusha, United Republic of Tanzania, in November 2002. HIGHLIGHTS OF JOINT ACTIVITIES ON PROGRAM- MATIC ISSUES A number of other activities that were carried out in col- laboration with other partners either within the Department or with other international agencies are summarized in Table 7.3. Details of these activities are given in other chapters of this report. PLANNED ACTIVITIES Activities planned for 2003 can be summarized under the fol- lowing main lines of work: •• Support and maintain institutions currently collaborating with the Department through institutional development grants to enable them to undertake research projects relevant to their identified reproductive health needs and priorities. •• Promote and further strengthen regional research net- works working on key issues such as maternal health, adolescent reproductive health, FGM, infertility, cervical cancer and HIV/AIDS. •• Promote dissemination and utilization of tools developed by the Department through Service Guidance Centres. •• In collaboration with other partners, increase efforts to institutionalize operations research training in the African Region. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 176 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 177 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 13 100 13 Women 6 46 6 from: AFRO 9 69 9 AMRO EMRO 4 31 4 EURO SEARO WPRO Annex 1 REGIONAL ADVISORY PANEL FOR THE AFRICAN AND EASTERN MEDITERRANEAN REGIONS IN 2002 Members Asya Al-Riyami, Department of Research and Studies, Ministry of Health, Muscat, Oman Mariame Ba, Department of Obstetrics and Gynaecology, University of Dakar, Dakar, Senegal Hassan Ba’aqeel, Department of Obstetrics and Gynaecology, King Khalid National Guard Hospital, Jeddah, Saudi Arabia Hyam Bashour, Department of Community Medicine, Faculty of Medicine, Damascus University, Damascus, Syrian Arab Republic Kim Dickson-Tetteh, Reproductive Health Research Unit, Department of Obstetrics and Gynaecology, Baragwanath Hospital, Johannesburg, South Africa Faysal El-Kak, American University of Beirut, Faculty of Health Sciences, Beirut, Lebanon Alex Ezeh, African Population and Health Research Centre, Nairobi, Kenya Osato Giwa-Osagie, Department of Obstetrics and Gynaecology, College of Medicine, University of Lagos, Lagos, Nigeria Bailah Leigh, National AIDS Control Programme, Ministry of Health and Sanitation, Freetown, Sierra Leone Boniface Nasah, Society of African Gynaecologists and Obstetricians (SAGO), Buea, Cameroon Babatunde Osotimehin, Social Science and Reproductive Health Network, University College Hospital, Ibadan, Nigeria Christine Sekadde-Kigondu, Department of Obstetrics and Gynaecology, University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya (Chairwoman) Christiane Welffens-Ekra, Department of Obstetrics and Gynaecology, University Hospital Yopougon, Abidjan, Côte d’Ivoire Collaborating agency scientists Marie-Hélène Bouvier-Colle, French National Institute of Health and Medical Research (INSERM), Paris, France A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 178 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 179 Annex 2 SCIENTISTS COLLABORATING IN 2002 African Region Michel Akotionga, Maternité du Centre Hospitalier National Yalgado Ouedraogo, Ouagadougou, Burkina Faso Eusebe Alihonou, Centre of Research in Human Reproduction and Demography, National University of Benin, Cotonou, Benin Mamadou Baldé, University Hospital of Donka, Conakry, Guinea Antonio Bugalho, Maputo Central Hospital, Maputo, Mozambique Virgile Capo-Chichi, Centre of Research in Human Reproduction and Demography, National University of Benin, Cotonou, Benin Zvavahera Chirenje, University of Zimbabwe, Harare, Zimbabwe Olukayode Dada, College of Health Sciences, Ogun State University, Sagamu, Nigeria Fadel Diadhiou, University of Dakar, Dakar, Senegal Djibril Diallo, Université Cheikh Anta Diop de Dakar, Dakar, Senegal Osato Giwa-Osagie, College of Medicine, University of Lagos, Lagos, Nigeria Justus Hofmeyer, University of the Witwatersrand, Effective Care Research Unit, Cecilia Makiwane and Frere Hospitals, East London, Eastern Cape, South Africa Guyo Jaldesa, Kenyatta National Hospital Campus, College of Health Sciences, University of Nairobi, Nairobi, Kenya Joseph Karanja, Kenyatta National Hospital Campus, College of Health Sciences, University of Nairobi, Nairobi, Kenya Christine Kaseba, University of Zambia, Lusaka, Zambia Daudi Langat, Institute of Primate Research, National Museums of Kenya, Nairobi, Kenya Robert Leke, University of Yaounde 1, Faculty of Medicine and Biological Sciences, Yaoundé, Cameroon Mairo Mandara, National Hospital for Women and Children, Abuja, Nigeria Florence Mirembe, Makerere University, Kampala, Uganda Jason Mwenda, Institute of Primate Research, National Museums of Kenya, Nairobi, Kenya Kwasi Odoi-Agyarko, Rural Help Integrated, Bolgatanga, Ghana Oladosu Ojengbede, University of Ibadan, Ibadan, Nigeria Friday Okonofua, University of Benin Teaching Hospital, Benin City, Nigeria Augustin Orhue, University of Benin, Benin City, Nigeria Joseph Otubu, Jos University Teaching Hospital, University of Jos, Jos, Nigeria James Oyieke, University of Nairobi, Nairobi, Kenya René Perrin, African Network of Reproductive Health Research, Cotonou, Benin Justine Tantchou, African Network of Reproductive Health Research, Yaoundé, Cameroon Marguerite Te Bonle, National Research Cellule of Reproductive Health, National Institute of Public Health, Abidjan, Côte d’Ivoire Emmanuel Wango, Reproductive Biology Unit, University of Nairobi, Nairobi, Kenya K. Monique Wasunna, Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya Eastern Mediterranean Region Badar Uddin Abbasi, National Research Institute of Fertility Control, Karachi, Pakistan Rim Ben Aissa, Research Centre for Human Reproduction, National Office for Family and Population, Tunis, Tunisia Abdulazis Gerais, University of Khartoum, Khartoum, Sudan Ezzeldin Hassan, The Egyptian Fertility Care Society, Cairo, Egypt Samina Jalali, Quaid-i-Azam University, Islamabad, Pakistan Mohamed El Fadil Saad, University of Khartoum, Khartoum, Sudan Sami Said, Shatby Maternity Hospital, Alexandria, Egypt Fahimeh Ramezani Tehrani, National Research Centre in Family Planning, Ministry of Health and Medical Education, Tehran, Islamic Republic of Iran A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 178 A n n u al Tech n ical R ep ort 2002 The WHO Regions of Africa and the Eastern Mediterranean 179 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 38 100 38 Women 9 24 9 from: AFRO 30 79 30 AMRO EMRO 8 21 8 EURO SEARO WPRO Annex 2 (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 180 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 181 The WHO Region of the Americas E. Ezcurra INTRODUCTION Strengthening research capacity of institutions in the Region of the Americas was undertaken to further enhance their potential to implement reproductive health research relevant to national and regional needs and to facilitate their participa- tion in the global research effort. The main goals established by the Regional Advisory Panel (RAP) for the 2002–2003 biennium were: (i) to continue strengthening research capacity, in Programme-supported collaborating institutions in the Region of the Americas, by promoting and supporting the implementation of well- designed research projects in topics relevant to national and regional reproductive health problems; and (ii) to promote the dissemination and utilization of relevant research findings. The following strategies were selected for attaining these goals: •• implementation of regional and national reproductive health research and participation in the global research effort, particularly through the strengthening of regional and national research networks in basic reproductive biology, clinical/epidemiological investigations and social sciences; •• development and strengthening of human resources; •• increased dissemination of relevant research results to facilitate their adaptation and utilization in reproductive health programmes and services; •• improved monitoring and evaluation of supported activi- ties; and •• increased coordination with the WHO Regional Office for the Americas (AMRO). The main activities implemented under these strategies are described in the following sections. RESEARCH ACTIVITIES The eight centres supported with research capacity strength- ening grants are involved in projects which address regional and national priorities. During 2001 (the last year for which complete data are available), from the overall number of 106 studies, four projects (4%) were implemented with support from the Programme’s capacity building grants: Long-term Institutional Development (LID) grants, Resource Main- tenance Grants (RMGs), and Re-entry Grants. Fifty-one projects were carried out at the centres with support from national sources (48%). The participation of the regional centres in the global research effort is exemplified by the 21 projects (20%) conducted in these collaborating institu- tions with support from the various teams of the Department. Likewise, the institutional strengthening efforts deployed by the Programme in its regional centres have enhanced their capacities for fundraising from other international agencies, to address topics of global or local relevance. During 2001, 30 projects (28%) carried out in these regional centres received support from international agencies other than WHO. With respect to capacity developed to address research issues through different methodological approaches, it is worth noting that, in 2001, from the 106 research studies, 56 (53%) were epidemiological or social science projects, the first time ever that such projects have accounted for more than half of all those undertaken at the centres being supported. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 180 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 181 Ongoing projects supported by LID grants include basic sci- ence work in the area of male fertility, an assessment to iden- tify priority interventions that would improve access to and quality of family planning, maternal and neonatal health care, and social science research in the area of male involvement in reproductive health. Maternal/infant health, family planning and sexual and reproductive health of adolescents were the main thematic areas covered by projects being implemented in centres receiving RMGs. DEVELOPMENT OF HUMAN RESOURCES Resources for Training Grants were awarded to the Institute of Nutrition in Mexico City, Mexico, to the National Institute of Public Health, Cuernavaca, Mexico, and to the Centre of Studies of Society and Development (CEDES), Buenos Aires, Argentina, to support regional postgraduate courses in reproductive biology, in reproductive epidemiology and in the social sciences, respectively. With respect to support provided to individuals, 10 scientists from regional centres received grants in 2002 to undergo training in different areas relevant to reproductive health. Table 7.4 summarizes the overall number of training grants awarded in 2002 which were supported with funds from the regional budget. Ten fel- lows (seven women) received grants for short and long-term training, mostly (eight) in centres located in Latin America. Training abroad of staff from the supported centres was com- plemented by extensive training programmes organized by the centres themselves for professional and technical staff from national institutions, including service providers. In 2001, the eight centres provided individual training to 112 staff from other local institutions. A total of 31 fellows participated in formal courses and 653 attended short, group-learning activi- ties such as seminars and workshops organized by the cen- tres receiving research capacity strengthening support. DISSEMINATION AND UTILIZATION OF RESEARCH FINDINGS Scientific publications During 2001, a total number of 143 research articles (128 original papers and 15 review articles) were published and 34 books and book chapters were authored by staff from the eight centres receiving research capacity strengthening support. Likewise, 186 presentations were made in national, regional or international scientific events and 20 official reports were pre- sented to national and international authorities and agencies. Figure 7.1 shows the distributions of publications and pres- entations in national/regional and international journals and meetings. Dissemination of results from national and regional research initiatives The Institute for Studies on Altitude of the Peruvian Univer- sity “Cayetano Heredia” recently completed a long cycle of research capacity strengthening support. A national work- shop was organized in Pachamac, Peru, on 21–23 February 2002 to discuss its contribution to research in reproductive health and the factors that determine the impact of these findings on society. The 42 participants in the workshop included researchers, health programme officers as well as representatives of nongovernmental organizations (NGOs) and other civil society groups. The main thematic areas dealt with during the workshop were maternal mortality and mor- bidity and neonatal health. Of particular importance were the information dissemination activities related to the regional research initiative “Reality and beliefs in the sexual and reproductive decision-making process: men’s perceptions and behaviour: a multicentre study in Argentina, Bolivia, Cuba and Peru”. Type of grant Area Number of trainees Females Males M.Sc. Course Reproductive epidemiology 1 1 M.Sc. Course Social sciences 1 1 M.Sc. Course Health systems 1 1 Diploma Course Reproductive biology 3 3 Workshop Programme evaluation 2 1 1 Workshop Communication 1 1 Course Molecular biology 1 1 TOTAL: 10 7 3 Table 7.4. Research Training Grants awarded in 2002 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 182 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 183 The first dissemination workshop was held in Buenos Aires, Argentina, in October 2002. For this activity, a special booklet was designed, produced and distributed. It included not only an easily understandable summary of the project’s findings and of their interpretation, but also specific recommenda- tions for policies and programmes. Oral presentations were made by the principal investigators on the results and on their policy implications, and there were extensive discus- sions with an audience of 106 people, including 52 scientists (researchers, representatives of professional associations, university professors), 23 health programme officers from the federal and provincial levels, 22 professionals in direct contact with the population (physicians, teachers, social workers) and nine representatives of NGOs and of interna- tional organizations and journalists. The workshop and the results of the study received press coverage: there were articles in two national newspapers and TV interviews with the project’s principal investigators. Facilitating enhanced utilization of research findings A regional workshop on utilization of research findings took place in San José, Costa Rica, 4–7 June 2002. It was funded and organized by the Population Council’s FRONTIERS Project, by the Department and by the Central American Centre for Population of the University of Costa Rica, San Jose, Costa Rica. The overall objectives of the workshop were: • to increase utilization of research results by reproductive health programmes in the Latin-American region through increasing researchers’ knowledge of what constitutes programmatically relevant research, and by enhancing the ability of researchers and programme managers to work together at all stages of the research process; •• to train researchers and managers in ways to improve utilization of results prior to beginning operations research activities at the WHO Collaborating Centres in the region; and •• to identify the utilization problems most frequently encountered by participants and suggest ways to over- come these problems. Participants came from various Latin American centres col- laborating with the Department in Argentina, Brazil, Guate- mala, Mexico, and Peru as well as staff from a small number of organizations in Costa Rica, El Salvador and Nicaragua. Those centres that were invited had experience in conduct- ing biomedical, epidemiological or social science research, strong links to reproductive health service delivery pro- grammes, and an interest in participating in future operations research activities. Discussions revealed that very few participants included dissemination and/or utilization plans or budgets in their research proposals, and that the Department did not require these plans for funding a study. Other problems included lack of relevance of the research for programmes and absence of close working relationships with managers and policy- makers. A full report of the workshop (Figure 7.2) is available on request. Figure 7.2. Report of regional workshop on utilization of research results, Costa Rica, June 2002 Figure 7.1. Publications and presentations in 2001 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 182 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 183 EFFECTIVE MONITORING AND EVALUATION OF REGIONAL AND COUNTRY ACTIVITIES The recent external evaluation of the Programme’s research capacity strengthening activities recommended that in-depth assessments be conducted of both achievements and the impact of capacity strengthening grants on the performance of centres being supported. The Institute for Experimental Biology and Medicine (IBYME), Buenos Aires, Argentina, is about to complete the first cycle (1998–2002) of LID grant support. A team of two Department staff members and one external consultant visited the Institute in December 2002. Important achievements were noted in the area of basic research in male fertility which is the core of the LID grant. In addition, support provided by the Department contributed to significant improvements when compared to the six- year period (1992–1997) preceding the award of the LID grant. Table 7.5 summarizes some of the main indicators of improved standing and performance. Experiences derived from this assessment and from the well- documented self-evaluation of improved performance done by the centre and verified by the site-visit team will contribute to the development of adequate monitoring mechanisms to document the relevance and impact of research capacity strengthening activities. INCREASED COORDINATION WITH AMRO The Scientific and Technical Advisory Group (STAG) recom- mended at its February 2002 meeting that regional desks should increase coordination with their respective regional office. During the past year, eight missions were jointly undertaken by staff from the Department and from AMRO to visit centres, to interact with ministries of health and/or to participate in relevant country or regional meetings. These missions included visits to Argentina, Brazil, Costa Rica, Guatemala, Nicaragua, Paraguay and Uruguay. The coordinator of the Regional Social Sciences Network is acting as a technical advisor to the AMRO multicentre project on promotion of men’s participation in reproductive health programmes in Central America. Finally, the Department and AMRO have initiated contacts in English-speaking Caribbean countries, in coordination with the Latin American and Caribbean Office of the Popula- tion Council, to undertake a study on providers’ views and perspectives on emergency contraception in Barbados and Jamaica. SUMMARY COUNTRY REPORTS In 2002, the Department collaborated with 18 institutions in 10 Latin American countries: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, and Peru. A brief description of the main developments at country level follows. Argentina Support has continued to the Centre for Perinatal Studies (CREP) in Rosario. CREP conducts research in the areas of maternal and infant health, adolescent health and repro- ductive health epidemiology and it serves as a training and research methodology referral centre for the country and the region. Its staff have worked closely with the Ministry of Health to facilitate the utilization of research results by pro- grammes and services. The Centre for Population Studies (CENEP) in Buenos Aires was the coordinator and one of the study sites of the regional multicountry social science study on “Men’s perceptions and behaviour with respect to decision-making processes affecting sexual and reproductive health”. It has developed concept papers for future initiatives on other relevant topics Indicator 1992–1997 1998–2002 Number of fellows in the Group 9 20 M.Sc. Degrees obtained by members of the Group 5 7 Ph.D. Degrees obtained by members of the Group 2 8 Courses organized at the centre 2 8 Number of staff participating as faculty in courses 10 14 Presentations in national scientific events 19 35 Presentations in international scientific events 5 32 Publications in national journals 1 5 Publications in international journals 4 18 Table 7.5. Some indicators of improved standing and performance, pre- and post-LID grant support. IBYME, Buenos Aires, Argentina A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 184 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 185 (sexual coercion, providers’ perspectives on emergency contraception). The Institute for Experimental Biology and Medicine in Buenos Aires continues to develop basic sciences research in the field of male fertility. The Centro de Estudios de Estado y Sociedad (CEDES) in Buenos Aires organized the M.Sc. course in social sciences and is involved in several global research projects supported by thematic groups of the Department. Bolivia Bolivian investigators associated with the Centre for Social Research, Appropriate Technology and Training (CISTAC), La Paz, participated in the four-country research initiative on “Men’s perceptions and behaviour in respect of decision- making processes affecting sexual and reproductive health”. The final country report was completed in February 2002 and plans for information dissemination and utilization are expected to be implemented in 2003. Brazil The Campinas Centre for Research and Control of Mater- nal and Infant Disease (CEMICAMP) of the University of Campinas has been the main recipient of Programme support in the country. Grants cover work undertaken on training in research methodology, on research dealing with clinical epidemiology and social science research relevant to contraceptive introduction and other aspects of women’s reproductive health. In September 2002, CEMICAMP organ- ized an international symposium on caesarean section. The centre is also implementing a Programme-supported study on counselling in family planning services. Chile Two institutions in Santiago continued to receive support from other thematic areas of the Department: the Institute for Mother and Child Research (IDIMI) and the Unit of Repro- ductive Biology and Development at the Catholic University of Chile. These centres participate in Programme-supported biomedical research on the mechanisms of action of emer- gency contraception preparations. Colombia The Centre at the University del Valle in Cali received sup- port from the Programme to take part in the “MAGPIE” Trial coordinated by Oxford University, Oxford, United Kingdom, that evaluates the use of magnesium sulfate for the treat- ment of pre-eclampsia. Costa Rica The Central American Population Centre of the University of Costa Rica has organized workshops on “Improving com- munication skills of researchers” and on “Programme evalu- ation”, in which several fellows from Programme-supported centres in Latin America have participated. In June 2002, the Centre also hosted the regional workshop on “Utilization of research results” supported by the FRONTIERS Project and the Department. Cuba Support to activities in Cuba is channelled through the National Coordinating Network for Research in Human Reproduction, comprising of the National Institute of Endo- crinology, the Hospital America Arias, the Ramon Gonzalez Coro Hospital and the National Centre for Sex Education (CENESEX). The National Institute of Endocrinology’s Social Sciences Unit implemented the four-country regional research initia- tive on “Men’s perceptions and behaviour in respect of deci- sion-making processes affecting sexual and reproductive health” and is also active in global research in the field of adolescent reproductive health. Dissemination of the find- ings of the study on men and plans for their utilization will be undertaken in 2003. The Institute and two obstetrics-gynaecology hospitals, members of the Network, are participating in two clinical trials concerned with improved non-surgical methods for pregnancy termination. Guatemala The Guatemalan Research Group in Reproductive Health based at the San Juan de Dios Hospital, Guatemala City, received support mainly to develop a reproductive health research programme focused on the country’s research priorities. During 2002, the final report of a strategic assess- ment conducted to identify priority interventions that would improve access to and quality of family planning, maternal and neonatal care in Guatemala was produced, and a draft proposal for Stage II action-research based on these findings was submitted for review. Mexico The Department of Reproductive Biology in the National Institute of Medical Sciences and Nutrition, Mexico City, is the main recipient of Programme support in the country. The institute is actively involved with the various thematic groups of the Department and other international funding agencies. In 2002, the institute continued to receive a Basic Resources for Training Grant, to partially support its extensive participa- tion in research training, particularly the diploma course on reproductive biology. Another grant supports the two-year M.Sc. degree pro- gramme in reproductive epidemiology organized by the National Institute of Public Health at its centre in Cuernavaca. The course has graduated students over the past 10 years A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 184 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 185 from Programme-supported centres in Argentina, Chile, Cuba, Guatemala, Mexico, Panama, Peru and Venezuela. Peru The Programme supported two centres affiliated to the Uni- versity Cayetano Heredia, Lima, which serves as a resource and training centre in reproductive health. Research carried out by the Institute of Research on Altitude, presently receiv- ing a Resource Maintenance Grant, includes studies in the areas of reproductive health of adolescents, reproduction at high altitude, and reproductive immunology. The Faculty of Public Health was one of the sites of the four- country, regional social science research initiative on “Men’s perceptions and behaviour in respect of decision-making processes affecting sexual and reproductive health”. The study was completed and a national dissemination work- shop is planned to take place in early 2003. The faculty also organized for the first time in 2002 a master’s degree course in sexual and reproductive health, which was attended by national and foreign students. PLANNED STRATEGIES The need to develop mechanisms to conduct research capacity strengthening activities in least developed countries in the Region of the Americas was identified as being of top priority for the immediate future. At its November 2002 meet- ing, the Americas RAP awarded Small Grants to centres in El Salvador, Honduras and Nicaragua; this is expected to facilitate an increased interaction with scientists and groups in these countries to better explore their capacity strengthen- ing needs so that adequate strategies are utilized to assist in their development. A site visit to Paraguay in December 2002 explored the possible implementation of the Strategic Approach in this country with support of research capacity strengthening grant. Special emphasis will continue to be placed on the dissemi- nation and utilization of research findings, particularly of find- ings resulting from national and regional research initiatives. At the same time, the regional networks will launch new ini- tiatives on topics of relevance to countries and to the region. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 186 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 187 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 5 63 3 37 8 Women 3 37 1 13 4 from: AFRO AMRO 5 63 3 37 8 EMRO EURO SEARO WPRO Annex 1 MEMBERS OF THE REGIONAL ADVISORY PANEL FOR THE AMERICAS Members Carlos Cáceres, REDESS Jovenes, Lima, Peru Stella Campo, Hospital de Niños, Buenos Aires, Argentina William Fraser, Laval University, Quebec, Canada Ana Cristina González, Santafé de Bogotá, Colombia Sylvia Guendelman, School of Public Health, University of California, Berkely, CA, USA (Chairwoman) Luis Rosero Bixby, Universidad de Costa Rica, San Jose, Costa Rica Silvia Salinas, La Paz, Bolivia Jim Trostle, Trinity College, Hartford, CT, USA Collaborating agency scientists Luis Bahamondes, PLACIRH, Mexico City, Mexico. Roberto Rivera, Family Health International, Research Triangle Park, NC, USA Raffaela Schiavon, The Population Council, Mexico City, Mexico A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 186 A n n u al Tech n ical R ep ort 2002 The WHO Region of the Americas 187 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 17 100 17 Women 6 35 6 from: AFRO AMRO 17 100 17 EMRO EURO SEARO WPRO Annex 2 PRINCIPAL INVESTIGATORS OF CENTRES IN 2002 Stella Campo, Endocrinology Research Centre (CEDIE), Buenos Aires, Argentina Guillermo Carroli, Centre for Perinatal Studies (CREP), Rosario, Argentina Horacio Croxatto, Chilean Institute of Reproductive Medicine (ICMER), Santiago, Chile Patricia Cuasnicú, Institute for Biology and Experimental Medicine (IBYME), Buenos Aires, Argentina Luigi Devoto, Institute for Maternal and Child Health Research (IDIMI), Santiago, Chile Oscar Díaz, National Institute of Endocrinology, Havana, Cuba Franklin García, Centre for Social Research, Appropriate Technology and Training (CISTAC), La Paz, Bolivia Gustavo Gonzales, Peru University Cayetano Heredia, Lima, Peru Ellen Hardy, Centre for Research and Control of Maternal and Infant Disease (CEMICAMP), Campinas, Brazil Bernardo Hernández, National Institute of Public Health, Cuernavaca, Mexico Edgar Kestler, Epidemiologic Research Centre, Guatemala City, Guatemala Fernando Larrea, National Institute of Nutrition, Mexico City, Mexico Carlos Moreno, Centre for Research in Human Reproduction, Panama Edith Pantelides, Centre for Population Studies (CENEP), Buenos Aires, Argentina Silvina Ramos, Centre for the Study of the State and Society (CEDES), Buenos Aires, Argentina Oscar Rojas, University of Valle, Cali, Colombia María Serón-Ferré, Pontifical Catholic University, Santiago, Chile A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 188 A n n u al Tech n ical R ep ort 2002 The WHO Regions of South-East Asia and the Western Pacific 189 The WHO Regions of South-East Asia and the Western Pacific A. Ntabona and M. Lusti-Narasimhan INTRODUCTION The WHO Regional Office for South-East Asia (SEARO) in New Delhi, India, covers 10 developing countries, of which five are least developed countries (LDCs). The countries of this region account for over 1.4 billion people. The WHO Regional Office for the Western Pacific (WPRO) in Manila, Philippines, includes 27 Member States and 9 territories and areas which are not responsible for the conduct of their own international relations; all participate in the work of WPRO. The total population of the countries and territories in this region is around 1.6 billion. The Regions of South-East Asia and the Western Pacific therefore comprise a very diverse population that makes up over 60% of the world’s total popu- lation. This fact, combined with the very large size of the ter- ritory represented, and diverse reproductive health profiles, makes the regions especially challenging. Since, owing to unforeseen circumstances, the meeting of the Regional Advisory Panel (RAP) was cancelled in 2001, in 2002, RAP met twice—in February and in October. At these meetings RAP recommended a strategic shift away from encouraging basic research in reproductive health to promoting regional initiatives and networking among national centres. Thus, the objectives for 2003 are to strengthen the regional initiatives through conferences, workshops and intraregional research aimed at promoting the three main priorities set for the regions, namely reducing maternal mortality, preventing unsafe abortion and controlling sexually transmitted infections (STIs) and reproductive tract infections (RTIs). CHANGE IN FOCUS FROM BASIC RESEARCH TO REGIONAL INITIATIVES One of the important recommendations of the 6th RAP meet- ing held in October 2002, was to shift focus from promoting basic research within the centres to encouraging a more regional and nationwide approach to reproductive health matters. This also implies that the future membership of the RAP advisors should include more social scientists and policy-makers. This shift had already been enacted during the last few years with the setting-up of national networks in China, Sri Lanka and Thailand. In 2003, projects of promoting regional priorities within the context of conferences and workshops will accelerate the process. In line with these objectives, proposals for basic research from the centres have not been approved if they did not have a wider range of application. One of the most important tasks during the site visits to the centres in 2003 will be to explain the shift in focus in order to help the centres develop research proposals aimed at strengthening the priority needs of their region. RESEARCH CAPACITY STRENGTHENING GRANTS AWARDED IN 2002 Table 7.6 shows the list of countries and names of Long- term Institutional Development (LID) grants and Resource Maintenance Grants (RMGs) recipient centres during 2002, and types of group learning activities that were proposed. There have been three Research Training Grants (RTGs) awarded to two scientists from China to study biostatistics and social sciences, respectively, and one from Mongolia A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 188 A n n u al Tech n ical R ep ort 2002 The WHO Regions of South-East Asia and the Western Pacific 189 to study epidemiology. Table 7.7 shows the types of work- shops that were held in the region. Owing to the fact that there was a five-month delay in holding the 5th RAP meeting from October 2001 to February 2002, there have also been delays in implementing some of the recommendations from the 2000–2001 RAP. NATIONAL NETWORKS Continued support was given by various parts of the Depart- ment to the national research institution networks established in China and Thailand. As stated in previous reports, these bodies play a leading role in the process of setting priorities for reproductive health research at national and institutional levels and in determining the goals and objectives of national reproductive health programmes. In China, the National Coordinating Board (NCB) brings together eight research institutions, namely: (1) National Research Institute for Family Planning, Beijing; (2) Shang- hai Institute of Planned Parenthood Research, Shanghai; (3) Peking Union Medical College Hospital, Beijing; (4) Institute of Population Research, Beijing; (5) Tianjin Municipal Research Institute for Family Planning, Tianjin; (6) Family Planning Research Institute of Zhejiang, Hanghzou; (7) Family Planning Research Institute of Sichuan, Chengdu; (8) National Evaluation Centre for the Toxicology of Fertility Regulation Drugs, Shanghai. The NCB helped formulate the Chinese National Reproduc- tive Health Programme for the next decade. This programme comprises four comprehensive community-based compo- nents on (i) improving quality of contraceptive care; (ii) STI intervention; (iii) healthy baby promotion; and (iv) integrated reproductive health services in Western China. It is proposed to undertake a review of the lessons learnt from the early implementation of some of these components and identify corrective measures where necessary. In Thailand, three university departments of obstetrics and gynaecology and seven regional hospitals have been brought together in a network that was supported until 2001 through RMGs. They have a strong working relationship with several teams in the Department and participate in global and regional research in the area of social sciences, STIs and RTIs, and maternal health, as well as on Cochrane Col- laboration reviews. REGIONAL INITIATIVES In order to make the research capacity strengthening efforts more cost-effective and to cover a much larger population, support was given to two regional initiative programmes as follows: •• The collaborative reproductive epidemiology research project on “Patterns and predictors of caesarean sec- tion in Asia”, is a 10-country joint research programme that was prepared in mid-2000. The countries involved are Bangladesh, China, Indonesia, Mongolia, Myanmar, Nepal, Philippines, Sri Lanka, Thailand and Viet Nam. The objectives of this study are to determine the compli- Type of grant Country Recipient centre Long-term Institutional Development (LID) Grants Indonesia Western Indonesian Reproductive Health Development Centre (WIRHDC), Faculty of Medicine, University of North Sumatra, Medan Reproductive Health Research Centre, Airlangga University, Surabaya Lao People’s Democratic Republic Maternal and Child Health Centre, Ministry of Health, Vientiane Mongolia State Research Centre on Mother and Child Health and Human Reproduction, Ulaanbaatar Myanmar Department of Medical Research, Ministry of Health, Yangon Sri Lanka National Coordination Committee for Research on Reproductive Health, Colombo Viet Nam Hung Vuong Hospital, Ho Chi Minh City Resource Maintenance Grants (RMGs) China National Coordinating Board India All India Institute of Medical Sciences, New Delhi Table 7.6. Type of grants and names of country/recipient centres in 2002 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 190 A n n u al Tech n ical R ep ort 2002 The WHO Regions of South-East Asia and the Western Pacific 191 cation rates with vaginal deliveries compared to elective and emergency caesarean sections. In addition, aver- age costs incurred by patients for the three procedures as well as predictors for elective and emergency caesar- ean sections for patients, obstetricians and hospitals will be estimated. Owing to a number of local constraints, five centres experienced delays in completing the first year of the study and data collection had to be extended until the end of 2002. •• The regional research initiative on adolescent migrants and reproductive health in the Greater Mekong region is a four-country joint research programme with centres in China, Lao People’s Democratic Republic, Thailand and Viet Nam. This study, which began in early 2000, targeted adolescent migrant populations, members of which were interviewed in 2002 as to their motivation for migration, their knowledge and perceptions of reproduc- tive health and their access to reproductive health ser- vices. Analysis of the results will be undertaken in 2003. COOPERATION WITH REGIONAL OFFICES Collaboration between the Department and WPRO has allowed implementation of a number of projects and work- shops: •• A programme funded by the United Nations Population Fund (UNFPA) and executed by WHO regarding the Medical eligibility criteria for contraception for the 10 Pacific Island Countries took the form of a workshop in Fiji in 2002. The Governments of these nations as well as China and Indonesia requested additional training in the domains of vasectomy and intrauterine device (IUD) and Norplant insertion. WPRO will have carried out the relevant training by December 2002. •• The WHO document, Managing complications of preg- nancy and childbirth: a guide for midwives and doctors has been translated into the languages of all six priority countries in the region: Cambodia, China, Lao People’s Democratic Republic, Mongolia, Papua New Guinea, Philippines and Viet Nam. The manual is also being inte- grated into medical internship and residency programmes in the Philippines. WPRO’s Reproductive Health Unit and the United Nations Children’s Fund (UNICEF) will con- duct workshops for the adaptation of the manual for the Philippines. •• Emergency obstetric care training was given to 36 participants from Cambodia, Lao People’s Democratic Republic and Mongolia at the Philippines General Hos- pital, Manila, Philippines. •• Field-testing and pilot study of the Pregnancy, childbirth and newborn care: a guide for essential care will be conducted at the Fabella Hospital, a WHO collaborating centre in Manila, Philippines. Country/recipient Type of workshop China—National Research Council • National conference on the collaboration between China and the Department • Development and utilisation of norms, tools and guidelines • 4th International symposium on reproductive endocrinology India—All India Institute of Medical Sciences • Safe abortion practices • Practical training in reproductive health research methods Indonesia—Western Indonesian Reproductive Health Development Centre High-risk pregnancy management for midwives Indonesia—Reproductive Health Research Centre Primary and secondary care of infertility in Indonesia Lao PDR—Maternal and Child Health Centre Clinical research Mongolia—State Research Centre on Mother and Child Health and Human Reproduction Preparation of research proposals and data management Viet Nam—Hung Vuong Hospital Intervention studies Table 7.7. Type of workshops and names of recipient centres in 2001–2002 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 190 A n n u al Tech n ical R ep ort 2002 The WHO Regions of South-East Asia and the Western Pacific 191 •• A workshop for the Making Pregnancy Safer initiative was conducted in Beijing, China, in December 2002, which included presentations of China’s associated sur- veillance system and software for maternal deaths, and of the experiences in Cambodia and China with maternal death audits. •• WPRO and the World Bank are evaluating the Safe Motherhood Project 1, and preparing for Project 2 in the Philippines. • WPRO has released a national plan of action on safe motherhood for six priority countries for 2001–2005, namely Cambodia, China, Lao People’s Democratic Republic, Mongolia, the Philippines and Viet Nam. PROPOSED ACTIVITIES FOR 2003 RAP has recommended the following activities for the Regions of South-East Asia and the Western Pacific for the year 2003: •• WPRO will conduct a six-country study on the determi- nants of spontaneous and unsafe abortion. The initial protocol for this study has been prepared and will be submitted to the usual review process in the Depart- ment. •• A regional conference for policy-makers, research lead- ers and users of research findings will be held in con- junction with the 7th RAP meeting in Bangkok, Thailand, in October 2003. The conference will highlight capacity strengthening and setting research priorities for repro- ductive health services in the region. •• A regional workshop will be organized on adolescent reproductive health. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 192 A n n u al Tech n ical R ep ort 2002 The WHO Regions of South-East Asia and the Western Pacific 193 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 7 88 1 12 8 Women 5 63 5 from: AFRO AMRO EMRO EURO SEARO 5 63 5 WPRO 2 25 1 12 3 Annex 1 REGIONAL ADVISORY PANEL FOR ASIA AND PACIFIC IN 2002 Members Victor Goh, Department of Obstetrics and Gynaecology, National University of Singapore, Singapore (Chairman) Sri Hatmadji, Demographic Institute, Faculty of Economics, University of Indonesia, Jakarta, Indonesia John Hearn, Research School of Biological Sciences, Australian National University, Canberra, Australia Nasreen Huq, Naripokkho, Dhaka, Bangladesh Matthews Mathai, Christian Medical College Hospital, Vellore, Chennai, India Than Than Tin, Central Women’s Hospital, Yangon, Myanmar Bencha Yoddymnern-Attig, Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand Zheng Xiao Ying, Institute of Population Research, WHO Collaborating Centre for Reproductive Health and Population Science, Peking University, Beijing, China Temporary advisers Harun Ar-Rashid, Bangladesh Medical Research Council, Mohakhali, Dhaka, Bangladesh Diana Galwaduge, Office of the Provincial Director of Health Services, Sangaraja Mawatha, Kandy, Sri Lanka Maimunah Hamid, Public Health Institute, Ministry of Health, Jalan Bangsar, Kuala Lumpur, Malaysia Sea-Baick Lee, Planned Parenthood Federation of Korea, Yeongdeungpo, Seoul, Republic of Korea A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 192 A n n u al Tech n ical R ep ort 2002 The WHO Regions of South-East Asia and the Western Pacific 193 Annex 2 HEADS OF CENTRES FOR ASIA AND PACIFIC IN 2002 Chen Hailin, National Evaluation Centre for the Toxicology of Fertility Regulating Drugs, Shanghai, China Virasakdi Chongsuvivatwong, Prince of Songkla University, Hat Yai, Thailand Nguyen Duc Vy, Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam Gao Ersheng, Shanghai Institute of Planned Parenthood Research, Shanghai, China Ge Qin-Sheng, Peking Union Medical College, Beijing, China Gu Zhongwei, National Research Institute for Family Planning, Beijing, China Hou Qingchang, Tianjin Municipal Research Institute for Family Planning, China Liu Xiaozhang, Family Planning Research Institute of Sichuan, Chengdu, China Delfi Lutan, University of North Sumatra, Medan, Indonesia Suneeta Mittal, All India Institute of Medical Sciences, New Delhi, India Piya Netrawichien, Chiang Mai University, Chiang Mai, Thailand Chander Puri, National Institute for Research in Reproductive Health, Mumbai, India Janchiv Radnaabazar, State Research Centre on Mother and Child Health and Human Reproduction, Ulaanbaatar, Mongolia Bouavanh Senesathith, Maternal and Child Health Institute, Ministry of Public Health, Vientiane, Lao People’s Democratic Republic Harshalal Seneviratne, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka Soe Thein, Ministry of Health, Yangon, Myanmar Nguyen Thi Thuy, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam Yang Hua, Family Planning Research Institute of Zhejiang, Hangzhou, China Zheng Xiaoying, Institute of Population Research, Peking University, Beijing, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 19 100 19 Women 8 42 8 from: AFRO AMRO EMRO EURO SEARO 7 37 7 WPRO 12 63 12 A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 194 A n n u al Tech n ical R ep ort 2002 Central and Eastern Europe, including the Newly Independent States and Central Asian Republics 195 Central and Eastern Europe, including the Newly Independent States and Central Asian Republics A. Ntabona INTRODUCTION According to recent estimates, women and men in most countries in the WHO European Region enjoy relatively low reproductive health risks. However, there are striking disparities between the market economies of the west and the transitional economies of the east. Some of the common features of countries of Central and Eastern Europe (CCEE) and Newly Independent States (NIS) are: (i) relatively high numbers of births for teenage girls; (ii) a large number of repeat abortions; (iii) reliance on ineffective methods of con- traception; (iv) levels of maternal deaths five times higher than in western Europe despite a universal coverage of care during pregnancy and childbirth; and (v) a potential explo- sion of the HIV epidemic as a result of growing numbers of sexually transmitted infections, injectable drugs use and prostitution. There is a growing concern about the overall decline in population growth owing to very low birth rates and the declining life expectancy in the east. Most countries have undertaken policy reforms aimed at improving the respon- siveness and stewardship of the health systems but the effects of these measures on the effectiveness and quality of reproductive health services are still being studied. OBJECTIVES The main objectives of the Department in the European Region are: •• to strengthen national capacity in reproductive health research, with a particular focus on providing training opportunities for CCEE, NIS and Central Asian Repub- lics (CAR); •• to assist the WHO Regional Office for Europe (EURO) in providing technical support to countries to implement their programmes in reproductive health. In this regard, the major steps taken by the Department since the early 1990s include: (i) the launching of the East- West European Initiative aimed at assessing the research and service needs and identifying priorities for collaborative research and research training in reproductive health; (ii) the coordination of research and research training activities through the establishment of the WHO Scientific Working Group (1994); and (iii) the formal establishment of a Regional Advisory Panel (RAP) for the European Region in 2001. PROGRESS Second meeting of the Regional Advisory Panel for Europe, 29–30 May 2002, Netherlands School of Public Health (NSPH), Utrecht, Netherlands The deliberations at this second meeting of the European RAP revolved around three major issues: (i) research and research capacity building in the region; (ii) input of RAP to the regional reproductive health programme; and (iii) other emerging issues of relevance to reproductive health in the region. As regards the regional priorities identified at the first meeting, RAP reiterated the need to bridge the gap between researchers and policy-makers, to develop models for col- laboration, and to strengthen WHO’s role in the collection of evidence and reliable data on reproductive health in the European Region, including evidence on the links between reproductive health and poverty. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 194 A n n u al Tech n ical R ep ort 2002 Central and Eastern Europe, including the Newly Independent States and Central Asian Republics 195 Research development and research training RAP was briefed on the outcome of the first operations research training course held in Romania. RAP decided that proposals prepared as part of research training will continue to be reviewed by RAP and processed through the Depart- ment’s review and implementation procedures, as part of the ongoing efforts for operations research capacity strengthen- ing in all regions. Out of seven proposals emanating from the first course, three focusing on the introduction of evidence- based medicine and best practices in the Czech Republic, the Russian Federation and Ukraine were approved with amendments and recommended to the Department for funding. RAP further recommended that the collaboration between the Department, EURO and the FRONTIERS Project should continue in order to develop and implement operations research in countries. Programmatic issues The WHO European Regional Strategy on Sexual and Reproductive Health had already been reviewed by RAP and was ready for publication, dissemination to Member States, professional bodies and nongovernmental organizations (NGOs). Actions recommended for the implementation of the strategy include, among others: (i) defining mechanisms for country adaptation of the strategy through multidisciplinary steering groups; and (ii) continued WHO support to national authorities for training or reorienting all stakeholders on the content of the strategy and mobilizing resources for its imple- mentation. Activities for the implementation of selected regional priori- ties are ongoing, as described below: Making Pregnancy Safer Continued technical support was provided for country adop- tion and adaptation of WHO evidence-based policies and standards for maternal and newborn care. Clinical guidelines on evidence-based medicine and appropriate use of tech- nologies were issued, targeting specific categories of health care providers and were used in Kazakhstan, Republic of Moldova, Turkmenistan, and Uzbekistan. There are also ongoing efforts to build links between the Making Pregnancy Safer initiative and relevant regional programmes in EURO: reproductive health, HIV/MTCT/STI, health systems, and rational drug use. Adolescent sexual and reproductive health Major achievements in this area included: (i) the develop- ment of an interagency1 framework for designing or expand- ing youth-friendly services in Europe and Central Asia; (ii) the publication of the guidelines on Counselling skills training in adolescent sexuality and reproductive health: a facilitator’s guide, jointly with the Department of Child and Adolescent Health and Development at WHO Headquarters and the NGO “EuTEACH” (European Training in Effective Adolescent Care and Health); and (iii) the establishment of a collaborative teaching programme on adolescent health at the Multidisciplinary Unit for Adolescent Health at the Lau- sanne University Medical Centre, Lausanne, Switzerland. Possibilities are being explored for collaborative work with the International Planned Parenthood Federation (IPPF) for providing adolescent sexual and reproductive health educa- tion in vocational schools in the same way as in secondary schools and for developing information, education and com- munication (IEC) materials for out-of-school adolescents. Gender and reproductive health EURO has prepared a Strategic Plan for Health of Women in Europe aimed at assisting governments to achieve gender equity in health and health care. Efforts are ongoing for mainstreaming gender equity in health as an advocacy tool as well as a political and technical process to guide the nec- essary changes in organizational cultures, setting goals and structures as well as allocating resources. Training in reproductive health There is a need to undertake an inventory of training insti- tutions that offer courses on reproductive health in the European Region. Some of these courses are specifically targeted to the developing countries but could be adapted to the needs of CCEE, NIS and CAR. The post-graduate course for training in reproductive medicine and reproductive biol- ogy being offered at the University of Geneva, Switzerland, since 1991, is a case in point. Regional research initiatives The Department and EURO provided support to a retrospec- tive study that is reviewing some examples of interventions that had an influence on the reduction of maternal mortality in Europe, such as legislative and policy actions (Finland, France, Portugal, Romania); society and community actions (Republic of Moldova); actions within the health sector (Hun- gary, Poland, United Kingdom) and actions from, or in col- laboration with, other sectors such as finance and the private sector. The report on this study will be available in 2003. 1 Agencies involved include WHO, the United Nations Children’s Fund (UNICEF), the United Nations Population Fund (UNFPA), the United Nations Development Programme (UNDP), the United Nations Drug Control Programme (UNDCP) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 196 A n n u al Tech n ical R ep ort 2002 Central and Eastern Europe, including the Newly Independent States and Central Asian Republics 197 Capacity building in operations research in CCEE, NIS & CAR This is a collaborative initiative between the Department and the FRONTIERS Project aimed at providing continued sup- port to investigators throughout all the steps up to the report- ing and dissemination of findings, with the emphasis being on bringing research into reproductive health programme management. The second course to be held in April 2003 at the Kazakhstan School of Public Health, Almaty, Kaza- khstan, will be run in Russian. PLANNED ACTIVITIES FOR 2003 Research development Two proposals recommended by RAP for funding, focusing on maternal and perinatal health, are being reviewed with a view to initiation in 2003. The review and clearance proc- ess for projects that emerge from the second operations research course will present an added challenge because of the language barrier. Research training At least 14 participants, two from each of seven countries, are expected to attend the second operations research course in Kazakhstan. These will include one scientist with a track record in research and one programme manager from central or district level. The course will be facilitated by three Russian-speaking alumni from the first course, with technical support from the Department and the FRONTIERS Project. Annual meeting of RAP The Department, in collaboration with EURO, plans to hold the third meeting of RAP in Estonia, in August 2003. Postgraduate course for training in reproductive medicine and reproductive biology, University of Geneva, Switzerland Support to this course will continue in 2003. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 196 A n n u al Tech n ical R ep ort 2002 Central and Eastern Europe, including the Newly Independent States and Central Asian Republics 197 Annex 1 REGIONAL ADVISORY PANEL FOR THE EUROPEAN REGION IN 2002 Members Ayse Akin, Hacettepe University, Sihhiye-Ankara, Turkey Elena Baibariana, Russian Academy of Medical Science, Moscow, Russian Federation Mihai Horga, Ministry of Health, Bucharest, Romania Helle Karro, University of Tartu, Estonia (Chairperson) Evert Ketting, Netherlands School of Public Health, Utrecht, Netherlands Gunta Lazdane, Family Planning Association, Riga, Latvia Alfred Merkle, Deutsche Gesellshaft für Technische Zusammenarbeit (GTZ), Eschborn, Germany Saule Nukusheva, School of Public Health, Almaty, Kazakhstan Petr Velebil, Research Institute for Maternal Health, Czech Republic Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 7 78 2 22 9 Women 5 55 5 from: AFRO AMRO EMRO EURO 7 78 2 22 9 SEARO WPRO A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 198 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 199 Policy and programmatic issues P. Fajans, M.A. Broderick1 INTRODUCTION The Department’s objectives in this area are to review, develop and test methodologies for the planning and imple- mentation of reproductive health services and to assist coun- tries in the strengthening of their reproductive health policies and programmes. Central to this work is the testing, refine- ment and promotion of the Strategic Approach. Although originally developed to address contraceptive introduction, the methodology has been adapted to assist countries in strategic planning on a range of reproductive health policy and programmatic issues. The Strategic Approach has three stages. Stage I is a strategic assessment of: (i) the needs and per- spectives of current and potential users; (ii) the extent of coverage, quality of care and capacity of the service delivery system; and (iii) the mix of technologies and other reproduc- tive health interventions. The assessments use a qualitative methodology and a field-based, participatory approach, involving programme managers, service providers, research- ers, and others with an interest in improving reproductive health, including women’s and youth organizations and other nongovernmental organizations (NGOs). A variety of recommendations for policy and programme development emerge from such a strategic assessment. Stage II is a means of testing, on a limited scale, the recom- mendations for policy change or other interventions to improve access, utilization and quality of care in service delivery. The purpose of Stage III is to disseminate and apply the find- ings from the Stage II action research for policy development and planning for wider implementation. MAIN AREAS OF WORK The main areas of work during 2002 included the dis- semination of, and support for, the utilization of the Strategic Approach by countries; the adaptation of the Stra- tegic Approach to other areas of reproductive health; and an increased focus on replication and scaling up of activities. With regard to application of the Strategic Approach to contraceptive introduction, sufficient experience has been gained in the assessment and Stage II testing of interven- tions. Efforts are therefore focusing on the dissemination and promotion of use of the Strategic Approach by others, as well as the testing and synthesizing of lessons learnt in the Stage III scaling-up process. A second area of activity is the adapta- tion and testing of the application of the methodology to other specific areas of reproductive health, such as reproductive tract infections, including HIV/AIDS, maternal and newborn health, adolescent sexual and reproductive health, abortion, and cervical cancer. The methodology is also being used to address simultaneously a broad range of issues in conduct- ing comprehensive reproductive health strategic assess- ments, with an emphasis on increasing access and utilization of services by the poor and other marginalized groups. Dissemination, advocacy and capacity building During 2002, a field guide was published entitled Making decisions about contraceptive introduction: a guide for con- ducting assessments to broaden contraceptive choice and improve quality of care. In addition, a document was pub- lished providing a summary of the framework and methodol- ogy of the approach, as well as summaries of experience with its implementation in 18 countries. 1 Deceased September 2002. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 198 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 199 Regional workshops to advocate for utilization of the Strate- gic Approach and to train national experts in implementation of strategic assessments were conducted, in collaboration with regional partners, including the International Council for the Management of Population Programmes (ICOMP) and the Population Council, Nairobi, Kenya. One workshop was held in Kunming, China, and included country teams from Cambodia, China, India, Mongolia, Pakistan, and Papua New Guinea. Another workshop held in Kenya included teams from Ghana, Kenya, Malawi, Nigeria, Uganda and United Republic of Tanzania. Participants in both workshops included senior country policy-makers and programme man- agers and representatives from NGOs and women’s groups, as well as from the WHO Regional Offices, and Country Sup- Figure 7.3. Countries implementing the Strategic Approach (supported by the Department and by other partners) A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 200 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 201 port Teams of the United Nations Population Fund (UNFPA). Facilitators included individuals who had participated in Strategic Approach activities in other countries in the region. A number of these country teams have initiated planning for future implementation of strategic assessments to address priority issues in their countries. As in previous years, country experiences with implemen- tation of the Strategic Approach have continued to be dis- seminated through presentations made at national and international conferences and workshops. Adaptation of the Strategic Approach Work is continuing on the adaptation of the Strategic Approach to address other reproductive health issues. The Department has continued working with the Population Council’s Horizons Project on the Programme Guidance Tool, an adaptation of the Strategic Approach to address policy and programme development related to reproduc- tive tract infections (see the chapter on Controlling sexually transmitted and reproductive tract infections). In 2002, plan- ning for a Strategic Assessment of issues related to abortion began in Mongolia, while dissemination workshops were implemented following an assessment related to abortion and contraception in Romania, and one focusing on both maternal health and family planning in Guatemala. Planning for strategic assessments addressing maternal and newborn health has begun in Nigeria, Paraguay and Uganda, while Cuba and Nigeria also intend to use the approach to develop strategies to address adolescent sexual and reproductive health needs. The Strategic Approach continues to be adapted by other partners as well. For example, EngenderHealth assisted Bolivia to use the methodology to address issues related to cervical cancer screening and treatment, while the Popula- tion Council, Brazil, supported an assessment of HIV preven- tion in six border regions of Brazil. There is a growing recognition of the need for a methodology and tools to assist countries in strategic planning and pro- gramming for comprehensive reproductive health services. In the past, strategic assessments that addressed a broader range of reproductive health concerns had been conducted in Ethiopia, Myanmar, and the Lao People’s Democratic Republic. During 2002, ICOMP, in collaboration with the Population Council, Bangkok, Thailand, and the Department tested further modifications of the methodology in conducting a comprehensive reproductive health assessment focusing on access and utilization of services by the poor in Yunnan, China and began working with partners in Rajastan, India, to plan a strategic reproductive health assessment to be con- ducted in early 2003. Stage III: replication and scaling-up A conference, entitled “From Pilot Projects to Policies and Programmes: Strategies for Scaling Up Innovations in Health Service Delivery”, is being planned for April 2003 to examine and synthesize knowledge about how to enhance scaling-up of service delivery research for broader policy and programme development. The conference will provide input into the development of a practical guide for policy-makers, programme managers, researchers, technical experts and donors intended to help facilitate the scaling-up of pilot projects and other service innovations. COUNTRY EXPERIENCES IN 2002 Ongoing activities in Africa Ethiopia The first of several Stage II activities has been the develop- ment of a project to investigate strategies to expand access to coitally dependent methods of contraception and dual protection for youth. The two-year project is being imple- mented by the Family Guidance Association of Ethiopia, and responds to findings from the assessment that sexually active youth were not interested in using routine contracep- tives, but desired coitally dependent methods. The study is using the introduction of the female condom and emergency contraception, and the reintroduction of the male condom and vaginal foaming tablets, as a means of enhancing the overall quality of youth-centred services. The project is strengthening providers’ and peer educators’ knowledge of all contraceptive methods, increasing youths’ knowledge of family planning and STI prevention options and emphasiz- ing dual protection. The study is funded by the United States Agency for International Development (USAID), with tech- nical support provided by the Population Council and the Department. Zambia A Stage II study tested interventions to enhance contracep- tive choice and quality of care in Zambia in 11 rural health centres, located in three districts in the rural Copperbelt region. The project introduced injectable contraceptives and emergency contraception, as well as offered training for pro- viders in the provision of all available contraceptive methods and in the syndromic management of STIs. This was sup- ported by the development of provider self-training manuals, and newsletters to share management interventions and suc- cessful innovations among participating districts and health centres. An end of project evaluation showed that providers in project sites had better technical skills and provided more information to clients, resulting in a doubling of the number of new acceptors each month and a broadening of the method mix in the intervention health centres, as compared to base- line and to control sites. During 2002, a Stage III project to replicate the strategy and the lessons learnt in all health centres in the Copperbelt region districts commenced with funding from USAID and WHO and technical support from the Population Council, A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 200 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 201 Nairobi, and the Secretariat. The project uses innovative strategies to scaling-up that support the development of districts’ capacities to formulate individual implementation plans for introducing a common package of interventions, while maximizing economies of scale and the use of local expertise so as to develop sustainable programmes. Ongoing activities in Asia China In 2001, the Department supported the implementation of a strategic assessment in Chongqing, China, that addressed the issue of contraceptive introduction, with an emphasis on intrauterine device (IUD) technologies available in the national family planning programme. Numerous important findings and recommendations emerged, including the need to: (i) strengthen providers’ capacity to provide all contracep- tive methods with improved quality of care; (ii) reduce the number of types of IUDs provided in the national programme and improve aspects of care related to both insertion and removal; (iii) strengthen the diagnosis and management of RTIs in the context of family planning health services; and (iv) review a number of the contraceptive products available with regard to either the quality of their manufacture and/or their long-term safety. The report of the assessment was published in Chinese and English and disseminated widely, and a summary of the report was published in the Chinese Journal of Family Planning. Follow-up activities began in 2002 with a system- atic review on the safety and efficacy of IUDs and hormonal contraceptive methods provided through the national family planning programme, with the goal of selecting a reduced number of the safest and most effective products. A proposal for a Stage II project to test a package of interventions rec- ommended by the assessment to improve informed choice and quality of care has been developed and is undergoing review and refinement, prior to implementation in 2003. In late 2002, the Yunnan Reproductive Health Research Association led a team representing a broad range of provincial level stakeholders in the implementation of an assessment in Yunnan Province that addressed a range of reproductive health issues. The focus was on strategies to improve access, utilization and quality of services for poor and marginalized groups, including ethnic minorities and urban migrants. The findings and recommendations of the assessment team will be presented and discussed at a dissemination workshop in early 2003 and are expected to provide important input to both provincial and national authorities who are facing challenges from the unexpected impacts of recent health reforms on access to and utilization of reproductive health services by the poor. Myanmar A Stage II research project is developing and testing a dis- trict-level model for improving the quality of care of family planning and other reproductive health services. Project activities include: the development of new information, edu- cation and communication (IEC) materials and activities; training for public sector basic health staff, private general practitioners, private drug shop staff, and district and com- munity level members of a national NGO, the Myanmar Maternal and Child Welfare Association (MCWA); a com- munity advocacy component; and efforts to strengthen the management capabilities of district-level and health centre staff related to planning, supervision and logistics. The project is being implemented in two districts with differing geographic conditions, ethnic composition and reproductive health needs. In late 2001, a mid-project evaluation was conducted, result- ing in revisions to project training materials. During 2002, refresher training was provided to health staff in the public and private sectors, including drug shop and pharmacy staff in the project districts. In addition, the provider training cur- ricula developed by the project were utilized by the Ministry of Health in training health staff in an additional 84 districts through the UNFPA country programme. The Myanmar Medi- cal Association provided training to private general practition- ers in 25 additional districts. The IEC materials developed by the project are also being adopted by the Ministry of Health and UNFPA for use in their project districts. Viet Nam A Stage II study assisted the Government of Viet Nam in developing a strategy for introducing the injectable contra- ceptive depot-medroxyprogesterone acetate (DMPA), while at the same time strengthening the quality of family plan- ning and reproductive health service delivery generally. This project developed training curricula for providers, improved family planning IEC materials, and trained providers and community level workers. The emphasis was on counselling and provision of balanced information, in addition to techni- cal information on all available contraceptive methods. The project also developed approaches to strengthening man- agement of services, including the use of supervision tools. A Stage III project to replicate and scale-up the interventions tested initially in three provinces came to an end in 2002. The introduction of DMPA was initially implemented in 21 prov- inces where government or donor support for strengthening health service delivery was already available, but by the end of the project, introductory activities had expanded with gov- ernment support to all but one of the nearly 60 provinces of Viet Nam. As in Stage II, the Stage III project was undertaken as a collaborative effort between the Ministry of Health, the National Committee for Population and Family Planning and the Viet Nam Women’s Union. It was jointly funded, primarily by the German Gesellschaft für Technische Zusammenarbeit A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 202 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 203 (GTZ) and UNFPA, with the Department providing technical support through ICOMP. The Ministry of Health has also begun implementing a project to follow-up the recommendations of a second strate- gic assessment which focused on issues related to reducing the recourse to abortion and improving of quality of care. This project is described in the chapter on Preventing unsafe abortion. Ongoing activities in eastern Europe Romania Activities in this country focused on reducing the recourse to abortion and improving the quality of care of family planning and abortion services. They are described in the chapter on Preventing unsafe abortion. Ongoing activities in Latin America Bolivia A Stage II study attempted to strengthen family planning and related reproductive health service delivery while introduc- ing DMPA, in the Departments of La Paz and Santa Cruz. Interventions focused on provider training, strengthening the management of services, and the development of commu- nity participation in guiding service delivery. Lessons learnt and materials developed through the project are now being used by the Ministry of Health in the broader introduction of DMPA, supported by the United Kingdom Department for International Development (DFID), with tech- nical assistance provided by the Population Council, Brazil. In a related activity, the NGO Reprolatina, with funding from the Bill and Melinda Gates Foundation, is assisting the Min- istry of Health in developing training capacities in the Depart- ment of Santa Cruz to support expansion and scaling-up of project activities focusing on improving quality of care. During 2002, the Ministry of Health received support from EngenderHealth, the Pan American Health Organization (PAHO) and Reprolatina to conduct a strategic assess- ment of cervical cancer screening and treatment services in Bolivia. The draft report presented a broad range of recom- mendations to strengthen access to effective and efficient services, and identified the need for several critical studies to support improving the quality of care in these services. Follow-up activities are currently being planned. Brazil The Brazil Stage II project had demonstrated that expan- sion of reproductive choice can occur at the municipal or district level within existing resource constraints. The Stage III project tested the replicability of activities in four additional municipalities. Efforts to expand and replicate activities and approaches in twelve additional municipalities in the north and south of the country are continuing through the Reprola- tina Project, an activity funded by the Bill and Melinda Gates Foundation through the NGO Reprolatina, the University of Michigan and the Population Council. In addition, the Stra- tegic Approach is being utilized by the Ministry of Health to address HIV prevention and the development of STI control activities, as mentioned earlier. Guatemala The Ministry of Public Health and Social Welfare of Guate- mala collaborated with the Department to implement a stra- tegic assessment in late 2001 to identify priority interventions that would improve access and quality of family planning and maternal health services, with emphasis on emergency obstetric care. Key findings and recommendations from the assessment were presented in a national dissemination workshop in 2002. A proposal for action research to test interventions to improve access to and quality of family planning and other reproductive health services was developed, reviewed and is currently being revised. EXTERNAL QUALITY ASSESSMENTS OF REPRODUCTIVE HEALTH SERVICES During late 2001, the Department began work on a review of the potential role of External Quality Assessments (EQAs) as a means of improving and ensuring the quality of care of reproductive health services. A consultant completed a review of the literature on the utilization of external and/or independent assessment processes for quality improvement, including accreditation, of reproductive health services. Twelve case studies of reproductive health services which had undergone an EQA process using explicit standards and indicators were subsequently undertaken to offer insight into the use and impact of EQAs from the perspectives of service providers, clients and stakeholders. A consultation was held in September 2002 with representatives from the case study sites and other experts in the field to discuss the lessons learnt. The final report will be completed in early 2003. The work represents the first efforts of the Department in this area, and will contribute to ongoing activities to assist countries to improve the quality of reproductive health serv- ice delivery. It is also expected to be of value in efforts to advise ministries of health in setting and ensuring norms and standards, including in the context of health reforms such as decentralization, where a key role of ministries lies in moni- toring and supporting adherence to standards and improving the quality of services. The Department will continue to work closely with WHO’s Department of Health Service Provision to gain further understanding and experience in this area and to support a range of effective processes and tools for improving quality of care. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 202 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 203 UNFPA/WHO/ILO-STEP/UNICEF PROJECT ON QUALITY OF CARE The Department has continued to play a role as a partner in the UNFPA/WHO/ILO-STEP/UNICEF project “Improving the quality of sexual and reproductive health care through empowering users”. The project addresses the question of whether the organization of community demand can influ- ence the quality of reproductive health care and, if so, what mechanisms can be used to effectively increase the capacity of communities to influence the way reproductive health care is delivered? The project is being undertaken in six countries: India, Kyr- gyzstan, Mauritania, Nepal, Peru and United Republic of Tanzania. In each country, action research projects are being planned to examine the impact of different approaches, including empowerment of women’s groups and develop- ment of community insurance schemes, on strengthening demand for high-quality reproductive health services. In addition, through the project, WHO will assist the Nepa- lese Ministry of Health to conduct a national reproductive health strategic assessment to provide input to the proc- ess of national reproductive health policy and programme development. THE IMPACT OF HEALTH REFORMS ON REPRODUCTIVE HEALTH In recent years, governments and international donors have designed and implemented major reforms in health systems. These health reforms have been promoted as means of improving effectiveness, efficiency, quality, equity, and financial soundness. Reforms have typically involved significant changes in the financing, payments, organiza- tion, and regulation of health systems. These broad system changes are likely to have important influences on sexual and reproductive health programmes and pose challenges to the development of interventions to promote and ensure reproductive health. There is a need to understand better the impacts of the various types of health reforms on access to, utilization of, and quality of reproductive health services, as well as on reproductive health outcomes and on the sexual and reproductive rights of individuals. This increased under- standing is a critical first step toward increasing the capacity of WHO and others to provide guidance to countries under- taking reforms of their health systems. A three-year research initiative to examine the interaction between health reforms and reproductive health was developed to begin implemen- tation in 2003. In the meantime, staff of the Department have been collabo- rating with the Women’s Health Project of the University of the Witwatersrand, South Africa, on a project entitled “Sexual rights and reforms”. The project is bringing together mem- bers of women’s health NGOs from Africa, Asia and Latin America. It aims to strengthen understanding among activ- ists and decision-makers of the role of health sector reform in facilitating or undermining efforts to achieve sexual and reproductive rights and health policies and programmes, as well as to identify and advocate for strategies to maximise positive outcomes with regard to sexual and reproductive health and services. The project is beginning by developing regional and global reviews of the literature and experiences on a series of key issues concerning the impact of health reforms on sexual and reproductive health and rights. The reviews will be presented and discussed at an expert consul- tation, with the objective of identifying knowledge gaps and developing an agenda for research and advocacy on these issues. POVERTY AND REPRODUCTIVE HEALTH The Department has begun to develop work documenting the relationships between poverty and reproductive health. Initial activities have focused on efforts to document the relationships between poverty and maternal and neonatal health and are described more fully in the chapter on Making pregnancy safer: implementation of evidence-based pro- grammes. A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 204 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 205 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 8 89 1 11 9 Women 3 33 3 from: AFRO 1 11 1 AMRO 1 11 1 EMRO EURO 1 11 1 SEARO 2 22 2 WPRO 4 45 4 Annex 1 SCIENTISTS IN 2002 Principal investigators Ayo Ajayi, The Population Council, Nairobi, Kenya Fang Ke-juan, Shanghai Institute of Planned Parenthood Research, Shanghai, China Philip Guest, The Population Council, Bangkok, Thailand Mihai Horga, Ministry of Health, Bucharest, Romania Thein Thein Htay, Department of Health, Yangon, Myanmar Edgar Kestler, Epidemiological Research Centre in Sexual and Reproductive Health, Guatemala City, Guatemala Liu Wei, Institute for Health Sciences, Kunming, China Jay Satia, International Council on Management of Population Programmes, Kuala Lumpur, Malaysia Kopkeo Souphanthong, Maternal and Child Institute, Vientiane, Lao People’s Democratic Republic Other scientists Catalin Andrei, Health Services Management Institute, Bucharest, Romania Katherine Ba-Thike, UNFPA Country Support Team, Bangkok, Thailand Tracy Baird, Ipas, Carrboro, NC, USA Karen Beattie, EngenderHealth, New York, NY, USA Radu Belloiu, National College of Physicians, Bucharest, Romania Cosmina Blaj, East European Institute of Reproductive Health, Targu-Mures, Romania Thomas Bossert, Harvard School of Public Health, Boston, MA, USA Marc Bygdeman, Karolinska Hospital, Stockholm, Sweden Francisco Cabral de Oliveira, CEMICAMP, Campinas, Brazil Miriam Cardona, President’s Office for Women, Guatemala Maria Dolores Castro, La Paz, Bolivia Marta Chajal, APROFAM, Guatemala Carlos Cipriani, Epidemiological Research Centre in Sexual and Reproductive Health, Guatemala City, Guatemala Ionela Cozos, East European Institute of Reproductive Health, Targu-Mures, Romania Dalila de la Cruz, APROFAM, Guatemala Margarita Diaz, Reprolatina, Campinas, Brazil Kim Dickson, Reproductive Health Research Unit, Johannesburg, South Africa Trinh Dinh Can, National Committee for Population and Family Planning, Hanoi, Viet Nam Nguyen Dinh Loan, Ministry of Health (MCH/FP), Hanoi, Viet Nam Daniela Draghici, NGO Coalition for Reproductive Health, Bucharest, Romania Monica Dunarintu, Marie Stopes Foundation, Bucharest, Romania Ilana Dzuba, EngenderHealth, New York, NY, USA Christopher Elias, Program for Appropriate Technology in Health, Seattle, WA, USA Constantin Enciulescu, East European Institute of Reproductive Health, Targu-Mures, Romania Rodica Fagarasan, East European Institute of Reproductive Health, Targu-Mures, Romania A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 204 A n n u al Tech n ical R ep ort 2002 Policy and programmatic issues 205 Michelle Gardner, The Population Council, Yangon, Myanmar Peter Hall, Reproductive Health Alliance, London, United Kingdom Sarah Hawkes, New Haven, CT, USA Suelen Hew, International Council on Management of Population Programmes, Kuala Lumpur, Malaysia Virginia Ionescu, Marie Stopes Foundation, Bucharest, Romania Ronnie Johnson, Ipas, Chapel Hill, NC, USA Borbala Koo, Society for Education on Contraception and Sexuality, Bucharest, Romania Dan Aurelian Lazarescu, National College of Physicians, Bucharest, Romania Gunta Lazdane, Medical Academy of Latvia, Riga, Latvia Luminita Marcu, Institute for Mother and Child Care, Bucharest, Romania Miguel Marroqin, Ministry of Public Health and Social Welfare, Guatemala City, Guatemala Olav Meirik, Santiago, Chile Zhang Minghua, Division of Science Research, State Family Planning Commission, China Jorge Monroy, Guatemalan Association of Sexual Education, Guatemala Theing Myint, Department of Health, Yangon, Myanmar Nancy Newton, Takoma Park, MD, USA Doina Ocnaru, National Health Insurance House, Bucharest, Romania Lidia Ortiz, President’s Office for Women, Guatemala Mihaela Poenariu, East European Institute of Reproductive Health, Targu-Mures, Romania Christian Posea, Romanian Society of Obstetrics and Gynaecology, Bucharest, Romania Silviu Predoi, Ministry of Health and Family, Ministry of Health and Family, Bucharest, Romania Florina Prundaru, East European Institute of Reproductive Health, Targu-Mures, Romania Lilian Ramirez, Epidemiological Research Centre in Sexual and Reproductive Health, Guatemala City, Guatemala Claudia Rosales, Guatemalan Association of Sexual Education, Guatemala City, Guatemala Patrick Rowe, Vesancy, France Lia Rugan, NGO Coalition for Reproductive Health, Bucharest, Romania Entela Shehu, Ipas, Bucharest, Romania Ruth Simmons, University of Michigan, Ann Arbor, MI, USA John Skibiak, The Population Council, Nairobi, Kenya Bela Szabo, East European Institute of Reproductive Health, Targu-Mures, Romania Placide Tapsoba, The Population Council, Dakar, Senegal Raluca Teodoru, Youth for Youth Foundation, Bucharest, Romania Thet Thet Zin, Department of Health, Yangon, Myanmar Tran Thi Luong, Ministry of Health, Hanoi, Viet Nam Tran Thi Phuong Mai, Ministry of Health, Hanoi, Viet Nam Do Thi Thanh Nhan, Viet Nam Women’s Union, Hanoi, Viet Nam Elizabeth Torpey, Cran-Gevrier, France Adrian Vaduva, Romanian Society of Obstetrics and Gynaecology, Bucharest, Romania Liza Vielman, The Population Council, Guatemala City, Guatemala Maxine Whittaker, Waigani, Papua New Guinea Wu Shangchun, Scientific Research Institute, State Family Planning Commission, Beijing, China Xiao Shaobo, Dept of Science and Technology, State Family Planning Commission, Beijing, China Mary Zama, Ministry of Health, Lusaka, Zambia Zhang Kaining, Institute for Health Sciences, Kunming, China Zhou Weijin, Institute of Planned Parenthood Research, Shanghai, China Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 34 48 23 33 13 19 70 Women 20 29 15 21 7 10 42 from: AFRO 4 6 4 AMRO 14 20 9 13 23 EMRO EURO 23 33 4 6 27 SEARO 4 6 4 WPRO 12 17 12 Annex 1 (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 206 A n n u al Tech n ical R ep ort 2002 207 Annex 2 PUBLICATIONS IN 2002 A strategic assessment of the need for contraceptive introduction in Chongqing Municipality, China. Geneva, World Health Organization, 2002 (WHO/RHR/02.10). Diaz M, Simmons R, Diaz J, Cabral F, Bossemeyer D, Makuch M, Ghiron L. Action research to enhance reproductive choice in a Brazilian municipality: The Santa Barbara Project. In: Haberland N, Measham D, eds. Responding to Cairo: case studies of changing practice in reproductive health and family planning. New York, The Population Council, 2002:355–375. Expandiendo opciones en salud reproductiva: Diagnostico para identificar intervenciones prioritarias que mejoren el acceso y la calidad de los servicios basicos de salud materna en Guatemala. Washington, DC, World Health Organization, 2002 (in press). Fang K, Zhou W, Cheng J, Zhou X, Bai S, Wang Y et al. A strategic assessment of the need for contraceptive introduction in Chongqing Municipality, China. Chinese Journal of Family Planning, 2002, 10(1):38–44. Making decisions about contraceptive introduction: a guide for conducting assessments to broaden contraceptive choice and improve quality of care. Geneva, World Health Organization, 2002 (WHO/RHR/02.11). Romanian Ministry of Health and Family. Evaluare strategicâ a politicilor, programelor si aspectelor de cercetare referitoare la întreruperea sarcinii. Bucharest, Ministry of Health and Family, 2002. Simmons R, Brown J, Diaz M. Facilitating large-scale transitions to quality of care: an idea whose time has come. Studies in Family Planning, 2002, 33(1):61–75. Solo J. The health of a nation: a case study for strategic thinking, planning and action. Nairobi, The Population Council, 2002. The strategic approach to improving reproductive health policies and programmes: a summary of experiences. Geneva, World Health Organization, 2002 (WHO/RHR/02.12). A n n u al T ec h n ic al R ep or t 2 00 2 Section 7 - Technical cooperation with countries 206 A n n u al Tech n ical R ep ort 2002 207 Section 8 Implementing best practices A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 208 A n n u al Tech n ical R ep ort 2002 Implementing best practices 209 Implementing best practices M. Gülmezoglu, M. Usher-Patel, J. Villar, A. Shah INTRODUCTION Adoption of evidence-based practices depends on having access to appropriate tools and having the capacity to interpret, critically appraise and apply the evidence. The best way to generate relevant evidence has not changed: high-quality research protocols that are implemented and reported appropriately. However, the methods of synthe- sis of evidence and the way evidence is communicated to target populations are changing and the organizations that have this mandate must keep up with new developments. The synthesis of evidence through systematic reviews is acknowledged to be a prerequisite for undertaking research and deciding on policy and practice. The field is constantly developing and there is a need for methodological work to address the difficulties in systematically reviewing epidemio- logical studies that address different types of questions (e.g. evaluation of screening tests, prevalence of morbidities). Strategies such as the Implementing Best Practice (IBP) Initiative that support the transfer of knowledge and change in practice are also of particular importance. These strategies are often regarded as complex interventions where a series of activities are packaged together to address the different institutional, organizational and individual barriers to change with the aim of improving practices and the quality of repro- ductive health. To address the issue of knowledge generation, synthesis, dissemination and implementation, the Department is work- ing on two major projects: (i) The WHO Programme to Map Best Reproductive Health Practices aims to generate evidence through rigorously conducted research, summarize this evidence through systematic reviews, disseminate up-to-date high-quality research evidence and build capacity in evidence-based medicine in countries in order to enable decision-makers to make the best use of this evidence. The WHO Reproductive Health Library (RHL) is very important in the dissemination of the evidence generated/synthesized, and is recognized as the leading resource for evidence-based reproductive health care. RHL is a unique conduit for developing new ways to communicate information on a global scale. (ii) The Department has led the development of a strategic approach—the IBP Initiative—to support the introduc- tion, adaptation and application of evidence-based best practices in countries. This initiative involves a collaborative network of partner agencies committed to harmonizing approaches and to supporting the use of technical guidelines, materials and tools that have been developed. The strategy uses a number of innovative approaches to manage the transfer of knowledge to support the development of programmes that prompt change from within the system and foster the applica- tion of managerial and technical skills to implement best practices in order to improve the quality of reproductive health. THE WHO PROGRAMME TO MAP BEST REPRODUCTIVE HEALTH PRACTICES Research activities Objectives The overall objective of this activity is to generate evidence to guide future strategies to improve practices. Specifically, the aim is to determine whether electronically provided, up- to-date information on the effectiveness of health care inter- A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 208 A n n u al Tech n ical R ep ort 2002 Implementing best practices 209 ventions presented through an active dissemination strategy actually changes clinical practice. Progress A randomized controlled trial to evaluate a programme pro- moting evidence-based medicine based on RHL is ongoing. The trial compares an active dissemination strategy through three workshops within a period of six months, to the stand- ard form of information sharing (control group) in place in the local settings. In 2002, the workshops were conducted in 22 intervention hospitals. Baseline clinical data from 36 053 women and the Care Provider Profile survey of 813 service providers have been analysed. Two articles, one describing the study methodology and another the characteristics of the settings are currently being drafted. Collection of outcome data is ongoing in 22 hospitals in Mexico and is due to start in February 2003 in Thailand. A qualitative evaluation of staff experiences in the intervention hospitals will also be carried out in 2003. Research synthesis Objectives Systematic reviews locate, appraise and synthesize evi- dence from scientific studies in order to provide informa- tive empirical answers to scientific research questions. In addition, by identifying what is known and not known, they are an invaluable first step before carrying out new primary research. The main characteristic of a systematic review is the use of an a priori protocol including an explicit and com- prehensive strategy to search, identify, critically appraise and then select studies for inclusion. Systematic reviews on the effectiveness of practices are conducted through the Col- laborative Review Groups of the Cochrane Collaboration, while those addressing other epidemiological questions are conducted independently. Progress In 2002, systematic reviews were conducted in all major areas of reproductive health (Table 8.1). The Department continues to work closely with Cochrane Collaborative Review Groups and Cochrane Centres, in both Cochrane systematic reviews and capacity strengthening activities, to provide technical support to reviewers. For non-Cochrane systematic reviews (e.g. screening, prevalence) the Depart- ment works closely with reviewers, providing technical sup- port when necessary. Dissemination of evidence-based reproductive health care information: The WHO Reproductive Health Library (RHL) Objectives The objective of RHL is to provide health care workers in developing countries with an affordable, efficiently distrib- uted, and user-friendly source of up-to-date systematic reviews in reproductive health (Figure 8.1). RHL is an elec- tronic review journal updated yearly, focusing on reproduc- tive health problems of high priority for developing countries. Systematic reviews included in RHL are Cochrane reviews which are supplemented with commentaries and the prac- tice implications of these reviews. The latter are prepared by researchers from developing countries or individuals with extensive knowledge of the conditions of practice in those countries. RHL is the product of collaboration between the Department, research centres in developing countries and the Cochrane Collaboration. Progress Contents In 2002, RHL No.5 was published in English and Spanish. The contents had been increased significantly from the previ- ous issue. The highlights of RHL No. 5 include the following: Updates: Fourteen Cochrane reviews and the corresponding commentaries and practical aspects were updated. New reviews: Twelve new reviews were included bringing the total to 70. Three reviews that were out of date were removed. Implementation aids: In this new section, practices for which there is strong evidence for implementation were comple- mented with documents to assist their adoption: Figure 8.1. RHL 5 in English and Spanish A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 210 A n n u al Tech n ical R ep ort 2002 Implementing best practices 211 • the manual for the implementation of the new WHO Antenatal Care model • a video demonstrating how to perform external cephalic version • a video programme on the need for and benefits of com- panionship during labour • a Powerpoint presentation describing the Better Births Initiative. Dissemination RHL subscriptions exceeded 12 000 at the end of 2002 and the RHL print volume has been increasing gradually (Figure 8.2). Since the initiation of the RHL project a concrete dis- semination strategy has been followed, which incorporates the following elements: • Subscriptions and other mail distribution: the Departmen- tal and WHO-Library newsletter mailing lists are used in a selective manner, encouraging all who receive a copy to subscribe in order to ensure continued access. These untargeted mailings have been reduced from approxi- mately 6000 in 1997 to 2000 in 2002 according to the original dissemination strategy. Currently, approximately 10 000 subscriptions are individual, requested subscrip- tions, with the remainder being routine mailings. • Active dissemination: conference presentations and WHO meetings serve the purpose of raising awareness of RHL and evidence-based medicine. RHL presenta- tions and workshops are conducted by the Depart- ment, RHL regional editors and collaborators within the Programme’s Maternal and Perinatal Health Research network. Table 8.2 shows the list of presentations/ workshops coordinated by the Department. When the activities of the regional editors are included, more than 100 workshop/presentations were conducted in 2002. The free-subscription system has substantially facilitated access to RHL in developing countries. The distribution of RHL subscriptions by WHO regions and the increase in sub- scriptions between 2000 and 2002 are shown in Figure 8.3. The publication of RHL in Spanish and active participation of the WHO Regional Office for the Americas and of centres collaborating with the Department have played a major role in increasing subscription in Latin America. Table 8.1. Distribution of systematic reviews by topic area (2002) Topic area New Reviews New Protocols published Updated Reviews Ongoing Reviews Maternal and perinatal health 3 2 7 3 HIV/AIDS/STI 3 1 1 - Fertility regulation (incl. unsafe abortion) 2 1 1 - Total 8 4 9 3 Figure 8.3. RHL subscription status (2000-2002) Figure 8.2. RHL print volume since 1997 1998 1999 2000 2001 2002 A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 210 A n n u al Tech n ical R ep ort 2002 Implementing best practices 211 Translations The experience with Spanish translations at Centro Rosa- rino de Estudios Perinatales (CREP) in Rosario, Argentina, meant that a system could be established that can be repli- cated for all translations. The use of translation-assistance software that compares documents, creates a vocabulary and ensures consistency has been helpful. The report pre- pared by CREP has helped the Department to determine the standards and requirements for other translations. Work on a Chinese version in collaboration with the Shanghai Institute of Planned Parenthood Research (SIPPR), Shang- hai, China, is ongoing. The translation is almost complete and it is anticipated that the Chinese version will be ready for publication by mid-2003. Efforts to raise funds and identify an institution for a French version are continuing but so far these efforts have not been successful. Capacity building in evidence-based reproductive health care In Africa, a training project entitled “Making evidence-based decisions in reproductive health care” was initiated jointly with the WHO Regional Office for Africa (AFRO). The South African Cochrane Centre in Cape Town, South Africa, devel- oped a four-day training package that includes manuals for workshop facilitators and participants (Figure 8.4) and a monitoring and evaluation module. The package was pilot- tested in April 2002 and the first workshop to train facilitators took place in December 2002. In 2003, workshops will be conducted in Mozambique, Nigeria and Zambia. The training manuals will be translated into Portuguese and French. The training programme was presented at the Global Forum for Health Research conference in Arusha, United Republic of Tanzania, in November 2002. In Latin America, support has been provided to CREP to implement a systematic RHL training and dissemination programme. Table 8.2. RHL presentations coordinated by the Department in 2002 WHO Regions Workshops/presentations Attended/trained Africa 7 316 Americas 13 2440 South-East Asia 3 250 Europe 6 203 Eastern Mediterranean 7 1000 Western Pacific 3 750 Headquarters 4 90 Total 43 5049 In Asia, the Thai-Cochrane Network was launched in 2002 with support from the Programme. The support specifically includes RHL training and support activities in Indonesia, the Philippines, and Viet Nam. In March 2003, an exploratory meeting to implement the training package mentioned above will be convened in New Delhi, India. Future challenges RHL has become a recognized source of evidence-based, up-to-date information in reproductive health. RHL is incor- porated into the medical curriculum of several universities and is an important resource for postgraduate training and college membership examinations. Furthermore, the RHL trial (see above) will provide useful insights into changing professional behaviour in under-resourced settings. As RHL activities—systematic reviews and capacity building in evidence-based reproductive health care decision-making— expand and become more widely known, new challenges will emerge. Figure 8.4. Manual for course participants A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 212 A n n u al Tech n ical R ep ort 2002 Implementing best practices 213 The WHO Programme to Map Best Reproductive Health Practices faces the following challenges: •• To ensure that, as recommended by the Department’s Scientific and Technical Advisory Group (STAG), sys- tematic reviews become an integral first step of all research activities undertaken by the Programme. This is already the case in maternal and perinatal research. •• To ensure that the Department’s recommendations for practices and implementation are based on best avail- able evidence from systematic reviews. •• To expand the content of RHL to cover systematic reviews of observational studies including systematic reviews of morbidities, mapping the burden of reproduc- tive ill-health. •• To maintain and improve the quality of RHL. The number and type of documents included in RHL increase every year, with about one-third of them needing revision and updating. This increase, as well as the translations into several languages already existing, create significant management challenges. By the end of the 2002–2003 biennium, RHL will include almost 80 Cochrane reviews, accompanying commentaries and practical aspects, all of which will be updated annually. The same machinery will be running for the Spanish and Chinese versions. •• To contribute to creating a critical mass of scientists in developing countries who are knowledgeable and com- petent in critically appraising and preparing systematic reviews in reproductive health. The training initiative jointly developed with AFRO and the South African Cochrane Centre could be instrumental in achieving this objective. •• To continuously improve dissemination strategies. New innovations in dissemination and training in health include the use of satellite-aided digital broadcasting and long-distance Internet-based possibilities, among others. The challenge will be to incorporate these emerging technologies into the overall dissemination strategy. IMPLEMENTING BEST PRACTICES The Implementing Best Practice Initiative Today there is a considerable body of knowledge that pro- vides the solid evidence base for establishing internationally recognized norms and standards in reproductive health. The challenge the Department is addressing through the IBP Initiative is the complex one of how to support the manage- ment and transfer of knowledge so that it impacts changes in practice at country level. The IBP Initiative involves a collaborative network of 17 partner agencies (Annex 4). All partners work on a cost-sharing basis and are committed to minimizing duplication of effort and maximizing the use of resources to support the transfer of knowledge, and the adaptation and adoption of best practices in reproductive health at country level. The IBP Initiative works with and expands networks of exist- ing in-country projects and programmes of partner agencies. It does not create new materials, but promotes the use of the technical, managerial and performance improvement materials and tools that already exist. The IBP Initiative is launched through inter-country meetings involving country teams of policy-makers and programme managers. Innova- tive methods are used to support the transfer of information and the exchange of country experience. Managerial tools are introduced to foster leadership skills and creative think- ing among key players, who are also encouraged to build on their experience to develop strategies for introducing best practices that meet their immediate programmatic needs. The IBP partners support the implementation of the plans created through a programme of mentorship and supportive follow-up. “Helping developing country health professionals capture and apply best practices in reproductive health” Progress IBP Consortium All partners have agreed to sign a Memorandum of Under- standing to form the Implementing Best Practice Consortium. The Consortium will be officially launched during the IBP Intra-Country Meeting of Partners and Country Teams, due to be held in India in April 2003. Through this Memorandum of Understanding, members of the IBP Consortium agree: •• To respect the diversity of circumstances in individual countries and work collaboratively with other members of the Consortium and local colleagues to introduce and support the implementation of culturally appropriate IBP strategies. •• To develop and maintain a style of interaction among the IBP member organizations characterized by transpar- ency, responsiveness, inclusiveness and goodwill. Figure 8.5. The IBP logo A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 212 A n n u al Tech n ical R ep ort 2002 Implementing best practices 213 In its capacity as the secretariat of the IBP Initiative, the Department coordinates the programme of activities of the IBP Consortium. Heads of agencies delegate technical staff as members of the IBP Coordinating Committee responsible for developing the programme of activities. Each member of the Coordinating Committee leads a Task Team responsible for undertaking a specific activity within a specified timeframe that supports the programme of work. The Task Teams are currently working on: (i) an advocacy kit; (ii) revision of the IBP Tool Kit; (iii) a literature review on knowledge manage- ment; (iv) the mini university agenda for the India meeting; (v) the technology café and information exchange fair; (vi) the preparation of managerial exercises; (vii) a mentorship and follow-up programme; (viii) an evaluation framework for the IBP Initiative; (ix) an intranet-based communication and management system; and (x) financial management systems for the IBP Consortium. Members of the IBP Coordinating Committee work directly with countries and provide a supportive follow-up programme for all activities undertaken with countries. Programme of activities A meeting was held with 18 representatives of partner agencies in July 2002 to review progress and prepare a programme of work for 2003–2006. All partners appreciated the effective collaboration of the IBP Initiative but recognized that its main weakness was the mentorship and supportive follow-up programme. In accordance with previous recommendations by STAG, the IBP Initiative has been presented to and has received sup- port from the Regional Advisory Panels, and plans are being developed to link the IBP Initiative more closely with the Stra- tegic Approach and the dissemination of RHL. Figure 8.6. Schematic representation of the IBP Consor- tium Funding proposals for IBP Consortium A meeting was convened in October 2002 to discuss mecha- nisms for generating external funding to support the current programme of work, and the inclusion of nongovernmental agencies and WHO collaborating centres from developing countries in the IBP Consortium. Task Teams were formed to prepare funding proposals and structure a transparent management system as part of the management portfolio for the Consortium. Electronic communication and management system As part of the management system for the IBP Consortium, the Department is working with the WHO Management Infor- mation System (WHO/MIS) group to develop an electronic communication and management system. This system will create virtual workspaces and enable the IBP partners to communicate effectively and efficiently between themselves, by storing, archiving and retrieving information, and conven- ing online meetings. It will also facilitate communication, support the exchange of information, and support follow- up activities with country teams. The development of this system is being supported by the information technology departments of all partner agencies. WHO/MIS has prepared a detailed design specification, which is currently under review by partner agencies. Regional and country activities Country-specific activities with the WHO Regional Office for the Eastern Mediterranean The IBP partners held an Inter-Country Meeting with Part- ners and Country Teams in Cairo, Egypt, in February 2002. A total of 152 senior managers and policy-makers attended the meeting, coming mainly from Egypt, Jordan, Lebanon, Pakistan, Palestine, Turkey and Yemen. The country teams formed as a result of the meeting have all taken action to implement the programme of work they committed to at the meeting. Supportive follow-up by partners to country teams has taken place, but it is still too limited. Corrective action is being taken and plans are being prepared to improve this component of the IBP Initiative. Country-specific activities with the WHO Regional Office for South-East Asia (SEARO) A team from India participated in both the Egypt and Nepal IBP inter-country meetings. They have continued to meet and work together since these meetings. Through SEARO and the Ministry of Health, Department of Health and Family Welfare, India, they requested that the IBP Initiative be launched in India. In August 2002, the Department collabo- rated with SEARO to lead an initial planning exercise with representatives from the ministries of health from two Indian States and six local partner agencies. One outcome of the meeting has been the formation of the IBP India Steering A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 214 A n n u al Tech n ical R ep ort 2002 Implementing best practices 215 Committee, which has now expanded to include 10 local partner agencies and representatives from the office of the WHO Representative and the Ministry of Health. The IBP India Steering Committee has identified the par- ticipants, local facilitators and the information and perform- ance improvement needs they would like the IBP Initiative to address. All partners, including members of the India Steering Committee have agreed to provide seed funding to cover administrative costs, and to fund a minimum of five participants. The meeting will involve participants from four states in India, and is due to take place in Agra, India, in April 2003. So far commitments have been made to fund 160 participants. Future plans During 2003, all partners will be expected to continue under- taking their agreed roles, contribute to activities on a cost- sharing basis and support the implementation of the agreed programme of work. The IBP Consortium will: •• expand, funding permitting, the partnership to include a broader representation from nongovernmental agencies and WHO collaborating centres from developing coun- tries; •• finalize and test the management portfolio for the Con- sortium and seek additional funding sources; •• use the Strategic Approach (see the chapter on Policy and programmatic issues) more widely and work with teams within the Department to support the dissemina- tion of research findings, tools and materials; •• improve the follow-up and mentorship programme in countries in which the IBP Initiative has been introduced, and monitor and report on progress; •• continue working with the IBP India Steering Commit- tee to prepare for, undertake and follow up the IBP India Intra-Country Meeting; •• work with AFRO to introduce the IBP Initiative into selected countries in Africa; and •• publish success stories and lessons learnt, finalize the IBP Tool Kit and advocacy pack, undertake a literature review and publish a paper on knowledge manage- ment. A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 214 A n n u al Tech n ical R ep ort 2002 Implementing best practices 215 Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Members 9 82 2 18 11 Women 4 36 4 from: AFRO 1 9 1 AMRO 3 27 2 18 5 EMRO EURO SEARO 3 27 3 WPRO 2 18 2 Annex 1 WHO PROGRAMME TO MAP BEST REPRODUCTIVE HEALTH PRACTICES EDITORIAL GROUP OF THE WHO REPRODUCTIVE HEALTH LIBRARY Guillermo Carroli, Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina Cheng Linan, International Peace Maternal and Child Health Institute, Shanghai, China Mario Festin, University of the Philippines, Manila, Philippines Jeremy Grimshaw, Ottawa Health Research Institute, Ottawa, Canada Justus Hofmeyr, University of the Witwatersrand, Johannesburg, South Africa Ana Langer, The Population Council, Mexico City, Mexico Pisake Lumbiganon, Khon Kaen University, Khon Kaen, Thailand Suneeta Mittal, All India Institute of Medical Sciences, New Delhi, India Manorama Purwar, Clinical Epidemiology Unit, Nagpur, India Kenneth Schulz, Family Health International, Research Triangle Park, NC, USA Juan Carlos Vazquez, America Arias Hospital, Havana, Cuba A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 216 A n n u al Tech n ical R ep ort 2002 Implementing best practices 217 Annex 2 SCIENTISTS IN 2002 Edgardo Abalos, Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina Hany Abdel-Aleem, Assiut University, Assiut, Egypt Lekan Adetoro, Ogun State University, Sagamu, Nigeria Isaac Adewole, Ibadan University, Ibadan, Nigeria Zarko Alfirevic, University of Liverpool, Liverpool, United Kingdom Fernando Althabe, Latin American Centre for Perinatology (CLAP), Montevideo, Uruguay Jurandyr Andrade, Faculty of Medicine Ribeirao Preto, University of Sao Paulo, Sao Paulo, Brazil Alvaro Atallah, University of Sao Paolo, Sao Paolo, Brazil Katherine Ba-Thike, UNFPA Country Support Team, Bangkok, Thailand Anthony Bamigboye, Nelspruit, South Africa Zulfiqar Bhutta, Aga Khan University, Karachi, Pakistan Michel Boulvain, University of Geneva, Geneva, Switzerland Heather Brown, University of Witwatersrand, Johannesburg, South Africa Eckhart Buchmann, University of Witwatersrand, Johannesburg, South Africa Haroldo Capurro, Latin American Centre for Perinatology (CLAP), Montevideo, Uruguay Guillerme Cecatti, State University of Campinas, Sao Paulo, Brazil Maureen Chisembele, University Teaching Hospital, Lusaka, Zambia Chompilas Chongsomchai, Khon Kaen University, Khon Kaen, Thailand Edgard Cobo, University of Valle, Cali, Colombia Agustin Conde-Agudelo, University of Cali, Cali, Colombia Peter Cooper, University of Witwatersrand, Johannesburg, South Africa Luis Gabriel Cuervo, British Medical Journal Clinical Evidence, London, United Kingdom Andres de Francisco, Global Forum for Health Research, Geneva, Switzerland Mercedes de Onis, Nutrition for Health and Development, WHO, Geneva, Switzerland Maria del Carmen Cravioto, National Institute of Nutrition, Mexico City, Mexico Charlotte Ellertson, Population Council, Mexico City, Mexico El-marie Farrell, University of Pretoria, Pretoria, South Africa Anibal Faundes, State University of Campinas, Sao Paulo, Brazil Bukola Favole, Federal Medical Centre, Abeokuta, Nigeria Anis Fekih, University of Geneva, Geneva, Switzerland Rui Ferriani, Faculty of Medicine Ribeirao Preto, University of Sao Paulo, Sao Paulo, Brazil Mario Festin, University of the Phillippines, Manila, Philippines Pedro Figueroa-Casas, Rosario University, Rosario, Argentina Fariyal Fikree, Population Council, New York, NY, USA Paul Garner, University of Liverpool, Liverpool, United Kingdom Teresa Gonzàlez-Cossio, National Institute of Public Health, Mexico City, Mexico David Grimes, Family Health International, Research Triangle Park, NC, USA Babar Hasan, Aga Khan University, Karachi, Pakistan Honest Honest, Birmingham Women’s Hospital, Birmingham, United Kingdom Charlotte Ingram, University of Witwatersrand, Johannesburg, South Africa Edgar Kestler, Epidemiological Research Centre in Sexual and Reproductive Health (CIESAR), Guatemala City, Guatemala Khalid Khan, University of Birmingham, Birmingham, United Kingdom Hirondina Langa, Hospital Central de Maputo, Maputo, Mozambique O. Okanlawon Lawrence, Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria Roberto Lede, Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina Jerker Liljestrand, World Bank, Washington, DC, USA Gerhardt Lindeque, University of Pretoria, Pretoria, South Africa Gunilla Lindmark, University of Uppsala, Uppsala, Sweden Yusuf Lukman, Addis Ababa, Ethiopia Pisake Lumbiganon, Khon Kaen University, Khon Kaen, Thailand James McIntyre, University of Witwatersrand, Johannesburg, South Africa Kassam Mahomed, University of Adelaide, Port Pirie, Australia Nandita Maitra, Baruda Medical College, Baruda, India Matthews Mathai, Christian Medical College, Vellore, India Joy Melnikow, University of Southern California, Davis, CA, USA Luciano Mignini, Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina Jack Moodley, University of Natal, Durban, South Africa Stephen Munjanja, University of Zimbabwe, Harare, Zimbabwe Dina Neeloufer-Khan, University of Geneva, Geneva, Switzerland James Neilson, University of Liverpool, Liverpool, United Kingdom A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 216 A n n u al Tech n ical R ep ort 2002 Implementing best practices 217 Cheryl Nikodem, University of Witwatersrand, Johannesburg, South Africa Olatunji Adetola Ojo, Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria Friday Okonofua, Women’s Health and Action Research Centre, Benin City, Nigeria Robert Pattinson, Pretoria University, Pretoria, South Africa Manorama Purwar, Government Medical College, Nagpur, India Siddarth Ramji, Maulana Azad Medical College, New Delhi, India H.P. Sachdev, Maulana Azad Medical College, New Delhi, India Haroon Saloojee, University of Witwatersrand, Johannesburg, South Africa Nandi Sigfried, South African Cochrane Centre (SACC), Cape Town, South Africa Helen Smith, Liverpool School of Tropical Medicine, Liverpool, United Kingdom Louise Spruyt, South African Cochrane Centre (SACC), Cape Town, South Africa Yawana Tanapat, Pramungkutlao Hospital, Bangkok, Thailand Nguyen Thi Nhu Ngoc, Hungvuong Hospital, Ho Chi Minh City, Viet Nam Jadsada Thinkhamrop, Khon Kaen University, Khon Kaen, Thailand Jorge Tolosa, Thomas Jefferson University, Philadelphia, PA, USA Cyril Van Gelderen, University of Witwatersrand, Johannesburg, South Africa Vanchai Vatanasapt, Khon Kaen University, Khon Kaen, Thailand Jimmy Volmink, Global Health Council, Washington, DC, USA Godfrey Walker, United Nations Population Fund, Bratislava, Slovakia Gijs Walraven, Medical Research Council Laboratories, Farafenni Field Station, Gambia David Wilkinso, Adelaide University, Whyalla, Australia Chris Williams, Oxford University, Oxford, United Kingdom Ray Yip, United Nations Children’s Fund (UNICEF), Beijing, China Annex 2 (continued) Developing countries Countries in transition Developed countries Totals Number % of total Number % of total Number % of total Scientists 60 72 1 1 22 27 83 Women 18 22 6 7 24 from: AFRO 26 31 26 AMRO 17 20 6 7 23 EMRO 3 4 3 EURO 1 1 14 17 15 SEARO 12 14 12 WPRO 2 2 2 2 4 A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 218 A n n u al Tech n ical R ep ort 2002 Implementing best practices 219 Annex 3 PUBLICATIONS IN 2002 COCHRANE REVIEWS 1Brocklehurst P, Volmink J. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. Kulier R, Nardin JM, Boulvain M, Peterson HB, Campana A. Techniques for the interruption of tubal patency for female steriliza- tion. 2Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after Caesarean section. Say L, Kulier R, Gülmezoglu M, Campana A. Medical versus surgical methods for first trimester termination of pregnancy. Thinkhamrop J, Hofmeyr GJ, Adetoro O, Lumbiganon P. Prophylactic antibiotic administration in pregnancy to prevent infec- tious morbidity and mortality. van den Broek N, Kulier R, Gülmezoglu AM, Villar J. Vitamin A supplementation during pregnancy. Wilkinson D. Nonoxynol-9 for preventing sexually acquired HIV infection. Wilkinson D. Nonoxynol-9 for prevention of sexually transmitted infections. Updated reviews Brocklehurst P, Volmink J. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. Gülmezoglu AM. Interventions for trichomoniasis in pregnancy. Gülmezoglu AM, Forna F, Villar J, Hofmeyr GJ. Prostaglandins for prevention of postpartum haemorrhage. Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Hofmeyr GJ. Amnioinfusion for meconium-stained liquor in labour. Hofmeyr GJ, Atallah AN, Duley L. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems. Hofmeyr GJ, Gülmezoglu AM. Maternal hydration for increasing amniotic fluid volume in oligohydramnios and normal amniotic fluid volume. Kulier R, Boulvain M, Walker D, De Candolle G, Campana A. Minilaparotomy and endoscopic techniques for tubal sterilisa- tion. Smaill F, Hofmeyr GJ. Antibiotic prophylaxis for Caesarean section. Protocols Abalos E, Carroli G. Bed rest with or without hospitalisation for hypertension during pregnancy. Abdel-Aleem H, Vogelsong K, d’Arcangues C, Gülmezoglu AM. Treatments for irregular bleeding associated with the use of injectable progestin-only contraceptives. 1This review appears again under Updated reviews because both reviews were published in 2002. 2This review appears again under Protocols because both reviews were published in 2002. A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 218 A n n u al Tech n ical R ep ort 2002 Implementing best practices 219 Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after Caesarean section. OTHER PUBLICATIONS Chalmers I, Lumbiganon P. The Cochrane Collaboration: providing research syntheses to inform health care and research. Science Asia, 2002 (supplement):9–14. Gülmezoglu AM, Villar J. The WHO Reproductive Health Library (RHL). In: Making childbirth safer through promoting evidence- based care. Washington, DC, Global Health Council, May 2002:12–14. Villar J, Gülmezoglu AM, Carroli G, Schulz KF, Lumbiganon P, Mittal S, Hofmeyr GJ, Langer A, Cheng L. Is it time to do away with conclusions in systematic reviews? WHO Reproductive Health Library (No.5), Geneva, WHO/RHR/02.1. Annex 3 (continued) A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 220 A n n u al Tech n ical R ep ort 2002 221 IMPLEMENTING BEST PRACTICES (IBP) INITIATIVE PARTNER AGENCIES 1. World Health Organization/Department of Reproductive Health and Research (WHO/RHR) 2. United States Agency for International Development (USAID) 3. United Nations Population Fund (UNFPA) 4. Centre for African Family Studies (CAF) 5. EngenderHealth 6. Family Health International (FHI) 7. Georgetown University, Washington, DC, USA 8. International Planned Parenthood Federation (IPPF) 9. Innovative Technologies for Health Care Delivery/Program of International Training for Health (INTRAH/PRIME) 10. Johns Hopkins Program of International Education in Gynecology and Obstetrics (JHPIEGO) 11. Johns Hopkins University/Center for Communication Programs (JHU/CCP) 12. Management Sciences for Health (MSH) and Advance Africa Project 13. Partners in Population and Development (PPD) 14. Pathfinder International and Catalyst Project 15. Population Leadership Program 16. Program of Appropriate Technology for Health (PATH) 17. Regional Centre for Quality Health Care, Makerere University, Kampala, Uganda Annex 4 A n n u al T ec h n ic al R ep or t 2 00 2 Section 8 - Implementing best practices 220 A n n u al Tech n ical R ep ort 2002 221 Section 9 Monitoring and evaluation A n n u al T ec h n ic al R ep or t 2 00 2 Section 9 - Monitoring and evaluation 222 A n n u al Tech n ical R ep ort 2002 Monitoring and evaluation 223 Monitoring and evaluation M. Gülmezoglu, A. Betran, L. Say INTRODUCTION Monitoring and evaluation work in the Department entails a series of activities that maintain and provide the means of monitoring and appraising progress towards the reduction of maternal and under-five mortality. These activities have two dimensions: (i) work towards better understanding of the extent of related morbidities and mortality; and (ii) work on the tools—”indicators”—used to monitor progress. Improved knowledge of the magnitude/burden of leading causes of maternal and newborn morbidity and mortality is crucial in identifying needs, setting targets and allocating resources for any improvement programme and for identi- fying new research priorities. This information needs to be reliable and up-to-date and to be generated and summarized on the basis of a rigorous scientific methodology. In addition to the need for improved knowledge on leading morbidities such as eclampsia, haemorrhage and low birth weight, other reproductive morbidities like genital prolapse, incontinence and depression (during pregnancy or postpartum) that affect large numbers of women but have been neglected to date, require attention. Indicators are important for the monitoring of health status locally. Unfortunately, there is a discrepancy between locally relevant indicators and those that are useful for global moni- toring purposes. Global indicators obscure differences in health status within countries, and between socioeconomic groups, rural and urban populations, different age groups and minority groups. Furthermore, there is limited experi- ence with some of the reproductive health indicators that have been agreed upon. Therefore, it seems that more research and capacity strengthening efforts are needed to improve data collection at country level before some of the indicators can be regarded as useful. It is also important to develop tools to provide access to and training in reproduc- tive health indicators. EPIDEMIOLOGY OF REPRODUCTIVE ILL-HEALTH Objectives The overall goal is to map reproductive morbidities in a comprehensive and systematic manner. Mapping will pro- vide evidence to help in identifying the priorities for future research on practices which prevent these morbidities, and support for the implementation of evidence-based country programmes and for advocacy. The specific objective is to calculate prevalence/incidence, case-fatality rates, sequelae and attributable fractions of pregnancy-related and repro- ductive morbidities, from systematic reviews of published or unpublished studies and datasets. Progress Maternal morbidity and mortality: a systematic review In 2002, the protocol for the systematic review on maternal morbidity and mortality was revised and finalized. A method- ology working group was convened to discuss the statistical and methodological challenges of conducting systematic reviews of observational data of incidence/prevalence. These challenges include the expected wide heterogeneity across studies with regard to study designs, population characteris- tics, setting characteristics, and definitions/diagnostic proce- dures. However, it is worthwhile and indeed crucial to face these problems in order to provide tabulations of data for the different characteristics and also to provide a standard set of definitions for important health conditions. Providing tabula- A n n u al T ec h n ic al R ep or t 2 00 2 Section 9 - Monitoring and evaluation 222 A n n u al Tech n ical R ep ort 2002 Monitoring and evaluation 223 tions for different characteristics/circumstances will be useful for future work on addressing the gap between global and locally relevant indicators. As summarized in Figure 9.1, a comprehensive search strat- egy was developed, tested and run for published/unpublished data from 1997. Over 8000 citations identified through the electronic search were screened by evaluating titles and/or abstracts. Of these, 971 were deemed to be potentially relevant and retrieved for full text evaluation. In addition, 1363 published/unpublished reports from 1997 have been identified from the previously compiled departmental data- base (Reproductive, Maternal and Newborn Health Data- base—RMN Database). They were appraised for inclusion in the systematic review. Out of these, 307—of which 213 were already captured in the electronic search—were considered to be potentially relevant. Figure 9.2 shows a flow diagram of the process of the reports identified through the departmen- tal database and how it relates to other sources of data for the systematic review. Other sources including conference proceedings, reference lists, circulating documents within the Department, and Internet search engines were scanned and this provided 33 more articles. Overall, 1098 reports were thoroughly appraised and the 417 that fulfilled the pre-determined inclusion criteria were included in the systematic review. For the year 1997, about 4.5% of all screened reports were finally included in the review. Data from the included reports were extracted on specifically designed data extraction forms. Data entry and descriptive analysis for the year 1997 was completed. The same process is being carried out for the year 1998. Data extraction, entry and detailed analysis for published/ unpublished reports released until the end of 2002 are planned to be finalized by mid-2003. It is expected that for all years to be included (1997–2002), screening of around 60 000 citations will result in the inclusion of about 3000 reports. The systematic review will be updated regularly. Skilled attendant at delivery The Millennium Development Goals (MDGs) include the proportion of births attended by a skilled health worker as a key indicator for tracking progress in reducing maternal mortality. Nationally representative data available up to 2001 as well as global, regional and subregional estimates of the proportion of births attended by skilled health worker were published on the Department’s web site. Regional estimates are compared with the established MDG, which states that by 2015, 90% of births should be attended by a skilled health worker. Skilled attendant estimates are updated annually and posted on the Department’s web site. These estimates will be reviewed and updated in 2003. The new estimates will also be published on the Department’s web site in 2003. Figure 9.1. Identifying and processing reports from 1997 for inclusion in the systematic review A n n u al T ec h n ic al R ep or t 2 00 2 Section 9 - Monitoring and evaluation 224 A n n u al Tech n ical R ep ort 2002 Monitoring and evaluation 225 Systematic review on genital prolapse The conduct of a systematic review to estimate the preva- lence, associated factors and consequences of genital organ prolapse was started in 2002 and the first draft is currently being reviewed. Antenatal care in developing countries An analysis of levels, trends and differentials of antenatal care in developing countries using data from Demographic Health Surveys (DHS), Multiple Indicator Cluster Surveys (MICS) and Pan Arab Project for Child Development (PAP- CHILD) surveys between 1990 and 2001 was carried out in 2002. The report concludes that levels of antenatal care use in developing countries have improved during the 1990s. However, there are significant disparities in access between rural and urban areas, low and high income. The impacts of wealth distribution and education appear to be among the major determinants of antenatal care use. REPRODUCTIVE HEALTH INDICATORS Objectives Reproductive health indicators are used at global, regional and national levels to monitor the reproductive health status of populations. There are 17 global reproductive health indi- cators that have been agreed upon at international forums. The Department’s work on mapping the epidemiology of reproductive ill-health will improve knowledge on the status of these indicators globally. The tools developed for the col- Figure 9.2. The distribution of reports from 1997 obtained from the Department’s RMN Database and from electronic/other searches and included in the systematic review lection and use of these indicators will help to build capacity in countries. Progress A database for reproductive health indicators is under devel- opment. The main purpose of the database is to provide up- to-date information at the national, regional and global levels on the 17 global reproductive health indicators short-listed for global monitoring. In addition, this database includes five additional reproductive health and 16 socioeconomic and demographic indicators. It will be published on the WHO web site, allowing the user to search the database by country/countries or region(s) and to easily generate tables and graphs from these data. Database files have been prepared. These include the latest available data for each indicator. In 2002, the database was improved to allow the data to be entered and information displayed more precisely and consistently. It is expected that the XML version of the application will be ready for testing by May 2003. FUTURE CHALLENGES Challenges in the area of monitoring and evaluation can be summarized as follows: 1. Introducing mapping of the burden of illness through systematic reviews to this public health component. In order to understand the true extent of reproductive ill- health, systematic reviews to evaluate the extent of mor- bidities, sequelae and prognosis of reproductive health conditions have to be conducted and regularly updated. A n n u al T ec h n ic al R ep or t 2 00 2 Section 9 - Monitoring and evaluation 224 A n n u al Tech n ical R ep ort 2002 Monitoring and evaluation 225 These reviews will cover neglected conditions that affect large numbers of women as well as leading morbidities. 2. Reproductive health indicators. How the chosen indica- tors reflect the reproductive health status of populations remains to be demonstrated. The gap between global goals and locally relevant and operational indicators must be addressed by international agencies. It is also important to develop tools such as computer-assisted programmes to facilitate training in reproductive health indicators. 3. Systems for global monitoring. The systematic review mentioned above will reveal gaps in data with regard to different morbidities. The next step will be to implement systems to collect these data in a more reliable way through prospective studies. Facility-based systems in randomly selected countries in each of the WHO regions are currently being developed for routine monitoring of important health conditions and for conducting prospec- tive research on emerging issues. Through these studies it will be possible to obtain facility-based data on mor- bidities that are representative of different regions. Once the system is established, it will be possible to look at those morbidities over time in order to assess trends. A n n u al T ec h n ic al R ep or t 2 00 2 Section 9 - Monitoring and evaluation 226 A n n u al Tech n ical R ep ort 2002 227 A n n u al T ec h n ic al R ep or t 2 00 2 Section 9 - Monitoring and evaluation 226 A n n u al Tech n ical R ep ort 2002 227 Section 10 Communication, advocacy and information A n n u al T ec h n ic al R ep or t 2 00 2 Section 10 - Communication, advocacy and information 228 A n n u al Tech n ical R ep ort 2002 Communication, advocacy and information 229 Communication, advocacy and information J. Khanna, C. Hamill, S. Kolev, J. Maurice INTRODUCTION The Communication, Advocacy and Information Group (CAI) seeks to facilitate access to reproductive health knowledge— within and outside the Department—in support of the WHO mandate and objectives in improving global reproductive health. The Group sees the following as its main objectives: •• to develop a strategic, proactive and cost-effective pro- gramme for the dissemination and communication of reproductive health knowledge to target audiences and stakeholders; •• to facilitate the transfer of reproductive health knowledge through appropriate strategies and media, focusing on participatory communication; •• to initiate, develop and manage a communication research programme in support of evaluation of the impact of dissemination activities as well as strengthen- ing of dissemination/communication strategies; and •• to initiate advocacy and public relations interventions. PROGRESS Production of documents and publications The following publications/documents were produced and distributed in 2002: Progress in reproductive health research The Department’s newsletter, Progress in reproductive health research, has continued to serve as a key instrument for dissemination of research information to policy-makers, programme managers, scientists and the general public. Three issues of the newsletter were published in 2002. The topics covered included adolescent reproductive health, dual protection against pregnancy and sexually transmitted infections, and intrauterine devices. Progress continues to be translated into Chinese and is published on the Depart- ment’s web site. CD-ROM: Department of Reproductive Health and Research 2000–2001 This elegantly designed CD-ROM contains key documents on the work of the Department, including the following (the documents in bold were prepared in 2002): 1. Highlights of 2000 2. Highlights of 2001 3. Annual technical report 2000 4. Annual technical report 2001 5. Research on reproductive health at WHO: biennial report 2000–2001 6. Better reproductive health—implementing the global agenda: biennial report 2000–2001 7. HRP Programme budget 2002–2003 8. RHR Programme budget 2002–2003 A n n u al T ec h n ic al R ep or t 2 00 2 Section 10 - Communication, advocacy and information 228 A n n u al Tech n ical R ep ort 2002 Communication, advocacy and information 229 In addition to the above, the CD-ROM includes the Depart- ment’s biennial reports for 1998–1999 (Reproductive health research at WHO: a new beginning: biennial report 1998– 1999 and Reproductive health programme development: implementing Cairo: biennial report 1998–1999) and Annual technical report 1999. Together, these documents provide a full package of information on the work of the Department from 1998 to 2001. Some 2500 copies of the CD-ROM had been distributed by December 2002, primarily to scientists and national and international policy-makers. Print copies of all the new documents were also produced and distributed. Safe motherhood—a newsletter of worldwide activity The safe motherhood initiative is a global effort to reduce maternal mortality and morbidity. As part of its contribution to the initiative, WHO began publishing Safe motherhood—a newsletter of worldwide activity in 1989. In 2002, one issue of the newsletter was published, covering the topic of skilled attendance. Other documents Table 10.1 lists all the documents produced by the Depart- ment in 2002. A total of 23 documents (including other-lan- guage versions and promotional materials) were produced and distributed. In view of the increased acceptance of, and demand for, documents in electronic form, many new docu- ments are now being produced on CD-ROM. In addition, in order to speed up and facilitate the availability of docu- ments, all new information products are first published on the Department’s Internet web site. Reproductive health web site The web site of the Department continues to expand and now houses over 3000 pages. New health topics added to the site in 2002 included: •• family planning •• best practices in reproductive health •• ethics •• gender and rights •• global monitoring and evaluation. Work on integrating the Programme’s web site into the Department’s web site was completed early in 2002 and the Making Pregnancy Safer pages were also revised. Updates and additions are made to all the health topic areas as nec- essary during the year. All of the Department’s documents are now listed on the site, either with full text online, or with instructions on how to obtain a hard copy. In addition, the Reproductive Health Home Page was given a fresh, new look. Web statistics became available during 2002 and, as of 11 November 2002 the following had been recorded: • The number of successful hits for the Department’s web site from 1 January to 11 November was 2 490 423. More tellingly, for the same period, the number of page visits (impressions) was 1 337 482. These views were made during the course of 378 456 visits of an average length of 11 minutes and 28 seconds. Visitors are prima- rily routed through the United States of America (52.4%), with 24.3% of visitors from other developed countries (primarily, Western Europe and Australia) and 23.4% from the rest of the world. Since large organizations, such as the United Nations agencies and national health and civil services, use caching proxies extensively, these figures are underestimates of the true figures: WHO cen- tral web services believe that the real number of visitors to the Department’s site is probably double the above. While web statistics remain at best very approximate guesses of visiting trends, the sheer size of these num- bers indicates the importance of the Department’s web site as a communication tool. Dissemination of The WHO Reproductive Health Library (RHL) No. 5 and production of RHL No. 6 The fifth issue of RHL was published in February 2002. Later in the year, its Spanish version was also published. A total of 20 000 copies of the English version and 9000 copies of the Spanish version were produced. By December 2002, all the 20 000 copies of the English version had been distributed. A key element of the dissemination strategy adopted for RHL has been free distribution on a subscription basis. Subscrip- tions to RHL continue to rise rapidly. By December 2002, there were more than 12 000 addresses in the mailing list for the English version. Individual physicians and health work- ers in developing countries and medical libraries make up almost 80% of the recipients of RHL. Other recipients include institutions and scientists associated with the Department. For the first time, RHL No. 5 included two training videos: one on social support during pregnancy and another on external cephalic version. During 2002, work was under way to produce RHL No. 6. Work was also started on a Chinese version of RHL. Press releases The Department issued two press releases in 2002. The first, in May 2002, reported the findings of the three-year study—dubbed the “MAGPIE” trial—which found that mag- nesium sulfate was effective in preventing pre-eclampsia and eclampsia. The second, issued in June 2002, highlighted the conclusions of a meeting of experts that nonoxynol-9 was ineffective in preventing HIV infection. Both releases gener- ated healthy media interest. A n n u al T ec h n ic al R ep or t 2 00 2 Section 10 - Communication, advocacy and information 230 A n n u al Tech n ical R ep ort 2002 Communication, advocacy and information 231 Electronic documents on CD-ROM 1. Department of Reproductive Health and Research 2000–2001 2. The WHO Reproductive Health Library No.5 3. Transforming health systems: gender and rights in reproductive health. A training curriculum for health programme managers Printed documents 1. A framework to assist countries in the development and strengthening of national and district health plans and pro- grammes in reproductive health: suggestions for programme managers 2. Programming for male involvement in reproductive health 3. Report of the In-depth Review Panel on research capacity strengthening 4. Annual technical report 2001 5. Selected practice recommendations for family planning 6. Clinical management of survivors of rape 7. Better reproductive health—implementing the global agenda: biennial report 2000 –2001 8. Reproductive health research at WHO: biennial report 2000–2001 (HRP) 9. A strategic assessment of the need for contraceptive introduction in the Chongqing municipality, China 10. Making decisions about contraceptive introduction: a guide for conducting assessments to broaden contraceptive choice and improve quality of care 11. The strategic approach to improving reproductive health policies and programmes: a summary of experiences 12. Expanding capacity for operations research in reproductive health: summary report of a consultative meeting 13. Current practices and controversies in assisted reproduction; report of a WHO meeting 14. Global action for skilled attendants for pregnant women Language versions 1. Managing complications of pregnancy and childbirth (French) Revised field-testing version 1. Essential care practice guide for pregnancy, childbirth and newborn care Promotional materials 1. Highlights of achievements 1990–2001 (HRP) 2. A strategy for research capacity strengthening in developing countries. A series of five brochures on different types of grants 3. A set of six leaflets on the work of Making Pregnancy Safer (including a poster on global action for skilled attendants for pregnant women) 4. Sexual and reproductive health: publications and documents, October 2002 Table 10.1. Documents produced in 2002 A n n u al T ec h n ic al R ep or t 2 00 2 Section 10 - Communication, advocacy and information 230 A n n u al Tech n ical R ep ort 2002 Communication, advocacy and information 231 Strengthening the capacity for communication and information dissemination of collaborating centres The Programme’s collaborating centres worldwide are its partners in the conduct of research. The Programme con- tinues to conduct various activities to enhance partnership in communication and dissemination of reproductive health research information as well. The Programme believes that a decentralized approach to communication will be more effective in reaching diverse audiences who speak different languages and use different communication channels. The Programme’s strategy involves convincing the collabo- rating centres of the value of communicating research knowl- edge to the public and policy-makers, strengthening the communication capabilities of individual researchers in the centres (through workshops on scientific writing and effective communication with the mass media), and helping the cen- tres to strengthen their capacity for information management and communication (by providing technical assistance in the setting-up or strengthening of communication units). Scientific writing workshops A description of the Programme’s scientific writing work- shops can be found in the Annual technical report 1995. These workshops focus on the skills involved in writing a sci- entific research paper and aim to encourage scientists in the Programme’s collaborating centres to publish more papers, especially in international peer-reviewed journals. During 2002, a scientific writing workshop was conducted at the Institute for Research in Reproductive Health, Mumbai, India. A total of 20 researchers were trained. An evaluation conducted by the institute after the workshop found that a great majority of the participants had found it to be “very useful”. The workshop included an observer and two partici- pants from the FRONTIERS project of the Population Coun- cil. The Department is discussing a collaborative activity under which, using the proven model of its own workshops, the Department will help the FRONTIERS project to develop a scientific writing workshop specifically for social scientists. A trainers’ scientific writing workshop was conducted at the Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. The 20 participants in the workshop were mostly senior medical staff in the Depart- ment of Obstetrics and Gynaecology. Workshops to improve communication skills and networking with the mass media Researchers have the responsibility not only to publish their findings in peer-reviewed journals, but also to make their findings known to the general public, who are investors in, and beneficiaries of, research. For these reasons, the Pro- gramme supports the improvement of communication skills among scientists, programme managers and policy-makers. In January 2002, a communication workshop was conducted at the Department of Social and Preventive Medicine, University of Malaya, Kuala Lumpur, Malaysia. The work- shop was attended by 22 participants, most of whom were middle-to-senior-level physicians involved in research and programme delivery in reproductive health. The participants were trained in communication strategy planning as well as in skills for communicating with the mass media. In an effort to enhance further the practical value of the communication workshops, a follow-up workshop was conducted in March 2002 to review how the participants had used their newly learned communication skills in the real world. Fifteen of the original 22 participants participated in this workshop. They presented five communications projects relevant to their work in the area of reproductive health. One project, presented by a group of six participants (including one jour- nalist) was particularly interesting: it involved creating a new reproductive health web site for Malaysian adolescents. The presenters believed they were close to getting funding from commercial advertisers for this novel project. Question Number of respondents Very (%) Quite (%) Somewhat (%) Not at all (%) How interesting are the topics? 2149 58 38 3 0 How useful is the information to you? 2145 51 39 10 0 How useful is the information to your organization? 2117 43 34 11 91 1These respondents did not belong to an organization. Table 10.2. Respondent’s rating of the newsletter in terms of interest value and usefulness of information A n n u al T ec h n ic al R ep or t 2 00 2 Section 10 - Communication, advocacy and information 232 A n n u al Tech n ical R ep ort 2002 233 Evaluation of information products Safe motherhood newsletter In 2000, the Department conducted a survey among the readers of the Safe motherhood newsletter. The results of this survey became available in 2002. A total of 21 215 questionnaires were mailed and 2273 responses were received. This response rate of over 10% can be regarded as more than satisfactory for a mailed questionnaire. Over- all, the respondents found the newsletter to be interesting, useful and relevant to their work: out of 2127 respondents who made an overall assessment of the newsletter and its contents, 28% found it to be excellent, 55% very good, 16% good, 1% fair. Only one respondent rated it as poor. Tables 10.2 and 10.3 provide a summary of the findings. Collaboration The Department of Communication, Cornell University, Ithaca, NY, USA, collaborates with the Programme in a variety of activities including the conduct of communica- Profession Number (%) of respondents Very interesting (%) Quite interesting (%) Somewhat interesting (%) Not at all interesting (%) Doctor/public 369 (17%) 52 45 3 0 Doctor/private 143 (6%) 50 46 4 0 Midwife 299 (13%) 71 26 3 0 Nurse 186 (8%) 69 27 4 0 Health worker 198 (9%) 56 40 4 0 Scientist 209 (9%) 50 45 5 0 Civil servant (government) 191 (9%) 60 37 3 0 Civil servant (international) 68 (3%) 48 48 3 0 Librarian 85 (4%) 57 35 7 1 Other 475 (21%) 57 40 3 0 Total 2223 58 39 3 0 Table 10.3. Respondent’s profession and their rating of the interest value of the newsletter tion workshops for scientists. Discussions were under way in 2002 to collaborate with the FRONTIERS project of the Population Council to develop a scientific writing workshop for social scientists. PLANNED ACTIVITIES In 2003, the Department will continue to produce its usual serial and non-serial publications, disseminate appropriate public relations material and conduct its scientific writing, communication and information management workshops. The Department intends to collaborate with the Popula- tion Council’s FRONTIERS project to develop a special dedicated workshop for training social scientists in writing research papers for peer-reviewed journals; this workshop will use the training methods developed in the Programme’s scientific writing workshop. The first workshop of this kind is expected to take place in Africa in 2003. Special emphasis will continue to be placed on the development of the Internet web site. It is planned to conduct scientific writing workshops in Sri Lanka and Oman. Other activities to strengthen the commu- nication capacity of collaborating centres will also continue. A n n u al T ec h n ic al R ep or t 2 00 2 Section 10 - Communication, advocacy and information 232 A n n u al Tech n ical R ep ort 2002 233 Section 11 Clinical trials and informatics support A n n u al T ec h n ic al R ep or t 2 00 2 Section 11 - Clinical trials and informatics support 234 A n n u al Tech n ical R ep ort 2002 Clinical trials and informatics support 235 Clinical trials and informatics support O. Ayeni, G. Piaggio, A. Peregoudov, S. Landoulsi INTRODUCTION The Clinical Trials and Informatics Support Unit provides technical support in statistics and data processing to the rest of the Department. Technical support to research activities includes statistical advice in the review and development of research projects and responsibility for the management and analysis of some single-centre and nearly all multicentre studies carried out by the Programme. The Unit also coordinates the implementa- tion of Good Clinical Practice (GCP) guidelines in all of the Programme’s research activities. In the area of technical support to countries the Unit assists in the formulation, execution and review of institution strengthening policies in statistics and data processing, and in the organization and conduct of workshops and training courses in these areas for scientists from collaborating institutions. Staff members of the Unit provide on-the-project training in research data man- agement and statistical analysis to staff members of centres participating in some multicentre studies or carrying out their own single-centre trials. They contribute to the development of appropriate techniques for the conduct, management and analysis of multicentre research projects in reproduc- tive health in developing countries. They also provide local informatics support to the administrative management of the Department. The Unit’s strategy is to coordinate international multicentre studies from Geneva while continuing to enhance the ability of individual centres to handle their own single-centre and national multicentre studies. SUPPORT TO RESEARCH ACTIVITIES Specific objectives The objectives are to provide high-quality and efficient statis- tical and data-processing support to all research conducted by the Programme and to ensure statistical and methodologi- cal rigour, including adherence to GCP guidelines. Progress Support to research projects Activities carried out by the Unit in 2002 in support of research projects included technical advice in their develop- ment and review; statistical design; assistance with project organization; data processing, monitoring and management; data analysis and preparation of statistical reports; and par- ticipation in the writing of scientific papers resulting from the projects. A total of 68 research projects were supported by the Unit. The distribution of these projects by their stage of support at the end of 2002 is shown in Table 11.1. In addition to the technical support given to these specific projects, all of which are being coordinated in Geneva, support was given to Programme staff with the technical review of projects submitted to them for funding and with the arrangements for logistic support to projects before launch- ing. The technical review focused mainly on the biostatistical and data-processing aspects of the protocol while logistic support arrangements included site visits to the proposed study and coordinating centres to review facilities and data collection mechanisms. A n n u al T ec h n ic al R ep or t 2 00 2 Section 11 - Clinical trials and informatics support 234 A n n u al Tech n ical R ep ort 2002 Clinical trials and informatics support 235 Implementation of GCP guidelines in research During the year, efforts continued to formally implement WHO GCP research guidelines throughout the Programme’s research activities. Work continued on the editing of the Standard Operating Procedures (SOPs). A consultant with experience in human research quality assurance and harmo- nization of regulatory quality assurance was contracted for this purpose. The exercise has reached an advanced stage and will be completed in early 2003. Development of methodological tools Staff of the Unit, in collaboration with an external consultant from the Department of Epidemiology and Biostatistics, Uni- versity of Western Ontario, Ontario, Canada, have continued work on statistical issues related to cluster randomization trials. One paper was accepted for publication. The Unit provided support to users of the software, “Acluster”, used for sample size determination and analysis of cluster rand- omization trials, which was developed by two staff members of the Unit during 1999/2000. Staff of the Unit, in collaboration with the London School of Hygiene and Tropical Medicine, London, United Kingdom, are involved in extending the Consolidated Standards of Reporting Trials (CONSORT) guidelines to clinical trials using various designs. Work on writing a chapter on methodology of clinical trials for a textbook on clinical trials is in progress. The WHO multicentre randomized controlled trial to evaluate the use of misoprostol in the management of the third stage of labour, completed and published in 2001, used an innova- tive approach for its randomization procedures. The methods of sequence generation, allocation concealment and blinding used in the trial were presented in a paper at the 23rd Annual Meeting of the Society for Clinical Trials in Arlington, VA, USA in May 2002. Work is also ongoing on the methodology of meta-analysis of observational studies. A staff member from the Unit partici- pated in a workshop on this theme organized by the Institut national de la santé et de la recherche médicale (INSERM), La Roche-Posay, France, in July 2002. SUPPORT TO INSTITUTION STRENGTHENING ACTIVITIES Objective The objective of these activities is to strengthen the statisti- cal and data-processing capabilities of selected developing country institutions to support their own research work. Activities Activities in 2002 included the following highlights: Training courses, seminars and workshops A staff member presented a course on “Advanced methods of epidemiological analysis” as part of a training programme in epidemiological research in the University of Uruguay, Montevideo, Uruguay. Another staff member served on the faculty of a training workshop on “Advanced statistical methods in reproductive health research” at the International Institute for Population Studies in Mumbai, India. An analyst- programmer in the Unit participated in teaching a course in SAS programming in Tervuren, Belgium. Site visits A statistician from the Unit visited three centres in east Africa to assess their data management capabilities for participation in the new study on the impact of highly active antiretroviral therapy during pregnancy and breastfeeding on mother-to- child transmission of HIV and mother’s health. The centres were the Department of Paediatrics, Faculty of Medicine, University of Nairobi, Nairobi, Kenya; the International Centre for Reproductive Health (ICRH), Mombasa, Kenya; and the Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania. Subsequently, two staff members from the Unit participated in the principal investigators meetings for the same study in Mombasa. Status of studies Number In the planning stage or just starting: protocol preparation, forms design, data management systems design, supplies distribution 27 Ongoing studies: data validation, data quality control, study monitoring, interim analysis 9 Final analysis: final data cleaning, preparation of final analysis 7 Statistical report drafted, manuscript in preparation, revisions and/or additions to final analysis 17 Final analysis completed 8 TOTAL 68 Table 11.1. Number of studies by stage of support (December 2002) A n n u al T ec h n ic al R ep or t 2 00 2 Section 11 - Clinical trials and informatics support 236 A n n u al Tech n ical R ep ort 2002 Annex 1 - Staff of the Department, December 2002 237 Annex 1 PUBLICATIONS IN 2002 Ali MM, Shah I, Cleland JG. Trends in reproductive behaviour among young single women in Colombia and Peru 1985–2000. Demography (submitted). Cui N for the WHO Task Force on Methods for the Natural Regulation of Fertility. The impact of breast-feeding pattern on the duration of lactational amenorrhoea in Chengdu, China. Journal of Reproduction and Contraception (accepted). Dada OA, Akesode FA, Olanrewaju DM, Olowu OA, Sule-Odu AO, Fakoya TA, Oluwole FA, Odunlami BV for the WHO Task Force on Methods for the Natural Regulation of Fertility. Infant feeding and lactational amenorrhea in Sagamu, Nigeria. African Journal of Reproductive Health (accepted). Donner A, Piaggio G, Villar J. Meta-analyses of cluster randomization trials: power considerations. Evaluation & the Health Professions, 2003 (accepted). Gross B, Burger H for the WHO Task Force on Methods for the Natural Regulation of Fertility. Breast-feeding patterns and return to fertility in Australian women. Australia and New Zealand Journal of Obstetrics and Gynaecology, 2002, 42(2):148–154. Hill Z, Cleland J, Ali M. Religious affiliation and extra-marital sex in Brazil. International Family Planning Perspectives (submit- ted). Langer A, Villar J, Romero M, Nigenda G, Piaggio G, Kuchaisit C et al. Are women and providers satisfied with antenatal care? Views on a standard and a simplified, evidence-based model of care in four developing countries. BMC Womens Health, 2002, 19:2(1):7 (available at http://www.biomedcentral.com/1472-6874/2/7). Lumbiganon P, Piaggio G, Villar J, Pinol A, Bakketeig L, Bergsjo P et al. for the WHO Antenatal Care Trial Research Group. The epidemiology of syphilis in pregnancy. International Journal of STD & AIDS, 2002, 13:486–494. Lumbiganon P, Villar J, Piaggio G, Gülmezoglu AM, Adetoro L, Carroli G for the WHO Collaborative Group to Evaluate Misopr- ostol in the Management of the Third Stage of Labour. Side-effects of oral misoprostol used in the third stage of labour during the 24 hours after administration. British Journal of Obstetrics and Gynaecology, 2002, 109:1222–1226. Piaggio G, Elbourne D, Schulz KF, Villar J, Pinol A, Gülmezoglu AM on behalf of the WHO Research Group. Methods for randomisation, concealment and blinding in the WHO misoprostol third stage of labour trial. Controlled Clinical Trials, 2002, 23(2S):39S–40S (abstract). von Hertzen H, Honkanen H, Piaggio G, Bartfai G, Erdenetungalag R, Gemzell-Danielsson K et al. for the WHO Research Group on Post-Ovulatory Methods for Fertility Regulation. WHO multinational study of three misoprostol regimens after mife- pristone for early medical abortion: I. efficacy. British Journal of Obstetrics and Gynaecology (submitted). von Hertzen H, Piaggio G, Ding J, Chen J, Si S, Bártfai G et al. and the WHO Research Group on Post-ovulatory Methods of Fertility Regulation. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicen- tre randomized trial. The Lancet, 2002, 360:1803–1810. WHO Working Group on the Growth Reference Protocol and the WHO Task Force on Methods for the Natural Regulation of Fertility. Growth of healthy infants and the timing, type, and frequency of complementary foods. American Journal of Clinical Nutrition, 2002, 76:620–627. Xiao, BL, von Hertzen H, Zhao H, Piaggio G. A randomised double blind comparison of two single doses of mifepristone for emergency contraception. Human Reproduction, 2002, 17(12):3084–3089. A n n u al T ec h n ic al R ep or t 2 00 2 Section 11 - Clinical trials and informatics support 236 A n n u al Tech n ical R ep ort 2002 Annex 1 - Staff of the Department, December 2002 237 Appendix 1 Staff of the Department, December 2002 Dr Paul Van Look (Director) Office of the Director 1 Anne ALLEMAND (Programme Assistant) 1 Luc BERNIER (Reproduction Equipment Operator) 1 Catherine d’ARCANGUES (Medical Officer) 1 Barbara KAYSER (Secretary) Craig LISSNER (Technical Officer) 1 Michael MBIZVO (Scientist) Bérengère NAIL (Secretary) 1 Corinne PENHALE (Programme Assistant) 1,2 Claire TIERNEY (Secretary) 1 Hazel ZIAEI (Administrative Assistant) Promoting Family Planning 2 Kathryn CHURCH (Technical Officer) 1 David GRIFFIN (Scientist) 2 Sarah JOHNSON (Technical Officer) Gloria LAMPTEY (Secretary) 1 Lynda PASINI (Secretary) Herbert PETERSON (Coordinator) 1,2 Johannes SCHMIDT (Medical Officer) 1 Lynn SELLARO (Secretary) 1,2 Effy VAYENA (Technical Officer) 1,2 Kirsten VOGELSONG (Scientist) Making Pregnancy Safer Shamilah AKRAM (Secretary) 1,2 Rowena BONDAD (Secretary) Luc DE BERNIS (Medical Officer) Bocar DIALLO (Project Manager) 1,2 Janette FERGUSON (Secretary) 2 Helga FOGSTAD (Technical Officer) 2 Kreeneshni GOVENDER (Secretary) 2 Rita KABRA (Medical Officer) 2 Catherine LEGROS (Clerk) 2 Ornella LINCETTO (Medical Officer) 1,2 Mario MERIALDI (Medical Officer) 2 Jane PIZOT EIRWEN (Secretary) 2 Annie PORTELA (Technical Officer) 1,2 Archana SHAH (Technical Officer) 2 Della SHERRATT (Midwife) 1 Jose VILLAR (Medical Officer) Jelka ZUPAN (Medical Officer) Controlling RTIs/STIs 1,2 Maria Agnes ANCIANO-MURIEL (Secretary) 2 Nathalie BROUTET (Scientist) 1 Sybil DE PIETRO (Secretary) 2 Isabelle DE VINCENZI (Medical Officer) 2 Bidia DEPERTHES (Technical Officer) 2 Sibongile DLUDLU (Medical Officer) 1 Timothy FARLEY (Coordinator) 1,2 Isaac MALONZA (Medical Officer) 1,2 Justin MANDALA (Technical Officer) 2 Sophie MERLET (Secretary) 2 Charles MORRISON (On secondment) 2 Doris MUGRDITCHIAN (Medical Officer) Francis NDOWA (Medical Officer) Carol PETERS (Secretary) Theresa RYLE (Secretary) 2 Julie SAMUELSON (Technical Officer) Preventing Unsafe Abortion 1 Maud KEIZER (Secretary) 1 Janette MAROZZI (Secretary) 1 Nicola SABATINI-FOX (Secretary) 1 Iqbal SHAH (Coordinator) 1 Helena VON HERTZEN (Medical Officer) 1 Ina WARRINER (Scientist) Technical Support Team 1 Heli BATHIJA (Scientist) 1 Jennifer BAYLEY (Secretary) 1 Catherine BLANC (Secretary) 1,2 Vanessa CAMPOS (Secretary) 1 David CHIKAMATA (Medical Officer) 1 Enrique EZCURRA (Scientist) 1,2 Amel FAHMY (Technical Officer) 2 Patricia GUILLOT (Secretary) 1 Margarit KAUFMANN (Secretary) 1,2 Manjula LUSTI-NARASIMHAN (Technical Officer) 1 Alexis NTABONA (Coordinator) 1 Jenny PERRIN (Secretary) 1 Zenaida ZOTOMAYOR (Secretary) Policy and Programmatic Issues 1 Peter FAJANS (Scientist) 1 Ruth MALAGUTI (Secretary) 1 Staff of the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction 2 Temporary staff A n n u al T ec h n ic al R ep or t 2 00 2 Annex 1 - Staff of the Department, December 2002 238 Implementing Best Practices 1 Åsa CUZIN (Technical Assistant) 1,2 Paulo DOS SANTOS (Clerk) 1 Metin GULMEZOGLU (Medical Officer) 2 Shalini JAYASEKAR (Technical Officer) 2 Lucy OKOT (Secretary) 2 Maggie USHER (Technical Officer) Gender and Reproductive Rights 1,2 Manuela COLOMBINI (Technical Officer) 1 Jane COTTINGHAM (Technical Officer) 2 Eszter KISMODI (Human Rights Adviser) 2 Adriane MARTIN HILBER (Technical Officer) 1 Karie PELLICER (Secretary) 2 Anne RICCIO-FAZLI (Secretary) Clinical Trials and Informatics Support 1 Mohamed ALI (Statistician) 1 Sola AYENI (Chief Statistician) 1 Annie CHEVROT (Assistant Statistics) 1,2 Rebecca CURTIN (Assistant Computer Systems) 1,2 Emilie DIAGNE (Clerk) 1,2 Lucio FERSURELLA (Clerk) 1 Catherine HAZELDEN (Assistant Statistics) 1 Evelyn JIGUET (Secretary) 1,2 Joyce KUKU-WINYI (Secretary) 1 Sihem LANDOULSI (Programmer Analyst) 1 Natalie MAURER (Office Equipment Operator) 1 Sasha PEREGOUDOV (Systems Analyst) 1 Gilda PIAGGIO SOTO (Statistician) 1,2 Christelle ROSNOBLET (Data Entry Operator) 1 Milena VUCUREVIC (Assistant Statistics) Communication, Advocacy and Information 2 Maureen DUNPHY (Document Assistant) Annette EDWARDS DE LIMA (Clerk Stenographer) Catherine HAMILL (Technical Officer) 1 Teresa HARMAND (Assistant Supplies) 1 Jitendra KHANNA (Technical Officer) 1,2 Svetlin KOLEV (Information Officer) 1 Linda KREUTZER (Clerk Stenographer) Susan LAMBERT (Secretary) 1,2 John MAURICE (Technical Officer) 2 Christine MEYNENT (Technical Assistant, Web) Maire NI MHEARAIN (Secretary) 1 Frederick SCHLAGENHAFT (Assistant Statistics) 2 Nalini WIJESUNDERA (Clerk) Monitoring and Evaluation 2 Ana-Pilar BETRAN (Medical Officer) 2 Harriet KABAGENYI (Secretary) 2 Lale SAY (Technical Officer) 1 Staff of the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction 2 Temporary staff

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