HRP biennial technical report 2009-2010 : UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction

Publication date: 2011

HRP Biennial Technical Report 2009–2010 WHO Library Cataloguing-in-Publication Data Biennial technical report 2009–2010 / Department of Reproductive Health and Research, including UNDP/UNFPA/ WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. 1.Reproductive medicine. 2.Reproduction. 3.Family planning services. 4.Contraception. 5.Research. I.UNDP/UNFPA// World Bank Special Programme of Research, Development and Research Training in Human Reproduction. II.World Health Organization. Dept. of Reproductive Health and Research. ISBN 978 92 4 150174 3 (NLM classification: WP 630) Acknowledgements We are grateful to all those who contributed to the work detailed in this report including our collaborating centres, details of which can be found on our web site at © World Health Organization 2011 All rights reserved. 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Printed by the WHO Document Production Services, Geneva, Switzerland. 1 Bi en ni al T ec hn ic al R ep or t 2 00 7– 20 08 Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Chapter 1 Promoting family planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Chapter 2 Improving maternal and perinatal health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Chapter 3 Controlling sexually transmitted and reproductive tract infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Chapter 4 Preventing unsafe abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Chapter 5 Gender, reproductive rights, sexual health and adolescence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Chapter 6 Research capacity strengthening and programme development: interregional activities . . . . . . . . . . . 82 Chapter 7 Research capacity strengthening and programme development: African and Eastern Mediterranean Regions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Chapter 8 Research capacity strengthening and programme development: Region of the Americas . . . . . . . . . . . 98 Chapter 9 Research capacity strengthening and programme development: South-East Asia and Western Pacific Regions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105 Chapter 10 Research capacity strengthening and programme development: Eastern Europe and Central Asian Republics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113 Chapter 11 Technical cooperation with countries: policy and programmatic issues . . . . . . . . . . . . . . . . . . . . . . . . . .116 Chapter 12 Mapping best reproductive health practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126 Chapter 13 Implementing best practices in reproductive health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133 Chapter 14 Monitoring and evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137 Chapter 15 Communication, advocacy and information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143 Chapter 16 Statistics and informatics services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148 Chapter 17 Primary health care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156 Chapter 18 Linkages between sexual and reproductive health and HIV interventions . . . . . . . . . . . . . . . . . . . . . . .160 Chapter 19 Universal access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166 Acronyms and abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169 2 Bi en ni al T ec hn ic al R ep or t 2 00 7– 20 08 Preface This biennial technical report of the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), presents HRP’s work in the context of the World Health Organization’s work in sexual and reproductive health. In odd numbered years, HRP produces a Biennial Technical Report, which is drawn from work pre- sented to HRP’s Scientific and Technical Advisory Group (STAG); this complements the Biennial Report, which is produced in even numbered years, and targeted at a wider audience, including policy-makers, programme managers and donors. The Department of Reproductive Health and Research (RHR), including HRP, has continued to address the various areas of sexual and reproductive health as elaborated within the WHO Global Reproductive Health Strategy. It is taking into account the contribution of sexual and reproduc- tive health to the achievement of the Millennium Development Goals (MDGs). Its global research and programme development work, including national research and technical capacity strength- ening, aim to accelerate progress towards universal access to sexual and reproductive health. The United Nations Secretary-General’s Global Strategy for Women’s and Children’s Health has provided additional impetus to our collective efforts to improve sexual and reproductive health. An external evaluation of HRP for the period 2003–2007 concluded that HRP remains a global leader in sexual and reproductive health research and research capacity strengthening, with par- ticular relevance to the needs of populations in resource-poor settings. It is with pleasure that I introduce this HRP Biennial Technical Report, 2009–2010, which provides scientific and technical details on the full range of activities undertaken by HRP in 2009 and 2010. This report is intended to be a key tool for disseminating information on sexual and reproductive health to scientists, researchers, programme managers and other partners. Highlights of HRP’s work for 2010 are available as a standalone, printed document. To conserve resources we have limited the number of printed copies of this document, but an electronic version is available from: Details of collaborating researchers and the departmental staff list are available in the online version. Dr Mike Mbizvo Director Department of Reproductive Health and Research June 2011 3 Bi en ni al T ec hn ic al R ep or t 2 00 7– 20 08 Chapter 1 Promoting family planning 1 . InTRodUCTIon Over the past few decades, family planning (FP) programmes have had increasing success in reaching couples to improve contraceptive prevalence rates globally. However, levels of unmet need for FP remain high, especially in specific popula- tions, and demand for infertility services is increasing world- wide. The RHR Promoting Family Planning Team (PFP) seeks to contribute to a substantial reduction in the unmet need for contraception and improved access to infertility pre- vention and care services, allowing people to achieve their fertility goals. Its programme of work aims at improving the quality of FP within sexual and reproductive health care glob- ally. The Team focuses on the development and dissemina- tion of evidence-based FP and infertility guidelines and tools, research into users’ and providers’ perspectives on FP and sexual and reproductive health services and technologies, the development of new or improved methods of fertility reg- ulation, the evaluation of the long-term safety and efficacy of existing methods, and technical assistance to country FP and sexual and reproductive health programmes in the adap- tation and implementation of technical and programmatic guidance. Research results and significant accomplishments from 2009 and 2010 are presented here. 2 . ConTRIBUTIon To WHo’S MEdIUM-TERM STRATEGIC PLAn 2008–2013 PFP’s work contributes to the achievement of WHO Strate- gic Objectives (SOs) 4 and 6. Specifically, these SOs aim to “Reduce morbidity and mortality and improve health during key stages of life … and improve sexual and reproductive health” (SO4) and “Promote health and development, and prevent or reduce risk factors for health conditions associ- ated with … unsafe sex” (SO6). Within SO4, the Team’s guidelines and research achieve- ments have contributed to the achievement of two WHO Organization-wide expected results (OWERs). The guide- lines work is targeted to OWER 7, which highlights the impor- tance of making available “guidelines, approaches and tools … with provision of technical support to Member States … towards the attainment of international development goals and targets related to reproductive health.” In 2009–2010, the Team focused on developing, updating, translating and disseminating appropriate, evidence-based guidelines in order to support countries to meet the needs of their popula- tions and ensure universal access to contraception and fertil- ity services. Collaborative activities to provide direct support to countries in adapting and implementing the PFP tools and guidelines have been of paramount importance, despite lim- ited funding for this work. OWER 2 within SO4 specifically calls for national research capacity to be strengthened and “New evidence, products, technologies, interventions and delivery approaches of global and/or national relevance” to be developed. The research supported by PFP in 2009–2010 served both to strengthen research capacity and provide new evidence regarding contraceptive and reproductive health products and technologies. Some of the research portfolio is targeted towards the development of new methods of family planning, designed to meet the needs of individuals and couples whose needs are not met by the currently available array of technologies and to provide options with improved safety, efficacy and acceptability profiles over existing meth- ods. Another component of the research establishes the long-term safety and efficacy of existing methods of family Biennial Technical Report 2009–2010 4 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 contraception, particularly for women who have certain con- ditions as identified in the FP Medical eligibility criteria guide- lines. All of the research is intended to provide evidence that can be taken into consideration when updating, modifying or adapting the PFP guidelines and tools. An additional component of the research conducted within PFP is related to SO6, OWER 6, which seeks to develop “Evidence-based and ethical policies, strategies, interven- tions, recommendations, standards and guidelines … to pro- mote safer sex” and to provide technical support to countries to “strengthen institutions in order to tackle and manage the social and individual consequences of unsafe sex.” A spe- cific set of research activities, conducted in collaboration with a research partner (Family Health International), has been identified, with the goal of expanding access to contra- ceptives and FP services, particularly among underserved groups, e.g. adolescents, the poor, people with disabilities, people living with HIV and those trafficked or in conflict situa- tions. This work has been established in 2009–2010, and will continue throughout the next biennium. Specific achievements resulting from the work of the Team in 2009–2010, as well as activities planned for the near-term future, are described below. 3 . GUIdAnCE dEVELoPMEnT Over the past few years, there has been an increasing demand for guidance on FP services, including counselling and provi- sion. The unmet need for FP remains high, and the various interventions designed to address this problem require that these are evidence-based and regularly updated. The four cornerstones of evidence-based and consensus-driven guid- ance have served as models to ensure that such unmet need is properly addressed. Aside from addressing the needs of the general population, guidance for specific groups, par- ticularly the underserved or disadvantaged, has also been developed. In addition, individuals and couples need to be assured that appropriate access to both contraception and infertility care will be provided if and when needed. The development of these guidelines and tools alone, while vital, is not enough to assure that FP services are of qual- ity and appropriate. Thus adaptations were developed for use by community-based health workers in order to achieve greater coverage by reaching out to populations. 3 .1 Progress The range of guidance materials developed by the Team, in collaboration with partners, includes those related to provid- ing various methods of contraception and offering a coun- selling model for providers and clients, and those related to services for infertility care. 3.1.1 Continuous Identification of Research Evidence (CIRE) system for updating guidelines in family planning Since 2002, the Internet-based Continuous Identification of Research Evidence (CIRE) system has been used to identify and critically appraise published research findings to ensure that the Department’s global FP guidance is based upon the best available evidence. CIRE is operated in partnership with the United States Centers for Disease Control and Pre- vention/WHO Collaborating Centre for Reproductive Health (CDC/WHO CC). During 2009–2010, new evidence was identified through CIRE on the following conditions: antiretroviral (ARV) therapy use; benign breast disease; breast cancer; cervical intraepi- thelial neoplasia; diabetes; dysmenorrhoea; endometriosis; fibroids; HIV infection; obesity; parity; postabortion; postpar- tum; pregnancy; risk of sexually transmitted infection; sickle cell disease; valvular disease; and young age. Further, new evidence for the six selected practice questions was identi- fied. ● When should advanced provision of emergency contra- ception be provided? ● When should combined oral contraceptives (COCs) be started?, ● What should be done when COCs are missed? ● When can progestin-only injectables be started? ● What can be done for women with bleeding abnormali- ties during implant use? What can be done for women with bleeding abnormalities during progestin-only inject- able use? Preparation of systematic reviews is under way for the major- ity of these topics. Reviews summarizing the safety of post- partum IUD insertion and use of hormonal contraception postabortion, as well as addressing what women should do if they miss taking COCs were completed. External review of these systematic reviews has confirmed that guidance in the WHO Medical eligibility criteria for contraceptive use (MEC) and Selected practice guidelines for contraceptive use (SPR) remains consistent with the body of evidence for these topics. An update to the Department-supported Cochrane review Treatment of vaginal bleeding irregularities induced by pro- gestin-only contraceptives, initially published in the Cochrane Database in 2007, was initiated in light of numerous new publications in this area, and in keeping with the Cochrane schedule. The update will be completed and submitted for publication in 2011. Chapter 1—Promoting family planning 5 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 3.1.2 Technical consultation on the use of combined hormonal contraception during the postpartum period In response to concerns raised by experts in the United States of America during their adaptation of the MEC, a sys- tematic review summarizing the risk of venous thromboem- bolism (VTE) among non-lactating women using combined hormonal contraceptive (CHC) methods during the postpar- tum period was prepared. At the advice of the Family Plan- ning Guidelines Steering Group (GSG), WHO convened a technical consultation via teleconference in January 2010 to evaluate thoroughly the current MEC recommendation for the use of CHCs among non-breastfeeding postpartum women to determine whether the recommendation remains consistent with the body of emerging evidence. It was found that the then-current WHO guidance on this issue was dis- cordant with the presented evidence, and that WHO guid- ance inadequately reflected the gradual declining risk of VTE during the postpartum and the potential impact of multiple risk factors on VTE formation during this period. The GSG issued interim guidance, developing 20 new recommenda- tions for postpartum, non-breastfeeding women, which are available in the fourth edition of the MEC, and a statement titled Combined hormonal contraceptive use during the post- partum period. The systematic reviews that provided the basis for the consultation have been accepted for publication in 2011 in Obstetrics & Gynecology. 3.1.3 External evaluation of the Continuous Identification of Research Evidence (CIRE) system An external evaluation of the CIRE system, completed in October 2010, looked at assessing the current methods for identifying evidence, evaluating whether the current pro- cess complies with WHO’s standards for guideline develop- ment, and providing recommendations on modifications to ensure the process adheres to those standards. To evalu- ate the bibliographic assessment, a comparison of the yield and relevance when searching for six high-priority topics, on POPLINE (the database used by CIRE since its inception) and on PubMed between April and June 2010, was per- formed. The assessment concluded that PubMed provided more citations, more relevant citations to the topics that were searched, was easier to use, and that citations were avail- able in a more timely manner compared with what POPLINE offered. In addition, the evaluators suggested that the CIRE Internet system should be hosted at WHO. To evaluate the process used to develop FP guidelines on its compliance with that stipulated by WHO’s Guideline Review Committee, structured interviews were conducted among staff at WHO; among staff at CDC; and with the GSG mem- bers. Information on the CIRE Internet system was exam- ined, and reports of prior meetings and consultations were analysed. The final evaluation reported that the system allows for the continuous identification of evidence pertain- ing to FP clinical guidelines, which is useful and beneficial to WHO during periods between guideline revisions. Further, the current process used for developing FP guidelines is not compliant with WHO requirements for guideline development in the following areas: scoping of guideline content; applying the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system to appraise the quality of evidence and formulate recommendations; ensuring exter- nal peer review of finalized revisions; and providing detailed plans for implementation and dissemination of the revised guidance. In conclusion, the evaluators recommended that WHO retain the CIRE system as a mechanism to identify research evi- dence that applies to FP guidelines, with modifications. WHO should revise the process to rely upon PubMed as the primary source for evidence identification and apply the GRADE system to appraise the quality of evidence and for- mulate recommendations. In addition, it will be important to distinguish membership and to specify the role of the GSG (which should operate during interim periods) from that of a Guideline Development Group (comprising WHO staff, CDC collaborators, topic experts, guideline users, methodologists and programmatic experts), which is responsible for revis- ing FP guidelines. WHO needs to ensure that this Guideline Development Group is geographically and gender-balanced. 3.1.4 Medical eligibility criteria for contraceptive use, fourth edition The fourth edition of the MEC was finalized and approved for publication in May 2010. Guidance within the fourth edition reflects recommendations that were developed during an expert Working Group meeting in April 2008, as well as two subsequent technical consultations to address issues related to postpartum VTE risk (in January 2010) and breastfeeding and risk of hormonal exposure in the neonate (in October 2008). Furthermore, new guidance on the use of the lacta- tional amenorrhea method (LAM) among women infected with HIV is offered, which is based upon updated recommen- dations promulgated in a December 2009 document pub- lished by WHO’s HIV/AIDS Department, Rapid advice: use of antiretroviral drugs for treating pregnant women and prevent- ing HIV infection in infants. Printed copies of the new edition of the MEC will be disseminated to ministries of health, WHO regional and country offices, UN partner agencies, nongov- ernmental organizations (NGOs), national health-provider associations, and medical and nursing institutions in early 2011. The document is currently available online through the WHO Library and the RHR web sites. Translations of the fourth edition into Spanish and French have been initiated and will be completed in early 2011, to be made available in hard copy and online. Biennial Technical Report 2009–2010 6 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Figure 1. New editions and versions of the Family Planning Guidelines and Tools (from left to right): Medical eligibility criteria for contraceptive use, fourth edition; MEC Wheel, updated; A guide to family planning for health workers and their clients. dations that well-trained community-based health providers can safely and effectively administer the hormonal injectable contraceptive, depot medroxyprogesterone acetate (DMPA); and (3) new WHO guidelines on HIV and infant feeding. 3.1.8 A guide to family planning for health workers and their clients The Department has developed A guide to family planning for health workers and their clients (Figure 1), which is an adaptation of the clinic-based Decision-making tool for family planning clients and providers (DMT) to address the needs of community health workers, who provide an increasing share of FP services. This smaller, less expensive and handier tool is both a counselling tool as well as a job aid for providers, incorporating the latest evidence-based technical informa- tion. This tool was developed collaboratively with the Minis- tries of Health of Ethiopia and Kenya, that have community health worker programmes; nongovernmental partners work- ing in FP and reproductive health; and community health workers currently providing FP services. It has also under- gone extensive internal and external review. The tool has been field tested in two countries in 2010, Guyana and the Philippines, through the support of the United Nations Population Fund (UNFPA) country offices. Feedback from 108 provider–client encounters from Guyana and 415 from the Philippines showed at least 94% favour- able responses on the use of the tool. The most commonly used pages included the sections on oral contraceptive pills, hormonal injectables, and the condom. The guide has been translated into Filipino/Tagalog, Visayan/Waray, and Ifugao for use in the Philippines. 3.1.9 Update on the recommendations for birth spacing In cooperation with the RHR Improving Maternal and Perina- tal Health Team (MPH), a follow-up to the June 2005 Techni- 3.1.5 MEC Wheel and interactive version To address the new recommendations in the fourth edition of the MEC, the MEC Wheel was updated in 2009. The updated MEC Wheel (in English) is available on the RHR web site and 15 000 copies were printed for distribution. The update includes reclassifications for several conditions such as drug interactions and viral hepatitis, and the new recom- mendations for conditions such as deep vein thrombosis and ARV therapy. In addition, a Spanish translation of the updated Wheel (Disco para determinar criterios médicos de eligibilidad para el uso de anticonceptivos) is available and 20 000 copies were printed for distribution in hispanophone countries, primarily in Latin America. The Russian translation of the MEC Wheel was also updated. These are available on the RHR web site and CD-ROM. Updating of the French MEC Wheel is under way. An interactive version of the MEC Wheel developed for per- sonal computer was first presented during the Department’s Policy and Coordinating Committee meeting (18–19 June 2009) and in other meetings. The interactive version can be used for teaching or for actual clinic use on a desktop or laptop computer. 3.1.6 Selected practice recommendations for contraceptive use The 2008 update of the SPR was translated into French, Spanish and Russian. These translations are published on the RHR web site. The French and Spanish translations have been printed and distributed globally. 3.1.7 Family planning: a global handbook for providers Family planning: a global handbook for providers (the Global handbook) is being reprinted with updates on three items: (1) new guidance on the postpartum use of combined hormo- nal methods by non-breastfeeding women; (2) recommen- Chapter 1—Promoting family planning 7 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 cal Consultation on Birth Spacing is being undertaken. On the basis of the evidence available at that point, the experts gathered in the consultation identified caveats and limitations of the studies and the need for further analysis. The Depart- ment is thus engaged in developing guidelines for birth spac- ing recommendations. The online consultation for the scoping of topics has been completed and systematic reviews of the topics are being carried out at the Centro Rosarino de Estu- dios Perinatales (CREP), in Rosario, Argentina. Further con- sultation will be completed in 2011. 3.1.10 Family planning training resource package RHR, in collaboration with Family Health International and IntraHealth, produced the Family planning training resource package, a package of up-to-date online training materials based on the Global handbook, MEC and SPR. The package is designed for FP and reproductive health trainers, supervi- sors and programme managers. It contains curriculum com- ponents and tools needed to design, implement and evaluate training. The package includes visual aids and materials for presentations, speaker notes, discussion questions, case- studies and interactive exercises. The materials could be used independently or included into existing FP training materials in pre-service or in-service courses. These are in modular formats; draft versions were uploaded to the Knowl- edge for Health web site ( for a period of public comment ending in January 2011. CD-ROM and USB flash drive versions will also become available when the materials have been finalized. 3.1.11 Dissemination of family planning guidance The FP guidance documents have been printed and trans- lated in many languages and versions (see end of Chap- ter). The updated FP guidelines and tools are available online at the Department web site and were included in the Department CD-ROMs distributed in many conferences and congresses in 2009 and 2010, such as the FIGO World Con- gress of Obstetrics and Gynecology in Capetown, South Africa, the International Conference on Family Planning in Kampala, Uganda, and the Women Deliver Conference in Washington, DC. A CD-ROM containing all FP guidelines available in Spanish and/or Portuguese was created for dis- tribution at many events in Latin America, such as the XXI Reunión Bienal de la Asociación Latino Americana de Inves- tigadores en Reproducción Humana (ALIRH) in Sao Paulo, Brazil; at national meetings for obstetricians, gynaecologists and endocrinologists in Costa Rica (June 2009) and Mexico (November 2009); in Mexico for the Ministry of Health (MoH) and organizations involved in sexual and reproductive health service delivery; and during the World Congress of Family Physicians (WONCA), held in Cancun, Mexico, in 2010. A number of oral presentations were given specifically on these guidance materials at national and international meet- ings, as listed at the end of the Chapter. 3.1.12 WHO laboratory manual for the examination and processing of human semen The fifth edition of the WHO laboratory manual for the examination and processing of human semen was published in 2010. The field of androl- ogy has evolved since the first WHO-recommended labora- tory procedures for semen analysis were published in 1980, and semen analysis results are now applied in a variety of research and clini- cal settings. The standard laboratory methods described are intended as a means to improve the quality of semen analy- sis and comparability of results among laboratories. The fifth edition includes numerous high-quality micrographs to aid in the assessment of sperm morphology; new sections on cryo- preservation and sperm preparation; and an updated and simplified section on quality control and quality assurance in the andrology laboratory. The manual has been updated with the first evidence-based reference distributions and ref- erence limits for various semen characteristics in fertile men; the reference values were published in late 2009. Numerous translations are ongoing and planned (see end of Chapter). 3.1.13 WHO tools on the diagnosis and management of infertility The WHO International Committee for Monitoring Assisted Reproductive Technologies (ICMART) revised glossary on ART terminology was simultaneously published in Novem- ber 2009 in both Fertility & Sterility and Human Reproduc- tion. Its objective is to develop an internationally accepted and updated set of definitions, to standardize and harmo- nize international data collection, and assist in monitoring the availability, efficacy and safety of assisted reproductive services being practised worldwide. The publication is avail- able in the six official WHO languages as well as in Portu- guese, Dutch and German, with translations performed by respective fertility societies. Hard and soft copies have been widely disseminated to fertility society memberships world- wide, including participants at the 2010 European Society for Human Reproduction and Embryology (ESHRE) and Ameri- can Society of Reproductive Medicine (ASRM) meetings. Presentations covering the glossary have been given at inter- national symposia at ESHRE, ASRM, ISMAAR (International Society for Modified Approaches to Assisted Reproduction), IFFS (International Federation for Fertility Societies), FIGO (International Federation of Gynecology and Obstetrics) and regional meetings. A tool on basic infertility packages for use by midlevel pro- viders in primary health care (PHC) facilities and in under- Biennial Technical Report 2009–2010 8 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 resourced settings is being developed with the new FIGO Reproductive Medicine Committee (RMC). Another tool under development has a colourful, e-health/e-mobile format intended for patient self-assessment of preconception issues and understanding infertility and of the risks of either being or becoming infertile. This is being developed in collabora- tion with Cardiff University in the United Kingdom, with the original tool, FertiSTAT, developed for the United Kingdom. A flip-chart tool for use during client–provider settings – such as FP or safe motherhood consultations for patients con- cerned with fertility issues – is being developed, utilizing cur- rent WHO guidelines and components from other WHO tools as a starting-point. This counselling tool will assist clients to address preconception issues and to understand infertility as well as the associated risks or risk behaviours that could result in becoming infertile; it is being developed together with IFFS and FIGO-RMC. 3.1.14 Collaborative guideline work Health promotion guidance In 2010, a cross-cluster task force on mainstreaming health promotion was formally constituted in WHO to develop a package of evidence-based, outcome-oriented health promo- tion actions for low- and middle-income countries addressing the priority public health conditions. A literature review was conducted with the objective to synthesize existing evidence for health promotion activities in the areas of FP, abortion, and female genital mutilation (FGM). In December 2010 the Department contributed to the task force meeting “Main- streaming health promotion, reviewing the health promotion actions for priority public health conditions”, at which a series of papers developed by consultants, and based on the litera- ture review, were reviewed. This work will continue towards the development of a broader document, which will follow the WHO formal process of evidence review and should be finalized by mid-2011. Contributions to the Essential Medicines List (EML) At the request of the Expert Committee on the Selection and Use of Essential Medicines, the Team is reviewing Sec- tions 18.4 (Estrogens) and 18.7 (Progestogens) of the WHO Essential Medicines List (EML) to advise on whether the following should remain on the EML or not: ethinylestradiol in tablet form (10 µg or 50 µg); norethisterone tablet 5 mg; and medroxyprogesterone acetate tablet 5 mg. Information on what the hormones are used for and their public health relevance would be provided. A Cochrane Group in Split, Croatia, was contracted to prepare systematic reviews and GRADE profiles on the evidence available on the use and public health relevance of these products. These syntheses will be reviewed by the PFP and submitted to the Expert Committee for consideration at the March 2011 meeting. Family planning use and promotion in emergen- cies or humanitarian settings The Team contributed to two documents issued by the Inter- Agency Working Group on Reproductive Health in Crises (IAWG on Reproductive Health in Crises). The Inter-agency field manual on reproductive health in humanitarian settings (IAFM), 2010 revision for field review outlines the priority min- imum reproductive health interventions to be implemented from the onset of an emergency and guides the introduction and/or strengthening of reproductive health interventions, including a chapter on FP counselling services. The IAFM can help health programme planners, managers and service providers reduce mortality, morbidity and disability during a humanitarian crisis. The Statement on family planning for women and girls as a life-saving intervention in humanitar- ian settings is used as an advocacy tool and was distributed at the 2010 IAWG on Reproductive Health in Crises Annual Meeting. See also the report of the Improving Maternal and Perinatal Health Team, Chapter 2. Family planning as a component of a strategy for the prevention of mother-to-child transmission of HIV Significant strides have been made in the coverage and quality of programmes for the prevention of mother-to-child transmission (PMTCT) of HIV. But work is still required to meet the goal of improving maternal and child health and sur- vival. Contraception has been called the best-kept secret in PMTCT, yet PMTCT programmes have been slow to under- stand the benefits of FP in the context of PMTCT. There is insufficient integration of FP into antenatal and postpartum care – the backbone of PMTCT programmes – and into HIV treatment programmes. The Team has contributed to the many activities of the PMTCT Team of the WHO HIV/AIDS Department, including the preparation of the PMTCT Strategic Vision 2010–2015 and the convening of the Technical Consultation on the Elimi- nation of Mother-to-Child Transmission of HIV, among others. The Team also participated in the PMTCT Inter-Agency Task Team Working Group, contributing to the preparation of the document Primary prevention of HIV and the prevention of unintended pregnancies in women living with HIV, in the con- text of PMTCT, Strategic framework, 2010–2015. The Team also promoted the use of the Reproductive choices and family planning for people living with HIV: counselling tool, designed for use in HIV service settings. 3 .2 Planned activities The guideline development work of the PFP will continue in the next biennium, in particular with the next consultation to develop the revision and updates of the MEC and SPR. Reviews on the other tools on FP and on infertility will also be undertaken. Guidance for underserved groups (for example, Chapter 1—Promoting family planning 9 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 people living with HIV) and for specific situations (the post- partum period) will also be pursued. 3.2.1 Guidelines for contraception ● Use of the CIRE system will continue, in order to ensure that WHO FP guidance (MEC and SPR) remains up to date, relevant, available and accessible to intended audiences. ● A manuscript documenting the CIRE evaluation and its findings will be prepared, to serve as a companion to the CIRE methods paper published in 2005. ● Recommendations from the external evaluation will be addressed and applied towards the development of the fifth edition of the MEC and updates of the SPR to be initiated in late 2011. It is anticipated that an expert com- mittee will be convened in 2013 to evaluate recommen- dations for revision. ● An update of the second edition of the SPR, with an electronic version that compiles the present version with updated recommendations and text clarifications, will be finalized. ● Translation and printing (as appropriate) of the updated FP guidance and tools, including the fourth edition of the MEC and the MEC Wheel, will continue. ● Development of a mobile phone-based application for the MEC and possibly the SPR will be initiated. Development and updates of other FP tools, guidelines and evidence will be initiated, to help address unmet require- ments for family planning among populations of greatest need. ● The DMT will be updated to ensure that the guidance in this provider tool remains up to date with the latest WHO guidance. ● Initiatives to develop service tools and guidance for health care providers outside of traditional FP services will be undertaken, including those for HIV service deliv- ery areas. ● A guide for family planning for health workers and their clients, a community-based, simplified counselling tool will be finalized (based on field-testing and user feed- back) and disseminated. ● The updated Cochrane review on treatment or preven- tion of irregular bleeding due to use of progestin-only methods of contraception will be completed and submit- ted to the Cochrane Database for publication in 2011. The review will be re-written as a manuscript and sub- mitted to a peer-reviewed scientific journal for publica- tion. 3.2.2 Guidelines for infertility Guidance related to infertility also remains a priority, and materials related to diagnosis and management of infertil- ity will be developed and disseminated in order to increase access to relevant and appropriate interventions, for those most in need. ● Additional translations of the fifth edition of the WHO laboratory manual for the examination and processing of human semen will be undertaken and made available; the Department will collaborate with WHO Press and the respective translators and publishers to ensure the wide- spread dissemination and availability of this tool. ● A tool to guide discussions and consultations on the ethics and legal and social implications (ELSI) of intro- ducing infertility interventions to be used on a national level will be developed. ● Practice guidelines for medically assisted reproductive interventions, such as ovarian stimulation and induc- tion, intrauterine insemination and in vitro fertilization, as lower-cost services for couples (including HIV-positive couples) with fertility problems will be developed. ● The guidelines on the diagnosis of the infertile woman will be updated. 4 . QUALITy of CARE In SExUAL And REPRodUCTIVE HEALTH SERVICES Quality of care in sexual and reproductive health services has been identified as a priority area of research for the Department. Accordingly, the Specialist Panel on Social Sci- ence and Operations Research on Sexual and Reproduc- tive Health has approved support to projects with the aim of expanding the evidence base in this area, some of which has been transformed into policy recommendations. 4 .1 Progress 4.1.1 Users’ perspectives on family planning and sexual and reproductive health services Between 2009 and 2010, 14 research studies focusing on users’ perspectives were conducted on the topic of FP. Of these, studies in Argentina, Brazil, China, Guatemala, India, South Africa, Uganda and the United Republic of Tanzania were completed and results published. A number of studies aimed at understanding the reproduc- tive health needs, perspectives and experiences of people living with HIV/AIDS (PLWHA) in Brazil, Kenya, South Africa, Uganda and the United Republic of Tanzania. These stud- ies variously examined the role of health providers, commu- nity members, partners, and perceived partner HIV-positive status on reproductive health choices including condom use and induced abortion. Biennial Technical Report 2009–2010 10 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 A study “Patient–provider communication and reproductive health among HIV-positive women in Rio de Janeiro, Brazil” was conducted to evaluate what values and preferences women living with HIV have regarding communication with their providers about reproductive health, specifically deci- sions surrounding timing and choice of childbearing. The investigators found that many study participants expressed dissatisfaction, especially in terms of receiving inadequate information and attention, and experiencing stigma and prej- udice during their appointments with their providers and/or health professionals. Findings indicate that there are many missed or ineffectively utilized opportunities to address contraceptive use, planned pregnancy and protected sex among PLWHA in ongoing HIV clinical care consultations. Most providers did not communi- cate at all with their patients about sexual behaviour, fertility intentions or contraception, and were perceived to ignore the realities of the relationships of their clients with their sexual partners. The few exceptions, where the provider assisted the client, were found to have had a great positive impact on the quality of life of both the female patient and her male partner. Even in the Brazilian context of free universal access to ARV therapy, patients lack appropriate reproductive health and family planning services to ensure fully informed deci- sions about when and whether to have children. Notably, when they decided to get pregnant, some participants faced stigma, resistance, and discrimination from their providers, rather than counselling and assistance reflecting their par- ticular reproductive needs. Findings from a study on “A qualitative exploration of HIV- positive pregnant women’s decision-making regarding abor- tion in Cape Town, South Africa” established that women seek abortions due to socioeconomic hardship in conjunction with their HIV-positive status. The investigators found that most respondents reported not using contraceptives, while describing their pregnancies as “unexpected”. In this study, respondents reported negative perceptions among members of the community towards HIV-positive pregnant women. A lack of community support for HIV-pos- itive pregnant women may be largely due to a perception that such women risked infirmity or death by becoming preg- nant, and would also infect their children with HIV. Such HIV- positive women were also thought of as being exceptionally needy and incapable of caring for themselves or others. Notably, the investigators found that induced abortion may be even more stigmatized than HIV/AIDS. Respondents were unlikely to get support for abortion given that it is deeply stigmatized regardless of HIV status. Women contended with social discrimination towards HIV-positive women becoming pregnant, yet were also simultaneously hindered in attempts to access safe abortions for unwanted pregnancies. Com- munity members as well as health facility staff had harsh judgements towards HIV-positive women, blaming them for becoming pregnant, whether this was planned or not. In some cases, abortion facility staff informed women that repeat abortions were not allowed. Despite no legal justifica- tion regarding the number of permissible abortions, women were informed that they could not have a second abortion, or were warned not to return for a second abortion. Fear of community censure was conspicuous and could compel women to continue an unwanted pregnancy, with possible health consequences for mother and baby. Despite this complex and often unsupportive social context, women’s realities compelled them to find solutions to unwanted preg- nancy, and access to safe abortion was critically important to them. Such findings indicate the need for efforts to be under- taken to ensure that women are not being denied access to safe abortion services, and that information and counsel- ling on abortion be integrated into a broader effort on sexual reproductive health in HIV care. The study “Postpartum reproductive behaviour and the role of antenatal HIV diagnosis and family planning counselling in Mwanza, Tanzania” sought to identify opportunities and barri- ers to integrating FP counselling into antenatal HIV services. This study was conducted within the context of very high unmet need for family planning, and pregnancy risk during the postpartum period in the United Republic of Tanzania. The study results revealed that uptake of PMTCT treatment at delivery by HIV-positive women was extremely low, par- ticularly in rural areas, with only 19% (compared with 29% of women in urban areas) having received drugs for them- selves and their baby. Location issues were a major barrier to uptake. Study findings indicated that HIV-positive women over- whelmingly desired to stop childbearing, mainly due to dis- suasive advice from health providers and worries about health deterioration during pregnancy. However, they also had to consider the heavy stigma of childlessness, which emerged stronger than HIV-related stigma (especially in the absence of status disclosure). The major barriers to contra- ceptive use in this population included negative community attitudes (particularly towards contraceptive use by married women), male resistance to family planning, and concerns over side-effects of contraceptive methods. In another study, “Reproductive health needs of people living with HIV in rural Kilimanjaro, Tanzania” a substantial pro- portion of PLWHA were found to desire children in spite of their HIV status. In this population, the prevalence of fertility desire was found to be 43% and the mean number of desired children was three. PLWHA were found to face considera- ble logistic, technical and social challenges in realizing their reproductive choices and intentions. Yet, the investigators found a substantially higher rate of family planning use in Chapter 1—Promoting family planning 11 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 the HIV-positive study population compared with the general population. Another WHO study “Can condom use within marriage con- tribute to HIV prevention: trends in South Africa and Uganda?” compared cross-sectional data on condom use within mar- riage for HIV prevention from adult men and women and their partners in Uganda and South Africa in 1998 and 2008. Con- cern about HIV infection from a cohabiting partner was found to have increased substantially in the study sites over the past decade. Four fifths of women in both countries reported concern in 2008. Among men, concern was found to have increased but remained at a lower level, about two thirds in the South African sites and 40% in Uganda. Consistent condom use among married and cohabiting partners rose substantially in both countries over this time period. HIV infection or perceived spousal HIV infection were found to be a major spur to consistent condom use in both countries over this decade. The percentage reporting consistent condom use in the South African sample of hus- bands increased from 2.5% in 1998 to 12% in 2008 and from 2.5% to 12% among wives. In Uganda, the corresponding figures are 1–8% for husbands and 4–9% for wives. In both countries, condom use was considerably higher among the minority of couples where one or both partners were thought to be HIV-positive. Notably, attitudes towards condom use within marriage were found to have become more positive and spousal discussion of condoms much more prevalent in 2008 than a decade earlier. Use of dual method protection was found to be much higher in South Africa than Uganda, likely reflecting the fact that non-barrier contraception was well established in South Africa before the advent of HIV, but not in Uganda. These findings suggest the need for coun- tries to give greater prominence to the contraceptive ben- efits in condom promotion through social marketing, mass media promotion and counselling than have heretofore been emphasized to married and cohabiting populations. This study also examined the relative influence of partners and motives for contraceptive use among married couples, and found that wives have a stronger role in influencing con- traceptive use than previously thought. In 1998, in both sites, data showed that the wife’s desire to delay or stop childbear- ing was the most powerful predictor of contraceptive use among couples, while in 2008 the data indicated that the wife’s perceived risk of HIV infection from her spouse was the most powerful predictor of condom use among couples. Importantly, these results suggest that most women are able to translate their fertility preferences into protective behav- iours regardless of the views of the husband. In a similar study in Brazil examining “Factors influencing contraceptive choice and discontinuation among HIV-positive women”, findings suggest that HIV status has some impact but is not the most important determinant of contraceptive choice among HIV-positive women in Brazil. Condom use was found to be largely determined by partner preferences. The joint Marie Stopes International (MSI) and WHO report Long-term contraceptive protection, discontinuation and switching behaviour: intrauterine device use dynamics in 14 developing countries provides an in-depth assessment of intrauterine device (IUD) use dynamics, comparing users of IUDs with users of other methods. Results are reported from the analyses of Demographic and Health Surveys (DHS) contraceptive calendar data from 14 nationally representa- tive surveys, mostly conducted between 1998 and 2008. The authors found that the contribution of the IUD to con- traceptive protection was variable across the 14 countries, accounting for about 2% of all contraceptive users in some countries but over half in others. Across the 14 countries, about half of all IUD use appears to be motivated by the wish to space or postpone childbearing. This analysis confirmed the low failure rate of IUDs and low discontinuation rates compared with other methods. Fol- lowing IUD discontinuation for method-related reasons, on average, half of all women switched to another reversible modern method within three months and an additional 11.5% switched to a traditional method. Over 40% of pill, injectable and condom users stopped use within 12 months, while the equivalent figure for IUD users was only 13%. The analysis revealed that the median length of uninterrupted use is typi- cally 30 or more months for IUDs, and typically 10 months for other methods. Thus the results established that the IUD offers, on average, three times the length of contraceptive protection offered by other modern reversible methods. The variable contribution of IUD use to contraceptive protec- tion was not found to be based in any cultural or biological factors inherent in the study samples. Hence, the investiga- tors concluded that the IUD is equally suitable for all soci- oeconomic and residential strata. The country-to-country variability was found to reflect country-specific policy choices as to which methods to promote, and biases in FP services. The authors highlighted the need for governments to con- sider more strongly advocating and supporting the IUD for contraceptive protection. 4.1.2 Elements of quality of care and services Based on recommendations from RHR’s Gender and Rights Advisory Panel (GAP), the Team initiated the development of a human rights-led quality improvement tool that would be based on the broad areas of: (1) access, (2) availability and (3) quality of FP services. The assumption is that improved services that respect and promote human rights will increase contraceptive use and constitute a right of FP clients. Since the 1990s the field of FP has been defined by the Bruce–Jain framework which defines quality of care in FP by the follow- ing six elements: (1) choice of contraceptive methods; (2) Biennial Technical Report 2009–2010 12 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 information given to patients; (3) technical competence; (4) interpersonal relationships; (5) continuity and follow-up; and (6) the appropriate constellation of services, but it has not focused on human rights as a paradigm. Other quality-of- care evaluation tools in FP have focused broadly on either (1) facilities (infrastructure, equipment, supplies and trained staff) or (2) provider–client interaction. The Team has undertaken a systematic review of human rights tools for service delivery and/or the effect of quality of care on contraceptive use. The Team also convened a con- sultation on the possible framework for the development of a tool that could be used by health-care providers (for self- assessment or managerial performance evaluation) or larger entities such as hospitals and ministries of health. This is part of a broader RHR project with the Gender, Reproductive Rights, Sexual Health and Adolescence (GRR) Team that will lead to the development of a human rights implementation tool. Initially, this new tool will focus on FP, but could be used to address all aspects of comprehensive sexual and repro- ductive health. The implementation tool will be based on cur- rent human rights standards and will address the following three levels: law and policy; operations (specifically health systems including programmes and budgeting); and service delivery. The audience and the implementing agencies for the implementation tool may differ depending on the level. 4 .2 Planned activities ● The quality of care in FP improvement tool will be com- pleted and field-tested. ● Social science studies on users’ perspectives will con- tinue, with a focus on vulnerable populations. ● Technical support and/or research capacity building will be provided to investigators conducting social sci- ence and/or operations research related to interventions that are in support of strengthening family planning use among underserved populations. ● Collaboration will continue with South African research- ers at the University of Cape Town and the NGO Cell- life for the development of, implementation and impact assessment of a mobile technology to promote family planning in the postabortion period. 5 . ConTRACEPTIVE RESEARCH And TECHnoLoGy HRP continues to play an important role in the development and evaluation of contraceptives. As the reproductive health needs of couples for reliable and acceptable methods of contraception and infertility services increase, and consider- ing the varying involvement of the private sector, the role of WHO and its public sector and academic partners becomes increasingly significant. 5 .1 Progress The Programme has made much progress on several stud- ies on contraceptive technologies over the past two years. There is a wide range of important findings on emergency contraception, new hormonal methods and on the safety and efficacy of present methods. 5.1.1 Emergency contraception Emergency contraception (EC) remains the only option for women to prevent pregnancy following an unprotected act of intercourse. HRP continues to advance this domain of FP by conducting research on the efficacy, safety and novel uses of methods of EC. The earlier a levonorgestrel (LNG) regimen is administered, the more effective it is. Although there is some evidence of decreasing effectiveness of LNG beyond 72 hours, the extent and time pattern of decrease between 72 and 120 hours has been unclear. Combination of results from two HRP trials provided some evidence of effectiveness until the fourth day following an unprotected act of sexual intercourse. A meta- analysis of HRP trials could provide increased power to esti- mate the relationship between delay in administration and effectiveness up to 120 hours after intercourse. To this end, data were combined from four HRP trials designed to test the efficacy of 1.5 mg of LNG for emergency contraception in a single dose or split in two doses 12 hours apart, within 48 hours, 72 hours or 120 hours of an act of unprotected intercourse. All four studies were randomized controlled trials, randomization being applied to different EC regimens. The proportions of women becoming pregnant among those receiving LNG in successive days after an unprotected act of intercourse were calculated for each trial and for all the trials combined, by day of delay. The odds ratios of pregnancy for each of the successive days of delay, for the four trials com- bined, were calculated using logistic regression and the first day as reference. The number of women with data on time interval between inter- course and treatment and analysed for delay was 6794. There was a significant effect of delay on the proportion of women who became pregnant (p<0.0001). The pregnancy rate varied between 0.7% (14/2065) and 1.6% (17/1059) during the first four days and increased to 5.2% (12/230; 95% CI 2.7% to 8.9%) on the fifth day (see Figure 2). This percentage was not significantly different from the 6% to 8% expected without treatment. The odds ratios for pregnancy in the second, third and fourth day with respect to the first day were not signifi- cantly different. On the fifth day, the odds ratio of pregnancy compared to the first day was almost 6. A high level of effec- tiveness of LNG through the fourth day is an important find- ing. It is uncertain whether LNG still provides some degree of protection, albeit diminished from earlier administration, if administered on the fifth day. This meta-analysis will be pub- lished in early 2011 in the journal Contraception. Chapter 1—Promoting family planning 13 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Figure 2. Odds ratios of pregnancy for intervals of delay between an unprotected act of intercourse and administration of LNG after 24 hours with respect to the first 24 hours, with 95%confidence intervals (CI), for combined data of four HRP studies. Data from an earlier multinational, randomized, controlled trial demonstrated the noninferiority of single-dose LNG with respect to the two-dose regimen. Because of Nige- ria’s very low contraceptive prevalence rate, high abortion rate and diverse cultural characteristics, collaborators in Nigeria and RHR staff hypothesized that results may differ from other countries regarding effectiveness, reported side- effects, and user and provider perceptions of the different dosing regimens of LNG. The purpose of this randomized, controlled, double-blind, multicentre, noninferiority trial was to compare the efficacy and side-effects of two EC treat- ments: two doses of 0.75 mg LNG given 12 h apart versus 1.5 mg LNG given in a single dose up to 120 h (5 days) after unprotected intercourse. The two EC regimens were compared among 3022 Nigerian women enrolled in the study. Efficacy was found to be similar between the treat- ment groups; post-treatment pregnancy rates were 0.57% in the two-dose regimen versus 0.64% in the single-dose regimen (risk difference 0.07% (95% CI −0.50 to 0.64). The majority of women menstruated the first day of expected menses and the groups did not differ regarding reported side-effects. The results from this study demonstrate that the simplified EC regimen of single-dose LNG is not infe- rior in efficacy to the two-dose regimen among Nigerian women. The results of this trial were published in the jour- nal Contraception in 2010. To determine the effectiveness of the Copper T380A (CuT380A) IUD as an emergency contraceptive, the Pro- gramme conducted a prospective, multicentre, cohort clini- cal study in 18 family planning clinics in China. A cohort of 1963 women, aged 18–44 years, requesting EC within 120 hours of unprotected sexual intercourse was enrolled and followed at 1, 3 and 12 months after the insertion of CuT380A. The primary outcome of the study was the efficacy of CuT380A as EC and for up to 12 months of post-insertion use. Insertion complication rates, reported side-effects and continuation rates at 12 months were also recorded. No pregnancies occurred prior to or at the first follow-up visit, making CuT380A 100% effective as EC in this study. The pregnancy rate over the 12-month period was 0.23 per 100 women. In all, 29 (1.5%) women experienced a difficult IUD insertion, requiring local anaesthesia or prophylactic antibiot- ics. No uterine perforation occurred. The main side-effects were increased menstrual bleeding and menstrual distur- bances. The 12-month post-insertion continuation rate was 94.0 per 100 woman-years. These data confirm that the CuT380A is a safe and very effective method for EC, while the advantages of CuT380A include its ability to provide effective, long-term contraception. The results of this study were published in BJOG: an international journal of obstet- rics and gynaecology in 2010. The Programme funded a trial at Instituto Chileno de Medicina Reproductiva (ICMER), in Santiago, Chile to deter- mine whether LNG EC can prevent the development of a clinical pregnancy after ovulation has taken place. This pro- ject is an extension of one funded by the Chilean National Research Fund. A cohort of women attending a FP clinic for EC was enrolled, and menstrual history, time of intercourse and time of intake of LNG EC were recorded. On the day of intake of LNG EC and during five days’ follow-up, blood samples were taken for examination of luteinizing hormone, estradiol and proges- terone concentrations, and vaginal ultrasound examinations were done to document the size of the leading follicle and/or corpus luteum. Thereafter, women were not contacted until the next menses or pregnancy occurred. Among the first 388 women enrolled, 122 women had inter- course on fertile days according to ultrasound and endocrine findings. At the time of LNG EC intake, 87 women were in days –5 to –1 and 35 women were in day 0 (day of ovulation) or beyond. With the use of the probability of clinical preg- nancy reported, expected numbers of pregnancies among the 87 and 35 women were 13 and 7, respectively, while 0 and 6 pregnancies, respectively, occurred. Therefore, prelim- inary results of this study, published in the journal Contracep- tion in 2010, support that LNG EC prevents pregnancy only when taken before fertilization of the ovum has occurred. A manuscript describing the final results of data from all 450 women enrolled is currently in preparation. 5.1.2 New methods of fertility regulation for women The Population Council developed a contraceptive vaginal ring releasing a daily dose of 150 μg of the proprietary pro- gestin Nestorone and 15 μg of ethinyl estradiol over one year. It conducted two phase III clinical trials of this device; 0.68 1.74 0.87 5.81 0−240−24 25−48 49−72 73−96 97−120 0.1 Delay (hours) 1 10 100 Od ds ra tio s Biennial Technical Report 2009–2010 14 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 HRP funded two of the participating centres. Preliminary data suggest that this ring has similar efficacy to the marketed Nuvaring. Its safety profile is similar to that of a third-gener- ation oral contraceptive and it was well accepted by women and their partners. Data analysis was ongoing in 2010 and the Population Council intends to file a New Drug Application with the United States Food and Drug Administration in 2011. 5.1.3 New methods of fertility regulation for men The results of the Phase III trial of testosterone undecanoate (TU) as a male injectable contraceptive were published in 2009. The study was supported by HRP, in collaboration with the National Population and Family Planning Commission of China and Zhejiang Xian Ju Pharmaceutical Co. Ltd of China. As reported previously, 1045 couples were enrolled into the study. Approximately 95% of men responded to the monthly testosterone injections with a reduction in sperm production to contraceptive levels; those men experienced a cumula- tive contraceptive failure rate of 1.1 per 100 men. No serious adverse events were associated with the regimen; spermato- genesis returned to levels generally considered as fertile in all but two men during the planned follow-up period. The regi- men was determined to be safe, effective and acceptable for a population of Chinese couples. In 2008, a multicentre Phase IIb study of the safety and efficacy of norethisterone enanthate (Net-En) plus TU as a two-monthly injectable for male contraception was initiated at five centres. In 2009, five additional centres were initiated and recruitment was ongoing at nine study sites, with the final site starting recruitment in March 2010. The recruitment period ended at all sites on 31 September 2010; 321 couples were enrolled. This is the first multinational clinical efficacy trial of a combined hormonal regimen for male contracep- tion; endpoints include contraceptive efficacy, suppression of spermatogenesis, safety, side-effects, and acceptability. The trial is co-funded with CONRAD (Arlington, VA, USA), and study drugs have been donated by Bayer Schering Pharma, AG (Berlin, Germany). An interim analysis was conducted on the data available in mid-2010. As seen in Figure 3, sper- matogenesis was suppressed to levels generally considered to offer contraceptive protection in 98% of all men who com- pleted the initial 24-week exposure period. These men were eligible to continue into the year-long efficacy portion of the study, during which they and their partners are expected to discontinue all other methods of contraception. 5.1.4 Long-term safety and efficacy of existing methods of fertility regulation Quinacrine hydrochloride, when formulated into pellets and inserted into the uterus of women, causes permanent scar- ring and closure of the fallopian tubes. This non-surgical pro- cedure has never been approved by any regulatory agency; however, it is believed that over 140 000 women have received intrauterine quinacrine for the purpose of steriliza- tion. In 2008, a committee of technical experts was convened to review pre-clinical and epidemiological data related to the long-term safety of this intervention. The evidence reviewed was primarily related to cancer risk; contraceptive efficacy and other potential health effects were not reviewed. The review panel recommended a thorough review of all epi- demiological data as they become available and continued surveillance of women who have received quinacrine steri- lization for risk of gynaecological cancer and other health complications. The experts concluded that, until all safety, effectiveness and epidemiological data have been reviewed, quinacrine should not be used for non-surgical sterilization of women in either clinical or research settings. An interim statement regarding the safety of this procedure as a method of non-surgical sterilization was published on the Depart- ment’s web site in 2009. Figure 3. Percentage of study participants achieving suppression of spermatogenesis to levels generally considered to offer contraceptive protection. 0 10 20 30 40 50 60 70 80 90 100 Number of days since f irst injection R at e (% ) S08 S12 S14 S16 S18 S20 S22 S24S00 Chapter 1—Promoting family planning 15 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 To address the association between hormonal contraceptive use and HIV progression, the Department supported the ret- rospective analysis of a database of 625 female HIV sero- converters from a Ugandan cohort study. A total of 27.5% of women reported ever using hormonal contraception. Time- varying hormonal contraceptive use was not associated with an increased hazard of death as compared with non-use of hormonal contraception (adjusted hazard ratio 0.76, 95% CI 0.41–1.39, p=0.37 ), and was associated with a significantly reduced hazard of progression to AIDS or death (adjusted hazard ratio 0.70, 95% CI 0.50–0.97, p=0.03). The conclu- sion was that hormonal contraceptive use was not associ- ated with faster progression to death, and was associated with a reduced hazard of progression to the composite out- come of AIDS or death. The multicentre, randomized clinical trial of safety, effective- ness and acceptability of the implantable hormonal con- traceptives Jadelle and Implanon continued. In 2006, the protocol was amended to study extended use of Implanon beyond its approved three years duration for its safety and effectiveness. Since then there have been no changes to the study protocol. At the end of 2009, two study centres (Campi- nas, Brazil, and Ankara, Turkey) completed the five years of clinical follow-up; the last centre will complete follow-up in 2013. In 2006, the implant study data entry and management responsibilities were outsourced. Lately, issues were raised on data quality that led to a recent decision, in August 2010, to bring back all data management to WHO headquarters in Geneva to ensure integrity and quality of study data. This delayed closing out the two study centres that have com- pleted participant follow-up until early 2011. Following that, admission and third year data will be synthesized for publica- tion. A protocol to study hormonal injectable contraceptives and their effect on bone mineral density (BMD) in adolescents was finalized, and an initial, pre-study-initiation investigator’s meeting was convened in mid-2010. This prospective, mul- ticentre cohort study was designed to evaluate the effect of the combined injectable contraceptive Cyclofem compared with progestogen-only formulations (DMPA and Net-En) and non-hormonal contraceptive use on adolescent women’s bone health during the period of peak bone mass acquisi- tion. The study was designed to include long-term follow-up, in order to provide data on BMD in early adulthood in the study cohort, during and after use of these methods. The Research Project Review Panel (RP2) recommended revis- ing the study to limit the investigation to Cyclofem compared with controls, as the effects of progestogen-only injectables have been evaluated by other protocols and reported already in published studies. For example, a five-year longitudinal study in South Africa supported by HRP reported evidence of lower BMD increases per year in Net-En and COC users compared to nonusers, but no difference between DMPA users and nonusers. Among Net-En users, an overall reduc- tion in BMD of 0.61% per year was reported; upon discontin- uation, an increase in BMD of 0.69% per year was reported. These results were considered by the panel to have ade- quately established the effects on bone due to use of pro- gestogen-only injectables. In addition, it will be important to address the difficulty of following up a cohort of adolescents, who often switch methods and frequently are lost to follow- up. The protocol will be revised and a late 2011 start date is targeted. At the request of the FP GSG, a sub-analysis of a mater- nal and infant database from the Avon Longitudinal Study of Pregnancy And Childbirth in the United Kingdom, was initi- ated to determine possible developmental effects of hormo- nal contraceptive use during breastfeeding. Previous studies have not well described the potential risks to breastfed new- borns exposed to hormonal contraceptives through breast milk, especially concerning infant growth, achievement of developmental milestones, and overall health. The present analysis shows no difference between breastfed children of women taking hormonal contraceptives at the time and breastfed children of women not taking hormonal contracep- tives, in terms of weight, height and body mass index (BMI) at two and four years of age. Analysis of the data regard- ing effects on behaviour as assessed by standard question- naires showed no effect of hormonal contraceptive exposure during breastfeeding on behaviour at four years of age. Limi- tations of the analysis include a significant amount of missing data and the relative difficulty of interpretation of contracep- tive use data. More in-depth analyses will be performed to address other issues related to specific contraceptive meth- ods and possible effects at older ages. 5 .2 Planned activities ● A multicentre study to evaluate the efficacy, safety and acceptability of pericoital use of LNG has been devel- oped in collaboration with Family Health International (FHI) and HRA Pharma. Trial start is anticipated for 2011. ● Follow-up of couples in the study of contraceptive effi- cacy and safety of Net-En + TU for male fertility regula- tion will continue until early 2013; the final clinical report is expected in 2014, with publications in a peer-reviewed journal to follow. ● A systematic review of the contraceptive efficacy and short-term safety and side-effects of quinacrine as a method of non-surgical sterilization in women will be finalized. An additional review of long-term safety and epidemiological data will be conducted, when data are available. The two reviews will inform the development of a final WHO statement on the safety and efficacy of this intervention. Biennial Technical Report 2009–2010 16 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 ● A manuscript describing the baseline data from the implant study will be prepared for publication, when vali- dated results are available (expected early 2011). The final sites implementing the study will be closed out in 2012. A second manuscript detailing the results of the first three years of the study will be prepared for publica- tion. ● The protocol to review the effects of combined hormonal injectable contraceptives on BMD of young women will be revised to address the methodological concerns. 6 . SUPPoRT To CoUnTRIES 6 .1 Progress In 2009, the Department conducted a consultation on the definition of competencies for the delivery of sexual and reproductive health, including FP, in an integrated manner within PHC services, with the goal of contributing to the achievement of health equity and universal access to sexual and reproductive health, particularly in developing country settings. The report was finalized and made available in late 2010 (see Report 8.8). In September 2009, the United Nations Population Fund (UNFPA), WHO’s Regional Office for the Americas, and the Department organized a workshop for 15 English- and Dutch-speaking Caribbean countries on how to use and introduce the DMT and the Global handbook into national FP programmes. Participants came from ministries of health and NGOs that provide FP services. Countries developed draft work plans to introduce the DMT and the Global handbook into their national FP programmes. A workshop for francophone Central African countries took place in Cotonou, Benin (23–27 November 2009) at which guidelines for FP, sexually transmitted infections and mater- nal and newborn health were introduced to national pro- gramme managers, and plans were made for adaptation and adoption into each country’s norms and standards. An existing document prepared by RHR describing the non- abortifacient nature of contraceptives was sent for use in advocating for reproductive health policies and services in Uganda in May 2010 and in the Philippines in October 2010, with the support of the RHR Technical Cooperation with Countries for Sexual and Reproductive Health Team (TCC). The IFFS developed a new plan of work on infertility and was awarded a renewal as an NGO in official relations with WHO in January 2010. Workshops, with presentations by WHO, were held in 2009 in Alexandria, Egypt and in Kampala, Uganda. In 2010, a joint IFFS–WHO infertility workshop was held in Surabaya, Indonesia and a joint IFFS–WHO sympo- sium on the ethics and legal and social implications of intro- ducing infertility interventions was held in Santiago, Chile. ICMART became an NGO in official relations with WHO fol- lowing the development of a joint plan of work for the moni- toring and surveillance of infertility interventions through the application of assisted reproductive technologies. Two sym- posia, planned jointly with WHO, were held each year to pre- sent ICMART data on worldwide monitoring at the ESHRE and ASRM annual meetings. 6 .2 Planned activities ● Additional technical support will be provided for further field-testing of A guide to family planning for health workers and their clients. This tool will be finalized and disseminated to regional offices and countries for adap- tation and use. ● A consultation will be held with partners in the African Region to discuss community health workers’ use of FP counselling tools. ● Technical support will be provided to Member States requesting assistance for the introduction, translation and dissemination of family planning guidelines and tools. ● Collaboration with the TCC and other partners will con- tinue on the dissemination, advocacy and adaptation of FP guidelines and tools at regional and country levels. ● A research project will be led with provision of technical support to Karnataka State National Rural Health Mis- sion, India in the development and impact assessment of an mHealth (mobile technology) reproductive health package in support of health service delivery by rural health providers. ● A consultation will be held with collaborators from the African and South-East Asian Regions on the adapta- tion of the family planning component of the “Packages of Interventions” into mobile technology equivalent tools. Chapter 1—Promoting family planning 17 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 PUBLICATIonS In 2009–2010 Peer-reviewed papers CIRE System Culwell KR, Curtis KM. Use of contraceptive methods by women with current venous thrombosis on anticoagulant therapy: a systematic review. Contraception, 2009, 80:337– 45. Culwell KR, Curtis KM, del Carmen Cravioto M. Safety of contraceptive method use among women with systemic lupus erythematosus: a systematic review. Obstet Gynecol, 2009, 114:341–53. Curtis KM, Nanda K, Kapp N. Safety of hormonal and intrauterine methods of contraception for women with HIV/ AIDS: A systematic review. AIDS, 2009, 23 suppl1:S55– S67. Curtis KM, Peterson HB, d’Arcangues C. Keeping evidence-based recommendations up to date: the World Health Organization’s global guidance for family planning. Contraception, 2009, 80:323–4. Curtis KM, Ravi A, Gaffield ML. Progestogen-only contraceptive use in obese women. Contraception, 2009, 80:346–54. Gaffield ME, Culwell KR, Ravi A. Oral contraceptives and family history of breast cancer. Contraception, 2009, 80:372–80. Gaffield ME, Kapp N, Curtis KM. Combined oral contraceptive and intrauterine device use among women with gestational trophoblastic disease. Contraception, 2009, 80:363–71. Gaffield ME, Kapp N, Ravi A. Use of combined oral contraceptives post abortion. Contraception, 2009, 80:355– 62. Kapp N. WHO provider brief on hormonal contraception and liver disease. Contraception, 2009, 80:325–6. Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception, 2009, 80:327–36. Kapp N, Curtis KM. Hormonal contraceptive use among women with liver tumors: a systematic review. Contraception, 2009, 80:387–90. Kapp N, Curtis KM. Combined oral contraceptive use among breastfeeding women: a systematic review. Contraception, 2010, 82:10–6. Kapp N, Curtis KM, Nanda K. Progestogen-only contraceptive use among breastfeeding women: a systematic review. Contraception, 2010, 82:17–37. Kapp N, Tilley IB, Curtis KM. The effects of hormonal contraceptive use among women with viral hepatitis or cirrhosis of the liver: a systematic review. Contraception, 2009, 80:381–6. Paulen ME, Curtis KM. When can a woman have repeat progestogen-only injectables – depot medroxyprogesterone acetate or norethisterone enantate? Contraception, 2009, 80:391–408. Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion; Centers for Disease Control and Prevention (CDC), Farr S, et al. US Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep, 2010, 18(59):1–86. Effects of contraceptives on HIV progression Polis CB, et al. Effect of hormonal contraceptive use on HIV progression in female HIV seroconverters in Rakai, Uganda. AIDS, 2010, 24(12):1937–44. Polis CB, et al. Effect of hormonal contraceptive use before HIV seroconversion on viral load setpoint among women in Rakai, Uganda. J Acquir Immune Defic Syndr, 2010, Nov 9 [Epub ahead of print]. Polis CB, et al. Trends and correlates of hormonal contraceptive use among HIV-infected women in Rakai, Uganda, 1994–2006. Contraception. (in press) Emergency Contraception Dada OA, Godfrey EM, Piaggio G, von Hertzen H, Nigerian Network for Reproductive Health Research and Training. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria. Contraception, 2010, 82: 373–8. Noé G, et al. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception, 2010, 81:414–20. Piaggio G, Kapp N, von Hertzen H. Effect on pregnancy rates of the delay in the administration of levonorgestrel for emergency contraception: a combined analysis of four WHO trials. Contraception. (in press) Steenland M, et al. Intrauterine contraceptive insertion post- abortion: a systematic review. (submitted) von Hertzen H, Godfrey EM. Emergency contraception: the state of the art. Reprod Biomed Online, 2009,18 Suppl 1:28–31. Westley E, Glasier A. Emergency contraception: dispelling the myths and misperceptions. Bull World Health Organ, 2010, 88:243–4. Wu S, et al. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort trial. BJOG, 2010, 117 (10):1205–10. Biennial Technical Report 2009–2010 18 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Infertility Fujii M, et al. Perinatal risk in singleton pregnancies following in-vitro fertilization. Fertil Steril, 2010, 94:2113–7. Zegers-Hochschild F, et al. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology. Hum Reprod, 2009, 24:1–5. Zegers-Hochschild F, et al. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology. Fertil Steril, 2009, 92:1502–24. Social science research on users’ perspectives Ahman E, Shah I. Contraceptive use, fertility, and unsafe abortion in developing countries. Eur J Contracept Reprod Health Care, 2010 Dec, 15(S2):S77–S82. Bastos FI. Influence of culture on contraceptive utilization among HIV-positive women in Brazil, Kenya, and South Africa. AIDS Behav. (in press) Cooper D, et al. Fertility intentions and reproductive health care needs of people living with HIV in Cape Town, South Africa: Implications for integrating reproductive health and HIV care services. AIDS Behav, 2009, 13 (Suppl 1):38–46. Huang Y, Wenqing W, Suiming P. The culture of talking about Xiaojie (FSWs): Constructing sexuality, gender and health in everyday life: A qualitative study of male construction workers in China. (submitted) Maharaj P, et al. Can condom use within marriage contribute to HIV prevention: trends in South Africa and Uganda? Int Perspect Sex Reprod Health. (in press) Shah IH. Family planning and reproductive health. Chapter 6 in the Encyclopedia on life support system (EOLSS). Paris: United Nations Scientific and Educational Organization (UNESCO). Stanback J, et al. Community-based health workers can safely and effectively administer injectable contraceptives: conclusions from a technical consultation. Contraception, 2010, 81:181–4. Wagman J. Integrating intimate partner violence prevention into an HIV/AIDS research program in rural Africa: an example from Rakai, Uganda. (submitted) WHO/Rockefeller initiative on implantation research Yuan JX, et al. Increased expression of heat shock protein 105 in rat uterus of early pregnancy and its significance in embryo implantation. Reprod Biol Endocrinol, 2009, 7:23. Methods for the regulation of male fertility Cooper TG, et al. World Health Organization reference values for human semen characteristics. Hum Reprod Update, 2010, 16:231–45. Gu Y, et al. Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men. J Clin Endocrinol Metab, 2009, 94:1910–15. Schwingl PJ, et al, on behalf of the HRP Multicenter study of prostate cancer and vasectomy. Prostate cancer and vasectomy: a hospital-based case-control study in China, Nepal and the Republic of Korea. Contraception, 2009, 79:363–8. Others d’Arcangues C. Os et contraception hormonale. Réalités en Gynécologie-Obstétrique, 2009, 135:29–32. d’Arcangues C. La contraception au niveau mondial: les grands enjeux. Médecine de la Reproduction, Gynécologie, Endocrinologie, 2009, 11(5):1–9. d’Arcangues C, et al. Women’s views and experiences of their vaginal bleeding patterns: An international perspective from Norplant users. Eur J Contracept Reprod Health Care, 2010 Dec 7. [Epub ahead of print]. de Francisco A, et al. Perceived research priorities in sexual and reproductive health for low- and middle-income countries: results from a survey. Global Forum for Health Research and World Health Organization, October 2009. Peterson HB, et al. Accelerating science-driven solutions to challenges in global reproductive health: a new framework for moving forward. Obstet Gynecol. (in press) Reports Ali MM, et al. Long term contraceptive protection, discontinuation and switching behaviour: Intrauterine Device (IUD) use dynamics in 14 developing countries. London, Marie Stopes International. (in press) Department of Public Health and Department of HIV/AIDS Prevention and Care, Ministry of Health, Government of Botswana. Rapid assessment of sexual & reproductive health and HIV&AIDS linkages in Botswana. Gabarone, 2009. World Health Organization. Strategic considerations for strengthening the linkages between family planning and HIV/AIDS policies, programs, and services. 2009. Policy briefs The safety of quinacrine when used as a method of non- surgical sterilization in women. Interim statement. http:// (2009). Chapter 1—Promoting family planning 19 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Community based providers in rural Guatemala can provide the injectable contraceptive DMPA safely. http://whqlibdoc. (2009). Centre for Research on Environment, Health and Population Activities. No way out: sexual violence within marriage in Nepal. CREHPA Reproductive Health Research Policy Brief, No 12, October 2010. Statements Progestogen-only contraceptive use during lactation and its effects on the neonate. reproductivehealth/publications/family_planning/WHO_ RHR_09_13/en/index.html (2009). Fact sheets WHO, ICEC, FIGO, IPPF: Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs). World Health Organization, Geneva, 2010. http:// pdf Combined hormonal contraceptive use during the postpartum period. RHR_10.15_eng.pdf (2010). Summary reports WHO, USAID, FHI. Community-based health workers can safely and effectively administer injectable contraceptives – conclusions from a Technical Consultation. http://www. WHO_CBD_brief.pdf (2009). Technical consultation on hormonal contraceptive use during lactation and effects on the newborn. Summary report. eng.pdf (2010). Conference presentations d’Arcangues C. “The evolution of family planning: current situation and future trends in the context of WHO Global Strategies for Reproductive Health.” First International Congress on Reproductive Health and Family Planning, Tehran, Islamic Republic of Iran, 21–23 January 2009. d’Arcangues C. “The situation of family planning worldwide.” Réseau africain francophone de télémédecine. 1 April 2009. d’Arcangues C. «Keeping the WHO family planning guidance up-to-date.» FIGO World Congress in Obstetrics and Gynecology, Cape Town, South Africa, 6 October 2009. d’Arcangues C. “Situation de la contraception dans le monde, sa contribution à la santé maternelle et infantile.” 6ème Congrès de la Société francophone de Contraception, Hammamet, Tunisia, 16–17 October 2009. d’Arcangues C. “Effets des méthodes de contraception hormonale sur le métabolisme osseux.” 6ème Congrès de la Société francophone de Contraception, Hammamet, Tunisia, 16–17 October 2009. d’Arcangues C. “Reproduction humaine – Réalisations et défis au niveau mondial.” University of Geneva, Switzerland, 16 December 2009. d’Arcangues C. «Sexual and reproductive health.» Athens University, Greece, 11 May 2010. d’Arcangues C. «Hormonal contraception, bone metabolism and adolescence.» 16th World Congress of Pediatric and Adolescent Gynecology, Montpellier, France, 22–25 May 2010. d’Arcangues C. «International perspectives on family planning.» Second International Congress on Reproductive Health and Family Planning, Orumieh, Iran (Islamic Republic of), 27–29 October 2010. d’Arcangues C. “Les adolescents et la contraception.” Journées d’Automne du GRSSGO, Montreux, Switzerland, 11–13 Novembre 2010. d’Arcangues C. “Les critières de choix des méthodes contraceptives actualisés.” 7ème Congrès de la Société francophone de Contraception, Libreville, Gabon, 23–24 November 2010. d’Arcangues C. “La recherche en contraception à l’OMS.” 7ème Congrès de la Société francophone de Contraception, Libreville, Gabon, 23–24 November 2010. d’Arcangues C. “Reproduction humaine – Réalisations et défis au niveau mondial”. University of Geneva, Switzerland, 15 December 2010. Festin M. Elements of successful family planning programmes. Regional workshop on the implementation of best practices in family planning, Amman, Jordan, 27–30 September 2009. Festin M. Elements of successful family planning programmes and Medical eligibility criteria updates. Reconvening Bangkok: 2007 to 2010 – Progress Made and Lessons Learned in Scaling Up FP MNCH Best Practices in Asia and the Middle East Region, Bangkok, Thailand, 6–8 March 2010. Festin M. “Updates on contraceptive technology and information sources.” Women Deliver Philippines Conference, Quezon City, Philippines, September 2010. Festin M. “Effective counselling strategies for family planning and reproductive health.” Women Deliver Philippines Conference, Quezon City, Philippines, September 2010. Biennial Technical Report 2009–2010 20 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Festin M. Panel on the critical role of family planning in the context of maternal mortality reduction and human rights. Women Deliver Philippines Conference, Quezon City, Philippines, September 2010. Pantelides EA, Gaudio M, Manzelli H. “Men´s needs for reproductive health services in two cities in Argentina.” VI Taller de Investigaciones Sociales en Salud Reproductiva y Sexualidad (VI Workshop on Social Sciences Research in Reproductive Health and Sexuality), Buenos Aires, Argentina, July 2010. Mbizvo M. “Integrating HIV and FP Services: Evidence at Hand, Evidence Needed.” International Conference on Family Planning, Kampala, Uganda, 16 November 2009. Peterson H, Festin M. “The new WHO contraceptive guidelines.” FIGO World Congress in Obstetrics and Gynecology, Cape Town, South Africa, October 2009. Thapa S. “Contraceptive use and correlates among the adolescents in developing countries.” 16th World Congress of Pediatric and Adolescent Gynecology, Montpellier, France, 22–25 May 2010. Vanderpoel S. “Infertility - essential components affecting family planning, maternal and perinatal reproductive health care programmes.” Third Alexandria Forum for Women’s Health, Alexandria, Egypt, 18 March 2009. Vanderpoel S. “WHO primary health care management of the infertile couple”; “WHO and international initiatives”; and “Low cost IVF”. 15th World Congress on IVF, the 4th World Congress on in vitro Maturation (IVM), Geneva, Switzerland, 19–22 April 2009. Vanderpoel S. “Infertility: the hidden tragedy within family planning.” International Conference on Family Planning, Kampala, Uganda, 17 November 2009. Vanderpoel S. “Infertility, access to care.” European Society for Reproductive Medicine and Embryology (ESHRE) Task Force for Infertility in Developing Countries, in association with the ESHRE Intrauterine Insemination Training Course, Genk, Belgium, 4 December 2009. Vanderpoel S. “Vulnerabilities, assessment of vulnerable populations - the infertile;” “Development of revised WHO guidelines for infertility” and “Affordable IVF initiatives.” Symposium on “Ethical Issues Related to Sexual Reproductive Health (SRH) Research,” New Delhi, India, 17–18 May 2010. Vanderpoel S. “Infertile in developing countries” and “Ethical aspects of introducing affordable infertility interventions.” International Federation for Fertility Societies, IFFS Symposium on “Infertility in low-resource settings”, Surabaya, Indonesia, 12–13 June 2010. Vanderpoel S. “The importance of monitoring assisted reproductive medicine interventions.” 26th Annual Meeting of the European Society for Reproductive Medicine and Embryology (ESHRE), Rome, Italy, 30 June 2010. Vanderpoel S. “Ethical aspects of reproductive research (infertility) and the need for non-human primate models.” 18th International Biomedical Research Conference in association with the National Museum of Kenya and the 50th Anniversary or the Institute for Primate Research, Nairobi, Kenya, 8 July 2010. Vanderpoel S. “Safeguarding sexual and reproductive rights and addressing barriers to care – achieving empowerment and equity to meet fertility intentions of indigenous peoples.” Annual Meeting of the UN Interagency Support Group on Indigenous Peoples Issues (IASG), Geneva, Switzerland, 16 September 2010. Vanderpoel S. “Fertility management tools for low resource environments” and “Perspectives and activities in reproductive medicine: Infertility.” International Federation for Obstetrics and Gynecology (FIGO)/Al Azhar Reproductive Medicine, Infertility diagnosis and management, Cairo, Egypt, 18–22 September 2010. Vanderpoel S. “Affordable assisted infertility interventions in developing and developed countries.” International Society for in-vitro fertilization (ISIVF) Symposium, Tunis, Tunisia, 8 October 2010. Vanderpoel S. “Recognition of infertility as a global public health problem” 66th Annual Meeting of the American Society for Reproductive Medicine (ASRM), Denver, Colorado, 25 October 2010. Vanderpoel S. “Addressing ethical challenges in a multicultural world. A global perspective.” Symposium on “Ethical challenges of modern reproductive medicine – infertility interventions”, Santiago, Chile, 12 November 2010. Vogelsong KM. Why do we need male contraceptive methods? 11th Congress of the European Society of Contraception and Reproductive Health, Den Haag, the Netherlands, 19–22 May 2010. Chapter 1—Promoting family planning 21 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Family planning guidelines and tools completed in 2009–2010 Guideline Versions available Versions completed in 2009–2010 Translations ongoing or planned Medical eligibility criteria for contraceptive use, 4th edition, 2010 English French, Spanish Selected practice recommendations for contraceptive use, 2008 update English, French Spanish Russian Family planning: A global handbook for providers, 2007 (updated in 2008) Arabic, Chinese, English, Farsi, French, Hindi, Kiswahili, Lithuanian, Portuguese, Romanian, Russian, Spanish, Urdu Farsi Decision-making tool for family planning clients and providers 2005 Arabic, Bahasa Indonesia, Bangali, Burmese, Chinese, Dari, Divehi, English, Farsi, French, Hindi, Kosovar, Mongolian, Nepali, Pashtu, Romanian, Russian, Spanish, Thai, Turkish, Uzbek, Vietnamese Kiswahili, Korean, Portuguese, Laotian Tool Versions available Versions completed in 2009–2010 Translations ongoing or planned Medical eligibility criteria Wheel, 2006 (updated in 2009) Arabic, Burmese, Chinese, English, French, Lithuanian, Mongolian, Portuguese, Romanian, Russian, Spanish, Uzbek Azeri, Bahasa Indonesian, Burmese, English electronic version (Flash), English (2009 update), English (India), English (Sri Lanka), Farsi, Latvian, Spanish (2009 update), Ukrainian, Uzbek Reproductive choices and family planning for people with HIV counselling tool, 2006 English, French (web) Spanish Dutch (Suriname), Khmer (Cambodia) WHO laboratory manual for the examination and processing of human semen, 5th edition 2010 English Chinese, French, German, Italian, Japanese, Russian, Spanish, Turkish, Vietnamese 22 Bi en ni al T ec hn ic al R ep or t 2 00 7– 20 08 Chapter 2 Improving maternal and perinatal health 1 . InTRodUCTIon RHR’s Maternal and Perinatal Health Team (MPH) fully embraces WHO’s collaborative approach in developing and carrying out its plan of work. MPH aims to learn from others through real collaboration and transform innovative ideas into concrete opportunities for the improvement of maternal and newborn health. 2 . ConTRIBUTIon To WHo’S MEdIUM-TERM STRATEGIC PLAn 2008–2013 HRP’s work in the area of maternal and perinatal health is conducted in the context of the activities specified under SO4 “Reduce morbidity and mortality and improve health during … pregnancy, childbirth, the neonatal period, … adoles- cence, and to improve sexual and reproductive health … for all individuals” and, more specifically, OWER 4.2 of WHO’s Medium-term Strategic Plan: “National research capacity strengthened as necessary and new evidence, products, technologies, interventions and delivery approaches of global and/or national relevance available to improve mater- nal, newborn, child and adolescent health, … and to improve sexual and reproductive health.” MPH’s workplan reflects the principles of the recently launched UN Global Strategy for Women’s and Children’s Health which calls for all partners to take action to reverse decades of underinvestment, increase the efficient delivery of services, and accelerate global progress towards Mil- lennium Development Goals (MDGs) 4 and 5. Suggested actions include a recommendation for national governments; international organizations; the business community; aca- demic institutions; foundations; health professional organi- zations and NGOs to make a concerted effort to align their priorities, increase their commitment to women and children, and invest in the establishment of effective collaborations with existing and new partners. In the context of the Global Strategy, MPH will contribute to WHO’s Medium-term Strategic Plan 2008–2013 by address- ing three major challenges: 1. The causes of many of the conditions leading to poor obstetric outcomes are still insufficiently understood and represent a major obstacle to the development of effec- tive interventions with universal application. 2. Many proven interventions for improving maternal and newborn survival are poorly implemented, especially in resource-constrained settings (e.g. magnesium sulfate for the treatment of eclampsia/pre-eclampsia, and cor- ticosteroids for the prevention of mortality in preterm babies). There is growing interest in the international community to develop new methodologies to effectively translate research findings into practice in low-resource settings and monitor and evaluate such translation efforts. 3. Pervasive inequities in maternal and newborn health have persisted in part because of lack of political prior- itization and awareness of the dangers associated with pregnancy and childbirth. However, maternal and new- born health is emerging as a global priority and high- level politicians are becoming increasingly interested in accelerating efforts to achieve MDGs 4 and 5. To best capitalize on these positive trends, innovative advo- cacy and financial mechanisms are needed to increase awareness of and mobilize resources for improving maternal and newborn health. Chapter 2—Improving maternal and perinatal health 23 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 3 . BASIC SCIEnCE Pre-eclampsia/eclampsia and preterm birth are major com- plications of pregnancy and are among the leading causes of maternal and perinatal morbidity and mortality worldwide. Despite considerable investments in research on their pre- vention and treatment, the causes of pre-eclampsia and pre- term birth are far from being understood. Progress in basic science research has the potential to reduce the death toll for women and infants due to these two conditions, as the ability to predict which women are likely to deliver preterm and/or develop pre-eclampsia could have significant implications for clinical practice, potentially leading to a reduction in negative pregnancy outcomes. 3 .1 Progress 3.1.1 Genetics and preterm birth: the Preterm Birth Genome Project (PGP) Since 2006, the Preterm Birth International Collaborative (PREBIC), a group of 60–70 preterm birth experts, has con- vened annually at WHO headquarters. Several ideas gener- ated at these meetings have turned into papers, approved study protocols and concrete opportunities. For example, the PREBIC group published the first ever global and regional estimates of preterm birth rates and a major synopsis of gene variants potentially associated with the risk of preterm birth. The work on genetic variants fostered a spin-off of PREBIC, the Preterm Birth Genome Project (PGP). At the 2007 annual meeting, discussion centred on how to apply an emerging genotyping technique, the genome wide association study (GWAS), to determine the genetic risk of preterm birth. Prior to the GWAS, genetic association studies of preterm birth were based on hypothesis testing that a priori defined gene variants that could increase risk of preterm birth. The GWAS made it possible to scan the whole genome for gene variants that appeared to be more frequent in women who deliver pre- term. The challenge discussed by the PREBIC group was how to develop a feasible research protocol with the limited resources available. To generate a large enough sample and on the basis of a suggestion of Dr Scott Williams, a geneti- cist from Vanderbilt University, Nashville, TN, USA, PREBIC members agreed to pool already collected samples. This was an unprecedented decision given that PREBIC members are all affiliated with different universities and institutions. Donors attending the meeting offered to provide start up funds for the project. Other donors followed suit, making the study possi- ble. Today PGP is the only GWAS on preterm birth that has produced positive results, making it a clear example of the effectiveness of collaboration. Figure 1 shows the gene variants significantly associated with risk of preterm birth replicating in two different cohorts. These results generated additional interest and enabled the PGP collaboration to find samples from three additional cohorts and the financial resources needed to replicate the results in independent populations. Analysis of the data from these additional cohorts is ongoing and results are expected by early 2011. Results will be presented at the annual meet- ing of the Society for Gynecologic Investigation (SGI), the premier society for basic, translational and clinical investiga- tion in the reproductive sciences and women’s health. 3.1.2 Angiogenic factors for the screening of pre-eclampsia Identifying biomarkers that could be used to identify preg- nant women at risk of developing pre-eclampsia is a major unachieved objective in obstetrics. A multicentre observa- tional study entitled: “Screening for pre-eclampsia: evalua- tion of the predictive ability of angiogenic factors” is ongoing, aimed at testing whether changes in serum and urinary angiogenic proteins, substances potentially involved in the genesis of hypertension in pregnancy, can be used as an effective method for identifying women at high risk of devel- Figure 1. Negative logarithm of the association P-value for each single nucleotide polymorphism with risk of preterm birth in two independent cohorts. Highlighted are the strongest associations detected among the ones that replicate in both cohorts. Biennial Technical Report 2009–2010 24 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 oping pre-eclampsia. If proven effective, dipsticks and other ready-to-use methods to detect angiogenic factors could be developed for use at point of care. The study is being implemented in eight countries (Argen- tina, Colombia, India, Italy, Kenya, Peru, Switzerland, Thai- land) and involves the recruitment of approximately 10 000 women. Analyses of blood and urine samples will be per- formed at the Perinatal Research Branch of the United States National Institute of Child Health and Human Devel- opment (PRB/NICHD) under an agreement between HRP and NICHD. PRB/NICHD will assume the costs of perform- ing laboratory analyses on collected samples to test the effi- cacy of several other biomarkers beyond angiogenic factors, which might provide the biological basis for more feasible screening tests for universal application. HRP’s role is to coordinate the collection of biological samples and informa- tion from large cohorts of women and their infants worldwide according to a well-defined methodological protocol. This collaboration will allow HRP and PRB/NICHD to test rapidly new research hypotheses without having to establish new ad-hoc research protocols and infrastructures. To date, the collaboration has produced important preliminary results as shown in Figure 2 depicting the predictive ability of angio- genic factors. 3 .2 Planned activities As new ideas surface within these collaborative networks, HRP is well positioned to facilitate their uptake into research projects. Following are some examples of exciting recent developments. 3.2.1 Biomarkers for preterm birth In the context of PREBIC, a systematic review was con- ducted to map out knowledge gaps in this area. The review showed that no single biochemical biomarker is capable of predicting with a high degree of accuracy which women will experience a preterm birth (PTB). In response, a two-phase study was planned to develop a multiple biomarker chip that could be useful for predicting PTB. In the first phase, the biomarker chip will be tested on stored blood samples from women at high risk for PTB that were collected for other studies. In the second phase of investigation, the chip will be tested prospectively in a cohort of women at two different times during pregnancy. 3.2.2 Systematic review of the genetic profile of successful pregnancy Adverse outcomes are frequent in human reproduction: approximately 15% of all pregnancies end in spontaneous abortions, 12% will result in a preterm delivery and at least Figure 2. Serum level of various angiogenic factors in women with and without pre-eclampsia (preliminary results). sEng: soluble endoglin; sFlt-1: soluble fms – like tyrosine Kinase-1; PIGF: placental growth factor. Chapter 2—Improving maternal and perinatal health 25 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 8% of all pregnant women will develop pre-eclampsia or other hypertensive disorders. Successful human pregnancy is the result of a complex interaction between genetic and envi- ronmental factors and between numerous fetal and mater- nal mediators, many of which are still unknown. A number of studies have shown that genetics play an important role in pregnancy. However, the exact genetic variants involved in pregnancy success have not been clearly identified. This may be due to the fact that most investigators concentrate on identifying genes involved in adverse pregnancy outcomes, instead of focusing on the genetic profile of women who deliver healthy, full-term, and adequately grown infants. The plan is to review the multiple polymorphisms described in the control groups of genetic profile studies published in the past 20 years. A final product of this systematic review is the crea- tion of an electronic database presenting the genetic profiles of healthy women of various ethnic groups with favourable pregnancy outcomes. This database could be useful for future studies aimed at identifying protective genes or alleles associated with a healthy pregnancy resulting in positive maternal and perinatal outcomes. 3.2.3 Biomarkers for pre-eclampsia First discovered in 1982, calcitonin gene-related peptide (CGRP) is a member of the calcitonin family of peptides and has multiple biological effects. It is one of the most important peptide vasodilators, involved in hypertension and associ- ated diseases, including pre-eclampsia. Adrenomedullin is another polypeptide that shares structural similarity to the calcitonin family. Although there are several primary studies on the use of CGRP and adrenomedullin as possible bio- markers for pre-eclampsia, no systematic review has been published on this topic. To address this gap, a systematic review will be conducted to explore the association between CGRP or adrenomedullin and pre-eclampsia and determine the possible usefulness of CGRP and adrenomedullin as potential predictive markers for pre-eclampsia. 4 . CLInICAL RESEARCH Historically, clinical trials have been the focus of the Team’s work. In the last few years the scope of this work was expanded to include studies aimed at establishing fetal growth standards for international applications, assessing the safety and appropriate use of ultrasonography in obstet- rics and developing innovative ideas with the potential of improving obstetric care especially in low-resource settings. Importantly, the success of PREBIC generated positive inter- est in horizontal approaches to managing research collabo- rations and led to the establishment of the Global Obstetrics Network (GONet) described below. 4 .1 Progress 4.1.1 Global Obstetric Network In 2010, Dr Chaty Spong, Chief of the Pregnancy and Peri- natology Branch at the NICHD, Bethesda, MD, USA, called for the establishment of a network of researchers conducting clinical science trials in obstetrics. Having witnessed the suc- cess and growth of PREBIC during the past few years, the Team became a founding member of GONet. GONet mem- bers proposed that WHO should be the hub of the new col- laboration and the Team organized the first official meeting in September 2010. The mission of GONet is to provide a forum for interaction and collaboration among international groups that perform clinical trials and observational stud- ies in maternal–fetal medicine and obstetrics. The purpose is to foster communication between the groups in order to improve ongoing and future trials. The goal is to open new avenues for cooperation in the design and conduct of large international trials/studies, seeking funding and highlighting evidence. The expectation is that this will lead to better stud- ies, more efficient use of resources and minimize duplica- tion. In addition, the group will cooperate on data elements to allow future collaborations, and identify pressing issues in maternal–fetal medicine. 4.1.2 Active management of the third stage of labour (AMTSL) trial Postpartum haemorrhage (PPH) is one of the leading causes of maternal death in developing countries. Active manage- ment of the third stage of labour (AMTSL) reduces the occur- rence of severe postpartum haemorrhage by approximately 60–70%. AMTSL consists of a package of interventions, but the relative contribution of each to mortality reduction is unknown. Controlled cord traction is one of the interventions that requires training for it to be performed appropriately. If this intervention could be removed from the package with- out a consequent reduction in efficacy of AMTSL, it would have major implications for effective clinical management of the third stage of labour at peripheral levels of health care – particularly in settings with severe human resource con- straints. The “Trial of active management of third stage of labour” is being conducted with the TCC and in collaboration with the US International Agency for International Develop- ment (USAID) to determine whether the simplified package of oxytocin 10 IU IM/IV without controlled cord traction is as effective as the full AMTSL package with regard to reduc- ing blood loss ≥1000 ml. Centres in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda are participating. Recruitment was completed in October 2010 and results are expected to be published in 2011. This activ- ity is part of a larger collaborative effort to develop updated guidelines for the prevention and treatment of PPH. Biennial Technical Report 2009–2010 26 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 4.1.3 Treatment for asymptomatic bacteriuria trial Based on the results of a Cochrane review on duration of treatment for asymptomatic bacteriuria (ASB), a multicen- tre, randomized, placebo-controlled double blind trial was conducted to compare the effectiveness of one-day versus seven-day nitrofurantoin treatment to eliminate ASB during pregnancy. Results showed that one-day nitrofurantoin treat- ment is significantly less effective than the seven-day regi- men. Results were published in 2009. 4.1.4 Misoprostol to treat postpartum haemorrhage trial HRP is contributing to the debate on the use of misoprostol for treatment and prevention of PPH by generating the evi- dence needed to develop guidelines for universal application. The study “Misoprostol to treat postpartum haemorrhage: a randomized controlled trial” was conducted in collaboration with Gynuity Health Projects. The results, recently published in The Lancet, showed no difference in effectiveness when adding misoprostol to routine administration of oxytocin. 4.1.5 Treatment of mild to moderate hypertension trial There is scarce evidence on whether treating pregnant women who develop mild to moderate hypertension in pregnancy can reduce the risk of pre-eclampsia. A sys- tematic review of the literature has shown that labetalol is the most promising drug to achieve a protective effect. To test its effectiveness, a randomized clinical trial is ongoing in Argentinean hospitals. The tight control needed on blood pressure management and the relative scarcity of eligible subjects makes this trial a long lasting investment to be con- ducted by well-trained research teams over several years. Approximately 10% of the pilot sample size (200 subjects) has been achieved. After the pilot phase will be completed it will be possible to assess if the study could be realistically expanded to other centres. 4.1.6 Pre-eclampsia Integrated Estimate of RiSk (PIERS) The idea to develop a clinical tool that can accurately quan- tify a woman’s risk for adverse outcomes once she is diag- nosed with hypertension in pregnancy has been proposed by Dr Peter von Dadelszen from British Columbia Univer- sity, Vancouver, Canada. He developed the Pre-eclampsia Integrated Estimate of RiSk (PIERS) prediction model that is based on clinical and laboratory data such as gestational age on admission and measures of cardiorespiratory, renal, hepatic and haematological functions. A reliable tool to assess the likelihood of adverse outcomes related to hyper- tensive disorders of pregnancy will inform clinical manage- ment on reducing the risk for women while safely prolonging pregnancies (and therefore improving fetal outcomes). This tool has been validated in Australia, Canada, New Zealand and the United Kingdom and results recently published in The Lancet showed that the PIERS model identified women at risk of adverse outcomes up to seven days before compli- cations actually occurred. Those results underline the poten- tial for the PIERS model to improve direct patient care in terms of informing decision on clinical management. A modi- fied version of PIERS, specifically designed to be feasible in low-resource settings is presently tested in Fiji, Pakistan, Uganda and South Africa. Results will be available in 2011. Recently Dr Von Dadelzens received a grant from the Bill and Melinda Gates Foundation (BMGF) to implement a com- prehensive project on Pre-eclampsia monitoring, prevention and treatment (PRE-EMPT), which includes PIERS valida- tion in developing countries as a major component. 4.1.7 Development of fetal growth standards for international applications The use of ultrasonographic machines to assess fetal growth and identify intrauterine growth anomalies is widespread even in low-resource settings. Health-care professionals have questioned the validity of the universal application of existing fetal growth reference charts developed in Cauca- sian populations (represented as default in all ultrasound machines). To develop universally applicable fetal growth standards, MPH is implementing the “WHO multicentre study for the development of growth standards from fetal life to childhood: the fetal component”. The study objective is to construct a set of growth standards (curves and tables) from conception to delivery to be adopted as an international framework for assessing fetal and newborn growth and related levels of neonatal morbidity and mortality. The inter- national standards produced by the study will also contribute to an understanding of the role of different determinants of fetal growth, and ultimately improve the clinical management of pregnant women. The study, conducted in collaboration with the Interna- tional Society of Ultrasound in Obstetrics and Gynecology (ISUOG), uses state of the art ultrasound equipment (Gen- eral Electric Voluson V8). It was launched at the University of Bergen, Norway, in 2009. Other participating centres are located in Argentina, Democratic Republic of the Congo, Denmark, Egypt, France, Germany, India and Thailand. In the context of the study, WHO and the Health Division of the International Atomic Energy Agency (IAEA) are collaborat- ing to develop international standards for infant and child body composition assessment. The Team is also working in close collaboration with NICHD on their study “The national standard for normal fetal growth” which aims at establishing fetal growth standards for the US population. The two stud- ies are implemented simultaneously, allowing for the merging of study findings and the production of uniform global fetal growth standards. As a result of this collaboration, a co- authored article was published on methodological issues in assessing fetal growth. Chapter 2—Improving maternal and perinatal health 27 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 4.1.8 Systematic review of the safety of obstetric ultrasonography During the process of scientific and ethical review of the “WHO Multicentre study for the development of growth stand- ards from fetal life to childhood: the fetal component”, the Department’s Scientific and Ethical Review Group (SERG) requested updated evidence on the safety of the use of ultra- sonography during pregnancy. In response, a systematic review was conducted of the scientific literature in collabo- ration with ISUOG. A total of 61 publications reporting data from 41 different studies out of 6735 screened citations. The results of the review showed that diagnostic ultrasonography during pregnancy appears to be safe in relation to short and long-term outcomes (adverse maternal or perinatal outcome; impaired physical or neurological development; increased risk for malignancy in childhood; subnormal intellectual per- formance or mental disease). 4.1.9 Systematic review of the use of ultrasonography for the treatment and management of placenta previa A diagnosis of placenta previa (PP) can cause emotional stress even if it is only a transitory finding and does not ultimately cause any harm to the mother or the fetus. The dismissal of all diagnoses of asymptomatic PP on second- trimester sonograms as technical artefacts, however, can miss preventable fetal and maternal morbidity and mortality. The exact probability of persistent PP at term after a second- trimester sonographic diagnosis of PP in symptomatic and asymptomatic women is unknown. This information would improve clinical practice by enabling timely referral of high- risk cases to appropriate facilities and better counselling on women’s risk of persistent PP. A systematic review of the lit- erature is ongoing to determine what percentage of sympto- matic and asymptomatic cases with a presumptive diagnosis of PP on second-trimester ultrasound actually persist as PP at delivery providing important information on the diagnostic value of the ultrasonographical examination. The review will be completed in 2011. This work is also contributing to the revision of the Integrated Management of Pregnancy and Childbirth (IMPAC) Guidelines prepared by the Department of Making Pregnancy Safer. 4.1.10 Odon Device A team of Argentinean obstetricians proposed to test a new device (see Figure 3) to facilitate fetal extraction during pro- longed second stage of labour. A feasibility and safety study is presently ongoing in Buenos Aires testing the device on 100 volunteers. Results are expected to be published in 2012. If proven effective, the device – consisting of a two foil plastic bag – could be produced in large quantities and at a minimum cost. The new instrument is called Odon Device, after the name of its inventor, Jorge Odon. For reference, a demonstration of the “Odon Device” is available on YouTube. 4.1.11 The Tanguieta funnel In 2010, the Team began planning with Brother Florent, and his collaborators in Benin, Togo (Hôpital de Afagnan) and France, a study to test the safety and efficacy of the Tan- guieta funnel (see Figure 3) as a life-saving procedure for recovery of intraperitoneal blood after haemorrhage in case Figure 3. Low-cost incubator, Odon Device, Tanguieta funnel and non-pneumatic anti-shock garment (NASG). Biennial Technical Report 2009–2010 28 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 of ruptured ectopic pregnancy followed by immediate auto- transfusion of this blood to the woman. In 1969, Brother Florent, a committed missionary priest and surgeon work- ing at the Hôpital Saint Jean de Dieu in Tanguieta (Benin) learnt from two nuns how they used rudimentary methods to recycle blood during abdominal operations. In the follow- ing years, Brother Florent worked on applying these methods and eventually developed and refined the Tanguieta funnel with the help of various partners (internationally renowned designer Piero Lissoni designed the last version). 4.1.12 Low-cost flat pack incubator Mark Levy is a young British engineer who developed an innovative idea for an incubator that could drastically reduce some of the costs associated with neonatal intensive care. A study is being designed to test the feasibility and safety of this new device. Increasing access to specialized newborn care by reducing the cost of the technology could be a new frontier in equitable access to health care similar to the rapid progress made in making HIV testing and treatment avail- able for millions of people worldwide. 4.1.13 Anti-shock garment trial A series of studies coordinated by the University of California at San Francisco, CA, USA indicated that the non-pneumatic anti-shock garment (NASG; see Figure 3) originally devel- oped for military use could be life saving when applied to women suffering from postpartum haemorrhage. This is being tested in Zambia and Zimbabwe in a cluster rand- omized trial that will provide the evidence to support scaling- up efforts to make the garment more accessible to women in need. The study, with a sample size of 1800 subjects, is due to be completed in 2012. 4 .2 Planned activities 4.2.1 Preconceptional calcium supplementation trial In a large trial coordinated by the Team and completed in 2005, it was found that calcium supplementation during the second half of pregnancy decreases the risk of severe com- plications of hypertensive disorders of pregnancy. Histori- cally, some of the most effective public health interventions have been micronutrient fortification of food (e.g. iodine, fluoride) and it is possible that calcium supplementation may be beneficial at population level. A protocol was designed to determine the effect of calcium supplementation before con- ception and in the first half of pregnancy on the incidence of pre-eclampsia in women with previous pre-eclampsia or eclampsia. The hypothesis is that calcium supplementation commenced before pregnancy reduces the incidence of recurrent pre-eclampsia more effectively than supplementa- tion starting at 20 weeks’ gestation. If an effect is found, staple food fortification with calcium could potentially be introduced and could profoundly impact the health and survival of preg- nant women. It is expected that the trial will commence in February 2011 in three sites in South Africa (Johannesburg, East London and Cape Town); sites in Argentina and Zimba- bwe may be added in the future to increase generalizability. The recruitment target is 1410 women. 4.2.2 Fistula trial A vaginal fistula is a devastating condition, affecting an esti- mated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including a dearth of available and motivated surgeons with specialized skills, operating rooms, equipment, and funding from local or international donors to support both surgeries and postoper- ative care. Finding ways of providing services efficiently and cost-effectively, without compromising surgical outcomes and the overall health of the patient, is paramount. Jointly with TCC and EngenderHealth, a facility-based, multicen- tre randomized controlled trial is being planned to examine whether short-term (7 day) bladder catheterization is inferior to longer-term (14 day) catheterization in terms of fistula repair breakdown in African countries. Shortening the dura- tion of catheterization following fistula repair surgery would increase treatment capacity (by freeing available bed space and increasing availability of nursing staff), lower costs of services and, potentially, lower the risk of nosocomial infec- tion among fistula patients. It is anticipated that study sub- jects will be recruited at eight centres to be defined for a total sample size of 1000 subjects. 4.2.3 Redefining criteria for the diagnosis of gestational diabetes Over 10 years have passed since the last official WHO rec- ommendations on gestational diabetes (GDM) and new evi- dence has become available which justifies an update of the recommendations. In collaboration with the Department of Chronic Diseases and Health Promotion (CHP), a revision of the evidence is being undertaken. It will inform a consultation with experts to review the current WHO diagnostic criteria for GDM and issue new, updated recommendations. In Decem- ber 2010 an expert consultation was held at WHO headquar- ters in Geneva, Switzerland, to discuss, among other things, systematic reviews conducted by consultants from both CHP and RHR. During 2011, it is expected that the final recom- mendations for the diagnosis of GDM will be issued. This work will have significant impact on antenatal care (ANC) programmes throughout the world, since the newly defined criteria could substantially increase the incidence of GDM, and this could be a problem especially for low and middle- income countries. Chapter 2—Improving maternal and perinatal health 29 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 4.2.4 Systematic review of the use of intrapartum ultrasonography diagnosis of gestational diabetes Progress during labour is normally assessed through repeated vaginal examinations to assess cervical dilation, fetal head position, descent and rotation. This evaluation is highly subjective and directly related to the experience and skill of the attending health professional. Errors in correctly assessing the fetal head position and station frequently lead to traumatic or failed instrumental deliveries or emergency caesarean sections (CS) in the second stage of labour, with increased risks of maternal perineal lacerations or haemor- rhage as well as perinatal morbidity and mortality. It is now possible to use “image technology” to monitor the progress of labour. There have been a series of studies on the use of transperineal ultrasound and computerized systems to evaluate patients during labour. The existing literature on this novel technology will be reviewed to assess the effective- ness and safety of this intervention in improving clinically rel- evant maternal and perinatal outcomes. 5 . SoCIAL SCIEnCES Sociocultural factors are highly related to health-seeking behaviours and outcomes. To explore how birth is conceptu- alized within the society, the Team focused on the increased use of caesarean section and the increased incidence of obstetric fistula. 5 .1 Progress 5.1.1 Caesarean section in women’s magazines – Io Donna CS rates have been increasing in most high and middle- income countries, despite the lack of sound scientific evi- dence indicating any benefits from increasing use and consistent reports of increased risks for the mother and baby. The modifiable causes of rising CS rates are complex. Contemporary women are exposed to a wide range of infor- mation on health topics, including their options for childbirth. This exposure can influence their opinion and affect their decision-making process. Additionally, women’s views and preferences on type of delivery are, for different reasons, being increasingly respected by practising obstetricians. Women’s magazines represent an important source of data on pregnancy and childbirth that can influence women’s opin- ion and decisions on these issues. Top selling women’s mag- azines were reviewed to search and analyse the content of all the articles that presented information or expressed views related to these topics and especially regarding CS versus vaginal delivery. Since women’s magazines are country- specific, this review intended to cover countries in Europe, Latin America, North America and Oceania, with Brazil, as one of the countries with the highest CS rates in the world, as the first country study. The analysis shows that the major- ity of articles published in women’s magazines do not use optimal sources of information. The information presented on CS is mostly balanced but often incomplete and may be leading women to underestimate the maternal and perinatal risks associated with this route of delivery. The results of this analysis have been published in the British Medical Journal (“Portrayal of caesarean section in Brazilian women’s mag- azines: a 20 year review”). Data extraction is advancing in Argentina and Spain where it is expected to be finalized in 2011. In collaboration with the PFP Team, colleagues in the Philippines have expanded the idea to collect and assess the information in women’s magazines related to contracep- tive methods. Additionally, the Italian magazine for women Io Donna and the Italian NGO ONDa (Osservatorio Nazion- ale sulla salute della Donna) have asked MPH to conduct a survey among its readers to better understand what women think about CS and what factors influence women’s deci- sions about mode of delivery. With 600 000 weekly readers, it is estimated that at least 0.1% (600) would take the survey. Importantly, Italy is the European country with the highest rate of CS (around 40% at national level). A similar survey is planned in Brazil in 2011. 5.1.2 Women’s Dignity Project The MPH collaborated with the NGO Women’s Dignity Pro- ject on the analysis and write-up of a formative research study in rural United Republic of Tanzania examining wom- en’s experiences re-integrating into society post-surgical fis- tula repair. The study findings suggest that communication campaigns raising awareness of the condition significantly reduced women’s experiences of stigma when living with and recovering from obstetric fistula. The study also suggests that women need access to long-term follow-up care includ- ing counselling after returning home from the hospital and training opportunities to enable them to best transition back into their communities. 5 .2 Planned activities Collaboration with countries will continue to study factors that influence women’s decisions about mode of delivery. In par- ticular, analysis of the information given on CS portrayed in women’s magazines will continue in Argentina, Philippines and Spain. The survey among readers of women’s maga- zines to better understand what women think about CS is planned to be undertaken in Brazil in 2011. 6 . EPIdEMIoLoGy The epidemiological work supported by the Team is action oriented. Good evidence is a prerequisite for effective action and the Team is committed to generating needed evidence, often making good use of the large data sets from studies conducted in the past. Biennial Technical Report 2009–2010 30 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 6 .1 Progress 6.1.1 Multicountry study on maternal and newborn health The WHO Multicountry Study on Maternal and Newborn Health, implemented in collaboration with TCC, is targeted at collecting information through short-term intensive surveys on cases of maternal and newborn severe morbidity and mortality. The study is presently ongoing in 27 countries and more than 300 000 facilities. The results will not only provide information on the main causes of maternal and perinatal mortality and morbidity but will also shed light on what are the management options available and not available to pre- vent and treat those conditions at the participating facilities. This kind of information, linking epidemiology to clinical man- agement, is most valuable for policy-makers planning future interventions and deciding on allocation of funds. 6.1.2 GLOBE: obesity and pregnancy outcomes The prevalence of obesity has grown in developed and devel- oping countries. An increased number of women are entering pregnancy overweight and this increases the risk for adverse pregnancy outcomes. The project GLOBE (Gestación Ligada a Obesidad y al Entorno. Estudio longitudinal multicéntrico de factores de riesgo asociados a la obesidad en el embarazo) is a multicentre longitudinal study coordinated by the Hospi- tal Universitario del Vall d’Hebron in Barcelona, Spain. The objective of this large study is to describe and analyse the differences in maternal and fetal outcomes between obese and non-obese women. MPH provided technical support in the development of the protocol and the study is expected to start in 2011. 6.1.3 Awareness Project CDC, HRP and the WHO Collaborating Centre International Clearing house for Birth Defect Surveillance and Research (ICBDSR) are developing the Awareness Project. The pro- ject, initiated at Utah University, in Salt Lake City, Utah, USA seeks to map the knowledge available on periconceptual interventions that could decrease the risk of birth defects. Several related systematic reviews have been completed or are ongoing. Considering that the World Health Assem- bly has recently approved Resolution WHA63.17 that com- mits WHO to work with countries on efforts to prevent birth defects, the Awareness Project is rapidly acquiring inter- est within the international public health community. MPH established critical links between the Awareness Project, the Division of Maternal and Child Health, Aga Khan University Medical Center, Karachi, Pakistan, and the WHO Depart- ment of Nutrition and Development who are conducting simi- lar activities, and a meeting of this extended collaboration is planned in 2011. 6.1.4 Systematic review of maternal BMI and preterm birth Spontaneous preterm birth (SPTB) is a major clinical and public health challenge. The risk factors associated with SPTB, are complex, multifactorial and involve different patho- physiologic pathways. Maternal pre-pregnancy (BMI, kg/m2) has been investigated as one of the modifiable risk factors associated with SPTB with discordant results. A systematic review was conducted to assess the association between high pregnancy maternal BMI and the risk of PTB. Results showed different effects on different types of PTB. Pre-obese (BMI 25–29.9) and obese I (BMI 30–34.9) women have a reduced risk for SPTB by approximately 16%. Obese II (BMI 35–40) women have a risk increased by 33% for PTB in gen- eral, moderate preterm birth (PTB) and very PTB. Obese III (BMI >40) women have a risk for very PTB multiplied by 2.27 over non-obese women. 6.1.5 Systematic review of obesity, race and preterm birth Genetic and biomarker studies documented significant dif- ferences in PTB between racial groups suggesting that the manifestation of risk factors in different races may be differ- ent. This led to the hypothesis that racial disparity exists in SPTB risk factors and these factors cannot be generalized. A case–control study was conducted to assess the role of race as a BMI associated modifier for risk of SPTB, which involved 447 SPTB cases and 1315 term-births in a group of African American (AA) and Caucasian (C) women deliv- ering singletons in Nashville, TN, USA. Crude and adjusted odds ratio for SPTB were calculated using normal BMI as reference. No significant differences were noted in the crude odds ratio for SPTB among different BMI categories when races were combined. However the odds ratio for SPTB in women with different pre-pregnancy BMI categories differed according to race: obese AA women had a decreased odds ratio for SPTB while C obese women had an increased risk compared with normal weight women. 6.1.6 Preterm birth global and regional rate estimates Mapping the burden of preterm birth at global and regional level was performed by updating the database of the sys- tematic review of maternal mortality and morbidity that was developed by HRP in previous years. The result was the pub- lication, for the first time, of global and regional estimates of preterm birth rates. Globally it is estimated that preterm birth occurs in 9.6% of pregnancies. Rates are higher in North America and Africa. Different risk factors play a role in the high rates of preterm birth in different regions. 6.1.7 Preterm birth rates and pollution Investigators from the University of Michigan, Ann Arbor, USA, and from the Universidad Autonoma de Mexico, Mexico City, Mexico, put forward the hypothesis of a potential Chapter 2—Improving maternal and perinatal health 31 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 role of air pollution in increasing the risk of preterm birth, and received support from National Institutes of Health to conduct a study on this issue in Mexico City, one of the most polluted cities in the world. The increased interest within WHO and the international community on the effects of climate change and pollution on health outcomes provided an opportunity to collaborate with them to examine the relationship between fine particulate matter concentrations (PM2.5), seasonality and preterm birth and low birth weight among 23 countries in the WHO Global Survey on Maternal and Perinatal Health. This analysis uses data from the Global Survey on 290 610 birth outcomes, including potential confounders among women (age, prenatal care, parity and other variables) as well as satellite and ground-based monitoring estimates of air pollution exposure within 50 km of the participating clinics. Furthermore, data on characteristics of the countries (Gini coefficients, health care expenditures per capita, etc.) were included in the analysis. The analysis is ongoing and results will be submitted for publication in 2011. 6.1.8 Child Health Epidemiology Reference Group (CHERG) MPH is participating in the activities of the Child Health Epi- demiology Reference Group (CHERG) to improve the meas- urement of coverage for high-impact maternal, newborn and child health interventions, and establish standards for assessing trends over time and uncertainty estimates for these measurements. In 2010, the Team provided technical and analytical support to the CHERG group in determining research gaps in coverage measurements for service deliv- ery contacts (i.e. ANC, birth, postnatal care for mother and baby) and for other health issues including CS utilization. In addition, the Team is collaborating with Johns Hopkins University, Baltimore, MD, USA, in a CHERG activity aimed at collecting and analysing data for large studies to investi- gate the association between intrauterine growth restriction (IUGR), preterm birth and neonatal outcomes. 6.1.9 Caesarean section classifications The worldwide rise in CS rates is a major public health con- cern and cause of considerable debate. However, in order to propose and implement effective measures to monitor and reduce or increase CS rates where necessary, an appropri- ate classification system is required. Several CS classifica- tion systems have been proposed which need comparative evaluation. Thus a systematic review was undertaken to: (1) identify the main CS classification systems used world- wide, and (2) analyse the advantages and deficiencies of each system. A total of 2948 citations were screened, 60 selected for full-text evaluation and 27 different classifications identified. These classifications were grouped into four gen- eral types, based on the main unit used: Indications (N=12), degree of urgency (N=5), woman characteristics (N=4), and other types (N=6). Results suggest that, among all classi- fications identified, women-based classifications in general, and Robson’s classification, in particular, would be the best to fulfil current international and local needs, and that efforts to develop an internationally applicable CS classification should build on this classification. The use of a single CS classification will facilitate auditing, analysing and comparing CS rates across different settings and allow the creation and implementation of effective strategies specifically targeted to optimize CS rates where necessary. 6 .2 Planned activities Most of the planned activities are based on the secondary analyses of large data sets from previous WHO studies and will be conducted in collaboration with investigators from dif- ferent countries. 6.2.1 Secondary analysis Global Survey An intensive effort began to take advantage of the data set of the WHO Global Survey on Maternal and Perinatal Health to generate new hypotheses and conduct secondary analyses of the database in coordination with researchers from all over the world. Results from one of those secondary analyses were pub- lished in 2009 while other analyses have been finalized and submitted to scientific journals, are ongoing or planned as shown in Table 1. 6.2.2 Optimal rate of caesarean section Does an optimal rate of CS exist and, if so, what should be the recommendation from WHO? The increase in CS rates observed in many developed and middle-income countries contrasts sharply with the very low rates in numerous low- resource settings, along with lack of access to emergency obstetric care. In 1985, a WHO conference generated a report that stated that there was no justification for a CS rate over 15%. This “recommendation” was based on the data available at the time, which was admittedly of poor quality, and did not support any benefit from higher rates in relation to maternal or perinatal mortality. It is planned to set up a scientific working group to assess different methodologies to review this figure and make new recommendations based on the large amount of evidence collected in the past few years. This will be framed in an open and collaborative approach including mechanisms for revision that would allow maxi- mum transparency and participation. 7 . HEALTH PoLICy/CoUnTRy foCUS 7 .1 Progress In 2009–2010, the Team published several policy papers on maternal and newborn health in diverse countries such as Brazil, Chile and Mongolia. Productive dialogue was estab- lished with representatives of faith-based organizations Biennial Technical Report 2009–2010 32 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 (FBOs) and the Inter-Parliamentary Union (IPU), and impor- tantly, work began with the Ministries of Health of Afghani- stan and Iraq. 7.1.1 Brazil The team collaborated with the MoH of Brazil to analyse the country’s efforts in reducing child mortality and improv- ing maternal health from 1990 through to 2007. The analy- sis showed declines in maternal mortality ratio from 220 to 110 per 100 000 and in infant mortality from 47.1 to 20.6 per 1000 over this period. Importantly, results demonstrated that proactive measures to reduce health disparities accom- panied by socioeconomic progress could result in measur- able improvements in the health of children and mothers in a relatively short interval. The analysis of Brazil’s successes and remaining challenges to reach and surpass MDGs 4 and 5 can provide important lessons for other low- and middle- income countries. 7.1.2 Chile A paper “Tackling health inequities in Chile: maternal, new- born, infant, and child mortality between 1990 and 2004” was published describing the remarkable achievements of the policies and health sector reforms implemented in Chile at national level: not only did maternal and newborn mortality decrease from 42.1 to 18.5 per 100 000 and from 9.0 to 5.7 per 1000, respectively, but the gap in these mortality indica- tors between the poorest and richest district quintiles also decreased. 7.1.3 Mongolia In 2001, recognizing the need to improve maternal health in the country, the Mongolian MoH launched the Maternal Mortality Reduction Strategy. The Strategy focused on: com- munity mobilization; quality of health facilities; standards of care; educational activities; involvement of the civil soci- ety; improvement of clinical care; management of human resources and improvement of the referral system. MPH wrote a policy paper in collaboration with the MoH showing that important reductions in maternal mortality in low-resource settings are possible through collaborative strategies based on a horizontal approach involving community mobilization and the coordinated action of key partners, including health ministries; national and international agencies and donors; health-care professionals; the media; NGOs and the general public. Secondary analysis Researchers’ team Status WHO Global Survey on Maternal and Perinatal Health in Latin America: classifying caesarean sections Global Survey network Published Global references for fetal/birth weight percentiles Japan, Germany, USA (NIH) Submitted Risk factors for intrauterine growth restriction Italy Ongoing Causes of stillbirths and newborn deaths Australia Ongoing Anaesthesia and analgesia in vaginal delivery Brazil Ongoing Anaesthesia and analgesia in caesarean section Brazil Ongoing Adverse maternal and neonatal outcomes in caesarean deliveries classified according to Robson´s groups Brazil, USA Ongoing Robson analysis of caesarean section (Africa, Asia, Latin America) Australia Ongoing Preterm birth and pollution Mexico, USA Ongoing Analysis of multiple births WHO Planned Repeated caesarean section in developing countries: indications, risk factors and outcomes Brazil Planned Breech in developing countries: assistance at delivery and maternal and perinatal outcomes Brazil Planned Pregnancy in adolescent and older women in developing countries Brazil Planned Instrumental delivery in developing countries (for single and cephalic fetus) Brazil Planned Risk factors for delayed breastfeeding in developing countries WHO Planned Macrosomic infants in developing countries: complications during pregnancy, route of delivery and analgesia Brazil Planned Table 1. Published, ongoing and planned secondary analyses of the WHO Global Survey in which MPH is involved Chapter 2—Improving maternal and perinatal health 33 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 7.1.4 Afghanistan Afghanistan has one of the highest maternal mortality ratios in the world, estimated at 1400 per 100 000. To improve monitoring, a collaboration was established in 2009 between the MoH in Afghanistan, the WHO Collaborating Centre in Reproductive Health at CDC in Atlanta, GA, USA, and MPH. The objective of this partnership is to document the develop- ment of a facility-based maternal and newborn health surveil- lance system for use in maternity hospitals in Kabul with the aim of improving the quality of care. In 2009, a manuscript was published in the International Journal of Gynecology & Obstetrics (“Caesarean delivery surveillance system at a maternity hospital in Kabul, Afghanistan”) showing the draw- backs of poorly coordinated resource flows to obstetric care. For example, appropriate training was not done in tandem with the upgrading of hospital facilities with equipment to per- form CS. This collaboration continues to develop with a focus on capac- ity building. In 2010 a member of RHR’s Statistics and Infor- mation Services Team (SIS) provided technical assistance to health staff of the Rabia Balhki Hospital, a Government maternity hospital, specifically for the analysis of survey data that measured patient outcomes over a one-month period. 7.1.5 Iraq The British Broadcasting Corporation (BBC) recently reported statements from health professionals in the city of Fallujah about alarming increases in birth defects rates. Such state- ments, If confirmed, would raise concerns of potential expo- sure to toxic or radioactive substances around the time of heavy fighting in 2004. The MoH of Iraq asked WHO country and regional offices for technical support and WHO head- quarters’ expertise was sought. A workshop was organized with the WHO Collaborating Centre, ICBDSR, Rome, Italy, CDC, and other major institutions (Istanbul, Turkey, Septem- ber 2010). Follow-up activities include assistance to the MoH to develop a surveillance system in the potentially affected districts in Iraq and training in birth defect surveillance for colleagues from Iraq. 7.1.6 Faith-based organizations (FBOs) In collaboration with missionary health professionals and reli- gious leaders, a systematic review was undertaken to map and assess the contribution of FBOs in maternal and newborn health care in Africa during the past 20 years. The review identified only six articles published in the peer-reviewed lit- erature, thus indicating the need for more scientific work to monitor and quantify the impact of FBOs on the health of populations in Africa. Therefore, data from Demographic and Health Surveys in African countries are being analysed to quantify the contribution of FBOs to maternal and neonatal health. These findings will potentially strengthen the dialogue between FBOs and MPH with the goal of more effectively uti- lizing FBOs to fill critical gaps in service delivery for women and children. 7.1.7 Countdown to 2015 The Countdown to 2015 for Maternal, Newborn and Child Survival is a global movement to use data to stimulate and support country progress towards the achievement of the health-related MDGs, with a particular focus on coverage of effective interventions for maternal, newborn and child health. Established in 2005, the Countdown is a collabora- tion of academic institutions, UN agencies, NGOs, health- care professional associations, donors, and governments, with The Lancet as a key partner. During 2010, the Team helped develop the 2010 Countdown report, The Lancet arti- cle on the key findings of the technical analyses for the 2010 cycle, and a funded proposal for cross-cutting analyses and advocacy activities for 2011–2012. In addition, the Team par- ticipated in the “coverage” technical working group. 7.1.8 Health-care professional associations In collaboration with the Partnership for Maternal, Newborn and Child Health (PMNCH) and members of health-care professional associations in Asia, a multicountry workshop aimed at strengthening the capacity of health-care profes- sional associations to collaborate to improve maternal, new- born and child health was held in Dhaka, Bangladesh (22–25 November 2008). The Team contributed to the publication of a report of the workshop. In addition, the Team developed a publication documenting the success of a similar multi- country workshop held in Amman, Jordan (17–19 December 2009) involving the participation of associations from coun- tries in the North African and Middle Eastern regions. 7.1.9 Inter-Parliamentary Union The Team contributed to a report jointly published by the IPU and the PMNCH entitled, “Taking the lead: Parliamentarians engage with maternal, newborn, and child health”. The report provides concrete examples of how Parliaments in develop- ing countries have exercised their representational, over- sight, budgetary and legislative roles to advance maternal, newborn and child health. It was launched on 16 July 2010 at the Swiss Parliament in Bern during a meeting where more than 20 women parliamentarians from diverse countries dis- cussed the importance of parliamentarians in taking action on maternal and child survival. 7.1.10 Alliance of the Italian hospitals in the world The Association “Alleanza degli Ospedali Italiani nel Mondo” (Alliance of the Italian hospitals in the world) was established by the Italian Government to coordinate the activities of 44 Italian hospitals abroad. Most of these hospitals are fully inte- grated into the national health systems. A collaboration was established with the Alliance which led to the organization of the Annual Meeting of the Alliance at WHO headquarters in Biennial Technical Report 2009–2010 34 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 April 2010. One important outcome of the meeting was the decision of five hospitals in Argentina to join the WHO Multi- country Survey on Maternal and Newborn Health. 7.1.11 United Nations Human Rights Council The United Nations (UN) Human Rights Council holds its annual meeting at the UN office in Geneva gathering dele- gates from all over the world. In 2010 the Team helped in the organization of a side event on maternal and newborn health as a human rights issue to highlight Resolution HRC/15/L.27 approved by the Council on this topic on 27 September 2010. Three ambassadors and the Human Rights High Commis- sioner chaired the event that was attended by delegates from more than 40 countries. 7 .2 Planned activities 7.2.1 China To date, there has not been a systematic evaluation of the Maternal mortality and neonatal tetanus reduction programme implemented in 2000 among the most disadvantaged popu- lations in Western China. In 2011, work is planned with the National Office for Maternal and Child Health Surveillance in China, and the Collaborating Centre in Reproductive Health at CDC in Atlanta, GA, USA, to perform a trend analysis of maternal and infant mortality data collected from 14 coun- ties through the National Mortality Surveillance Network from 1996 to 2008. The health resources, health worker trainings and related policies for the delivery of care at community level will also be assessed. 7.2.2 Mozambique To assess progress in the implementation of the strategy to reduce maternal and neonatal mortality at facility level, the MoH of Mozambique conducted a national survey at facility level (Needs Assessment for Maternal and Neonatal Health, 2006–2007) to assess the quality of care of maternal and child health services. Upon request from the MoH, the Team is working with SIS on an in-depth analysis of this national database which will also provide the basis for the forma- tive research for the study “A demonstration project for the implementation of the WHO ANC model in Mozambique: acluster randomized controlled trial”, described below in Section 9.1.3. 7.2.3 Systems for monitoring and accountability In response to a specific request from the UN Secretary- General and the G8, WHO established the “Commission on Information & Accountability for Women & Children’s Health” to “propose international institutional arrangements for global reporting, oversight and accountability on women and chil- dren’s health, including through the UN system”. The Team will contribute to this work by conducting a systematic review of existing national level systems and policies to monitor maternal mortality. 8 . HUMAnITARIAn AId In 2009, the Team began addressing sexual and reproduc- tive health in emergencies, in collaboration with WHO’s Health Action in Crises Cluster (HAC) and the Global Health Cluster (GHC), focusing on generating knowledge for action in humanitarian settings. 8 .1 Progress 8.1.1 Interagency group With the rising occurrence of disasters, conflicts and other crises, WHO is assuming a greater operational role in emer- gencies. As lead agency for the GHC, WHO is responsible for coordinating humanitarian health agencies and imple- menting humanitarian reforms. The GHC comprises over 30 international humanitarian health organizations, builds part- nerships and develops coordinated approaches to humani- tarian health services. The Department is contributing to this effort – including using its expertise in knowledge synthesis and implementation research to build the evidence base. WHO is also a founding member of the IAWG on Reproduc- tive Health in Crises, a key partnership and leadership body comprising over 130 member organizations, including the UNFPA, the Office of the United Nations High Commissioner for Refugees (UNHCR), and UNICEF. The Department is actively participating in a number of IAWG on Reproductive Health in Crises activities including the New and Underu- tilized Technologies subworking group and the IAWG on Reproductive Health in Crises Training Partnership. In addi- tion, the Inter-agency field manual on reproductive health in humanitarian settings, 2010 Revision for Field Review (IAFM) has been launched and widely disseminated in col- laboration with HAC. A number of products and activities are developed through these partnerships and are published through various col- laborative/interagency processes, including a Report of the WHO-UNFPA follow-up consultation on sexual and repro- ductive health in protracted crises and recovery. MPH is also contributing to a chapter on “Conflict and post conflict situations in programme implementation” in the book entitled Maternal and perinatal mortality in developing countries. 8.1.2 Systematic review of reproductive health kits WHO is participating in the technical review for the revision of the Inter-agency reproductive health kits for crisis situa- tions. A number of knowledge synthesis and implementation research needs have been identified and requested from the review team led by UNFPA. The Team has initiated a system- atic review of the reproductive health kits, a key first step in building the evidence base for this work. Chapter 2—Improving maternal and perinatal health 35 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 8 .2 Planned activities 8.2.1 Central African Republic, Chad, Democratic Republic of the Congo, Kyrgyzstan, Uganda Technical updates will be provided to countries based on recently released guidance in the Inter-agency field manual on reproductive health in humanitarian settings 2010 Revi- sion for field review. Thus far, requests were received from Central African Republic, Chad, Democratic Republic of the Congo, Kyrgyzstan and Uganda. These technical updates will cover response to emergencies, emergency prepared- ness, capacity building as well as recovery. 8.2.2 Implementation of the Inter-agency Field Manual on Reproductive Health in Humanitarian Settings An implementation research project is being conducted, using focus group discussions (FGDs), to obtain information from field staff (e.g. from NGOs, government and UN agen- cies) about their views of the IAFM. FGDs will be conducted with staff who have used the IAFM in a variety of situations, allowing for the investigation of its applicability to different types of crises. Study findings will contribute to the ongoing revision of the IAFM. 8.2.3 New documents In collaboration with HAC’s Risk Reduction and Emergency Preparedness (RRP) Team, two key documents are being prepared: Disaster risk reduction and emergency prepared- ness – sexual and reproductive health fact sheet – building resilient communities and reproductive health systems and the WHO/Global Watch for Humanitarian Affairs (GWHA)/ UNICEF/International Federation of Red Cross and Red Crescent Societies/UNHCR Joint Statement Scaling up the front-line health workforce to increase the safety and resil- ience of communities to disasters and emergencies. The joint statement will be followed by further guidance on identi- fying, coordinating and building the capacity of the front-line health workforce in emergencies. 8.2.4 UN H4+ in humanitarian settings In the context of the UN H4+ (UNAIDS, UNFPA, UNICEF, The World Bank and WHO) plan, a UN H4+ working group for humanitarian settings will be established, and a paper on the added value of UN H4+ in crisis situations will be developed. Furthermore, MPH will support coordination of humanitarian and development sectors. This work includes collaborating with HAC on joint assessment and support mis- sions to humanitarian settings such as Haiti and the Demo- cratic Republic of the Congo as well as on the planning of implementation efforts. 9 . IMPLEMEnTATIon SCIEnCE Implementation science represents a rapidly expanding area of work given its potential to result in substantial impacts at country level. It is also a needed area of research to con- tribute to the success of the UN Secretary-General’s Global Strategy for Women’s and Children’s Health. 9 .1 Progress Ongoing activities include a collaborative framework to bridge the know–do gap by synergizing resources and focusing on ultimate objectives and several large cluster randomized trials. 9.1.1 Implementing the UN Secretary-General’s Global Strategy for Women’s and Children’s Health: a UN collaboration using implementation science to dra- matically accelerate the progress in meeting countries’ needs for preventing maternal and newborn deaths The opportunity With the launch of the United Nations Secretary-General’s Global Strategy for Women’s and Children’s Health in Sep- tember 2010 and the related commitments to its success, the world now has an unprecedented window of opportunity to reduce dramatically maternal and newborn deaths in the 49 lowest income countries in which the majority of such deaths occur. Implementation science is needed to rapidly accelerate progress in at least three major areas: (1) the implementation of interventions in low-resource settings; (2) the development and use of innovative technologies and processes in these settings; and (3) the transformations in health systems in these settings needed for implementation of life-saving services. Further, such innovations should be linked to a package of interventions in sexual and reproduc- tive health, including family planning to prevent unintended pregnancies, and HIV prevention and treatment. The collaboration During the previous year, several meetings and activities have been carried out to create a new collaboration. The collaboration will be action oriented and problem solving- focused and will support UN H4+ in rapid implementation of the Global Strategy. Strong commitments to this workforce have already been made by CDC and CARE and it is antici- pated that new partners will join soon. Figure 4. Linking implementation science to implementation. Biennial Technical Report 2009–2010 36 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 The framework The collaboration will use a conceptual framework that links implementation science to solving implementation chal- lenges in countries (Figure 4). Successful translation of this framework into effective action-oriented plans for meeting countries’ needs will require the development of priorities by ministries of health. Agencies with lead responsibilities for implementation will need to work closely with those with lead responsibilities for implementation science, primarily HRP, in both the planning and execution phases of this collaborative effort. Proof of concept The MoH of Malawi has expressed strong interest in receiv- ing support for its efforts in preventing maternal and newborn deaths in Malawi, and its strong support for using this innova- tive collaborative effort as “proof of concept” for developing similar strategies in other countries, including ones that build on the infrastructure and capacity associated with HIV, TB and malaria programmes. The initial collaboration that has been created to undertake this work in Malawi will be scaled up as the Secretary-General’s Global Strategy continues to take off and realizes its full potential for preventing maternal and newborn deaths globally. The launch This innovative collaborative approach will be launched in Atlanta, GA, USA, during a CDC and CARE-hosted meet- ing of UN H4+ that will include the MoH of Malawi (19–21 January 2011). The launch will follow extensive preparatory work by WHO, UNFPA, UNICEF, CDC, CARE and the MoH, including meetings with the Ministry in Lilongwe. The launch will include representatives not only from the MoH and UN H4+, CDC and CARE headquarters but also representatives from the UN, CDC and CARE in Malawi. During the launch a plan for rapid action in Malawi with focus on integration and improved quality of services as well as human resources management will be agreed upon, and implementation in Malawi will start in 2011. 9.1.2 Trial to increase the use of corticosteroids for the prevention of mortality in preterm newborns A highly effective perinatal intervention to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth. However, the literature consistently shows low implementation rates of this intervention in developing countries. In 2000, it was estimated that in the 42 countries with 90% of all childhood deaths, only 5% of appropriate candidates received antenatal corti- costeroids. MPH has been collaborating with the US National Institute of Health (NIH) Global Network for Women’s and Children’s Health Research to implement a pragmatic cluster randomized controlled trial designed to evaluate the effects of a multifaceted intervention that will improve the identifi- cation of pregnancies at high risk of preterm birth and will facilitate the appropriate use of steroids to women at risk of preterm delivery, with the goal of reducing neonatal mor- tality rates among preterm infants in communities with low antenatal steroid use. The intervention will target the health system, not individual patients. The second investigators’ meeting was held in Geneva in August 2010. Participants represented research teams and Ministries of Health from Argentina, Democratic Republic of the Congo, Guatemala, India, and Pakistan that are committed to effective collabora- tion between researchers and policy-makers on this topic. The establishment of partnerships between governments and research institutions is a priority for MPH, in line with the international agenda set out by the Global Forum for Health Research. The trial is expected to start in 2011. 9.1.3 Antenatal care in Mozambique In collaboration with the Flemish International Cooperation Agency (FICA) and the MoH of Mozambique, a demonstra- tion project for the implementation of the WHO ANC model in Mozambique is being launched as a cluster randomized con- trolled trial. The primary objective of the project is to deter- mine the impact of an intervention designed to increase the use of evidence-based practices included in the ANC pack- age by health professionals in prenatal clinics in Mozam- bique. In addition, it will assess the effect of the integration of key interventions into routine ANC on obstetric and newborn outcomes as well as the detection, treatment and prevention of major health-related conditions (e.g. anaemia, and infec- tious diseases such as HIV/AIDS, malaria and congenital syphilis). The project is presently being implemented in 10 districts and will continue through 2012. 9.1.4 Birth plans in United Republic of Tanzania A study was conducted in Ngorongoro, rural United Republic of Tanzania to examine the effect of successfully introducing birth plans into routine ANC on health-seeking behaviours for skilled delivery and immediate postnatal care. The study was coordinated by Dr Moke Magoma, a doctoral student at the London School of Hygiene and Tropical Medicine (LSHTM). MPH participated in the analysis and write-up of the findings of the study that showed statistically significant increases in coverage of skilled delivery care among women who com- pleted birth plans during ANC visits in comparison to women who did not develop birth plans. 9 .2 Planned activities 9.2.1 Management of eclampsia An implementation research project is in preparation to evaluate the effectiveness of a multifaceted intervention to improve quality of care for women with eclampsia at hospitals Chapter 2—Improving maternal and perinatal health 37 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 and primary health-care clinics in Mozambique, measured as the proportion of women that received care appropriate for their condition. This will be a pragmatic pre–post clus- ter randomized trial that will help bridge the know–do gap in maternal health. 9.2.2 Implementation of reproductive health kits Revision of the interagency reproductive health kits is under way, led by UNFPA (12 kits with commodities for compre- hensive RH services for use at community, primary health care, and referral levels). Of note, in 2006–2007 over 18 000 RH kits were ordered from UNFPA Procurement and Supply Branch alone. This number is expected to have markedly increased by now, and other agencies have their own kit systems (Médecins sans Frontières, UNICEF, Save the Chil- dren, WHO). MPH is engaging in implementation research on kits for emergency situations which will potentially have an impact on cost-saving practices and lead to improved sexual and reproductive health services. 10 . CAPACITy BUILdInG Capacity-building activities are a critical function of MPH’s work. Fostering collaborations that include world leaders in research, clinical and public health science offers invalu- able opportunities to younger colleagues to further develop a career path in public health. Interns work with the Team on specific projects and are invited to participate in courses offered in Geneva, abroad and through web-based applica- tions. 10 .1 Progress 10.1.1 Capacity building in humanitarian aid In collaboration with the Uganda WHO Country Office and Save the Children, a training course on reproductive health in humanitarian situations was held in Kampala. Participants came from Afghanistan, Bangladesh, Democratic Republic of the Congo, Ethiopia, Haiti, Kenya, Liberia, Mozambique, Pakistan, Philippines, Sudan, Uganda and Yemen. 10.1.2 Health Cluster Coordinator training The Team contributed to the Health Cluster Coordinator train- ing by leading a session on sexual and reproductive health aimed at preparing participants for deployment in acute and chronic emergency situations. 10.1.3 Postgraduate course in research methodology in reproductive health As in the past 15 years, Team members participated in the postgraduate course in research methodology in reproduc- tive health organized by the WHO Collaborating Centre Geneva Foundation for Medical Education and Research (GFMER). In 2010 the course was offered for the first time online and was attended by more than 100 participants mostly from developing countries. 10.1.4 Lectures at the Royal Tropical Institute (KIT) Every year since 2005, Team members have been teaching students enrolled in the Master’s in International Health Pro- gramme at the Royal Tropical Institute in Amsterdam, The Netherlands. 10.1.5 Second Life In collaboration with Boston University, a location was cre- ated in the virtual world Second Life targeted at educational activities. The output was a course on diabetes taught to more than 30 participants from different locations in the USA. Each of the participants, the lecturer and the facilitators attended the same virtual lectures through their “avatars”. The experience was published as an example of the pro- vision of medical education activities through Second Life. Activities are planned to extend the use of Second Life to the GFMER postgraduate course. 10 .2 Planned activities In the context of the Fetal Growth Study, and in collaboration with ISUOG and General Electrics (GE), courses on obstetric ultrasonography have been planned at the GE training cen- tres in Milwaukee, WI, USA, and Munich, Germany, as well as capacity building site visits. It is expected that 20 sonogra- phers from 10 different countries will be trained. Additionally, it is intended to conduct a course in obstetrics and gynae- cology sonography in Argentina to replicate the success of the 2010 workshop on pre-eclampsia which drew to Rosario more than 250 participants from Argentina and other Latin American countries. 11 . ACTIVISM/nGoS Establishing partnerships with NGOs has the potential to result in the development of comprehensive approaches to addressing the needs of women and children on the ground. Ideas generated through this collaborative process can then be presented in well-articulated proposals to policy-makers. 11 .1 Progress 11.1.1 National Observatory for Women’s Health (ONDa) The Team collaborated with the National Observatory for Women’s Health (ONDa) – an Italian NGO – in reviewing and identifying key issues in reproductive health that could be discussed in a meeting with a bipartisan group of Ital- ian Parliamentarians working with ONDa. On 23 January 2009, the first annual meeting with this group of legislators was held at WHO headquarters. The meeting was jointly organized by RHR, PMNCH, ONDa, the Permanent Mission of Italy to the United Nations Office and other international Biennial Technical Report 2009–2010 38 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 organizations based in Geneva. Two key issues were dis- cussed: (1) The alarming rise in caesarean sections in Italy, and (2) the importance of increasing development aid for the achievement of MDGs 4 and 5 at a time of global financial crisis and particularly in African countries. The meeting with the Italian Parliamentarians resulted in two parliamentary resolutions approved by the Italian Parliament and is now an official event held annually in Geneva. The two motions were instrumental to committing the Italian Government to develop guidelines for the use of CS at national level and to maintain the financial contribution to WHO for maternal and newborn health. In addition, the Parliamentarians engaged in holding several regional workshops on CS in collaboration with ONDa and HRP. 11.1.2 Organizations of parents of preterm infants In the past few years several organizations were established in Europe by parents who experienced preterm delivery. The birth of a preterm infant is often an unexpected event that places enormous emotional and financial strain on parents. The European Foundation for the Care of the Newborn Infant (EFCNI) functions as the European coordinator of several country-based organizations. The aim of the Foundation is to improve the conditions of infants and families who experi- ence preterm birth and to stimulate new research. The Team collaborated with EFCNI representatives in developing and publishing the European report on Prematurity. A meeting of European Union Parliamentarians is planned in Geneva in 2011 to agree on political action to be taken to support efforts to reduce the burden of preterm birth. A working group on preterm birth was established, coordinated by the Ital- ian organization Vivere, affiliated to EFCNI, which produced the first “Declaration of the rights of the preterm infant”. The declaration, endorsed by the Italian Societies of Neonatol- ogy and of Gynaecology and Obstetrics and the Italian Par- liament, was officially presented at an event at the Italian Senate in December 2010. 11 .2 Planned activities 11.2.1 Emergency Emergency is a human rights driven NGO established in 1994 by former Red Cross surgeons to provide the highest stand- ards of care for free even in conflict and postconflict settings. The Team was invited to join an Emergency advisory board that will provide technical support to the establishment of four maternity and paediatric hospitals and affiliated community clinics. A study is planned to evaluate the impact at popula- tion level of the hospitals on maternal and infant mortality. A similar effort is presently ongoing using data collected at the emergency hospital in the Panshir valley in Afghanistan. 12 . AdVoCACy And InnoVATIVE fInAnCInG Increasing awareness of and mobilizing resources for mater- nal and newborn health is a cornerstone of the Team’s work. It will continue to make every effort to raise the visibility of MNCH in the context of growing recognition of the impor- tance of this area to overall development. 12 .1 Progress 12.1.1 Art for Health In 2006, in collaboration with the PMNCH, the Art4Health project was launched – a project using the power of art to put global maternal health on the radar screen of the general public. Art4Health first commissioned a series of contempo- rary paintings depicting inspiring portraits of women from nations worldwide. The paintings have been on an interna- tional tour of public events ever since, and part of the col- lection was auctioned at Christie’s in Rome. The exhibit is available online ( The project has now evolved into Women Create Life (WCL). 12.1.2 Women Create Life WCL merges the art, design and consumer markets to gen- erate awareness and resources to improve maternal health worldwide – one of the objectives set at the last G8 summits and in the UN Secretary-General’s Global Strategy for Wom- en’s and Children’s Health. WCL builds on artistic creativity, the drive for global development as well as on the need for innovation in financing for international aid. WCL celebrates, through art, women who not only give birth to babies but also often generate the conditions that promote life and develop- ment in their communities, thus contributing to global health. How does it work? Each year, WCL will commission a series of paintings portraying women through the brush of a new artist or group of artists. WCL will partner with brand-name designers and companies to integrate the WCL logo and the images painted by featured artists into a range of products. Interested companies will associate their products with WCL and collaborate with companies in low-resource settings through joint ventures. A percentage of the sale of each WCL product will be invested in grass-roots initiatives to improve the health and life conditions of women and their families. 12.1.3 Gracias a Dios In 2009, the Team commissioned director Valerio Spezza- ferro to film a documentary on Mosquitia, a remote area in Honduras, with a focus on describing challenges in provid- ing and accessing care. The documentary also highlighted health-care activities supported with the funds generated at the Art4Health Christie’s auction. The documentary was screened at a specially organized event endorsed by National Geographic and participated in several international contests. It won the First International Journalism Solidar- ity Prize awarded at the Global Congress for Maternal and Chapter 2—Improving maternal and perinatal health 39 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Infant Health held in Barcelona in September 2010. The director is now producing a new documentary showing the settings, living conditions and challenges of the post-earth- quake situation in Haiti with specific emphasis on the condi- tion of women. 12.1.4 Oportunidades “Oportunidades” is a film based in Argentina and produced by parents of children with disabilities to highlight difficul- ties such children experience integrating into elementary schools. The Team promoted the movie through a collabora- tion with WHO’s Department of Violence and Injury Preven- tion. “Oportunidades” was screened at WHO as part of the celebrations of the International Day of Persons with Disabili- ties on 3 December 2010. The movie will also be shown at the launch of the World report on disability in 2011. Related activities are being planned with the Argentina WHO Country Office. These activities are in keeping with the World Health Assembly resolution on birth defects. 12.1.5 TV, newspapers and magazines Team activities have been featured in several newspapers and magazine articles as well as in TV programmes, includ- ing popular national TV programmes in Italy and Brazil. 12 .2 Planned activities Artakt is a group at the University of the Arts in London, United Kingdom, that conceives and produces exhibitions and events that study the relationship between art and sci- ence. Artakt has invited the Team to plan the exhibition: “Born: Childbirth in Science, Art and Culture.” This unprec- edented exhibition will bring together the fields of science and art, medicine and culture in order to tackle key issues concerning childbirth, its history and how we approach this most universal of events. It will show that birth has always been a critical feature of our consciousness; in the way we think, express and understand ourselves. Objects will span from the skeleton of Lucy (3–4 million years old) to contem- porary art. It is proposed that the exhibition will be inaugurated in Rome at the time of the 2012 FIGO Congress. The exhibit could also travel to other countries. An exhibition catalogue, with contributions from health-care providers, anthropologists and artists, will be produced and a series of lectures and workshops will be planned to coincide with the exhibition. Biennial Technical Report 2009–2010 40 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 PUBLICATIonS In 2009–2010 Peer-reviewed papers Abalos E, et al. Effects of calcium supplementation on fetal growth in mothers with deficient calcium intake: a randomised controlled trial. Paediatr Perinat Epidemiol, 2010, 24(1):53–62. Abdel Aleem H, et al. The effect of calcium supplementation during pregnancy on fetal and infant growth: a nested randomized controlled trial within WHO calcium supplementation trial. J Matern Fetal Neonatal Med, 2009, 22(2):94–100. Barros FC, et al. Recent trends in maternal, newborn, and child health in Brazil: progress toward Millennium Development Goals 4 and 5. Am J Public Health, 2010, 100(10):1877–89. Bates DW, et al. Global priorities for patient safety research. BMJ, 2009, 338:b1775. Beck S, et al. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ, 2010, 88(1):31–8. Betrán AP, et al. WHO Global Survey on Maternal and Perinatal Health in Latin America: classifying caesarean sections. Reprod Health, 2009, 6:18. Bhutta ZA, et al. Countdown to 2015 decade report (2000– 10): taking stock of maternal, newborn, and child survival. Lancet, 2010, 375(9730):2032–44. Bustreo F, Requejo J and Johnston A. Effect of development assistance on domestic health expenditures. Lancet, 2010, 376(9741):591–3. Cabeza Vengoechea PJ, et al. Clasificación de cesáreas por Grupos de Robson en dos periodos comparativos en el Hospital de Manacor. Progresos Obstetricia Ginecología, 2010, 53(10):385–90. Carroli G, et al. Effects of calcium supplementation on uteroplacental and fetoplacental blood flow in low-calcium- intake mothers: a randomized controlled trial. Am J Obstet Gynecol, 2010, 202(1):45–9. Caulfield LE, et al. Nutritional influences on maternal autonomic function during pregnancy. Appl Physiol Nutr Metab, 2009, 34(2):107–14. De-Regil LM, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev, 2010, 10. Dolan SM, et al. Synopsis of Preterm Birth Genetic Association Studies: The Preterm Birth Genetics Knowledge Base (PTBGene). Public Health Genomics, 2010,13:514– 23. Froen JF, et al. Making stillbirths count, making numbers talk - issues in data collection for stillbirths. BMC Pregnancy Childbirth, 2009, 9:58. Gonzalez R, et al. Tackling health inequities in Chile: maternal, newborn, infant, and child mortality between 1990 and 2004. Am J Public Health, 2009, 99(7):1220–6. Guidotti RJ, et al. Monitoring perinatal outcomes in hospitals in Kabul, Afghanistan: The first step of a quality assurance process. J Matern Fetal Neonatal Med, 2009, 22(4):285–92. Gulmezoglu AM, et al. Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial. Reprod Health, 2009, 6:2. Health Care Professional Association Writing Group 2009. Delivering services and influencing policy: Health care professionals join together to improve maternal, newborn, and child health. Int J Gynaecol Obstet, 2010, 105:271–4. Kandasamy T, et al. Cesarean delivery surveillance system at a maternity hospital in Kabul, Afghanistan. Int J Gynaecol Obstet, 2009, 104(1):14–7. Keller M, et al. Policy benchmarking report on neonatal health and social policies in 13 European countries. Acta Paediatr, 2010, 99(11):1624–9. Lawn JE, et al. Setting Research Priorities to Reduce Almost One Million Deaths from Birth Asphyxia by 2015. PLoS Med. (in press) Lumbiganon P, et al. One-day compared with 7-day nitrofurantoin for asymptomatic bacteriuria in pregnancy: a randomized controlled trial. Obstet Gynecol, 2009, 113(2 Pt 1):339–45. Magoma M, et al. High ANC coverage and low skilled attendance in a rural Tanzanian district: a case for implementing a birth plan intervention. BMC Pregnancy Childbirth, 2010, 10:13. Mattar R, et al. [Obesity and pregnancy]. Rev Bras Ginecol Obstet, 2009, 31(3):107–10. Menon R, et al. Racial disparity in pathophysiologic pathways of preterm birth based on genetic variants. Reprod Biol Endocrinol, 2009, 7:62. Mignini L, et al. Accuracy of diagnostic tests to detect asymptomatic bacteriuria during pregnancy. Obstet Gynecol, 2009, 113(2 Pt 1):346–52. Peterson HB, et al. Accelerating science-driven solutions to challenges in global reproductive health: A new framework for moving forward. Obstet Gynecol. (in press) Pope R, Mangser M, Requejo J. Restoring dignity: social reintegration after obstetric fistula repair in Ukerewe, Tanzania. Glob Public Health. (in press) Chapter 2—Improving maternal and perinatal health 41 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Requejo J, et al. Health care professional associations in select countries in Africa and the Middle East join together to improve maternal, newborn, and child health. Int Childbirth J. (in press) Requejo JH, et al. The World Health Organization policy on global women’s health: new frontiers. J Womens Health (Larchmt), 2010, 19(11):2115–8. Requejo JH, et al. Regional collaborations as a way forward for maternal, newborn and child health: the South Asian healthcare professional workshop. J Health Popul Nutr, 2010, 28(5):417–23. Torloni MR. The Cochrane Collaboration and the World Health Organization: new perspectives for an old relationship. Sao Paulo Med J, 2010, 128(2):104–5. Torloni MR, et al. Maternal BMI and preterm birth: a systematic review of the literature with meta-analysis. J Matern Fetal Neonatal Med, 2009, 22(11):957–70. Torloni MR, et al. Safety of ultrasonography in pregnancy: WHO systematic review of the literature and meta-analysis. Ultrasound Obstet Gynecol, 2009, 33(5):599–608. Torloni MR, et al. Prepregnancy BMI and the risk of gestational diabetes: a systematic review of the literature with meta-analysis. Obes Rev, 2009, 10(2):194–203. Torloni MR, et al. Classifications for caesarean section: a systematic review. PLoS ONE. (in press) Torloni MR, et al. Portrayal of caesarean section in Brazilian women’s magazines: a 20 year review. BMJ. (in press) Villar J, et al. World Health Organisation multicentre randomised trial of supplementation with vitamins C and E among pregnant women at high risk for pre-eclampsia in populations of low nutritional status from developing countries. BJOG, 2009, 116(6):780–8. von Dadelszen P, et al. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the full PIERS model. Lancet. (in press) Widmer M, et al. Misoprostol as an adjunct to standard uterotonics for treatment of postpartum haemorrhage: a multicentre, double-blind randomised trial. Lancet, 2010, 375(9728):1808–13. Widmer M, et al. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database Syst Rev. (in press) Wiecha J, et al. Learning in a virtual world: experience with using Second Life for medical education. J Med Internet Res, 2010, 12(1):e1. Yadamsuren B, et al. Tracking maternal mortality declines in Mongolia between 1992 and 2007: the importance of collaboration. Bull World Health Organ, 2010, 88(3):192–8. Zhang J, et al. Defining normal and abnormal fetal growth: promises and challenges. Am J Obstet Gynecol, 2010, 202(6):522–8. Reports, book chapters Requejo J, Bustreo F. Global perspectives on child well- being: Response. In: Worthman C, et al., eds. Formative experiences: The interaction of caregiving, culture, and developmental psychobiology. Cambridge University Press, 2010. Requejo J, Merialdi M. Chapter 1: The global burden of preterm birth. In: Berghella V, ed. Preterm birth: Prevention and Management. Wiley-Blackwell Press, 2010. Price Waterhouse & Coopers. Women Create Life – Art for Health. Final report. Geneva, 2010. Merialdi M, Harris Requejo JA. New directions in maternal health. The State of the World’s Children 2009. New York, United Nations Children Fund. Requejo J, Merialdi M. A4H: Using art for action to improve women and children’s health. Abaton: The Global Health Issue 2009; Des Moines University. Howson CP, et al. March of Dimes White Paper on Preterm Birth: The global and regional toll. White Plains, NY, USA: March of Dimes, 2009. The Role of Health Care Professionals in Reaching MDGs 4 and 5, Amman, Jordan, 17–19 December, 2009. Lauer JA, et al. Determinants of caesarean section rates in developed countries: supply, demand and opportunities for control. Geneva, World Health Organization, 2010 (WHR2010 Background Paper, 29). Gibbons L, et al. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. Geneva, World Health Organization, 2010 (WHR2010 Background Paper, 30). Requejo J, Production editor. Requejo J, Bryce J. Lead authors of the Countdown 2010 report; WHO, PMNCH and ONDa. La salute materno-infantile: il parto cesareo. Io Donna, Rome, Italy, 2010. 42 Bi en ni al T ec hn ic al R ep or t 2 00 7– 20 08 Chapter 3 Controlling sexually transmitted and reproductive tract infections 1 . InTRodUCTIon The RHR Controlling Sexually Transmitted and Reproduc- tive Tract Infections Team (STI team) develops strategies, guidelines and tools for the prevention and control of STIs, including HIV infection and other non-sexually transmitted reproductive tract infections (RTIs). The STI Team is also responsible for research on the prevention of mother-to- child transmission of HIV (MTCT) and other infections such as syphilis, and advocates for research on the development and deployment of safe and effective microbicides to prevent the sexual acquisition of HIV in women. The STI Team is also involved in the development of guidelines and training activi- ties, in collaboration with the WHO HIV/AIDS Department, to ensure that male circumcision procedures for the prevention of HIV infection are conducted safely, and adverse events are monitored and documented. 2 . ConTRIBUTIon To WHo’S MEdIUM-TERM STRATEGIC PLAn 2008–2013 The STI Team contributes mainly to SO4, “To reduce mor- bidity and mortality and improve health during key stages of life, such as the neonatal period, childhood and adoles- cence and improve sexual and reproductive health … for all individuals”. The work responds more specifically to OWER 4.2 by supporting creation of “… new evidence, products and technologies”, and promoting “interventions to improve maternal, newborn, child and adolescent health and improve sexual and reproductive health”. This is achieved through the development of guidelines for the control and surveillance of STIs; research and product registration in the areas of micro- bicides and male circumcision devices for the prevention of HIV infection; and research in areas of preventing MTCT. In addition, the STI Team contributes to OWER 4.7 by devel- oping and providing “guidelines and tools … to accelerate progress towards the attainment of international develop- ment goals and targets related to reproductive health”. And, as some STIs facilitate the transmission and acquisition of HIV infection, the STI Team also contributes to OWER 2.1 through its work on guidelines, tools and interventions for the prevention of HIV infection and care for persons living with HIV infection. 3 . ConTRoL of STIS The Global Strategy for the Prevention and Control of Sexu- ally Transmitted Infections 2006–2015 has been presented at international, regional and national conferences, and action plans for implementation or strategic frameworks to guide its implementation have been produced at the regional levels. A number of key support documents are under production to support the implementation of the Strategy. 3 .1 Progress Efforts to strengthen interventions for the control of STIs have been made in all the WHO regions. The WHO European Region developed a Regional Framework for the Implemen- tation of the WHO Global Strategy for the Prevention and Control of Sexually Transmitted Infections in the WHO Euro- pean Region, 2010–2017, and convened a consultation in August 2010 with some countries of the Region to agree on priorities, targets, and performance indicators for implement- ing the framework in the countries of the European Region. In October 2010, the South-East Asia and Western Pacific Regions held midterm reviews of their respective Strategic Chapter 3—Controlling sexually transmitted and reproductive tract infections 43 Bi en ni al T ec hn ic al R ep or t 2 00 9– 20 10 Frameworks for STI control, and identified constraints, gaps and opportunities for scaling up STI interventions in the coun- tries of the regions. Staff from the STI Team were requested by the regional offices to provide technical support during all these meetings. 3.1.1 Gonococcal antimicrobial resistance monitoring In respon

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