IPPF Medical and Service Delivery Guidelines for Sexual and Reproductive Health Services
Publication date: 2004
MEDICAL AND SERVICE DELIVERY GUIDELINES FOR SEXUAL AND REPRODUCTIVE HEALTH SERVICES THIRD EDITION 2004 Cover photos: from left to right, starting at the top left corner: Maryse Hodgson/ Vietnam; Mahua Sen/ Uganda; Wendy Knerr/Brussels - Belgium; IPPF/UNESCO/Paul Almasy; P. Wolmuth/Dominican Republic; Jenny Mathews/Pakistan This document may be freely reviewed or abstracted. It may be reproduced and translated by country programmes, in part or in whole, provided that due acknowledgement is given to the authors and the International Planned Parenthood Federation. This document should not be offered for sale by individuals or organizations other than the IPPF or its Member Associations. ISBN 0-86089-126-7 © International Planned Parenthood Federation, 2004 Price US $25.00 (£14.00 UK only) including postage. Any income generated from the sale of this publication will be put towards future editions and reprints. Payment can be made by cheque or credit card by contacting IPPF. Free of charge to individuals and organizations in developing countries. on NW1 4NS United Kingdom. Designed by Spencer du Bois IPPF is incorporated by UK Act of Parliament and is a UK Registered Charity No 229476 Fatiha Terki, MD Usha Malhotra, MD Edited by Mark Powlson International Planned Parenthood Federation Regent’s College, Inner Circle, Regent’s Park, London, NW1 4NS, United Kingdom. Tel +44 (0)20 7487 7900 Fax +44 (0)20 7487 7950 Email firstname.lastname@example.org www.ippf.org MEDICAL AND SERVICE DELIVERY GUIDELINES FOR SEXUAL AND REPRODUCTIVE HEALTH SERVICES THIRD EDITION 2004 TABLE OF CONTENTS Preface 2 Acknowledgements 4 Instructions for use 6 Chapter 1 Clients’ rights and providers’ needs 12 1 Introduction 12 2 Clients’ rights 12 3 Providers’ needs 17 Chapter 2 Counselling 22 1 What is counselling? 24 2 Counselling in sexual and reproductive health 25 settings 3 Who can do the counselling? 26 4 Environment 27 5 The link between education/information and counselling 29 6 Contraceptive counselling 30 6.1 Choice of method 30 6.2 Explanation of how to use the method of choice 32 6.3 Return for follow-up 33 6.4 Problems using the method 34 6.5 Method failure 34 6.6 Integrating STI and HIV/AIDS counselling 35 7 Counselling for groups with special needs 35 Chapter 3 The normal menstrual cycle 38 1 Introduction 40 2 The ovarian cycle 41 2.1 The follicular phase 41 2.2 The luteal phase 43 3 The endometrial cycle 43 4 The cervical cycle 43 5 Conception 44 Chapter 4 Reproductive health screening for well women 46 1 Introduction 48 2 Health conditions targeted by reproductive health screening 48 3 Who is eligible for reproductive health screening? 49 4 Who can provide reproductive health screening? 49 5 Requisites for a successful reproductive health screening programme 49 6 Reproductive health screening 50 6.1 Taking a history 50 6.2 Physical examination 53 6.2.1 Breast cancer screening 54 6.2.2 Pelvic examination 56 6.3 Other investigations 58 6.4 Frequency of reproductive health screening for well women 59 6.5 Other issues to consider during reproductive health screening 60 7 Cervical cancer screening 60 8 The menopause 69 Chapter 5 Hormonal contraception 74 1 Introduction 76 2 Combined oral contraceptives (COCs) 76 2.1 Definition 76 2.2 Indications 77 2.3 Medical eligibility criteria 78 2.4 Special situations 81 2.5 Counselling and information 84 2.6 Who can provide COCs? 84 2.7 Health assessment 85 2.8 Choice of COC 86 2.9 Instructions to the client 87 2.10 Follow-up care 93 2.11 Provision of COCs 93 2.12 Side-effects 94 2.13 Service management 94 3 Progestogen-only pills (POPs) 95 3.1 Definition 95 3.2 Indications 96 3.3 Medical eligibility criteria 96 3.4 Special situations 97 3.5 Counselling and information 98 3.6 Who can provide POPs? 99 3.7 Health assessment 99 3.8 Instructions to the client 99 3.9 Follow-up care and provision of POPs 102 3.10 Side-effects 103 3.11 Service management 103 4 Management of oral contraceptive services 103 4.1 Community-based family planning services 103 4.2 Clinical services 105 4.3 Provision of pills 106 4.4 Storage, shelf-life and supplies 106 5 Progestogen-only injectable contraceptives (POIs) 107 5.1 Definition 107 5.2 Indications 108 5.3 Medical eligibility criteria 108 5.4 Special situations 110 5.5 Counselling and information 112 5.6 Who can provide POIs? 113 5.7 Health assessment 113 5.8 POI provision 113 5.9 Instructions to the client 116 5.10 Follow-up care 117 5.11 Side-effects 118 5.12 Service management 119 6 Combined injectable contraceptives (CICs) 119 6.1 Definition 119 6.2 Indications 120 6.3 Medical eligibility criteria 120 6.4 Special situations 123 6.5 Counselling and information 124 6.6 Who can provide CICs? 124 6.7 Health assessment 125 6.8 CIC provision 125 6.9 Instructions to the client 127 6.10 Follow-up care 128 6.11 Side-effects 128 6.12 Service management 129 7 Management of injectable contraceptive services 129 8 Subdermal implants 130 8.1 Definition 130 8.2 Indications 132 8.3 Medical eligibility criteria 132 8.4 Special situations 134 8.5 Counselling and information 134 8.6 Who can provide subdermal implants? 135 8.7 Health assessment 135 8.8 Choice of implant 136 8.9 Insertion and removal 136 8.10 Instructions to the client 138 8.11 Follow-up care 140 8.12 Side-effects 141 8.13 Service management 141 9 Other delivery systems for combined hormonal contraceptives 143 9.1 Transdermal patch 143 9.2 Vaginal ring 143 Chapter 6 Intrauterine devices 146 1 Definition 148 2 Indications 149 3 Medical eligibility criteria 150 4 Special situations 154 5 Counselling and information 154 6 Who can insert IUDs? 155 7 Health assessment 155 8 IUD selection 156 9 Timing of insertion 157 10 Inserting the IUD 158 11 Instructions to the client 160 12 Follow-up care 162 13 Side-effects 162 14 Complications 163 14.1 Perforation 163 14.2 Excessive bleeding 164 14.3 Pelvic inflammatory disease 165 15 Pregnancy 165 16 Lost threads 166 17 When to remove the IUD 167 18 Service management 167 18.1 Client records 167 18.2 Supplies 167 18.3 Training 168 Chapter 7 Barriers 170 1 Introduction 172 1.1 General indications 172 1.2 Medical eligibility criteria 173 1.3 Health assessment 174 1.4 Service management 174 2 Condoms 175 2.1 Definition 175 2.2 Indications 177 2.3 Medical eligibility criteria 178 2.4 Counselling and information 178 2.5 Condom selection 179 2.6 Instructions to the client 179 2.7 Side-effects 180 2.8 Service management 180 3 Diaphragms 181 3.1 Definition 181 3.2 Indications 182 3.3 Medical eligibility criteria 182 3.4 Counselling and information 183 3.5 Health assessment 184 3.6 Diaphragm selection 184 3.7 Who can provide diaphragms? 184 3.8 Fitting the diaphragm 184 3.9 Instructions to the client 187 3.10 Follow-up care 188 3.11 Side-effects 188 3.12 Service management 189 4 Spermicides 190 4.1 Definition 190 4.2 Indications 190 4.3 Medical eligibility criteria 191 4.4 Counselling and information 191 4.5 Spermicide selection 192 4.6 Instructions to the client about spermicides 192 4.7 Side-effects 193 4.8 Service management 193 Chapter 8 Female and male sterilization 196 1 Introduction 198 1.1 Definition 198 1.2 General indications 198 1.3 Pre-operative screening 198 1.4 Counselling and information 199 1.5 Informed consent 201 1.6 Health assessment 202 1.7 Anaesthesia 202 1.8 Surgical principles for ensuring safety 202 1.9 Post-operative instructions 203 1.10 Complications 203 1.11 Reversal 204 1.12 Service management 204 2 Male sterilization 208 2.1 Definition 208 2.2 Indications 208 2.3 Medical eligibility criteria 208 2.4 Counselling, information and informed consent 210 2.5 Who can perform vasectomy? 210 2.6 Health assessment 210 2.7 Pre-operative preparation 211 2.8 Anaesthesia and operative procedure 211 2.9 Post-operative care 213 2.10 Instructions to men after the procedure 213 2.11 Follow-up care 213 2.12 Complications 214 3 Female sterilization 214 3.1 Definition 214 3.2 Indications 215 3.3 Medical eligibility criteria 215 3.4 Counselling, information and informed consent 218 3.5 Who can perform female sterilization? 218 3.6 Health assessment 219 3.7 Timing of female sterilization procedures 220 3.8 Pre-operative preparation 221 3.9 Anaesthesia and operative procedure 221 3.10 Post-operative care 224 3.11 Instructions to women after the procedure 224 3.12 Follow-up care 225 3.13 Complications 225 Chapter 9 Fertility awareness-based methods 228 1 Introduction 230 1.1 General indications 232 1.2 Indications 232 1.3 Conditions that require careful consideration 232 1.4 Special situations 233 1.5 Counselling and information 233 1.6 Who can provide information about the method? 234 1.7 Health assessment 234 1.8 Teaching the method 234 1.9 Follow-up care 235 2 The basal body temperature (BBT) method 235 2.1 Definition 235 2.2 Indications 235 2.3 Counselling and information 235 2.4 Instructions to clients 236 3 The cervical mucus (Billings’) method 240 3.1 Definition 240 3.2 Indications 241 3.3 Conditions that require careful consideration 241 3.4 Counselling and information 241 3.5 Instructions to clients 242 3.6 The modified mucus method 244 4 The calendar or rhythm (Ogino-Knaus) method 245 4.1 Definition 245 4.2 Indications 245 4.3 Conditions that require careful consideration 245 4.4 Counselling and information 245 4.5 Instructions to clients 245 5 The sympto-thermal method 246 5.1 Definition 246 5.2 Indications 246 5.3 Counselling and information 246 5.4 Instructions to clients 246 6 The standard days method (SDM) 247 6.1 Definition 248 6.2 Indications 248 6.3 Instructions to clients 248 Chapter 10 Emergency contraception 252 1 Introduction 254 1.1 General indications 254 1.2 Types of emergency contraception 255 2 Emergency contraceptive pills (ECPs) 255 2.1 ECP regimens 255 2.2 Efficacy 256 2.3 Side-effects 257 2.4 Indications 257 2.5 Medical eligibility criteria 257 2.6 Who can provide ECPs? 258 2.7 Counselling and information 258 2.8 Health assessment 260 2.9 Instructions to the client 260 2.10 Follow-up care 261 2.11 Starting regular contraception after ECP use 261 3 Copper-releasing intrauterine devices (IUDs) 262 3.1 Efficacy 262 3.2 Indications 262 3.3 Medical eligibility criteria 263 3.4 Special situations 264 3.5 Who can provide IUDs? 264 3.6 Counselling and information 264 3.7 Health assessment 264 3.8 Insertion of the IUD 265 3.9 Instructions to the client 265 3.10 Follow-up care 265 3.11 Side-effects 266 4 Service management 266 4.1 Advocacy 266 4.2 Providing information 266 4.3 Increasing accessibility 267 4.4 Service delivery outlets 267 Chapter 11 Diagnosis of pregnancy 270 1 Introduction 272 2 Clinical (non-laboratory diagnosis) 272 3 Symptoms and signs of pregnancy 273 3.1 Symptoms 273 3.2 Signs 273 4 Laboratory diagnosis 273 4.1 Agglutination inhibition slide tests 274 4.2 Immunometric tests and radioimmunoassay 274 5 How to be reasonably sure that the woman is not pregnant 275 6 Counselling after diagnosis of pregnancy 275 Chapter 12 Safe abortion 278 1 Introduction 280 1.1 Definition 280 1.2 General indications 281 1.3 Counselling and information 281 2 Informed consent, confidentiality and privacy 283 3 Pre-abortion care 283 3.1 History 283 3.2 Physical examination 284 3.3 Laboratory testing 284 4. Methods of abortion 285 4.1 Medical methods 288 4.2 Surgical methods 288 5 Follow-up 293 5.1 Monitoring during recovery period 293 5.2 Instructions for care after abortion 294 5.3 Signs and symptoms requiring urgent attention 294 5.4 Management of abortion complications 294 6 Contraceptive and STI counselling 296 Chapter 13 Reproductive tract infections and sexually transmitted infections 298 1 Introduction 300 1.1 Definition 300 1.2 The role of sexual and reproductive health/family planning services 301 2 Prevention 302 3 Management of RTIs/STIs 304 3.1 Syndromic management 304 3.2 Syndromic plus clinical management 315 3.3 Syndromic plus clinical and limited laboratory tests 315 3.4 Clinical management plus laboratory tests (aetiological diagnosis) 316 4 Counselling and information 317 4.1 Instructions to clients 317 5 Partner management 318 6 Follow-up care 319 6.1 Treatment failure 319 7 Service management 320 7.1 Administration 320 7.2 Training 322 7.3 Guidelines 323 7.4 Referral systems 323 7.5 Monitoring and supervision 324 Chapter 14 HIV infection and AIDS 340 1 Introduction 342 1.1 Definition 342 1.2 Transmissibility 342 1.3 The role of sexual and reproductive health/family planning services 342 2 Prevention 343 2.1 Prevention of sexual transmission 344 2.2 Prevention of non-sexual transmission 344 2.3 Prevention of perinatal transmission 344 2.4 Prevention of transmission in health care facilities 344 3 Management of HIV/AIDS 345 3.1 Voluntary counselling and testing (VCT) 345 3.2 Follow-up counselling 347 3.3 Partner notification/counselling 348 3.4 Sexual behaviour 349 3.5 Reproductive decision-making 350 3.6 Contraception 353 3.7 Treatment 356 3.8 Care and support for infected individuals 358 Chapter 15 Infection prevention and control 362 1 Introduction 364 2 Definitions 364 3 Antisepsis 365 3.1 Indications 365 3.2 Selection of antiseptics 365 3.3 Preparation, storage and dispensing of antiseptics 366 4 Procedures for processing of equipment and instruments 368 4.1 Decontamination 368 4.2 Cleaning 372 4.3 High-level disinfection (HLD) 372 4.4 Sterilization 376 5 Processing of individual items 381 5.1 Pelvic examination tabletop or other large surface areas 381 5.2 Linens for surgical procedures (caps,masks, gowns and drapes) 382 5.3 Gloves (rubber or plastic) 383 5.4 Instruments for pelvic examination 384 5.5 Instruments for male and female sterilization (except laparoscope), insertion and removal of Norplant implants and IUD insertion 384 5.6 Endoscopes (laparoscopes) 385 5.7 Needles and syringes 385 5.8 Storage containers for instruments 386 5.9 Water 386 6 Storage of sterilized or disinfected equipment 387 7 Care during procedures 388 7.1 Handwashing 388 7.2 Gloving 391 7.3 Injection procedures 393 8 Environment 393 8.1 Cleaning of activity areas 394 8.2 Traffic flow 396 8.3 Processing area for instruments and other items 397 8.4 Transport of clean, disinfected, sterile and soiled items 398 8.5 Waste disposal 398 9 Prophylactic antibiotics 402 10 Management 402 10.1 Administration 403 10.2 Guidelines 404 10.3 Training 404 10.4 Monitoring and supervision 406 Suggested Reading 407 Abbreviations 413 Index 415 1 PREFACE For fifty years IPPF has worked to make sexual and reproductive health education and services available to millions of people worldwide. Through its six regional offices and its global network of 149 Member Associations, IPPF is uniquely placed to provide, and campaign for, sexual and reproductive health care and rights. IPPF’s vision is of universal access to sexual and reproductive health care for women, men and young people. It is now more evident than ever that the right to decide the number and spacing of their children and to enjoy good sexual health helps people improve their lives. Against a background of scarce resources and increasing opposition from conservative forces, IPPF’s Strategic Plan, newly approved in 2003, focuses on four unresolved reproductive health challenges: (i) meeting the sexual and reproductive health needs of young people worldwide;(ii) the fight against HIV/AIDS; (iii) eliminating unsafe abortion and improving access to safe abortion, and (IV) addressing the sexual and reproductive health unmet need of the marginalized and the poor. A fifth priority area is advocacy, based on both evidence and experience, allowing IPPF to take the lead in defending and expanding the above reproductive rights. To ensure the success of the Strategic Plan, IPPF is also committed to ensure throughout its network the provision of high quality services. These guidelines are an important part of IPPF’s ongoing commitment to raising standards of care. The IPPF Medical and Services Delivery Guidelines are intended to improve knowledge, skills and confidence among service providers and to ensure that service providers are able to meet their clients’ needs. In order to do this, the guidelines have been designed to be technically sound (supported by scientific research), socially sound (acceptable to those who will use them) and operationally sound (validated and updated). The guidelines have also been written to be easily adapted to the needs and resources of different environments where they will be used. 2 This Third Edition builds on the success of previous editions and expands on them to reflect the needs and rights of both service providers and their clients. This edition includes four new chapters: The normal menstrual cycle, Reproductive health screening for well women, Safe abortion, and HIV infection and AIDS. Knowledge of contraception expands continuously; therefore, the existing chapters on methods have been updated. This has required a review of the recent contraceptive literature, and these chapters also incorporate the products of a very important consensus building activity - the review of Medical Eligibility Criteria for Contraceptive Use, sponsored by the World Health Organization (WHO) in October 2003, as well as the Selected Practice Recommendations meeting organized by WHO in April 2004. All the leading organizations active in the field of family planning policy and programmes participated in these efforts, and IPPF and its International Medical Advisory Panel (IMAP) played an active role. Information on contra-indications and conditions requiring special consideration regarding the use of the various methods of contraception has been reviewed to make it consistent with the updated WHO criteria. As with previous editions the guidelines have been developed under the guidance of IMAP. Experience has shown us that the guidelines are only effective if they are accessible to those who would benefit most from them. We would like you to use them as part of your own training and discussions, and would welcome comments and feedback to improve future editions. I am pleased to commend these guidelines to all those working for better sexual and reproductive health. Dr Steven W Sinding IPPF Director-General London 2004 3 Acknowledgements These guidelines have been developed thanks to the help and guidance of the International Medical Advisory Panel (IMAP) of the IPPF. Several chapters have been written using IMAP statements. Members of IMAP are: Dr Halida Akhtar Dr Ward Cates Dr Soledad Diaz Dr Lindsay Edouard Dr Anna Glasier Dr Herbert Peterson Dr Helen Randera-Rees Professor Fred Sai Dr Paul Van Look Dr Edith Weisberg Special thanks are expressed to Dr Carlos Huezo, co-author of the first and second editions and who initiated the process for the development of this third edition, to Dr Usha Malhotra who is co-author of this edition and contributed to the following new chapters: Safe abortion, HIV infection and AIDS and Reproductive health screening for well women, to Mark Powlson who edited the guidelines. The chapters of the guidelines were also reviewed by Regional Quality of Care advisors and by staff of the central office of IPPF. They include: Dr Gayane Dolyan Dr Magdy Khaled Dr Rim Esghairi Dr Pratima Mittra Ilka Maria Rondinelli Dr Nehemiah Kimathi Dr Cheikh Ouedraogo Ms Patricia Mathews Dr Mariama Barry 4 The following staff of EngenderHealth also made important contributions to this third edition of the guidelines: Carmela Cordero, M.D., Associate Medical Director John Pile, M.P.H., Director of Family Planning, and Roy Jacobstein, M.D., M.P.H., Medical Director. Dr Victoria Jennings, Director of the Institute for Reproductive Health at Georgetown University Medical Center contributed to the Fertility awareness-based methods chapter. Special thanks are also expressed to the following IPPF staff: Ms Susanne Hamm for contributing to the technical aspects of the guidelines Ms Laura Feeney for overseeing the logistics of the production Ms Doortje Braeken for her contribution to the Counselling chapter Dr Marcel Vekemans for reviewing the Safe abortion chapter Dr Nono Simelela for reviewing the HIV infection and AIDS chapter The encouragement and support of IPPF’s Director-General Dr Steven W Sinding and Deputy Director Ms Lyn Thomas during the preparation of this book are sincerely appreciated. 5 INSTRUCTIONS FOR USE 1 Purpose of the Guidelines The IPPF Medical and Service Delivery Guidelines for Sexual and Reproductive Health Services are designed to be used in sexual and reproductive health service programmes, including family planning: • As a guide for the delivery of services These guidelines provide clear guidance to managers and service providers for the planning and performance of tasks which are related to their duties. • As a reference document for assessing quality of care The focus of the guidelines is on providing services which reach essential standards of quality. Therefore, the quality of services can be assessed by comparing actual performance with the recommendations and instructions contained in the guidelines. • As a training instrument Each chapter of the guidelines can serve as the basis for the development of training curricula. • As a tool for supervision The guidelines can serve as a reference to supervisors in identifying situations which require corrective actions and in identifying training needs. The supervisors can use the guidelines for bringing to the attention of service delivery personnel essential elements of quality of care and proper procedures. 6 2 Intended users The intended users of the guidelines are: programme planners and managers, clinical services providers, and trainers and supervisors of clinical and community-based services. The guidelines are appropriate for doctors, nurses, midwives and other health professionals. The content of the guidelines relevant to community-based services can be used for developing materials for these workers, but this can best be done at the local level. 3 Format The guidelines consist of 15 chapters. As well as being extensively revised, this Third Edition includes 4 new chapters to the 1997 edition. These are: The normal menstrual cycle (chapter 3); Reproductive health screening for well women (chapter 4); Safe abortion (chapter 12) and HIV infection and AIDS (chapter 14). Cross-references To avoid unnecessary duplication of information provided, cross-references are made between and within chapters of the guidelines. These cross- references refer to the specific chapter by number and to the specific section of the chapter also by number. Most often the cross-references are to other sections of the same chapter. 7 8 SEXUAL AND REPRODUCTIVE RIGHTS THE RIGHT to life THE RIGHT to liberty and security of the person THE RIGHT to equality, and to be free from all forms of discrimination THE RIGHT to privacy THE RIGHT to freedom of thought THE RIGHT to information and education THE RIGHT to choose whether or not to marry and to found and plan a family THE RIGHT to decide whether or when to have children THE RIGHT to health care and health protection THE RIGHT to the benefits of scientific progress THE RIGHT to freedom of assembly and political participation THE RIGHT to be free from torture and ill treatment WWW.IPPF.ORG C LI EN TS ’R IG H TS A N D P R O VI D ER S’ N EE D S 1 1 CLIENTS’ RIGHTS AND PROVIDERS’ NEEDS 10 11 1 Introduction The aim of sexual and reproductive health programmes is to improve the quality of life of all women, men, and young people. To achieve this aim, all services that clients receive must be of consistently high quality, and reflect this ideal. Since the late 1980s, special focus on the concept of quality of care, and an increased attention to its importance, has enhanced client satisfaction and has led to increased demand for, and acceptability of, sexual and reproductive health services, including family planning. A high quality of care ensures that clients are empowered to make informed, confidential and timely decisions about their sexual and reproductive health. Since access to sexual and reproductive health services and family planning has been recognized as a right of all individuals and couples, quality of care can now be understood as a right of the client, extending the definition of the client not only to those who approach the health care system for services, but also to everyone in the community who is in need of such services. The client should be at the centre of all sexual and reproductive health and family planning activities. A client-centered approach means that providers of these services should be aware of clients’ needs, and must meet and respect their rights. Managers and supervisors should also be aware that if the rights of clients are to be fulfilled, the needs of the service providers must also be met. Taken together, the clients’ rights and the service providers’ needs form the two pillars of quality of care in the provision of such services. 2 Clients’ rights The right of all individuals and couples to decide freely the number and spacing of their children has been internationally established for many years. The Tehran Declaration of Human Rights in 1968, for example, stated that “Parents have a basic human right to determine freely and responsibly the number and spacing of their children”. The 1994 International Conference on Population and Development (ICPD) held in Cairo reinforced this declaration, and also stated that it is “the right of women and men to be informed and have access to sexual and C LI EN TS ’R IG H TS A N D P R O VI D ER S’ N EE D S 1 12 reproductive health services of their choices, which are safe, effective, affordable and acceptable”. In line with these statements, the rights of clients can be outlined as follows: 2.1 Right to information All individuals in the community have a right to know about the benefits and availability of sexual and reproductive health services for themselves and their families. They also have a right to know where and how to obtain more information and services for planning their families and for sexual and reproductive health care. All sexual and reproductive health programmes should be active in disseminating information about sexual and reproductive health and family planning not only at service delivery sites, but also at the community level. 2.2 Right to access All individuals in the community have a right to obtain sexual and reproductive health services, regardless of their race, gender or sexual orientation, marital status, age, religious or political beliefs, ethnicity or disability, or any other characteristics which could make individuals vulnerable to discrimination. Fulfilment of this right requires ensuring access through various health care providers as well as service delivery systems. Sexual and reproductive health programmes should take the necessary steps to ensure that services will reach all individuals who need them, especially those for whom health services are not yet easily accessible. 2.3 Right of choice Individuals and couples have the right to decide freely whether or not to control their fertility and which method to use. When seeking contraceptive services, clients should be given the freedom to choose which method of contraception to use. Sexual and reproductive health programmes should assist individuals in the practice of informed, free choice by providing unbiased information, education and counselling, as well as an adequate range of contraceptive methods. Clients should be able to obtain the method which they have decided to use provided there are no contraindications to their use of that method. 13 A client’s concept of acceptability and appropriateness changes with circumstances. Therefore, the right of choice also involves clients’ decisions about discontinuation of a method of contraception and method switching. Another aspect of choice should be considered: as far as is practical, clients have a right to choose where to go for sexual and reproductive health services, and the type of service provider with whom they feel most comfortable. Choosing where to go may involve a choice of physical location or a choice of service delivery mode (e.g., community-based services, pharmacy or over-the-counter service, hospital, health centre or sexual and reproductive health clinic). Governmental, non-governmental and private sector providers should welcome the establishment of alternative service outlets. 2.4 Right to safety Clients have a right to be protected from unwanted pregnancy, disease and sexual violence and, when receiving sexual and reproductive health services, this right to safety implies the following: • Although it is well recognized that the benefits to health from family planning outweigh the risks, clients have a right to protection against any possible negative effect of a contraceptive method on their physical and mental health. • Since unwanted pregnancies may represent a risk to health, the right of the client to safety also includes the right to effective contraception. • When receiving services, clients also have a right to protection against other health risks which are not related to a method of contraception (for example, protection against the possibility of acquiring an infection through the use of contaminated instruments). Safety relates to the quality of service provision, including both the adequacy of the service delivery facility itself, and the technical competence of the service providers. Ensuring the client’s right to safety includes assisting the client in making an informed choice of contraceptives, screening for contraindications, use of the appropriate techniques to provide the method (if applicable), teaching the client about the proper use of the method and ensuring proper follow-up. The conditions in service delivery sites, together with the materials and instruments, should be adequate for the provision of safe services. C LI EN TS ’R IG H TS A N D P R O VI D ER S’ N EE D S 1 14 Any complications or major side-effects should receive appropriate treatment. If this treatment is not available at a particular service site, the client should be referred to another facility. 2.5 Right to privacy Clients have a right to discuss their needs or concerns in a private environment. Clients should know that their conversation with the counsellor or service provider will not be listened to by other people. When a client is undergoing a physical examination, it should be carried out in an environment in which her/his right to bodily privacy is respected. The client’s right to privacy also involves the following aspects related to quality of services: • When receiving counselling or undergoing a physical examination, the client has the right to be informed about the role that each individual inside the room, besides those directly providing services, is playing (e.g., individuals undergoing training, supervisors, instructors, researchers, etc.). Where the presence of individuals undergoing training is necessary, the prior permission of the client should be obtained. • A client has a right to know in advance the type of physical examination which is going to be undertaken. The client also has a right to refuse any particular type of examination if s/he does not feel comfortable with it or to request that this examination be done by another service provider. • Any case-related discussions held in the presence of the client (particularly in training facilities) should involve and acknowledge the client. 2.6 Right to confidentiality Clients should be assured that any information they provide or any details of the services received will not be communicated to third parties without their consent. The right to confidentiality is protected under the Hippocratic oath. As such, sexual and reproductive health services should be performed in conformity with local legal requirements and in accordance with ethical values. A breach of confidentiality could cause the client to be shunned by the community or negatively affect the matrimonial status of the client. 15 It may also lessen a target group’s confidence and trust in the staff of a service delivery programme. In accordance with the principle of confidentiality, service providers should refrain from talking about clients by name or in the presence of other clients. Clients should not be discussed outside service sites. Client records should be kept closed and filed immediately after use. Similarly, access to client records should be controlled. 2.7 Right to dignity Clients have a right to be treated with empathy, courtesy, consideration, attentiveness and with full respect of their dignity regardless of their level of education, social status or any other characteristics which could single them out or make them vulnerable to abuse. In recognition of this right of the client, service providers must be able to put aside their personal gender, marital, social and intellectual prejudices and attitudes while providing services. 2.8 Right to comfort Clients have the right to feel comfortable when receiving services. This right of the client is intimately related to adequacy and organization of service delivery facilities (e.g., service delivery sites should have proper ventilation, lighting, seating and toilet facilities). Clients should spend only a reasonable amount of time at the premises to receive the required services. The environment in which the services are provided should be in keeping with the cultural values, characteristics and demands of the community. 2.9 Right of continuity Clients have a right to receive sexual and reproductive heath services and supplies, such as contraceptives, for as long as needed. The services provided to a particular client should not be discontinued unless this is a decision made jointly between the provider and the client. In particular, a client’s access to other sexual and reproductive health services should not depend on whether s/he continues the contraceptive services or not. The client has a right to request transfer of her/his clinical record to another clinical facility, and in response to that request, the clinical record or a copy of it should be sent to that facility or given to the client. Referral and follow-up are two other important aspects of a client’s right to continuity of services. 16 C LI EN TS ’R IG H TS A N D P R O VI D ER S’ N EE D S 1 17 2.10 Right of opinion Clients have the right to freely express their views on the services that they receive. Clients’ opinions on the quality of services, be they in the form of thanks or complaint, together with their suggestions for changes in service provision, should be viewed positively in a programme’s ongoing effort to monitor, evaluate and improve its services. Any new programme or service delivery facility should ideally involve clients at the planning stage. The aim is to satisfy would-be clients’ needs and preferences in ways that are appropriate and acceptable to them. Programme managers and service providers should achieve fulfilment of all rights of the clients. This goal is directly related to the availability and quality of sexual and reproductive health and family planning information and services. 3 Providers’ needs The needs of service providers must also be addressed in order to make clients’ rights a reality. Without these needs being met – in terms of adequate resources, support, knowledge and training, for example – it becomes impossible for service providers truly to meet clients’ rights. The needs of the service providers can be outlined as follows: 3.1 Need for training Service providers must have access to the knowledge and skills needed to perform all the tasks required to do their work. It would be most unfair to the service provider and her/his clients if providers were required to perform a task for which they had not received the appropriate training. It is, therefore, the responsibility of the managers to identify staff training needs and to take the necessary steps to provide all required training. Programme managers should bear in mind that the training needs of service providers include technical aspects and communication skills. Effective communication is essential for clients to understand the background information, to which everyone is entitled, that will support the decision-making process and the implications of any choices made, including the personal risk/benefit balance. Effective communication is also required to establish the providers’ perception and understanding of the clients’ circumstances. 18 3.2 Need for information All service providers need to be kept informed on issues related to their duties. Moreover, service providers do not work in isolation, and they can work more efficiently if they are also informed on aspects related to the work of their colleagues in the service delivery team and other areas of the programme. Access to updated technical information can assist service providers to talk with authority and to act with confidence. 3.3 Need for infrastructure Service providers need to have the appropriate physical facilities and organization to provide services at an acceptable level of quality. This right to the appropriate infrastructure applies not only to services provided in a clinical environment, but also to services provided at the community level. The need for efficient organization at community level is just as important as it is for clinical services. Service providers must also be assured their working environment is safe. This includes safety from being unnecessarily exposed to the risk of an infection, such as HIV/AIDS. 3.4 Need for supplies Service providers need continuous and reliable supplies of the methods of contraception and materials which are required for the provision of sexual and reproductive health services at appropriate standards of quality. It is highly frustrating for a service provider who wants to do a good job to have to turn away clients without giving them the method of contraception they want to use. An adequate supply of materials should include educational materials, as well as those which are required to provide safe and effective services to the clients. 3.5 Need for guidance Service providers need clear, relevant and objective guidance: the type of guidance which will reinforce their commitment and competence for delivery of high-quality services. This guidance should be in the form of written service guidelines, practical checklists and effective supportive supervision. 3.6 Need for back-up Service providers need to be reassured that whatever the level of care at which they are working – from the community level to the most comprehensive clinical service delivery site – they are members of a C LI EN TS ’R IG H TS A N D P R O VI D ER S’ N EE D S 1 19 larger grouping in which individuals or units can provide support to each other. To fulfil their commitment for quality of care, service providers may find themselves needing to request a consultation or technical support, or to refer clients to another provider or another level of care. Sexual and reproductive health and family planning programmes should develop the mechanisms to facilitate this process. 3.7 Need for respect Service providers need recognition from the programme of their competence and potential, and respect for their human needs. They also need the support of the system in their efforts to gain the respect of the clients. For example, referrals made by community workers to clinical facilities should be given adequate attention and clinic staff should show respectful consideration of the concerns of the community workers. Behavioural factors which may negatively affect the respect of the clients towards a service provider must be avoided – e.g., calling the attention of the provider to mistakes or problems in the presence of the clients in a way which may cause embarrassment or shame. Service providers must be protected from any verbal, psychological and physical harassment or abuse from clients, other staff and supervisors. 3.8 Need for encouragement Service providers need stimulus in the development of their potential and creativity. They should be encouraged to work at a level of autonomy in accordance with their capabilities. Their motivation and commitment to quality of care should be strengthened. Motivation and commitment are the most essential ingredients for successful sexual and reproductive health and family planning services which work at acceptable levels of quality. 3.9 Need for feedback Service providers need feedback concerning their competence and attitudes as judged by others. This knowledge will assist service providers in improving their performance and in being responsive to the clients’ needs. Feedback is necessary from all those involved in the service delivery system, including managers, supervisors, other service providers and especially the clients. Feedback works best if given in a positive and constructive way. Providers should be given the opportunity to improve their performance based on the knowledge of how they are seen by 20 others. If service providers are motivated towards quality of care and are continuously encouraged to improve, feedback will be effective in improving the quality of care. 3.10 Need for self-expression All service providers, regardless of the level of care at which they are working, need to express their views concerning the quality and efficiency of the programme. But they also need to be listened to and to know that their opinion is taken into account when making management decisions. Policy makers and programme managers should assess and care for the needs of service providers in order to ensure good quality of services. This is the best way to meet the rights of the clients and maintain the credibility and reputation of the programme. C LI EN TS ’R IG H TS A N D P R O VI D ER S’ N EE D S 1 21 C O U N SE LL IN G 2 2 COUNSELLING Photo: Fatiha Terki/Vietnam 22 23 1 What is counselling? Counselling is a face-to-face process of communication by which one person helps another individual, couple, family or group to identify her/his or their needs and to make appropriate decisions and choices. Counselling is a structured conversation between two or more people that assists one or more of the participants to work through particular issues that she or he faces with regard to sexual and reproductive health (SRH) needs and contraception, to explore their feelings and to find ways to deal with them. Counsellors encourage people to recognise and develop their own coping capacity, so they can deal more effectively with issues of concern. Counselling not only helps people with their immediate needs, but also helps them to recognise and draw upon their own resources, which they can use for future problems they may encounter. Counselling is about creating new perspectives and change. The change may be inside the person (helping them to feel differently about a situation); or a change in their behaviour (e.g., practising safer sex); or a change in something in their environment. Counselling aims to help people to: • Understand their situation more clearly. • Identify a range of options for improving that situation. • Make choices, including contraceptive choices, which fit their values, characteristics, feelings and needs. • Make their own decisions and act upon them. • Cope better with any problems. • Develop life skills such as being able to talk about sex with a partner. • Provide support for others while preserving their own strength. C O U N SE LL IN G 2 24 2 Counselling in sexual and reproductive health settings In sexual and reproductive health settings, counselling can be used for a variety of tasks which include: • To decide whether or not she, he or they need and want to use a method of contraception. • To make an informed, free choice of a contraceptive method. • To learn about the method of choice. • To use the method of choice properly. • To overcome anxieties and make adequate decisions if problems occur. • To help with concerns about sexually transmitted infection (STI) and/or HIV infection. • To prepare couples for parenthood. • To make informed decisions about breastfeeding. • To help women decide whether to terminate a pregnancy. • To discuss any issues around sexuality and sexual relations, infertility, menopause and other sexual and reproductive health issues. Effective counselling is particularly important in helping people with concerns about sexual and reproductive health because many people feel unable to talk with relatives or friends about these concerns. They may not even feel able to talk to their partner about contraceptives, safer sex or a diagnosis of STI. These situations can be complex and clients need time to talk them through and to make an appropriate decision. Family planning/reproductive health counsellors have many opportunities to counsel clients on sexual and reproductive health issues including family planning. By expanding family planning counselling to sexual and reproductive health counselling, the client is looked at in a holistic way. This is more helpful to the client in terms of family planning and their sexual life generally, and makes clients feel that the counsellor cares about them as people rather than contraceptive acceptors. The use of the existing facilities is maximized. The counsellors have already been trained, are used to counselling and are trusted by the community, and the counsellor can reach a wider group of clients with unmet needs, including young people, men and those not at risk of pregnancy. 25 3 Who can do the counselling? In many clinical settings, there may not be a formal specialist counsellor, but several clinic staff such as nurses, educators, receptionists, doctors and community workers could be trained to provide counselling. People who are motivated to counsel are more likely to make empathetic and proficient counsellors. Managers should motivate and support providers, community workers or volunteers to be involved in counselling. All staff members and community workers who provide counselling on a regular or occasional basis should be provided with appropriate training on counselling and communication skills. To be a counsellor one needs: • To have knowledge: - Of relevant sexual and reproductive health issues. - Of all available resources for sexual and reproductive health matters in their locality, including HIV prevention, support and/or care for victims of gender-based violence. (Counsellors might draw a map of all the resources in their district and use it to refer clients as appropriate). - Of trends and changes in sexual and reproductive health needs. • To be motivated and committed. • To have counselling skills including: - Active listening. - Non verbal communication. - Paraphrasing. - Asking questions. - Reflecting feelings. - Providing information. • To have the right attitudes, including: - Being non-judgmental. - Not imposing one’s own values on clients. - Being warm and approachable. - Being empathetic. - Having respect for clients. - Being committed to the client’s well-being. C O U N SE LL IN G 2 26 - Being willing to learn continuously and from one’s own mistakes. - Knowing oneself. - Having knowledge of life and of people with different cultures and ways of life. 4 Environment It is important to make clients feel at ease and to make them feel safe and confident. Creating a safe environment for counselling includes consideration of the physical environment. Wherever counselling takes place, whether at home or in the clinic, it must be held privately. • Ensure that counselling is done in private and is confidential so that every client feels comfortable to discuss risk factors, including sexual behaviour. • Provide a space where accompanying children can play with supervision while the mother is counselled. • Make sure that the room is arranged in such a way that the communication between the client and the counsellor is private and confidential and that it facilitates communication between the client and the counsellor. • Use visual aids to facilitate discussions, such as flip charts, anatomical and contraceptive posters or pelvic models. The counsellor’s approach and attitude is crucial. The counsellor can make the clients feel safe and confident by treating them in a warm and respectful way and communicating with them in a language and terminology they understand. The appearance and approach of the counsellor should be such that clients do not feel overpowered and feel secure enough to open up. Whenever possible and practical, counsel both the client and the partner and/or the family when appropriate. • As soon as you meet a client, give them your full attention. • Greet them politely and introduce yourself (name and title). • Explain that any information they share with you is confidential. • Ask the client what is the reason for their visit and how you may help them. 27 • Listen attentively and demonstrate this through positive body language and non-verbal communication. • Give the client enough time to express her or his ideas and to make their own decision. Value silence while the client thinks deeply or copes with her or his emotions. • Be aware of possible or known cultural differences between you and your client and ask for a fuller explanation if you do not understand or need to know more. • Good interpersonal communication requires appropriate eye contact. However this may not always be culturally acceptable. • Do not write and listen at the same time. Give your full attention to listening and then make notes with the client’s permission if you need to. • Encourage the client to speak or continue speaking by words such as “I see”, “go on” etc. These small signs are vital to show that you are interested and pleased that the client is expressing her/himself. • Assist the clients to talk about their needs and encourage them to ask any questions to help them with their sexual and reproductive health needs. • Explain to them that you are asking questions to help them with their needs. • Help the client to focus on issues where they can actively do some positive change, rather than being overwhelmed by the whole issue or problem. Help them to identify others that they can rely on and receive help from. • Try to answer your client’s questions honestly, accurately and fully, however difficult they are. It does not help the client to give false reassurance to stop them worrying. • Involve new clients in the process of completing any acquired forms accurately and completely. For continuing clients, involve them in updating their records with any new information. • If counselling is taking place in a clinic, as opposed to the client’s home or other place in the community, explain the steps of the clinic visit, including who they will see, what examinations and tests will be performed and the reasons they are necessary, how long the visit will take and whether any payment is necessary. • Refer the client to a range of services as needed. • Provide ongoing support but avoid dependency and help clients to develop their own coping skills. 28 C O U N SE LL IN G 2 5 The link between education/information and counselling Information obtained by clients before counselling will make the counselling process easier and will save time during personal interviews. Clients should learn about family planning, contraception, safer sex, STIs, HIV/AIDS and other sexual and reproductive health issues through other education activities, including posters and pamphlets (in appropriate languages) placed in waiting areas; films or videos; and by taking part in group discussions. Time in waiting areas should be used to educate clients on reproductive health, contraception, STI/HIV/AIDS prevention and other sexual and reproductive health issues. Counselling is part of the information and education process. Giving information and education before the counselling can save some time in individual counselling but the counsellor still needs to check that the client understands the basic facts in relation to her or his own life. During individual counselling, learning is enhanced by clients receiving information and education to their specific needs. In group information-giving, the provider (or a video or printed pamphlet) gives the basic facts about an issue (e.g., family planning, contraceptives, safer sex, STIs, HIV/AIDS, transmission routes, potential advantages and disadvantages of having an HIV test and the process of counselling and testing). The provider or video needs to give the information in a clear and interesting way that relates to people’s lives. Ask the group if they have any questions and encourage discussion through the information giving. If you have enough time, have some discussion after each topic. Warn the group that you cannot guarantee confidentiality and it is safest to talk about issues in a general way rather than disclose personal information. This can happen later in the individual counselling session. The ideal size for the group depends on the venue and the time available; between ten and twenty people gives opportunities for discussion. In certain settings and cultural norms around sexual and reproductive health matters, group counselling such as in (extended) family or community groupings may be preferred. In group counselling, the counsellor guides a process of rapport building, exploration of the issues around prevention, options for risk reduction and other sexual and reproductive health information. The group is smaller (maybe up to ten people) and made up of people who will feel comfortable to talk together 29 (e.g., single-sex groups of a similar age and status, couples or families). They may share their feelings and experiences but with the understanding that confidentiality is not guaranteed. The group can share successful strategies for safer sex and, support and encourage each other and leave the session with more understanding of their options, their own feelings and values. 6 Contraceptive counselling 6.1 Choice of method Clients should make their own decision on which contraceptive method is appropriate for them. The counsellor should help each client to match her or his family planning needs and preferences to a safe and appropriate method. If the client is visiting the clinic to start using a method of contraception, ask the client if s/he has a particular method of contraception in mind. If the client is considering a particular method: • Try to determine by discussion and review of the client’s medical and social history if the method is appropriate for the characteristics, needs and circumstances of the client. - If the method is appropriate, determine if the client knows about other contraceptive options and make sure that s/he is firm about her/his choice. - If the method is not appropriate (e.g., if she is breastfeeding, is less than 6 months postpartum and wants to use combined oral contraceptives; or if a barrier is unlikely to be used properly when an unwanted pregnancy would be a high risk), explain the disadvantages of using such a method and inform the client about other more appropriate contraceptive options. • If, after discussing all the contraceptive options, the client chooses the originally preferred method, this method can be provided if the benefits outweigh the risks and there are no absolute contraindications. • If the client has a relative contraindication and the method is provided, advise her of the warning signs relevant to her condition. In these cases, the participation of a senior member of staff in the screening and counselling process may be required. 30 C O U N SE LL IN G 2 If the client is not considering a particular method: • Ask the client which methods of family planning s/he knows about. (This gives an opportunity to determine the client’s level of knowledge as well as an opportunity to correct any misinformation). • Briefly describe each method to the client. Provide additional information on the methods in which the client is interested. Show the methods to the client and let her/him examine them. Make sure information on all the following is included: - How the method works. - Effectiveness of the method. - Medical contraindications. - Possible side-effects. - Advantages. - Disadvantages. • Encourage questions. • Discuss advantages and disadvantages of the various methods in relation to the characteristics and needs of the client (e.g., current family situation, ability to remember to take a pill every day, partner’s cooperation, frequency of sexual intercourse, number of partners). Advise the client that except for barrier methods no other method provides protection against STIs and that the condom is the only method demonstrated to protect against HIV (see chapter 14: HIV infection and AIDS). • Determine if the client is ready to make her/his decision by specifically asking “What method have you decided to use?” • After listening to all the contraceptive options available, the client may still be unable to decide and may ask you to recommend a method. Through continuous education and counselling, the choices will become clearer and the client will eventually be able to make her/his decision. In the meantime, suggest a method which is best suited to the client’s particular characteristics and needs. If this is done, explain the reason for recommending that method and make sure that the client has understood those reasons and agrees with the recommendation. If the client does not agree, recommend another method until the client is satisfied. If there is still some hesitation, give the client some more time to consider before making her/his choice. 31 Never try to impose a method against the will of the client. Special situations • Some clients cannot use the method they choose for health reasons. When this occurs explain to the clients what the contraindications are and help them choose another method. • If the client chooses a method which you do not have in stock or do not offer, make a referral to a location where the method of choice may be obtained. Help the client choose a method which can be used until her/his preferred method is available. • If the client chooses female or male sterilization, she or he will have to receive special counselling, since this is a permanent method. The client must sign a specific informed consent form (see chapter 8: Male and female sterilization). 6.2 Explanation of how to use the method of choice • The specific information that a client should receive about each method is stated in the chapters on each method. The following general areas must be covered when discussing the chosen contraceptive method: - How to use the method. - Possible side-effects. - Management of side-effects. - Warning signs that indicate need for medical follow-up, and where to obtain this follow-up. - Re-supply information, if applicable. - When the next follow-up visit should take place. • Ask clients what they have understood about each of the above points by asking them to repeat the instructions in their own words. If necessary, repeat the instructions, emphasizing the points which the client has not understood well. Correct any misunderstandings and provide any information that is missing. • Provide each client with printed information on the chosen method in a language appropriate to their reading level. When serving illiterate clients, provide carefully designed pictorial materials as a support for the one-to-one counselling. These materials are especially important 32 C O U N SE LL IN G 2 for methods such as the pill and barriers, which are dependent on correct use to be effective. • Explain when the client should return for routine follow-up and re- supply. Also, explain the importance of a return visit if the client: - Is experiencing any side-effects. - Has any questions. - Wishes to switch to a different method. - Wants to stop using the method. 6.3 Return for follow-up Enabling a client to understand complete information about family planning is not something that is usually accomplished in one visit; assisting clients to plan their families throughout their reproductive life is an ongoing process. Follow-up visits are an important opportunity to: • Reinforce the decision clients have made to plan their family. • Discuss any problems they are having with their method of choice. • Answer any questions they may have. • Explore changes in their current health status or life situation which indicate a need to switch to another contraceptive method or stop using any method. During a follow-up visit: • Briefly review the chart for the main details of the reproductive health history. • Ask the client how s/he feels with the method and if there are any questions. • If s/he is having any problems with the method, assess the nature of the problem and discuss possible solutions. • If the problem is a side-effect, assess how severe it is and offer suggestions for managing it or refer the client for treatment. • If the client is not using the method any more, ask why not (it may be due to problems related to misunderstanding, side-effects or supply). If the client still wishes to continue using a contraceptive answer her/his questions and provide information that will enable her/him to continue with a contraceptive of choice. 33 • If the client is still using the method, determine if it is being used correctly. Instruct the client on the correct use of the method if necessary. • Ensure that the client receives re-supplies and an appropriate examination if necessary. • Assist the client in selecting another contraceptive method if the client is not satisfied with a method, if her/his situation has changed, or if the method is no longer safe. • If a client wishes to become pregnant, help her to stop her method and provide information on the return of fertility. Emphasize the importance of antenatal care and where to obtain it. 6.4 Problems using the method • If a client seeks help because of problems with the method, it is important that service providers take care of the psychological needs of the client as well as the medical condition. Comfort the client and give emotional support. • If the client is unhappy about the method being used, ask about the reasons; if appropriate, give reassurance about the method or advise about other contraceptive options. • If a client is having complications which indicate that the method should be discontinued, give advice on other contraceptive options. 6.5 Method failure If pregnancy has occurred, it is necessary to discuss it with the client (ideally with the couple) and to give her all the support and advice she may need. Try to determine if the pregnancy is the result of method failure and identify, if possible, any factors that may have contributed to it. (Please refer to chapters on specific methods). It is usually impossible to anticipate accurately the effect of this event on the pregnant woman and her partner. The immediate reactions vary widely. Providers should be sensitive and understanding of changing feelings and provide support as required. The client should be supported and encouraged to return for further counselling if desired. 34 C O U N SE LL IN G 2 • If the woman plans to continue the pregnancy: Advise her on the importance of early antenatal care and nutritional counselling and where and how to obtain it. A referral should be provided if necessary. • If the woman does not wish to continue the pregnancy: Counselling should be provided in accordance with local laws and regulations. Explain to the client the dangers of unsafe abortion practices. 6.6 Integrating STI and HIV/AIDS counselling Counsellors who are mainly involved in family planning may feel that STI and HIV/AIDS counselling is an additional task that involves all kinds of problems that are difficult to resolve. They will need to understand the benefits of integrating STI/HIV counselling, given a chance to express their concerns, and to identify the support that they will need. STIs, including HIV/AIDS are major problems, and clients should understand the risks and decide how to protect themselves. For each contraceptive method, providers should explain whether it protects or not against STIs/HIV and promote dual protection when appropriate (see chapter 14: HIV infection and AIDS). 7 Counselling for groups with special needs Programmes serving clients with special needs should ensure that providers of counselling are well trained in the needs of these groups and what specific approaches may be useful. Examples of such client groups include adolescents, as well as non-literate or low-literate populations. 35 C O U N SE LL IN G 2 36 37 3 THE NORMAL MENSTRUAL CYCLE Photo: Miguel Cruz/Dominican Republic TH E N O R M A L M EN ST R U A L C YC LE 3 38 39 1 Introduction Basic knowledge of the biology and physiology of the menstrual cycle facilitates understanding of the mechanisms of reproduction and of the action of various methods of contraception. Sexual development and reproductive function are regulated by interaction of the hypothalamus, pituitary gland and ovaries – the hypothalamic-pituitary-ovarian axis. At the beginning of pubertal development, the sensitivity of the hypothalamic-pituitary-ovarian axis (see Figure 3.1) changes. The hypothalamus starts to release its main peptide, gonadotrophin-releasing hormone (GnRH), in a pulsatile fashion. This, in turn, stimulates the pituitary to release the gonadotrophins follicle stimulating hormone (FSH) and luteinizing hormone (LH). These pituitary gonadotrophins stimulate the ovaries in a cyclical manner, inducing the production of ovarian steroids – androgens, oestrogen and progesterone. The ovarian androgens and oestrogen, together with androgens from the adrenal glands (notably dehydroepiandrosterone), induce the pubertal changes in the female, in particular: • Breast development; • Sexual hair growth; and • Maturation of the genital organs, including proliferation of the endometrium. Figure 3.1 The hypothalamic-pituitary-ovarian axis TH E N O R M A L M EN ST R U A L C YC LE 3 40 Information from higher centres in the brain Oestrogen/ progesterone negative feedback Hypothalamus GnRH LH FSH Ovary Pituitary Menarche, or the first menstruation, is usually not preceded by an ovulation, but as the hypothalamic-pituitary-ovarian axis develops the ovarian cycle is established. Oestrogen and progesterone have an inhibitory effect on the hypothalamus and the pituitary (negative feedback), homoeostatically regulating the release of gonadotrophins. In the periovulatory phase, increasing oestradiol concentrations stimulate the hypothalamus/pituitary to produce an LH surge, which in turn induces ovum release from the ovary. Other factors can modulate the cyclical function of the hypothalamic- pituitary-ovarian axis. These influences include: • Thyroid and adrenal gland activity, as shown by the association of hypothyroidism with menstrual disturbances. • Olfactory, visual and emotional stimuli, some of which operate via neurotransmitters such as catecholamines, dopamine, serotonin and opioids. The limbic system and the pineal body also influence hypothalamic function, partly through melatonin. • Nutritional factors, as shown by inhibition of the menstrual cycle in eating disorders or chronic diseases. 2 The ovarian cycle Each fetal ovary contains 6-7 million immature primordial follicles, only a few of which will develop and produce an ovum approximately every month during a woman’s fertile life. Most of the follicles are destined to follow a cycle of growth and atresia until the follicle population “expires” at the menopause. The ovarian cycle (see Figure 3.2) describes the events that occur in the ovary during a menstrual cycle before, during and after ovulation. The ovarian cycle is divided into the follicular phase (pre-ovulatory) and the luteal phase (post-ovulatory). 2.1 The follicular phase FSH rises shortly before menstruation, stimulating the growth and maturation of a batch of ovarian follicles. The maturing follicles produce oestrogens, mainly oestradiol. By days 5-7 of the cycle one follicle becomes dominant, and the egg (ovum) which will be released from 41 the ovary that month develops within it. The other maturing follicles in the batch recede and become atresic. Small amounts of LH are released continuously throughout the cycle, again in a pulsatile fashion. Some 24-48 hours before ovulation, a surge in oestradiol production by the dominant follicle triggers a surge of LH from the pituitary. This is the final stimulus to ovulation – rupture of the mature graafian follicle and release of the ovum. FSH and LH can be measured in plasma. Their concentrations are inversely related to ovarian activity, and remain constantly high during the menopause. FO LL IC LE D IA M ET ER (m m ) MENSTRUATION DOMINANT FOLLICLE OVULATION 25 20 15 10 5 0 8 6 4 2 0 50 25 200 300 400 100 0 26 1 5 10 15 20 25 28 0 MENSTRUATION CORPUS LUTEUM OESTRADIOL PROGESTERONE DAYS OF CYCLE FSH LH O ESTR A D IO L (pg/m L) P R O G R ES SI VE (n g/ m L) FS H ,L H (U /L ) Figure 3.2 The ovarian cycle TH E N O R M A L M EN ST R U A L C YC LE 3 42 2.2 The luteal phase After ovulation the walls of the ruptured follicle collapse. The cells in the wall accumulate lipids and the pigment carotene, which gives them a yellow appearance. With this transformation the follicle becomes the corpus luteum (yellow body). The corpus luteum produces oestradiol, progesterone and androgens. Progesterone dominates this phase of the cycle and prepares the endometrium to receive the fertilized egg if fertilization occurs. If fertilization does not occur, or if the fertilized egg fails to implant, the corpus luteum regresses 11-14 days after ovulation. Oestradiol and progesterone concentrations in the mid-luteal phase suppress the release of FSH and LH from the pituitary. The atresia of the corpus luteum if no implantation occurs decreases oestrogen and progesterone in the circulation, thereby withdrawing the support of these hormones to the endometrium and leading to menstruation. 3 The endometrial cycle The ovarian cycle of oestrogen production before ovulation, followed by oestrogen and progesterone in the post-ovulatory phase, is reflected in the endometrium. The endometrium proliferates in both glandular and stromal elements under oestrogen stimulation, in what is called the proliferative phase. After ovulation, under the effect of progesterone, the endometrium undergoes secretory changes in the glands and swelling of stromal cells, in what is called the secretory phase. As oestrogen and progesterone concentrations fall in the late secretory phase, the endometrial arterioles contract, leading to superficial ischaemia and subsequent shedding of the endometrium. The expulsion from the uterus of this endometrial material, together with blood, is what constitutes the menstrual period. The endometrium starts to repair through the proliferation of basal gland cells within 48 hours. 4 The cervical cycle In the early pre-ovulatory phase of the menstrual cycle the cervical mucus is thick, sticky and opaque, and forms a plug blocking the cervical canal. With the increasing concentrations of oestrogen as ovulation approaches, the mucus becomes copious, thin, elastic and clear, reaching a peak at ovulation to facilitate the ascent of spermatozoa to the endometrial cavity and upper genital tract. Progesterone reverses these changes after 43 ovulation, producing viscid, scarce, sticky and opaque mucus, which again forms a barrier to spermatozoa. The changes in cervical mucus, accompanied by sensations in the vagina and vulva during the cycle, are the basis of the cervical mucus method of fertility awareness. Together with the physical changes in cervical mucus, there is a pH shift from an acidic pH of around 4 before ovulation to an alkaline pH of 7-8 in the periovulatory and post-ovulatory part of the cycle. 5 Conception In a fertile cycle, coitus around the time of ovulation will result in rapid entry of sperm through cervical mucus to the upper genital tract. Spermatozoa have been demonstrated in the fallopian tubes 5 minutes after ejaculation (although most sperm take considerably longer), and they can survive in the female genital tract for 5 days or more. Fertilization usually occurs within a few hours of ovulation, in the outer third of the fallopian tube. The fertilized ovum starts to divide in the lumen of the fallopian tube, resulting in a ball of cells called the morula. By day 3 after fertilization the morula (or developing embryo) reaches the uterine cavity. It takes another 2-3 days to start implanting, and approximately another 3 days to implant successfully. On average it takes 6 days after ovulation for the developing embryo to start implantation. Once the embryo is in the uterine cavity, the cells surrounding it start to produce chorionic gonadotrophin, which is detectable in maternal blood from the 8th or 9th day after ovulation. Completion of implantation is regarded as the point of conception. Many fertilized ova (about 50%) do not implant and are lost during the next menstrual flow. Chorionic gonadotrophin maintains the corpus luteum, with continuing secretion of both progesterone and oestrogens until the placenta takes over this function later in the pregnancy. 44 TH E N O R M A L M EN ST R U A L C YC LE 3 45 4 REPRODUCTIVE HEALTH SCREENING FOR WELL WOMEN Photo: Fatiha Terki/Vietnam R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 46 47 1 Introduction Health screening is an important aspect of health care, which promotes population and individual wellbeing by early recognition of treatable disease and identification of those individuals who are at higher than normal risk of developing a particular disease and might therefore benefit from closer follow-up. Sexual and reproductive health (SRH)/family planning clinics often provide the most convenient opportunity for the reproductive health screening of well women. Where available, well-woman screening should be offered to all clients of SRH/family planning clinics, especially to those women with a risk factor (see section 6). However, the provision of SRH/family planning services should not be conditional on women accepting any kind of well-women screening services. In general, population screening programmes should target diseases that are: • Prevalent enough and cause a sufficient degree of morbidity and mortality to merit a large-scale screening programme. • Detectable by relatively simple means. • Amenable to early treatment. 2 Health conditions targeted by reproductive health screening These conditions fall into three main groups: • Reproductive tract infections (RTIs) and sexually transmitted infections (STIs). • Cancer (breast, cervical, endometrial and ovarian). • The menopause. R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 48 3 Who is eligible for reproductive health screening? Ideally, reproductive health screening should be available to: • All women who attend SRH/family planning clinics. • All women in high-risk groups. • All women who request a check up. 4 Who can provide reproductive health screening? With appropriate training, subject to local regulations and practice, reproductive health screening may be provided by: • Doctors. • Nurses. • Midwives. 5 Requisites for a successful reproductive health screening programme Key actions needed to provide a successful well-woman screening programme in SRH/family planning clinics include the following: • Ensure that the clinic setting is user-friendly and easily accessible to clients in terms of its location, times of opening, and administrative procedures. Fees charged, if any, should be affordable to the target population. The environment should impart a sense of warmth and privacy. • Set out clear protocols and establish proper staff training and supervision to ensure that appropriate service standards are met. Emphasize skills in communication as well as in performing clinical tasks. • Create an environment where clients trust all staff and feel comfortable in talking about any fears that they may have about their own physical and psychological wellbeing. Client confidentiality must be maintained. • Put across the message of the importance of regular reproductive 49 health checks and screening procedures in terms that are understood by clients. • Provide information through the distribution of educational pamphlets and the organization of health talks and demonstrations, with the use of appropriate audiovisual aids where available. • Keep accurate and complete records, and plan regular follow-up so that clients are not lost after the visit. • Ensure that specially trained health professionals can provide proper counselling of women found to have a disease. • Establish channels for referral to specialist care and further management, and make the referral process as efficient and trouble- free as possible. The provision of reproductive health screening in SRH/family planning clinics should not overwhelm their facilities or personnel such that some women are denied the SRH/family planning services they are looking for. On the other hand, when SRH/family planning clinics do provide reproductive health screening services, these should not be made conditional on the use of any form of contraception. 6 Reproductive health screening Reproductive tract infections (RTIs) and sexually transmitted infections (STIs) are discussed in detail in chapter 13. In this chapter, discussion centres on general aspects of reproductive health screening, and factors of special relevance to gynaecological cancers and the menopause. 6.1 Taking a history As with all consultations, it is important to take an adequate medical history. All the usual aspects of the medical and social history should be covered (see Box 4.1), including demographic data; relevant family history; past general medical history, with identification of present and past illnesses including diabetes mellitus, anaemia, or immunodepression; menstrual, gynaecological, obstetric contraceptive and sexual history, with discussion of RTIs/STIs, including HIV, pelvic inflammatory disease (PID) and risk factors to STI such as multiple partners; and social history. R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 50 In the well-woman health screening setting, most clients will be symptom free, so it is necessary to ask each client specific questions to elicit possible early symptoms related to high-risk conditions that might not otherwise be volunteered (see Box 4.2 for questions in relation to relevant high-risk conditions). 51 Box 4.1-Medical and social aspects to be covered in the history • Demographic data: Age, parity. • Family history: Health of parents, siblings. • Medical history: Previous illnesses or operations, history of blood transfusion, any current medications or treatments, any allergies. • Immunization history: Rubella, hepatitis vaccination. • Menstrual history: Date of last menstrual period, age of menarche, regularity of cycles, amount and duration of menstrual flow, presence and severity of associated symptoms such as dysmenorrhoea and premenstrual tension, details about any abnormal vaginal bleeding (For a menopausal or perimenopausal woman, the presence and severity of postmenopausal symptoms). • Gynaecological history: Previous illnesses including infections, any current or recurrent symptoms, such as vaginal discharge or vulval itchiness, RTIs/STIs. • Obstetric history: Dates and details of past pregnancies and deliveries. • Contraceptive history: Methods ever used and any side-effects. • Sexual history: Age at first intercourse, number of sexual partners, any sexual problems including dyspareunia and post-coital bleeding. • Social history: Smoking and alcohol intake. 52 Box 4.2-Risk factors for breast, cervical, endometrial and ovarian cancers Breast cancer: • Age over 40 years. • Family history of breast cancer, especially in a first-degree relative (mother/sister) who developed the disease before menopause. • Early menarche or late menopause. • Nulliparity or first pregnancy after the age of 30 years. • History of atypical hyperplasia in the breast. • High-fat diet and obesity. • Had hormone replacement therapy (HRT) for 5 years or more. • Never breast-fed. Cervical cancer: • Sexual intercourse before age 20 years. • Multiple sexual partners. • Infection with human papillomavirus (HPV). • Cigarette smoking. • History of sexually transmitted infections (STIs). Endometrial cancer: • Age over 50 years. • Family history of endometrial cancer. • Menstrual irregularity associated with anovulatory cycles. • Late menopause. • Nulliparity/infertility. • Use of unopposed oestrogen. • History of endometrial hyperplasia. • History of diabetes mellitus and/or hypertension. • High-fat diet, obesity. Continued on following page R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 6.2 Physical examination The physical examination will be guided by the history elicited, including the method of contraception chosen by the client, and should include general routine clinical examination, breast examination and pelvic examination. These procedures should be fully explained to the client in terms that are readily understood, and the client should be encouraged to relax and be reassured that the examination can be stopped at any time if she so requests. Male health workers or the client may request a chaperone for the physical examination. General examination Cover the following aspects in the general examination: • General appearance; build; gait and posture; speech pattern. • Body weight and height; body mass index (especially if obese). • Blood pressure; pulse. • Presence of pallor, jaundice, leg varicosities, ankle oedema, abnormal skin pigmentation or markings. • Thyroid enlargement (ask the client to swallow); cervical and supraclavicular lymph nodes and other neck masses on palpation. • Breath and heart sounds. • Presence of abdominal scars, enlargement or tenderness of the liver, spleen or kidneys; any other abdominal mass (e.g., gravid uterus). • Presence of inguinal lymph nodes. 53 Box 4.2-continued Ovarian cancer: • Age over 50 years. • Family history of ovarian cancer, especially in a first-degree relative. • Early menarche and late menopause. • Nulliparity or first pregnancy after age 30 years. • High-fat, low-fibre diet. 6.2.1 Breast cancer screening Guidance on the value of breast cancer screening programmes should take into consideration the needs and realities of resource-constrained settings. In these settings, the benefit of putting resources into breast cancer screening programmes should be weighed against the benefits of allocating them to other health services. The risks and benefits of screening will vary from setting to setting. The provision of follow-up services is crucial for effective screening programmes. Mammography The best currently available method for early detection of breast cancer is mammography combined with clinical breast examination. Where resources are available, regular mammography is usually offered to women aged 50-70. The frequency of mammography will depend on age- specific incidence rates and local health policy but is normally every 1-2 years. Current evidence does not show a survival benefit for mass screening for breast cancer and evidence on breast cancer mortality is inconclusive. Clinical breast examination When mammography is not available, clinical breast examination may be offered. At present, it is not possible to make evidence-based recommendations on which women should be examined or how often. However, it is prudent to offer clinical breast examination to women over 40 and those under 40 with other risk factors, which are primarily related to family history (eg, breast cancer in a first-degree relative). The breasts should also be examined, with palpation of the axillae to detect abnormal masses or tenderness. Inspection: • Explain the procedure to the client and the reason for doing it. • Make the client sit at the end of the examination table with her arms relaxed by her side. Ask her to remove her gown up to the waist. • Observe the following: - Contour and symmetry of breasts. - Any dimpling, swelling, discoloration and flattening of skin. - Nipple retraction or any discharge. 54 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 Palpation: • Ask the client to lie down on her back, remove the gown from one breast and put her hand behind her head on that side. • Use the pads of the three middle fingers. Wear gloves if there are open sores or any discharge. • Begin palpation at the junction of the clavicle and sternum. Use small circular movements and vary the pressure applied by the fingers in three grades: light for the superficial layer, moderate for the middle layer and firm for deep layers. • Palpate the breast in overlapping vertical strips and continue until the entire breast, including the axillary tail, has been covered. • Palpate around areola and the depression under the nipple. Press the nipple between the thumb and index finger to see if there is any discharge. • Lower the client’s arm and palpate for axillary lymph glands. • Repeat the same on the other side. Instruction about breast self-awareness Breast self-examination does not decrease mortality and should no longer be recommended as a screening tool. However, women should be “breast aware”; and a woman who finds an abnormality in the course of her regular activities should have it checked by a trained professional. Service providers need to instruct the client about breast self-awareness. Explain to her that breast cancer is one of the most common forms of cancer in women, and in its early stages it rarely causes symptoms and often first presents as a painless breast lump or a change in the appearance or feel of the breasts. Some breast cancers are first identified by women themselves, and the earlier breast cancer is detected, the higher the cure rate. Clients should be told to look for the following warning signs: • Any lump or thickening in the breasts, whatever the size. • Any change in the appearance or shape of the breasts. • Alteration in the position or level of the nipples. • Dimpling of the skin surface. 55 • Retracted nipples. • Discharge or bleeding from the nipples. • Puckering of the skin surface like that of an orange (p’eau d’orange). Tell the client to go to a doctor to have a thorough examination if she finds any unusual changes in her breasts. 6.2.2 Pelvic examination Pelvic examination should be offered to women as part of reproductive health screening and should only be carried out if the woman accepts it. If this is the client’s first gynaecological examination, it is particularly important to put her at ease by a careful explanation of the procedure involved and the reasons for doing it. Encourage her to relax, and reassure her that the examination can be stopped at any time if she so requests. Pelvic examination wearing gloves (not necessarily sterile) must be done in all women requesting an IUD, surgical sterilization or diaphragm insertion, and it should be offered to all women who visit the clinic for the first time and are aged 18 years or older or have been sexually active before 18 years of age. During the pelvic examination: • Ask the client to lie in the supine position with her legs bent at the knees, with the knees apart and the ankles together. • Inspect the external genitalia, including the labia, prepuce, clitoris, urethral opening, perineum and anal opening. (If there is a history of vaginal prolapse or urinary stress incontinence, the client should be asked to strain with a full bladder to see if any cystocoele, rectocoele or leakage of urine is found). • Palpate the vulva for tenderness and/or masses, particularly around Bartholin’s glands. • Ensure an adequate, adjustable light source. • Insert a vaginal speculum of the appropriate size. In general, a larger instrument will be needed for a multiparous woman with lax vaginal walls, and a narrow speculum should be used for a nulliparous woman. The most commonly used models are the bivalve Cusco’s and Graves’ 56 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 speculum or the Sims’ speculum. Water may be used for lubrication: if a cervical smear is to be taken (see section 7), KY jelly must not be used, but in other circumstances application of a very small amount may be helpful. • Inspect the vagina for rugae, discharge (noting its colour, amount, consistency and odour) and any protruding mass. If indicated and laboratory facilities are available, a vaginal swab can be obtained from the fornices for bacterial culture. • Expose the cervix and inspect its appearance, the presence of any erosion or cyst, any masses, or contact bleeding. A cervical smear may be obtained from the squamo-columnar epithelium junction between the ectocervix and the endocervix (see section 7). If indicated (e.g., in a client with suspected pelvic inflammatory disease or at high risk of STIs), take an endocervical swab for culture. • Withdraw the speculum and perform a bimanual examination, using KY jelly. • With the index and middle fingers in the vagina, assess the vaginal tone. • Feel the consistency of the cervix and note any pelvic tenderness on moving the cervix from side to side. • Place the other hand suprapubically and palpate the uterus between two hands, noting its size, position, regularity, and any tenderness. • Palpate each lateral fornix for abnormal masses or tenderness. Assess any masses detected for size, consistency, position, and mobility. • A rectovaginal examination is not routinely carried out, but may be indicated if the client has symptoms and/or signs of pelvic tumour or endometriosis. With the index finger in the vagina and the middle finger of the same hand in the rectum, palpate the uterosacral ligaments and rectovaginal septum for nodularity and other lesions. A bimanual pelvic examination is not necessarily indicated after routine cervical smear screening, but should always be performed in the presence of pelvic symptoms (see Box 4.3). 57 Remember at all times during the physical examination that the presence of abnormal vaginal discharge and foul smelling fishy or musty odour is suggestive of bacterial vaginosis and trichomonas vaginalis (see chapter 13 for discussion of the management of RTIs and STIs). 6.3 Other investigations Urinalysis Some clinics routinely do simple dipstick analysis to detect sugar, protein, blood and bilirubin. Laboratory investigations Some clinics may have their own laboratories, whereas others may need to send samples or refer clients for further testing. In some clients the following investigations may be indicated by the history or physical examination: • Haematology: Haemoglobin, full blood count, clotting studies. • Biochemistry: Renal function tests, liver function tests, fasting sugar, lipid profile, iron status. • Immunochemistry: Syphilis serology, rubella and hepatitis serology, HIV antibody status (see chapter 14); hormone concentrations. • Microbiology: Culture and sensitivity tests (particularly useful in cases of suspected RTIs/STIs (see chapter 13). 58 Box 4.3-Pelvic symptoms indicating a need for bimanual pelvic examination • Very heavy or painful periods. • Intermenstrual bleeding. • Urinary symptoms. • Abdominal swelling. • Lower abdominal pain or discomfort. • Dyspareunia (pain on sexual intercourse). R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 Ultrasonography The use of routine ultrasound examination in early detection of pelvic masses, especially ovarian tumours, has not been universally adopted - mainly for logistical reasons. Staff must be adequately skilled and the equipment of sufficient resolution so as not to miss small symptomless lesions. Although ultrasonography may not be routinely available in the setting of an SRH/family planning clinic, there should be an established channel for the referral for further investigation of women in whom a pelvic mass has been detected on pelvic examination. Endometrial biopsy Women at high risk of endometrial cancer (see Box 4.2) and those with dysfunctional perimenopausal bleeding may be referred for endometrial sampling. Various techniques are available, including aspiration cytology and curettage. Bone densitometry Measurement of bone density may form part of the assessment of women being considered for hormone replacement therapy (HRT). 6.4 Frequency of reproductive health screening for well women The age at which women should begin to have regular gynaecological examinations for the purposes of health screening, the interval between subsequent visits, and the age at which such screening programmes should stop depend on the availability of resources (e.g., clinic personnel, time, facilities) and on the presence or absence of risk factors in individual clients. As noted above in specific relation to mammography, the provision of screening services is influenced by weighing the medical benefit appropriately against the economic and social costs of the examination, and different countries may come to different conclusions (see section 6.2.1). In any discussion of recommended intervals for any screening programme, it should always be borne in mind that these are minimum standards; high-risk individuals may need to be screened more frequently, and if symptoms develop between screening intervals they should, of course, be dealt with appropriately. For gynaecological conditions, the existence of SRH/family planning clinics enables these services to be readily available (see section 7). 59 6.5 Other issues to consider during reproductive health screening Reproductive health screening can also represent an opportunity to enforce proactively messages in relation to sexual health and healthy lifestyle issues. The latter are considered in section 8, but are generally applicable at all ages. 7 Cervical cancer screening Cervical cancer screening may take place during the pelvic examination phase of reproductive health screening. The two techniques are: 1) Cervical cytology, involving: • Obtaining an adequate cervical smear; • Fixing the smear; and • Laboratory processing and examination of the smear. Cervical cytology does offer an indirect way to diagnose human papillomavirus (HPV) infection by means of highly specific and very sensitive tests for HPV DNA (e.g., by use of the polymerase chain reaction or hybrid 11 capture), but these techniques are very expensive and not widely available. Although obtaining cervical smears for the purposes of screening for cervical cancer is an integral part of reproductive health screening, the particular features of this process are dealt with here in a separate section for ease of cross-reference. Other features discussed earlier in this chapter also apply to cervical cancer screening programmes. Exfoliative cytology Exfoliative cytology is the study of cells that have been shed by various membranes or epithelia, which can be collected, spread onto slides, and the resulting smears stained and examined under the microscope. In clinical practice, surfaces are usually scraped to provide cells for study. In the case of cervical cytology, examination of these cells shows whether the cervical epithelial lining is normal, inflamed, or has evidence of cervical intra-epithelial neoplasia (CIN) or carcinoma. The purpose of cervical cancer screening programmes is to detect cervical cancers from premalignant lesions, when the cure rate for intervention is very high. 60 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 Cervical cytology (pap screening) Cervical cytology is currently the best available method for the detection of pre-malignant and malignant disease of the cervix. When routine pap screening is available it should start 2-3 years after the onset of sexual activity and be repeated every 1-3 years. When only limited pap screening is available, it should at the very least be offered at around the age of 35 to all women who have ever been sexually active. Screening for cervical cancer by means of cervical smears should be available in all reproductive health screening programmes. Ensure that there: • Is access to reliable laboratory facilities for the cytological analysis of cervical smears; • Are adequate facilities for tracing women with a positive result; and • Are adequate facilities for referral. The extra equipment needed for taking a cervical smear during the pelvic examination (see Figure 4.1) consists of: • Aylesbury spatula. • Endocervical brush. • Glass slides. • Fixing jar or spray fixative. • Hard pencil. 61 Figure 4.1 Equipment required for cervical smear A = Aylesbury spatula; B = Cytobrush; C = Glass slides; D = Fixing jar; E = Spray fixative. Before collecting the cervical smear the essential equipment for making and fixing the smear should be assembled and preferably laid out on a tray. Slides should be carefully labelled with a hard pencil on the ground glass edge (or etched; ink will dissolve during processing). A simple information checklist for cervical cancer screening is shown in Box 4.4. 62 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 A B C D E 63 Box 4.4-Information checklist for cervical cancer screening • First name and surname. • Age. • Clinic registration number. • Date of last menstrual period (LMP). • Length of menstrual cycle. • Pregnancy status. • Number of previous pregnancies. • Date and type of previous gynaecological operations. • Any history of radiotherapy treatment. • Results of previous smears. • Symptoms (if any). • Any intrauterine device (IUD) fitted. • Any oral contraceptives or other hormones taken currently or previously. Site of collection Material for cytological examination may be collected from the: • Posterior, anterior, or lateral fornix of the vagina (for evidence of endometrial or endocervical adenocarcinoma). • Ectocervix and squamo-columnar junction. • Endocervical canal. • Upper third of the lateral vaginal wall (for evidence of endometrial or endocervical adenocarcinoma). The choice of site and technique depends largely on the facilities available and the purpose of the examination. Most smears from the female genital tract are for the detection of cervical lesions, and for this purpose it is sufficient to collect material from the ectocervix, squamo-columnar junction, and endocervical canal (Exfoliative cytology for early detection of endometrial or endocervical adenocarcinoma is insensitive and unreliable). Collection of the cervical smear With the cervix exposed by an unlubricated speculum: • Lightly scrape the ectocervix, any area that appears abnormal (e.g., an erosion) and the squamo-columnar junction between the ectocervix and endocervix, with the shaped end of the spatula (see Figure 4.2). Figure 4.2 Scraping the squamo-columnar junction of the cervix • Always scrape the full circumference of the squamo-columnar junction. When the squamo-columnar junction is well exposed, as in some multiparous women, better results are obtained with a larger spatula or by using the flatter end instead of the shaped end for scraping. • Withdraw the spatula carefully from the vagina with the speculum still holding the walls apart. • Place the scrapings immediately on one or two glass slides kept in readiness. • Spread the secretions evenly over the previously prepared and labelled glass slide (see Figure 4.3): - Apply the spatula flat onto the slide and transfer the sample by a lengthwise sweep; - Repeat with the other side of the spatula (a circular or zigzag motion may be more effective in transferring the material); - Ensure that all the material is removed from both sides of the spatula; any material clinging to the spatula can be removed by scraping the 64 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 Uterus Cervix Vagina Aylesbury Spatula spatula on the edge of the slide; - Break up any lumps by exerting a little pressure with the spatula; - If using a brush, spread the sample on the slide with a gentle rolling motion. • Remember that speed is essential because air drying damages the cells in the smear and interferes with their staining properties and cytological interpretation. • Fix the slides while the smears are still wet. • Immerse the slides in jars filled with fixing fluid, or spray them with a commercial spray fixative (see Figure 4.4). Spraying is probably better and simpler, but sprays are expensive and not always readily available. • Remove the speculum from the vagina after the smears have been fixed. Figure 4.3 Spreading the cervical scrapings onto a glass slide A single slide is almost always sufficient, but if there is a large amount of material a second slide may be needed. If only a scanty sample is obtained, a second scrape may be indicated. If two samples (e.g., scrape and brush or two scrape samples) are spread on one slide, the first sample should be fixed before the second sample is obtained. Fix the slides immediately while the smears are still wet to stop them drying in the air. Rapid fixation is especially important for smears that contain blood and for smears from postmenopausal women, which dry very quickly. 65 Fixing in fluid Suitable containers for fixing fluids are clean jam or honey jars and commercially available Coplin jars made of glass or plastic. When jam or honey jars are used, no more than one pair of slides should be immersed in each jar. Coplin jars can take up to five pairs of slides; these slides should be placed back to back (smear-carrying sides outwards) into the grooves of the fixing jar. Fixing fluids commonly used are various alcohols (e.g., 95% ethyl alcohol, methyl alcohol, isopropyl alcohol) or mixtures of different alcohols, such as three parts of 95% ethyl alcohol with seven parts of tertiary butyl alcohol. The slides should remain in fixative for at least 15 minutes, but may be left there for as long as 7 or even 10 days without deterioration. Spray fixation Spray fixation gives excellent results and overall is much simpler and more economical, with savings in both time and equipment. The spray fixative must be spread evenly over the whole of the smeared area on the slide (see Figure 4.4). Figure 4.4 Spray-fixing smear The spray must not be held closer than 15 cm from the slide or it may tend to wash the specimen away. The various spray fixatives marketed contain an aerosol agent and different mixtures of alcohol, acetic acid, or ethylene or propylene glycol. Once spray-fixed slides are dry (usually within 10 minutes), they can be dispatched to the laboratory for staining directly without additional measures. Commercially available spray 66 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 fixatives are relatively expensive; ordinary hair sprays are as effective and are considerably cheaper. Staining After adequate fixation, the slides are ready for staining. The staining procedure requires laboratory facilities and should be carried out by a trained technician. When such facilities are not available, it may be necessary to dispatch the slides to a laboratory for further processing. For transportation, slides fixed in fluid should be removed from the fixing jars after adequate fixation and dried in the air. Dry fixed slides should be sent to the laboratory in flat cardboard or wooden boxes. On arrival in the laboratory they will be resuspended in fixative and stained. This process often involves use of Papanicolaou stain, based on aqueous haematoxylin with multiple counterstaining dyes in 95% ethyl alcohol, which gives great transparency and delicacy of detail for examination by a skilled cytologist—hence the term Papanicolaou (or Pap) smear. Errors in smear taking and processing Typical causes of error in smear taking and processing are shown in Box 4.5. Other aspects of reproductive health screening programmes related to cervical cancer screening are discussed earlier in this chapter. 67 68 Box 4.5-Causes of error in smear taking and processing • Cervix not visualized adequately. • Cervix not scraped firmly enough. • Transformation zone not completely scraped. • Material collected from wrong site (e.g., by scraping posterior vaginal wall instead of cervix). • Slides insufficiently cleaned or degreased before use. • Material incompletely transferred from spatula to slide. • Sample poorly spread (too thick, too thin or distortion from excessive pressure). • Air drying before fixation or during the staining procedure. • Insufficient fixation (time too short or alcohol too weak). • Incorrect staining (e.g., incorrect staining time, insufficient dehydration or mistakes in preparation of the stains). • Smear consists mainly of blood or purulent exudates. R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 2) Direct visual inspection of the cervix If pap screening is not available, visual inspection of the cervix should be offered. It should start 2-3 years after the onset of sexual activity and be repeated every 1-3 years. In this simple test, during pelvic examination the cervix is visualized, washed with normal saline, inspected, and then washed with a solution of 3-5% acetic acid (e.g., vinegar) and inspected again after 1 minute to identify areas of acetowhitening suggestive of precancerous lesions by direct vision. It can be used for cervical screening where cost is a major consideration and cervical smear testing cannot be offered to the whole of a large population. In such circumstances the acetic acid test is held to be negative if no area of acetowhitening can be seen, and the client can be followed up at the normal screening interval, or earlier if symptoms develop. If infection is suspected, a swab should be taken and if confirmed it should be treated accordingly. The extra equipment needed for direct visual inspection of the cervix during the pelvic examination consists of: • Normal saline. • A syringe for lavage. • Acetic acid 3-5%. • A bowl. Do not perform the examination if the client is having her menstrual period or using intravaginal medication; ask her to come back after menstruation or treatment. If acetowhitening is seen (a positive acetic acid test) on direct visual examination, with no evidence of infection, a cervical smear should be taken. If cervical cytological examination is not available, colposcopy, cryotherapy or loop electrosurgical excision could be considered – but may also not be available in such circumstances. Referral where further investigation and treatment can be carried out is indicated. 8 The menopause Although strictly speaking not part of reproductive health screening or SRH/family planning services, the menopause is also discussed here. Apart from the gynaecological malignancies already mentioned, conditions associated with the menopause are increasingly gaining the attention of providers of health care, especially in developed countries, because of their potential effects on the physical and psychological wellbeing of many otherwise healthy women. The menopause is associated not only with short-term acute symptoms that may cause women discomfort and distress, but also, and more importantly, with long-term complications (particularly osteoporosis and cardiovascular disease, major causes of mortality and morbidity among postmenopausal women) that have a profound effect on the general health status of and cost of health care in the community. Screening women who are at high risk of developing these long-term complications, and advising them accordingly, forms an important function of reproductive health care. Clinical features of the menopause are shown in Box 4.6. 69 Counsel women about ways in which they can improve their overall health and quality of life by following a healthy lifestyle and eating a balanced diet. Particular points include: • Smoking: Counsel women who do smoke about the hazards of smoking and encourage them to give up the habit. • Exercise: Regular exercise (including swimming and aerobic exercises) promotes cardiovascular health; weight-bearing physical activity (such as brisk walking) slows down bone loss and stimulates regeneration of bone tissue. Therefore recommend moderate exercise three or four times each week. • Diet: Encourage clients to have a balanced diet. This should be low in saturated fats, sugar and salt; include plenty of fresh fruit, vegetables, whole grain and fibre; and contain sufficient protein, vitamins and minerals. • Weight: Monitor weight and note gains or losses; aim to avoid obesity. • Stress: Advise clients to avoid unnecessary stress. • Alcohol: Suggest that clients limit alcohol intake to no more than two units (one to two drinks) daily. For women at high risk of osteoporosis (see Box 4.7), a calcium supplement (e.g., 1,000 mg daily) or other drug treatment (e.g., with vitamin D or a bisphosphonate) may be considered appropriate. For women at high risk of osteoporosis and/or with severe menopausal symptoms, hormone replacement therapy (HRT) may be considered. 70 Box 4.6-Clinical features of the menopause • Amenorrhoea. • Hot flushes. • Mammary atrophy. • Atrophic vaginitis. • Pelvic floor atrophy. • Osteoporosis. R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 Such interventions should be tailored to availability, feasibility, and individual circumstances, and must take account of the latest available evidence in relation to costs, potential benefits, side-effects and contraindications. 71 Box 4.7-Risk factors for postmenopausal osteoporosis • Early age of menopause (idiopathic or due to ovarian ablation from surgery or irradiation). • Thin build, fair complexion. • Family history of osteoporosis. • Smoking/excess alcohol intake. • Sedentary lifestyle due to lack of exercise or chronic illness. • Use of corticosteroids. 72 R EP R O D U C TI VE H EA LT H SC R EE N IN G FO R W EL L W O M EN 4 73 74 5 HORMONAL CONTRACEPTION Photo: Fatiha Terki/Ethiopia H O R M O N A L C O N TR AC EP TI O N 5 75 1 Introduction Hormonal methods provide millions of users with safe and effective contraception. All hormonal methods are systemic in nature and are based on either a progestogen combined with an oestrogen or a progestogen alone. The methods discussed in this chapter are: • Combined oral contraceptives (COCs); • Progestogen-only pills (POPs); • Progestogen-only injectable contraceptives (POIs); • Combined injectable contraceptives (CICs); and • Subdermal implants. 2 Combined Oral Contraceptives (COCs) 2.1 Definition Combined oral contraceptives (COCs) are preparations of synthetic oestrogen and progestogen which are highly effective in preventing pregnancy. There are 2 types of COCs: • Monophasic: A fixed concentration of oestrogen and progestogen hormones throughout the cycle. Currently available COCs are usually a combination of ethinyloestradiol in doses that range from 15 to 50 µg and a progestogen. These are taken in constant amounts for 21 days, followed by an interval of seven days. During the interval, no active pills are taken. However, in some brands either placebo or iron pills are taken. H O R M O N A L C O N TR AC EP TI O N 5 76 • Multiphasic: 2 (biphasic) or 3 (triphasic) variations of concentration of oestrogen and/or progestogen throughout the cycle. There is no evidence that multiphasic COCs are more effective or safer than monophasic COCs, and their clinical effects are similar. The progestogens contained in existing pills include levonorgestrel, norethisterone, desogestrel, gestodene, cyproterone acetate, drospirenone and norgestimate. Mode of action: The contraceptive effect of COCs is mainly due to inhibition of ovulation; they also cause thickening of the cervical mucus, making it difficult for sperm to pass into the uterine cavity and move towards the fallopian tubes. The receptivity of the endometrium to the blastocyst is also reduced, although there is no evidence that this change contributes to the contraceptive effectiveness. 2.2 Indications COCs should be provided to any woman who requests them after appropriate counselling and reaching an informed decision, and who does not have any contraindication (a condition that is category 4 in the World Health Organization (WHO) medical eligibility criteria) to their use. COCs may be particularly appropriate for women who wish to use hormonal contraception and who: • Want a highly effective method of contraception. • Are motivated and willing to use a method which requires action daily, and will be able to obtain supplies on a continuous basis. • May benefit from one or more of the ancillary protective health effects of COC use. This would apply to women who have: - Anaemia from heavy menstrual bleeding. - A history of ectopic pregnancy. 77 - Painful menstrual periods. - Recurrent benign ovarian cysts. - A history of, or are at risk of, acute pelvic inflammatory disease (PID). - Family history of ovarian cancer. 2.3 Medical eligibility criteria The International Planned Parenthood Federation and other bodies have collaborated with the WHO in the development of eligibility criteria for the use of various contraceptive methods. The following classification (the WHO medical eligibility criteria) was agreed: • Category 1: A condition for which there is no restriction for the use of the contraceptive method. • Category 2: A condition where the advantages of using the method generally outweigh the theoretical or proven risks. • Category 3: A condition where the theoretical or proven risks usually outweigh the advantages of using the method. • Category 4: A condition which represents an unacceptable health risk if the contraceptive is used (i.e., the contraceptive is contraindicated). Pregnancy itself is no longer listed as a contraindication to starting or continuing use of a hormonal method of contraception because women who are already pregnant do not require contraception (i.e., there is no indication for contraceptive use). If COCs are used in the unknown presence of pregnancy, there is no harm for the woman, the course of her pregnancy or her fetus; however, they should be stopped if pregnancy is confirmed because there is no indication for their use. Category 4 (contraindications) COCs should not be used in the presence of: • Breast-feeding and less than 6 weeks’ postpartum. • Current and history of ishaemic heart disease or stroke. • Smoking 15 or more cigarettes daily in a woman aged 35 years or more. • Raised blood pressure (systolic ≥ 160 or diastolic ≥ 100 mmHg). • Hypertension with vascular disease. • Migraine with aura. H O R M O N A L C O N TR AC EP TI O N 5 78 • Diabetes mellitus with vascular complications (including hypertension, nephropathy, retinopathy or neuropathy) or of > 20 years’ duration. • Past or present evidence of deep vein thrombosis or pulmonary embolism (DVT/PE). • Major surgery with prolonged immobilization. • Known thrombogenic mutations (e.g., Factor V Leiden, prothrombin mutation, protein S, protein C and antithrombin deficiency). • Complicated valvular heart disease. • Breast cancer within the past 5 years. • Active viral hepatitis. • Benign or malignant liver tumour. • Severe (decompensated) cirrhosis. Category 3 COCs should generally not be used in the presence of: • Smoking up to 15 cigarettes daily in a woman aged 35 years or more. • Raised blood pressure (systolic 140-159 or diastolic 90-99 mmHg). • History of hypertension (where blood pressure cannot be evaluated) or adequately controlled hypertension, where blood pressure can be evaluated. • Known hyperlipidaemia. • Migraine without aura in a woman aged 35 years or more (if migraine develops during use of COCs, it becomes a category 4 contraindication). • History of breast cancer with no evidence of disease for the last 5 years. • Breast-feeding from 6 weeks’ to less than 6 months’ postpartum. • Less than 21 days postpartum. • Mild compensated cirrhosis. • History of cholestasis related to past COC use. • Symptomatic gallbladder disease. • Drug treatment affecting liver enzymes: rifampicin and certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine). When any category 3 condition is present explain the potential risks to the client and counsel her about alternative methods (see also chapter 2: Counselling). If the client chooses a COC because other contraceptive 79 options are not available or are unacceptable, the method should be provided by a properly qualified practitioner and she should remain under medical supervision. If a woman has more than one of the first five conditions above, which increase the risk of cardiovascular disease, clinical judgment must be exercised. In most instances, the combined conditions should be regarded as belonging to category 4 (contraindication). If the method is provided, record the woman’s special condition in the clinical record and advise her of warning signs relevant to her condition. Category 2 COCs can generally be used with precaution in the presence of: • Smoking in a woman aged less than 35 years. • Migraine without aura in a woman aged less than 35 years (if migraine develops during COC use, it becomes category 3). • Diabetes mellitus without vascular complications. • Family history of DVT/PE (in first-degree relatives). • Breast-feeding and 6 months or more postpartum. • Superficial thrombophlebitis. • History of high blood pressure during pregnancy (where current blood pressure is measurable and normal). • Uncomplicated vascular heart disease. • Unexplained vaginal bleeding, suspicious of a serious condition, before evaluation. • Cervical intraepithelial neoplasia (CIN) or cervical cancer (awaiting treatment). • Undiagnosed breast mass. • Symptomless gallbladder disease. • Sickle cell disease. • Obesity 30 kg/m2 body mass index (BMI). • Treatment with griseofulvin. • Antiretroviral therapy. H O R M O N A L C O N TR AC EP TI O N 5 80 When any of these conditions are present, careful screening and appropriate monitoring will allow the benefits of using COCs to outweigh any potential risks. However, when a woman has more than one of the first three conditions, which increase the risk of cardiovascular disease, clinical judgment must be exercised. In most instances, the combined conditions should be regarded as belonging to category 3. If the method is provided, record the woman’s special conditions in the clinical record and advise her of warning signs relevant to her condition. 2.4 Special situations Special consideration needs to be given in certain circumstances (see Table 5.1). First 3 weeks postpartum COCs should not be used during the first 3 weeks after delivery to avoid the risk of thromboembolic complications, whether or not the mother chooses to breast-feed. After 21 days, blood coagulation and fibrinolysis are essentially back to normal, and COCs can then be used if the mother chooses not to breast-feed. Progestogen-only pills (POPs) can be started at any time after delivery if the mother chooses not to breast-feed. Lactation During lactation, withhold COCs until 6 months after delivery or until the infant is weaned, whichever is earlier. Use of COCs during breast-feeding diminishes the quantity of breast milk, decreases the duration of lactation and may thereby adversely affect the growth of the infant. If the mother wishes to start oral contraception during breast-feeding, POPs should be recommended and can be started after the sixth week postpartum (see section 3.4). 81 Table 5.1—Conditions that require special consideration First 3 weeks postpartum Elective surgery Sickle cell disease Lactation Drug interactions Varicose veins Adolescents Abnormal vaginal bleeding Parasitic diseases Age over 35 years Malignancy of the genital tract Positive HIV status and AIDS Adolescents The benefits of COCs are especially important for adolescents who are at risk of pregnancy. Indications and contraindications are the same in this age-group as for older women. Women aged over 35 years COCs can be used by most healthy women over 35 years of age if there are no cardiovascular risk factors, such as smoking, hypertension or diabetes mellitus. Elective surgery The degree of risk of DVT/PE associated with major surgery varies depending on the length of time a woman is immobilized. COCs should be stopped approximately 4 weeks before any elective surgery that involves prolonged immobilization, which increases the risk of deep vein thrombosis (DVT). COCs can be restarted 2 weeks after the woman is ambulant. Advise on the use of alternative effective contraception if needed during this time. In emergency procedures, the surgeon may consider the use of prophylactic anticoagulant measures and should encourage early mobilization. Drug interactions Drugs that induce liver enzymes, particularly those used in long-term treatments, may reduce the efficacy of COCs. Such drugs include rifampicin, griseofulvin, phenytoin, ethosuximide, carbamazepine, glutethimide, barbiturates, primidone, topiramate, oxcarbazepine and some antiretroviral agents. Interference should be suspected if a client has inter-menstrual bleeding and spotting when using any of the above drugs together with COCs. Advise on alternative or supplementary forms of contraception. Abnormal vaginal bleeding If a woman has vaginal bleeding suggestive of a condition related to pregnancy or of underlying pathology such as pelvic malignancy, it should be investigated before starting COCs. However, irregular menstrual bleeding patterns are not uncommon among healthy women: do not withhold COCs in the absence of any reason to suspect a pathological condition. H O R M O N A L C O N TR AC EP TI O N 5 82 Malignancy of the genital tract Women with cancer of the genital tract may use COCs while awaiting treatment. With most genital tract malignancies, the treatment is such that there will be no further pregnancies. However, if the condition is diagnosed at a time when the woman is using no contraceptive method, she may need contraceptive protection while awaiting treatment. Women with pre-malignant disease of the cervix which has been successfully treated will generally preserve their fertility and can continue to use any method of contraception, including COCs. The treatment of choriocarcinoma may not preclude further pregnancies; pregnancy should be avoided during treatment and follow-up so that the disease can be monitored properly, and COCs may be used if this method is chosen by the woman. Sickle cell disease Sickle cell trait is not a contraindication to the use of COCs, but women with homozygous sickle cell disease may be at increased risk of thrombosis. Recommend the use of other contraceptive methods to these women, especially long-acting progestogen-only contraceptives, which may have a beneficial effect on sickle cell disease. Sexually transmitted infections (STIs) There is some evidence that COCs may protect against pelvic inflammatory disease (PID). However, hormonal contraceptives do not protect against STIs, including HIV, and clients must be made aware of this fact. Advise use of condoms to any client at high risk of acquiring STIs. Varicose veins COCs may be used by women who have uncomplicated varicose veins with no history of DVT and who otherwise have no contraindications. Parasitic diseases The use of COCs has not been found to be affected by parasitic diseases although more research is needed in this area, particularly into any possible interactions with antiparasitic drugs. Positive HIV status and AIDS Although there is little scientific evidence on this subject, current opinion is that COCs are safe for use by women who are HIV positive. However, 83 interactions with some antiretroviral drugs (ARVs) may affect the efficacy or toxicity of the COC or the ARV. 2.5 Counselling and information All clients must receive appropriate counselling for the selection and use of COCs before starting this method of contraception. Encourage clients to ask all their questions so that any uncertainties and misunderstandings can be cleared up at the outset. (See also chapter 2: Counselling.) Selection of COCs as means of contraception Discuss the following points clearly with each client in language that she understands: • Advantages and disadvantages of COCs including effectiveness, risks and benefits, side-effects and cost. (Reassure clients that any increase in the risk of cancer would be minimal, and that there is definite evidence that COCs protect against cancers of the ovary and endometrium). • Alternative family planning methods, including information on effectiveness, risks and benefits, side-effects and cost as appropriate. • Selection of the most appropriate type of COC. • Remind clients who smoke that smoking increases the risks of serious circulatory disorders, and advise all women who intend to use COCs to stop smoking. Use of COCs See section 2.9 of this chapter. 2.6 Who can provide COCs? Doctors, non-doctor clinic personnel and community health workers trained in the education and counselling of clients can provide oral contraceptives, depending on local regulations and practice. Whoever normally meets the health needs of the community can be an appropriate person to distribute COCs. Community-based services (CBS) is the term used when COCs are provided in the community through non-clinical services (see Box 5.1). H O R M O N A L C O N TR AC EP TI O N 5 84 Social marketing, by which contraceptives are provided over the counter through subsidized commercial channels, is another method of COC provision. Social marketing programmes should ensure adequate client information and education about the proper use of the method and what to do if there are any concerns or need for further information, while protecting the rights of clients to privacy and confidentiality. See section 4 of this chapter for further information. 2.7 Health assessment The purpose of the health assessment is to determine the client’s suitability to use this method of contraception. It should also be taken as an opportunity to offer the client other available sexual and reproductive health services as appropriate. Community-based family planning services (CBS) The CBS health assessment consists of identification of those conditions which require referral for a more complete clinical assessment (see the checklist for dispensing oral contraceptives in CBS on page 144). Workers in clinical facilities that provide COCs should be prepared to offer a health assessment to clients who are referred from the CBS or the social marketing system. Clinical services Health assessment at the clinic should include medical and relevant social history, physical examination and any necessary laboratory examinations. 85 Box 5.1-Provision of COCs by community-based services (CBS) The community or field worker must: (a) be given appropriate training; (b) follow clear guidelines; and (c) have adequate supervision and back-up referral facilities. Training should include the use of appropriate checklists (see checklist for dispensing COCs in CBS on page 144) to guide the worker in the identification of clients who need to visit a health care facility or SRH/family planning clinic for screening their eligibility for COC use. • Medical and social history: At the clinic a medical and social history should be obtained with special attention to conditions relevant for medical eligibility (see sections 2.3 and 2.4 of this chapter). It should include age, relevant family and past medical history, gynaecological history including last menstrual period and menstrual pattern, smoking history and any current medications. • Physical examination: The initial physical examination at the clinic should include weight, blood pressure, examination for varicosities or signs of deep vein thrombosis, check of the skin and eyes for jaundice, breast examination and other examinations as indicated by the medical and social history. Bimanual pelvic examination and speculum vaginal examination are not required for prescription and use of COCs, but whenever possible and appropriate they should be offered to women as part of reproductive health services. • Laboratory tests: These are not routinely required for the use of COCs, except when indicated by medical history and physical examination. Whenever possible and appropriate, selected tests should be offered to women as part of reproductive health services, including: - Urine analysis for glucose and protein. - Syphilis screening (with VDRL). - Cervical cancer screening should start 2-3 years after the onset of sexual activity and be repeated every 1-3 years (see chapter 4: Reproductive health screening for well women). If the medical history gives no reason to suspect a category 4 contraindication, COCs should not be withheld because part or all of the physical or laboratory examinations are lacking. COCs should be started, but all the required examination(s) should take place within the following 3 months. The medical/social history and the results of the examinations must be documented in the clinical record of each client, especially the presence of any conditions that fall under category 2, 3 or 4 of the medical eligibility criteria. 2.8 Choice of COC COCs that contain the lowest effective and acceptable dose of oestrogen and progestogen should be used for all clients. H O R M O N A L C O N TR AC EP TI O N 5 86 • Start with a combined monophasic preparation which contains 30-35 µg of oestrogen. • Change the dose or type of pill only if there are side-effects significant enough to cause the client to consider discontinuing or changing pills (see section 2.12). The progestogens contained in the COCs presently available include levonorgestrel, norethisterone, desogestrel, gestodene, cyproterone acetate, norgestimate and drospirenone. There are no medical reasons to prefer any of them although they differ in cost and this will be a consideration. Desogestrel and gestodene may carry a small additional risk of DVT/PE beyond that of COCs which contain levonorgestrel. The 30 µg ethinyloestradiol/150 µg levonorgestrel combination is the pill for which the most information on safety is available, and is the most widely used. NOTE: For information about brand names and composition of oral contraceptives available around the world, see the IPPF’s Directory of Hormonal Contraceptives (available from IPPF’s website at: www.ippf.org). 2.9 Instructions to the client COCs are available in packets of: • 21 pills, where 1 pill containing the oestrogen/progestogen combination is taken every day for 21 days, then a break from pill-taking occurs for 7 days before starting a new packet; and • 28 pills, where 1 pill containing the oestrogen/progestogen combination is taken every day for 21 days then, instead of a break, 7 placebo or iron pills are taken as the other pills in each packet to complete a full 28-day cycle. Use a sample pill packet to explain its use. If the client is to use a 28-day packet, explain to her about the placebo pills representing the week when the menstruation will occur. Show the client how to distinguish between the active and the placebo pills. The placebo pills usually have a different colour, different size or both. Provide the instructions clearly and in terms that will be readily understood by the client. 87 Starting the pill The client can start the first cycle of pills within the first 5 days of her menstrual period, preferably on the first day. Some women find it convenient to start the pill on a particular day of the week (e.g., Sunday); if a woman wishes to do so and that day is beyond the fifth day of her menstrual cycle, make reasonably certain that she is not pregnant and advise her to use additional contraceptive protection against pregnancy for the next 7 days. For the amenorrhoeic client • She can start COCs at any time, if it is reasonably certain that she is not pregnant. • She will need to abstain from sex or use additional contraceptive protection for the next 7 days. For the postpartum client • If the client is breast-feeding and she wishes to use the pill, recommend the progestogen-only pill, which can be started after the sixth week postpartum (see section 3.8). COCs should be withheld until 6 months postpartum or until the infant is weaned, whichever is earlier. • If not breast-feeding, the client can start the pill at 3-6 weeks’ postpartum (blood coagulation and fibrinolysis are essentially back to normal 21 days after delivery). If the client wishes to start after the sixth week postpartum and she has not yet seen the first postpartum menses, rule out the possibility of pregnancy before starting the COC (see chapter 11: Diagnosis of pregnancy). Switching from another hormonal method • The client can start COCs immediately if she has been using her other hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period. • If her previous method was an injectable contraceptive, she should start COCs when the repeat injection would have been given. No additional contraceptive protection is needed. H O R M O N A L C O N TR AC EP TI O N 5 88 Switching from a non-hormonal method (other than the IUD) • The client can start COCs within 5 days after the start of her menstrual bleeding. No additional contraceptive protection is needed. • She can also start COCs at any time if it is reasonably certain that she is not pregnant. If it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the first 7 days of COC use. Switching from an IUD (including a hormone-releasing IUD) • The client can start COCs within 5 days after the start of her menstrual bleeding. No additional contraceptive protection is needed. The IUD can be removed at that time. • The client can also start COCs at any time if it is reasonably certain that she is not pregnant. • If the client has been sexually active in the current menstrual cycle, and it has been more than 5 days since menstrual bleeding started, it is recommended that the IUD be removed at the time of her next menstrual period. • If she has not been sexually active in the current menstrual cycle and it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the first 7 days of COC use. If that additional protection is to be provided by the IUD she is using, it is recommended that this IUD be removed at the time of her next menstrual period. • If she is amenorrhoeic or has irregular bleeding she can start COCs as advised for other amenorrhoeic women. Taking the pill The client should take 1 pill every day at the same time until the packet is finished; advise the client that she should not interrupt taking the pills before a packet is finished, even if she does not have sexual intercourse. Starting a new packet • If the client is using the 28-pill packet, she should start a new packet without a break the day after she finishes the previous packet. 89 • If the client is using the 21-pill packet, she should skip 7 days before starting a new packet. If the pills are taken correctly, the client will always start a new packet on the same day of the week. Missed pills Emphasize the importance of not forgetting any pill. Advise the client that if she misses one or more hormonal pills, she may have some spotting or breakthrough bleeding and, more importantly, that she will be at a greater risk of becoming pregnant. The greatest risk is when the client misses hormonal pills at the beginning or at the end of the cycle, because that is equivalent to prolonging the interval during which she does not take hormonal pills. Give the client the following instructions: For 30-35 µg ethinyloestradiol pills • If 1or 2 hormonal pills are missed, the client should take that pill as soon as she remembers. The client should take the next pill at the usual time; this might mean that she has to take 2 pills on the same day or at the same time. She does not need any additional contraceptive protection. • If 3 or more consecutive hormonal pills are missed or she starts a pack 3 or more days late, the client should take the hormonal pill as soon as possible and then continue taking pills daily, one each day. She should also use condoms or abstain from sex until she has taken hormonal pills for 7 days in a row. - If she missed the pills in the third week she should finish the hormonal pills in her current pack and start a new pack the next day, not taking the 7 inactive pills. - If she missed the pills in the first week and had unprotected sex, she may wish to consider the use of emergency contraception (see chapter 10, Emergency contraception). For 20 µg or less ethinyloestradiol pills • If the client misses 1 hormonal pill, she should follow the above instructions for missing 1 or 2 30-35 µg ethinyloestradiol pills. H O R M O N A L C O N TR AC EP TI O N 5 90 • If the client misses 2 or more hormonal pills or if she starts the pack 2 or more days late, she should follow the above instructions for missing 3 or more 30-35 µg ethinyloestradiol pills. For 30-35 µg and 20 µg or less ethinyloestradiol pills • If 1 or more non-hormonal (placebo) pills are missed, the client should discard the missed placebo pill(s) and continue taking the remaining pills once daily. Start the new pack as usual. No additional contraceptive protection is required. Whenever possible, ensure that the supply given to the woman will allow her to have a standby packet of pills always available. It might be good practice to provide the woman with a supply of condoms when she is given her initial packets of pills in case she needs to use them for additional protection. Vomiting and diarrhoea Acute vomiting and/or diarrhoea will interfere with the effectiveness of COCs. If vomiting occurs within 1 hour after taking an active hormonal pill, the client should take another active pill. If symptoms persist for more than 24 hours, recommend the use of additional contraceptive protection until the client has been without these symptoms for 7 days. If severe vomiting or diarrhoea continues for more than 2 or more days, she should follow the procedure for missed pills. Other medications Tell the client that certain medicines reduce the effectiveness of COCs, so she must always share information on all her medications with all providers of health and family planning care, whatever the reason for her consultation. Side-effects Advise the client about possible side-effects (see section 2.12). 91 Warning signs Advise the woman to consult a clinic if pregnancy is suspected or if she experiences any of the following warning signs of complications: • Severe abdominal pain. • Severe chest pain, cough or shortness of breath. • Severe headache. • Loss of vision or blurring. • Severe pain in calf or thigh. • Jaundice (yellowness of the eyes and skin). To prevent anxiety, explain to the client that serious complications of COC use are very rare. You can reassure her that her health will be better protected by use of this highly reliable method of contraception than if an unintended pregnancy were to occur. Follow-up Advise the client to visit a clinic or to see a CBS worker about 3 months after starting COCs for a routine follow-up. Thereafter, a routine annual follow-up is advisable. Tell the client the date of the next visit and the name of the pill she has been given. If the client is being seen at a clinic, make sure that she knows the clinic name, address and telephone number. If the client is being given pills through CBS, then give her the name, address and telephone number of the nearest clinical facility to consult if any problems should arise. This information, and a list of warning signs to look out for, can be put on a card or leaflet and given to the client: it should be written and presented in a way in which the client or somebody close to her (in case the client cannot read) can readily understand. Encourage the client to ask questions to clear up any uncertainties and ask her to repeat the basic instructions to check that she understands them. H O R M O N A L C O N TR AC EP TI O N 5 92 2.10 Follow-up care Routine follow-up at a clinic or by a CBS worker is recommended at about 3 months after starting COCs, and annually thereafter. 3-month follow-up protocol • Update the client’s address and how to make contact with her. • Assess the client’s satisfaction with the method. • Determine if the client has had any problems or possible side-effects and, if so, record them in the clinical record. • If any serious problem or side-effect is detected in the CBS, refer the client to a clinical facility. • At the clinic, update the medical history; measure blood pressure and weight; and perform any other examination which may be indicated by the history. • Provide appropriate counselling and/or treatment as required. • Review with the client her instructions for taking COCs and the warning signs to look out for, then re-supply her with COCs and give instructions for annual follow-up. • Encourage the client to contact a CBS worker or the clinic at any time if she has any questions, complaints or problems. Annual follow-up protocol • Follow the 3-month protocol with an updated medical history and an assessment of satisfaction with the method. • Offer the client other relevant reproductive health services available at the facility, such as cervical cancer screening. Duration of use: In women who are otherwise well, COCs may be continued for many years, with no need for periodic discontinuation. 2.11 Provision of COCs The supply system should be flexible, so that the client can obtain pills easily in the amount and at the time she requires. It is important to keep the number of re-supply visits to a minimum. In general, if the client does not request otherwise, provide 3 cycles of pills at the first encounter, then up to 10 cycles at the 3-month follow-up encounter if there are no problems. At the first annual follow-up, and annually thereafter, a full 93 year’s supply of 13 cycles may be given if there continue to be no problems or conditions that require particular consideration. In certain cases service providers may find that a smaller supply is more convenient for some clients (e.g., those who may not be able to store so many pills safely). 2.12 Side-effects The following side-effects (which should not be a reason to discontinue the method) are common during the first 3 cycles of COC use, and then usually disappear: • Breakthrough bleeding; • Mild nausea and/or dizziness; • Breast tenderness; and • Mild headaches. Other side-effects include weight gain, fluid retention and depression. Most side-effects are usually tolerated by clients if they are supported by counselling. Sometimes symptomatic treatment may be required. If this management does not help, or if the problem is of serious concern to the client, consider whether she should discontinue COCs and, if so, advise her about alternative methods of contraception. Missed periods (amenorrhoea) may also occur because of taking COCs, which necessitates ruling out pregnancy (see chapter 11: Diagnosis of pregnancy), especially if pills have been missed or taken late. If missed periods continue in the absence of pregnancy, reassure the client that this does not mean any health risk. Another type of pill may be tried. 2.13 Service management See section 4 of this chapter. H O R M O N A L C O N TR AC EP TI O N 5 94 3 Progestogen-only pills (POPs) 3.1 Definition The progestogen-only pill (POP) is an oral hormonal contraceptive that contains a progestogen only, in a smaller dose (typically 10-50%) than that used in the combined oestrogen/progestogen pill. Thus, depending on the type of progestogen, POPs may contain only 30 µg (e.g., for levonorgestrel) to 600 µg (e.g., for norethisterone) of progestogen (0.03-0.6 mg). The most commonly available POPs contain levonorgestrel, desogestrel, norethisterone or lynestrenol. One pill is taken regularly at the same time every day, without a break, regardless of the bleeding pattern. The efficacy of the POP is slightly lower than that of the COC, especially in younger women, but is effectively similar to that of the COC in women aged over 35 years. NOTE: For information about brand names and composition of oral contraceptives available around the world, see the IPPF’s Directory of Hormonal Contraceptives (available from IPPF’s website at: www.ippf.org). Mode of action: As with other progestogen-only contraceptives, the POP has 2 modes of action: • The effect of the progestogen on cervical mucus is the main factor in the contraceptive efficacy of POPs. The mucus becomes viscous and scanty, inhibiting sperm penetration. • The progestogen acts on the hypothalamus and pituitary, and suppresses the LH surge responsible for ovulation. Ovulation is prevented in at least half of the cycles. Progestogens also cause histological changes in the endometrium according to the dose administered; there is no evidence that these changes contribute to the contraceptive effect. 95 3.2 Indications Progestogen-only pills should be provided to any woman who requests them after appropriate counselling and reaching an informed decision, and who does not have any contraindication (a condition that is category 4 in the WHO medical eligibility criteria) to their use. POPs are particularly appropriate for women who wish to use oral hormonal contraception and have a condition that preclude the use of oestrogens, such as those who are breast-feeding. 3.3 Medical eligibility criteria POPs have no effect on blood pressure or coagulation factors and a negligible effect on lipid metabolism and liver function. They therefore have fewer medical eligibility restrictions than COCs. Category 4 (Contraindications) POPs should not be used in the presence of: • Breast cancer within the past 5 years. Counsel any woman who has a contraindication to POPs as well as COCs about alternative methods of contraception (see also chapter 2: Counselling). Category 3 POPs should generally not be used in the presence of: • Current deep vein thrombosis or pulmonary embolism (DVT/PE). • Active viral hepatitis. • Liver tumour (benign or malignant). • Severe decompensated cirrhosis. • History of breast cancer with no evidence of disease for the last 5 years. • Breast-feeding and less than 6 weeks postpartum. • Drug treatment affecting liver enzymes: rifampicin and certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine). When any category 3 condition is present, explain to the client the potential risks and counsel her about alternative contraceptive methods. H O R M O N A L C O N TR AC EP TI O N 5 96 If the client chooses POPs because other contraceptive options are not available or are unacceptable, it is particularly important to advise her that close medical follow-up is required. Category 2 POPs can generally be used with precaution in the presence of: • Current or history of ischaemic heart disease or stroke (if either develops during POP use, it becomes category 3). • History of hypertension where blood pressure cannot be evaluated. • Raised blood pressure (systolic ≥ 160 or diastolic ≥ 100 mmHg). • Hypertension with vascular disease. • Migraine with aura or development of migraine without aura at any age during POP use (if migraine develops during POP use, it becomes category 3) . • Diabetes with or without complications (history of gestational disease is category 1). • History of DVT/PE. • Major surgery with prolonged immobilization. • Mild compensated cirrhosis. • Gallbladder disease. • Undiagnosed breast mass. • Previous ectopic pregnancy. • Known hyperlipidaemia. • Irregular, heavy or prolonged vaginal bleeding or unexplained vaginal bleeding, suspicious for serious underlying condition, before evaluation. • Treatment with griseofulvin. • Antiretroviral therapy. When any of these conditions are present, careful screening and appropriate monitoring will allow the benefits of using POPs to outweigh any potential risks. 3.4 Special situations The advice given for use of COCs in relation to abnormal vaginal bleeding, drug interactions, STIs and malignancy of the genital tract (see section 2.4) also applies to POPs. 97 First 3 weeks postpartum Progestogen-only pills (POPs) can be started at any time after delivery if the mother chooses not to breast-feed. Lactation Hormonal methods are not the first method of contraceptive choice for breast-feeding women. Although progestogen-only contraceptives do not seem to interfere with lactation, there is concern that they lead to release into the milk of orally active progestogens which are then absorbed by the infant. Any progestogen method should not be started before the sixth week postpartum by women who are breast-feeding, unless other contraceptive options are not available or acceptable. The estimated daily dose received by the infant is much greater with progestogen-only injectables than with POPs. Other special situations POPs may be used by women who otherwise have no contraindications and who: • Are adolescents. • Are aged over 35 years. • Have varicose veins. • Have sickle cell disease. 3.5 Counselling and information All clients must receive appropriate counselling for selection and use of POPs before starting this method of contraception. Encourage clients to ask all their questions so that any uncertainties and misunderstandings can be cleared up at the outset. (See also chapter 2: Counselling.) Selection of POPs as means of contraception Please refer to chapter 2: Counselling and to section 2.5 of this chapter. In addition, raise the following points when counselling for the use of POPs: • In general, the effectiveness of POPs is slightly lower than that of COCs, particularly when a pill is missed. • Breakthrough bleeding and amenorrhoea are common with POPs. • If the woman is breast-feeding and concerned about transmission of the H O R M O N A L C O N TR AC EP TI O N 5 98 hormone in her milk, explain that there is no present evidence that the amount of hormone found in breast milk as a result of POP use has ever caused a baby any harm. Use of POPs See section 3.8 of this chapter. 3.6 Who can provide POPs? The advice given for COCs in section 2.6 of this chapter also applies to POP provision. 3.7 Health assessment The purpose of the health assessment is to determine the client’s suitability for the use of this method. It should also be used as an opportunity to offer the client other available sexual and reproductive health services. The guidelines for COC assessment (see section 2.7) also apply in general to clients who receive POPs. However, there are fewer medical eligibility restrictions for POPs (compare sections 2.3 and 2.4 with sections 3.3 and 3.4). 3.8 Instructions to the client Use a sample pill packet to explain its use. Provide the instructions clearly and in terms that the client will readily understand. Starting the POP The client should ideally start the first cycle of pills within the first 5 days of her menstrual period, preferably on the first day. No additional contraceptive protection is then needed. She can also start POPs at any other time, if it is reasonably certain that she is not pregnant, but if it is more than 5 days since menstrual bleeding started she will need to abstain from sex, or use additional contraceptive protection, for the next 2 days. For the amenorrhoeic client • She can start POPs at any time, if it is reasonably certain that she is not pregnant. • She will need to abstain from sex or use additional contraceptive protection for the next 2 days. 99 For the postpartum client • If the client is breast-feeding and she wishes to use the pill, she can start POPs after the sixth week postpartum, but not earlier. If a client with lactational amenorrhoea requests the pill between 6 weeks and 6 months postpartum, give POPs if you can establish that she is not pregnant (see chapter 11: Diagnosis of pregnancy). • If the client is more than 6 weeks postpartum and her menstrual cycles have returned, she can start POPs as advised for other women having menstrual cycles. • If the client is not breast-feeding, she can start POPs immediately or at any time within the first 6 weeks postpartum. If the client wishes to start after the sixth week postpartum and she has not yet had the first postpartum menses, rule out the possibility of pregnancy before providing the POPs. Switching from another hormonal method • The client can start POPs immediately if she has been using her other hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period. • If her previous method was an injectable contraceptive, she should start POPs when the repeat injection would have been given. No additional contraceptive protection is needed. Switching from a non-hormonal method (other than the IUD) • The client can start POPs within 5 days after the start of her menstrual bleeding. No additional contraceptive protection is needed. • She can also start POPs at any time if it is reasonably certain that she is not pregnant. However, if it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the first 2 days. Switching from an IUD (including a hormone-releasing IUD) • The client can start POPs within 5 days after the start of her menstrual bleeding. No additional contraceptive protection is needed. The IUD can be removed at that time. H O R M O N A L C O N TR AC EP TI O N 5 100 • The client can also start POPs at any time if it is reasonably certain that she is not pregnant. • If the client has been sexually active in the current menstrual cycle, and it has been more than 5 days since menstrual bleeding started, it is recommended that the IUD be removed at the time of her next menstrual period. • If she has not been sexually active in the current menstrual cycle, and it has been more than 5 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the first 2 days of POP use. If that additional protection is to be provided by the IUD she is using, it is recommended that this IUD be removed at the time of her next menstrual period. • If she is amenorrhoeic or has irregular bleeding she can start POPs as advised for other amenorrhoeic women. Taking the POP The client should take 1 pill every day at the same time until the packet is finished; she should start a new packet the day after she finishes the previous packet, without a break. If the pills are taken correctly, the client will always start a new packet on the same day of the week. Missed pills Emphasize the importance of not forgetting any pill, even just for a few hours. Advise the client that if she misses 1 or more pills, she may have some spotting or breakthrough bleeding and, more importantly, that she will be at a greater risk of becoming pregnant. She should restart taking the pills as soon as possible. If she missed taking the pill by more than 3 hours, advise her to abstain from sexual intercourse or use a barrier method of contraception during the first 48 hours after restarting the pills. The use of emergency contraception should be considered if she has already had intercourse during the unprotected period (see chapter 10: Emergency contraception). If the client is breast-feeding and amenorrhoeic and has missed 1 or more pills by more than 3 hours, she should take the pill as soon as possible and continue to take the pill as usual. If she is less than 6 months postpartum, no additional contraceptive protection is needed. 101 Other medications Tell the client that some medicines may reduce the effectiveness of POPs, so she must always share information on all her medications with all providers of health and family planning care, whatever the reason for her consultation. Side-effects Advise the client about possible side-effects (see section 3.10). Follow-up Tell the client the date of the next visit and the name of the pill she has been given. If the client is being seen at a clinic, make sure that she knows the clinic name, address and telephone number. If the client is being given pills through CBS, then give her the name, address and telephone number of the nearest clinical facility to consult if any problem should arise. This information, and a list of warning signs to look out for, can be put on a card or leaflet and given to the client: it should be written and presented in a way in which the client or somebody close to her (in case the client cannot read) can readily understand. Advise the client to consult a clinic or to see a CBS worker (if applicable and more convenient) if she experiences a problematic side-effect or has any other concern or problem in relation to the pill. Encourage the client to ask questions to clear up any uncertainties and ask her to repeat the basic instructions to check that she understands them. 3.9 Follow-up care and provision of POPs Follow the guidelines given for follow-up and provision of COCs in sections 2.10 and 2.11 of this chapter. Duration of use: When a special indication for POP use (such as breast- feeding) no longer exists, consideration should be given to the use of COCs, which are more effective and have a better cycle control. However, POPs can be used indefinitely if that is the wish of the client and there are no serious side-effects. H O R M O N A L C O N TR AC EP TI O N 5 102 3.10 Side-effects Common side-effects include breakthrough bleeding, amenorrhoea, breast tenderness and headaches. These side-effects are usually tolerated by the client if supported by counselling, although symptomatic treatment is sometimes required. If this management does not help, or if the problem is of serious concern to the client, consider whether she should discontinue the pill and, if so, advise her on alternative methods of contraception. 3.11 Service management See section 4 below. 4 Management of oral contraceptive services An SRH/family planning programme which provides oral hormonal contraception may use complementary approaches — for example, community-based services (CBS) and social marketing as well as clinical services. CBS services reach individuals who: • Are beyond the usual catchment area of the clinics; or • Find CBS more acceptable and convenient. Clinical services: • Offer a more comprehensive reproductive health service to individuals within their catchment area; and • Give clinical back-up to the CBS. In addition, a third approach, social marketing, provides some contraceptive methods through subsidized commercial channels. 4.1 Community-based family planning services (CBS) Health screening checklists These should be used in CBS to help the service provider to identify possible contraindications to the use of oral contraceptives and/or clients who need to be referred to a clinical facility for further evaluation. 103 For an example of such a check-list see the work-sheet for dispensing oral contraceptives in CBS on pages 144. Referral systems These should be in place so that CBS clients who need further evaluation, request another method of contraception such as an IUD or sterilization, or require other sexual and reproductive health services can be referred to the most convenient and appropriate clinical facility. • This facility could be a clinic of the government, a family planning association or another non-governmental organization. Links and collaboration between institutions need to be developed for this purpose. • Physical and/or pelvic examinations are not essential for the provision of oral contraceptives. However, back-up clinical facilities are needed so that such examinations can be available and carried out if necessary. • If a CBS client has a possible problem related to the use of oral contraception, she should be referred to a clinic. The care provider at the clinic will determine if oral contraceptives: - May be used under the supervision of a community health worker; - May be used under clinic supervision; or - Are not indicated and another method is recommended. The outcome must be communicated to the CBS worker. Stock of pills Community-based services should stock no more than 2 types of pills: • A COC containing 30-35 µg of oestrogen, which is suitable for most women; and • A POP, mainly for use by breast-feeding clients. Training Community workers should be trained in the following: • How to provide information on all available contraceptive options to help the user make her/his own choice of an appropriate method. • How to provide education and counselling before, during and after the adoption of a contraceptive method. H O R M O N A L C O N TR AC EP TI O N 5 104 • How to use checklists for screening of clients. • How to recognize when the client requires referral to a clinic for further evaluation, based on use of the checklists. • How to recognize the warning signs of pill complications, to explain them to the client, and to refer her to a clinical facility if required. • The use of basic records for client management and programme evaluation. 4.2 Clinical services Client records A standard clinical record form should be used for all clients. This form serves: • To document essential client information. • As a guide for staff to ensure that medical eligibility for pill use is accurately and completely assessed. • To record the contraceptive method provided and other services given to the client. • To record follow-up services. Stock of pills No more than 4 formulations of COCs should be available: • 2, or at the most 3, types of low-dose pills (30-35 µg of oestrogen); and • Not more than 1 high-dose (50 µg oestrogen) pill. Pills that contain 50 µg of oestrogen should be used only for emergency contraception and in the rare cases where specific conditions make this dose necessary (e.g., drug interactions or when the low-dose pill does not provide adequate cycle control). • Start all new clients who request oral contraceptives, and for whom there is no contraindication, on low-dose COCs. If side-effects indicate a change of pill, document the reasons. • In addition, 1 POP formulation should be available, mainly for use by breast-feeding clients. • Do not stock or use COCs that contain more than 50 µg of oestrogen. 105 Training A system of training should exist so that providers of care obtain current information and skills on all aspects of quality of care and hormonal contraceptive practice. Training should include management of side- effects, as well as updates on the medical eligibility criteria and the possible risks of oral contraceptive use. Equipment The basic essential equipment for a clinic that supervises provision of oral contraception is: • A sphygmomanometer (blood-pressure cuff); and • A weighing scale. Basic laboratory equipment and access to laboratory facilities at the clinic are desirable, but not essential. 4.3 Provision of pills Provide 3 cycles of pills at the first encounter if there are no contraindications, then up to 10 cycles at the 3-month follow-up encounter if there are no problems. At the annual follow-up, a year’s supply, 13 cycles, may be given if there continue to be no problems or contraindications. In some cases the service providers may find that a smaller supply is more convenient for certain clients. However, it is important to keep the number of re-supply visits to a minimum. The re- supply system should be flexible, so that the client can obtain pills easily in the amount and at the time she requires. 4.4 Storage, shelf-life and supplies • Storage areas for oral contraceptives should be secure, pest-free, well ventilated and moisture-free. Stored packets should be kept out of sunlight. Keep boxes of oral contraceptives at least 10 cm off the floor and at least 30 cm from the walls. Put the date of arrival on each box and use the older ones first. • Use oral contraceptives within 5 years of the stamped date of manufacture. • Ensure sufficient supplies for continuing and new users. The necessary amounts for a particular year can be estimated as follows: - Multiply the number of expected continuing users by 13 cycles; and H O R M O N A L C O N TR AC EP TI O N 5 106 - Multiply the number of expected new users by 6.5. The reason for multiplying the number of new users by 6.5 is that they will be starting the pill at different times during the year; on average, they will need only half the cycles required for a continuing user. 5 Progestogen-only injectable contraceptives (POIs) 5.1 Definition Progestogen-only injectable contraceptives (POIs) are composed of synthetic steroid hormones which resemble the female hormone progesterone. The injectable preparation is released slowly into the bloodstream from the site of injection in the muscle. A single injection provides safe and highly effective contraception for 2 or 3 months. The most commonly used POIs are: • Depot medroxyprogesterone acetate, or DMPA: each dose of 1ml contains 150 mg of DMPA and is given every 3 months. • Norethisterone oenanthate, or NET-EN: each dose of 1ml contains 200 mg of NET-EN and is given every 2 months. Mode of action: As with other progestogen-only contraceptives, POIs have 2 modes of action: • Effect of the progestogen on cervical mucus, which becomes viscous and scanty, thus inhibiting sperm penetration. • The progestogen acts on the hypothalamus and pituitary and suppresses the LH surge responsible for ovulation. Ovulation is prevented in at least half of the cycles. In most cases the endometrium shows signs of suppression. However, this effect does not play an important role in the efficacy of POIs because the changes in cervical mucus and anovulation would prevent fertilization. 107 5.2 Indications POIs should be provided to any woman who requests them after appropriate counselling and reaching an informed decision, and who does not have any relevant contraindication to their use. POIs may be particularly appropriate for women who: • Want a highly effective method of contraception. • Are breast-feeding. • Desire the convenience of not having to keep contraceptive supplies at home. • Have problems remembering to take oral contraceptives. • Should not use oestrogen-containing contraceptives. • May clearly benefit from the ancillary protective health effects of POI use: - Sickle cell disease: Women who use DMPA have significantly fewer crises. - Anaemia: POIs can increase haemoglobin concentration, mainly by reducing blood loss. 5.3 Medical eligibility criteria Historically, the contraindications to POIs were considered to be the same as for COCs. However, POIs have no effect on blood pressure or coagulation factors (and therefore pose no risk of venous thrombosis), have a negligible effect on lipid metabolism and have very little effect on liver function. Thus contraindications for POIs may be considered separately from those for COCs. Category 4 (Contraindications) Do not advise the use of POIs or provide them to women with: • Breast cancer within the past 5 years. Category 3 The use of POIs should generally not be used in the presence of: • Current deep vein thrombosis or pulmonary embolism (DVT/PE). • Current or history of ischaemic heart disease or stroke. • Raised blood pressure (systolic ≥160 or diastolic ≥ 100 mmHg). H O R M O N A L C O N TR AC EP TI O N 5 108 • Hypertension with vascular disease. • Diabetes mellitus with vascular disease (including nephropathy, retinopathy or neuropathy) or of > 20 years’ duration. • Active viral hepatitis. • Severe decompensated cirrhosis. • Benign or malignant liver tumour. • History of breast cancer with no evidence of disease for the last 5 years. • Breast-feeding and less than 6 weeks postpartum. • Unexplained vaginal bleeding, suspicious for serious underlying condition, before evaluation. When any category 3 condition is present, explain to the client the potential risks and counsel her about alternative contraceptive methods. If the client chooses POIs because other contraceptive options are not available or are unacceptable, it is particularly important to advise her that close medical follow-up is required. (See also chapter 2: Counselling). Category 2 POIs can generally be used with precaution in the presence of: • Raised blood pressure (systolic 140-159 or diastolic 90-99 mmHg). • History of hypertension where blood pressure cannot be evaluated (including hypertension in pregnancy) or adequately controlled hypertension where blood pressure can be evaluated. • Diabetes mellitus (if vascular disease develops during POI use in diabetes mellitus it becomes category 3). • Migraine with or without aura at any age (if migraine with aura develops during POI use, it becomes a category 3). • Known hyperlipidaemias. • History of deep vein thrombosis or pulmonary embolism (DVT/PE). • Major surgery with prolonged immobilization. • Mild compensated cirrhosis. • Gall bladder disease. • Undiagnosed breast mass. 109 • Cervical intraepithelial neoplasia (CIN) or cervical cancer (awaiting treatment). • Irregular, heavy or prolonged vaginal bleeding. • Drugs which affect liver enzymes (e.g., rifampicin, barbiturates, anticonvulsants etc.). • Antiretroviral therapy. When any of these conditions are present, careful screening and appropriate monitoring will allow the benefits of using POIs to outweigh any potential risks. However, if a woman has more than one of the first three conditions above, which may increase the risk of arterial cardiovascular disease, she should be considered to be at category 3 of the medical eligibility criteria. If the method is provided record the woman’s special condition in the clinical record and advise her of warning signs relevant to her condition. 5.4 Special situations Lactation Hormonal methods are not the first method of contraceptive choice for breast-feeding women. Although progestogen-only contraceptives do not seem to interfere with lactation, there is a concern that they lead to release into the milk of orally active progestogens which are then absorbed by the infant. Any progestogen method should not be started before the sixth week postpartum by women who are fully or nearly fully breast-feeding unless all other contraceptive methods are not available or acceptable. The estimated daily dose received by the infant is much greater with POIs than with POPs. Adolescents The benefits of progestogen-only contraception for pregnancy protection are particularly important for adolescents. However, there are concerns about the hypo-oestrogenic effects of POIs on women aged under 18 years because of possible changes in bone mass and density. Any obvious risk factors for osteoporosis, such as chronic corticosteroid therapy should be taken into account when advising such young women on the use of POIs. Where available, a CIC may be the more suitable injectable contraceptive. H O R M O N A L C O N TR AC EP TI O N 5 110 Women aged over 35 years POIs may be safely used by most healthy women over 35 years of age. Any risk of cardiovascular disease will be minimal for these women if they do not smoke and have no other risk factors such as hypertension or diabetes mellitus. There are some theoretical concerns with regard to the hypo-oestrogenic effect of DMPA in women aged over 45 years because of possible effects on bone density. Drug interactions Drugs which induce liver enzymes, particularly those commonly used in long-term treatments, may reduce the efficacy of hormonal contraceptives. Such drugs include rifampicin, griseofulvin, phenytoin, ethosuximide, carbamazepine, glutethamide, barbiturates, primidone, topiramate, oxcarbazepine and some antiretroviral agents. If a client is taking any of these medicines long term, advise her to use simultaneously a supplementary method of contraception, such as condoms. Abnormal vaginal bleeding If a woman has vaginal bleeding suggestive of a condition related to pregnancy or of underlying pathology such as pelvic malignancy, it should be investigated before starting POIs. However, irregular menstrual bleeding patterns are not uncommon among healthy women: do not withhold POIs in the absence of any reason to suspect a pathological condition. Nevertheless, advise the client that her bleeding problem may increase with the use of POIs and, if she chooses to use POIs, she should be closely monitored. Malignancy of the genital tract Women who are using POIs and who are diagnosed to have cancer of the genital tract may continue to use POIs while awaiting treatment. With most genital tract malignancies, the treatment is such that there will be no further pregnancies. Women with pre-malignant disease of the cervix which has been successfully treated will generally preserve their fertility and can use any method of contraception, including POIs. The treatment of choriocarcinoma may not preclude further pregnancies: pregnancy should be avoided during treatment and follow-up so that the disease can be monitored properly. POIs may be used if this method is chosen by the woman. 111 Sickle cell disease POIs may be used by women who have sickle cell disease: in addition to the contraceptive benefit, progestogen-only contraceptives may have a beneficial effect on the underlying disease. Sexually transmitted infections (STIs) Hormonal contraceptives do not protect against STIs, including HIV, and clients must be made aware of this fact. Advise use of condoms to any client at high risk of acquiring STIs. Strict aseptic techniques should be maintained when giving the injections to avoid the risk of transmitting any infection, including HIV. 5.5 Counselling and information All clients must receive appropriate counselling for the selection and use of POIs before starting this method of contraception. Encourage clients to ask all their questions so that any uncertainties and misunderstandings can be cleared up at the outset (See also chapter 2: Counselling). Selection of POIs as means of contraception Discuss the following points clearly with each client in language that she understands: • Advantages and disadvantages of POIs including effectiveness, risks and benefits, the possibility of delayed return to fertility, other side-effects and cost. • The possibility of change in menstrual bleeding patterns, including: - Amenorrhoea: Reassure the client that amenorrhoea is an expected side-effect, and that she can expect menstrual cycles to return to normal within 6 months of discontinuing the POI. - Menstrual irregularity: Breakthrough bleeding and spotting are common. • Alternative family planning methods including information on effectiveness, risks and benefits, side-effects and cost as appropriate. • Timing of the injection: When the woman will receive the first injection, when the next will be due, and how often she will receive the injections. • The specific POI to be used. H O R M O N A L C O N TR AC EP TI O N 5 112 Use of POIs See section 5.9 of this chapter. 5.6 Who can provide POIs? Any health care provider who has been trained in the education and counselling of clients and the administration of injectables may provide this method, depending on local regulations and practice. 5.7 Health assessment The purpose of the health assessment is to determine the client’s suitability for the use of this method. It should also be used as an opportunity to offer the client other available sexual and reproductive health services. The guidelines for COC assessment (see section 2.7) also apply in general to clients who receive POIs. However, there are fewer medical eligibility restrictions for the POIs (compare sections 2.3 and 2.4 with sections 5.3 and 5.4). 5.8 POI provision The initial injection Give the initial injection within the first 7 days of the menstrual cycle. No additional contraceptive protection is required. The client can also have the first injection at any other time, if it is reasonably certain that she is not pregnant, but if it has been more than 7 days since menstrual bleeding started she will need to abstain from sex, or use additional contraceptive protection, for the next 7 days. For the amenorrhoeic client • The client can have the first injection at any time, if it is reasonably certain that she is not pregnant. • She will need to abstain from sex or use additional contraceptive protection for the next 7 days. For the postpartum client • If the client is breast-feeding and she wishes to use a POI, give the initial injection from the sixth week postpartum, but not earlier. If a 113 client with lactational amenorrhoea requests the POI after 6 weeks postpartum, give the initial injection if you can establish that she is not pregnant (see chapter 11: Diagnosis of pregnancy). • If the client is not breast-feeding, she can receive the initial injection immediately or at any time within the first 6 weeks postpartum. If the client wishes to start the POI after the sixth week postpartum and she has not yet had the first postpartum period, rule out the possibility of pregnancy before giving the initial injection. Switching from another hormonal method • The client can have the first injection immediately if she has been using her other hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period. • If her previous method was another injectable contraceptive, she should start the POI when the repeat injection would have been given. No additional contraceptive protection is needed. Switching from a non-hormonal method (other than the IUD) • The client can have the first injection immediately if it is reasonably certain that she is not pregnant. There is no need to wait for her next menstrual period: - If she is within 7 days of the start of her menstrual bleeding, no additional contraceptive protection is needed. - If it has been more than 7 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next 7 days. Switching from an IUD (including a hormone-releasing IUD) • The client can have the first injection within 7 days after the start of her menstrual bleeding. No additional contraceptive protection is needed. The IUD can be removed at that time. • She can also start the POI at any time if it is reasonably certain that she is not pregnant. • If the client has been sexually active in the current menstrual cycle, and it has been more than 7 days since menstrual bleeding started, it is H O R M O N A L C O N TR AC EP TI O N 5 114 recommended that the IUD be removed at the time of her next menstrual period. • If she has not been sexually active in the current menstrual cycle, and it has been more than 7 days since menstrual bleeding started, she will need to abstain from sex or use additional contraceptive protection for the next 7 days. If that additional protection is to be provided by the IUD she is using, it is recommended that this IUD be removed at the time of her next menstrual period. • If she is amenorrhoeic or has irregular bleeding she can have the injection as advised for other amenorrhoeic women. Repeat injections Provide repeat injections as follows: • DMPA: 1 ml (which contains 150 mg) at every 3 months. • NET-EN: 1 ml (which contains 200 mg) at every 2 months. If the client is early for an injection • The repeat injection can be given up to 2 weeks early. If the client is late for an injection • The repeat injection for DMPA and NET-EN can be given up to 2 weeks late without any need for additional contraceptive protection. • If the client is more than 2 weeks late for either DMPA or NET-EN she can have the injection if it is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next 7 days. • She may wish to consider the use of emergency contraception if appropriate (see chapter 10: Emergency contraception). Switching between DMPA and NET-EN • Interchangeable use of DMPA and NET-EN injections is not recommended. • If it is necessary to change from one POI to the other, the switch should be made at the time when the repeat injection would have been given. 115 For a repeat POI when the previous type of injectable and /or the timing of injection is unknown • The client can have the injection if it is necessary and it is certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next 7 days. • She may wish to consider the use of emergency contraception if appropriate. Injection technique • Use only sterile or high-level disinfected syringes and needles. Disposable syringes and needles must not be re-used (For instructions on the processing of syringes and needles see chapter 15: Infection prevention and control, section 5.7). • Shake the vial thoroughly. (If the vial has been cooled, as may be the case with NET-EN, warm it to room temperature first). • Remove the protective the cap of vial carefully, so as not to contaminate the stopper. • Aspirate contents into a sterile syringe to the exact volume required. • Clean the injection site. • Insert the sterile needle deep into the gluteal (upper outer quadrant) or deltoid muscle. (Many providers prefer to give oil-based injections, such as NET-EN, only in the gluteal muscle to reduce any pain associated with injections). • Do not massage the injection site. • Dispose of the disposable needles and syringes as appropriate. (See chapter 15: Infection prevention and control, sections 5.7 and 8.5). 5.9 Instructions to the client Before administering the first injection, it is essential that every potential user fully understands the following: Repeat injections Regular repeat injections are essential if pregnancy is to be avoided. The client needs to have an injection every 3 (DMPA) or 2 (NET-EN) months. Advise the client to visit the clinic as soon as possible if she is late for the next injection. H O R M O N A L C O N TR AC EP TI O N 5 116 Side-effects Advise the client about possible side-effects (see section 5.11). Return to fertility Women using POIs may remain with amenorrhoea and not become pregnant for several months after their last injection, but the injection will not harm their fertility in the long term. Warning signs Advise the client to consult or visit the clinic if pregnancy is suspected or if any of the following problems occur: • Unusually heavy menstrual bleeding. • Severe headaches. • Unusual discomfort or other problem at the injection site. To prevent anxiety in the client, explain to her that serious complications are very rare. You can inform her that her health will be better protected by use of this highly reliable method of contraception than if an unintended pregnancy were to occur. Follow-up Tell the client the name of the injection and the date when her next injection is due. This information, a list of warning signs, and the name, address and telephone number of the clinic can be put on a card or leaflet and given to the client. This should be written and presented in such a way that the client or somebody close to her (in case she cannot read) can readily understand it. 5.10 Follow-up care Repeat injection protocol If practicable, do a follow-up review when the client obtains the first repeat injection: • Update the client’s address and how to make contact with her. • Assess the client’s satisfaction with this method of contraception. • Determine if the client has had any problems or side-effects and, if so, record them in the clinical record. 117 • Update the medical history, measure blood pressure and weight, and perform any other examination which may be indicated by the history. • Provide appropriate counselling and/or treatment as required. • Encourage the client to get in touch with the clinic at any time if she has any questions, complaints or problems. Annual follow-up protocol • Follow the repeat injection protocol with an updated medical history and an assessment of satisfaction with the method. • Offer the client other relevant reproductive health services available at the facility, such as cervical cancer screening. 5.11 Side-effects Amenorrhoea Amenorrhoea is a common side-effect and usually occurs by the third injection. If the possibility of pregnancy is excluded, there is no reason for concern. If the client finds it unacceptable, discontinue the POI and help her to choose another method. Spotting or light bleeding Spotting or light bleeding (breakthrough bleeding) is common, especially following the first 2 injections. These symptoms are often temporary, and are rarely a risk to health. Careful counselling of women starting to use POIs has reduced the number who discontinue this method because of these side-effects. Clients who are fully informed beforehand about what to expect will be better able to understand and cope with these and other side-effects, and this method usually results in a high degree of satisfaction among women. If minor bleeding persists, gynaecological problems should be excluded. If an STI or PID is diagnosed, the client can continue her injections while receiving treatment, and be counselled on condom use. If no gynaecological problem is identified, and she prefers to discontinue the POI, help her to choose another method of contraception. Heavy or prolonged bleeding (more than 8 days or twice as much as her usual menstrual period) Explain to the client that heavy or prolonged bleeding is common in the first injection cycle. However, if bleeding persists or becomes too heavy it is essential to exclude any underlying gynaecological problem. When this H O R M O N A L C O N TR AC EP TI O N 5 118 has been done, and heavy bleeding persists, treatment with oestrogens, combined oral contraceptives or non-steroidal anti-inflammatory drugs may be tried. To prevent anaemia, review the client’s diet and, if necessary, provide an iron supplement. If treatment is not effective and the problem becomes unacceptable to the client or a threat to her health, POIs should be discontinued and the client should be helped to choose an alternative method of contraception. Other minor side-effects These include weight gain and mild headaches. These symptoms are not dangerous, and the client should be reassured and encouraged to continue with this method of contraception. 5.12 Service management See section 7 of this chapter. 6 Combined injectable contraceptives (CICs) 6.1 Definition Combined injectable contraceptives (CICs) contain a short-acting oestrogen and a long-acting progestogen. The injectable preparation is released slowly over the course of 28 days from the site of injection. A single injection is given each month. The 2 preparations currently available are: • 25 mg medroxyprogesterone acetate/5 mg oestradiol cypionate (Cyclofem, Cycloprovera, Lunelle, and Novafem). • 50 mg norethisterone oenanthate/5 mg oestradiol valerate (Mesigyna and Norigynon). 119 In some countries other combined injectable contraceptive formulations are available; however, current data about safety and efficacy are not sufficient to make a recommendation about them. Mode of action: CICs exert their contraceptive effect mainly by suppression of ovulation. The cervical mucus is also affected, mainly by progestogen, and rendered inhospitable to sperm penetration. The receptivity of the endometrium to the blastocyst is also reduced, although there is no evidence that this contributes to the contraceptive effectiveness. 6.2 Indications Combined injectable contraceptives should be provided to any woman who requests them after receiving appropriate counselling and reaching an informed decision, and who does not have any relevant contraindication to their use. CICs might be useful for women who: • Want a highly effective method of contraception. • Desire the convenience of not having to keep contraceptive supplies at home. • Have problems of compliance with oral contraceptives. • Want the convenience of an injectable contraceptive without the bleeding irregularities associated with POIs. Although full data are not available for CICs, the ancillary protective health effects attributed to COCs, noted in section 2.2 of this chapter, may also apply to CIC use. 6.3 Medical eligibility criteria When sufficient clinical data are not available, the medical eligibility criteria for CICs are based on data for combined oral contraceptives (COCs) and progestogen-only injectables (POIs). Category 4 (Contraindications) CICs should not be used in the presence of: • Breast-feeding and less than 6 weeks postpartum. • Past or present evidence of deep venous thrombosis or pulmonary embolism (DVT/PE). H O R M O N A L C O N TR AC EP TI O N 5 120 • Major surgery with prolonged immobilization. • Current and history of ishaemic heart disease or stroke. • Complicated valvular heart disease. • Raised blood pressure (systolic 160 or diastolic 100 mmHg). • Hypertension with vascular disease. • Migraine with aura. • Breast cancer within the past 5 years. • Diabetes mellitus with vascular complications (including nephropathy, retinopathy and neuropathy) or of > 20 years’ duration. • Active viral hepatitis. • Malignant liver tumour. Category 3 CICs should generally not be used in the presence of: • Raised blood pressure (systolic 140-159 or diastolic 90-99 mmHg). • History of hypertension where blood pressure cannot be evaluated or adequately controlled hypertension, where blood pressure can be evaluated. • Smoking 15 or more cigarettes daily in a woman aged 35 years or more. • Known hyperlipidaemia. • Migraine without aura symptoms in women aged 35 years or more (if migraine develops during CIC use, it becomes category 4). • Breast-feeding from 6 weeks to < 6 months postpartum. • Less than 21 days in postpartum non-breast-feeding women. • Severe decompensated cirrhosis. • Benign liver tumour. • History of breast cancer with no evidence of disease for the last 5 years. When any category 3 condition is present, explain the potential risks to the client and counsel her about alternative contraceptive methods. If CICs are chosen because other contraceptive options are not available or are unacceptable, it is particularly important that this method should be provided by a properly qualified practitioner and that the woman be kept under medical supervision. If a woman has more than one of the first 5 121 conditions above, which increase the risk of cardiovascular disease, clinical judgment must be exercised. In most instances, the combined criteria should be considered as belonging to category 4 (contraindication). Category 2 CICs can generally be used with precaution in the presence of: • Smoking in women aged less than 35 years or smoking less than 15 cigarettes daily in a woman aged 35 years or more. • Migraine without aura in women aged less than 35 years (if migraine develops during CIC use, it becomes category 3). • Diabetes mellitus without vascular complications. • Obesity ≥ 30kg/m2 body mass index. • History of high blood pressure during pregnancy (where current blood pressure is measurable and normal). • Superficial thrombophlebitis. • Family history of deep venous thrombosis or pulmonary embolism (DVT/PE). • Breast-feeding and 6 months or more postpartum. • Uncomplicated vascular heart disease. • Unexplained vaginal bleeding, suspicious of a serious condition, before evaluation. • Mild (compensated) cirrhosis. • Symptomatic or asymptomatic gallbladder disease or history of cholestatasis. • Sickle cell disease. • Cervical intraepithelial neoplasia (CIN) or cervical cancer. • Undiagnosed breast mass. • Drug treatment affecting liver enzymes: rifampicin and certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine). • Antiretroviral therapy. When any of these conditions are present, careful screening and monitoring will allow the benefits of CIC use to outweigh any potential risks. However, when a woman has 2 or more of the first 4 conditions H O R M O N A L C O N TR AC EP TI O N 5 122 above, which increase the risk of cardiovascular disease, clinical judgment must be exercised. In most instances the combined conditions should be regarded as belonging to category 3. If the method is provided, record the woman’s special condition in the clinical record, and advise her of warning signs relevant to her condition. 6.4 Special situations The advice given for use of POIs in relation to abnormal vaginal bleeding, drug interactions, malignancy of the genital tract and STIs also apply to CICs (see section 5.4 of this chapter). Lactation There are no data on the effects of CICs on the quantity and quality of breast milk or the duration of lactation. Until such data become available, CICs should be generally withheld until 6 months after delivery or until the infant is weaned, whichever is earlier. If the woman wishes to start an injectable contraceptive during breast-feeding, a POI should be recommended. Adolescents The benefits of CICs for pregnancy protection are especially important for young people and the indications and contraindications are the same in this age-group as for older women. When there is concern about a possible hypo-oestrogenic effect of POIs, the combined injectable is a more suitable option. Women aged over 35 years CICs can be used by most healthy women over 35 years of age. Any possible increased risk of cardiovascular disease would be minimal for these women if they do not smoke and have no other risk factors, such as hypertension or diabetes mellitus. Elective surgery It is advisable to stop using CICs approximately 4 weeks before elective surgery which involves prolonged immobilization, and to restart CICs 2 weeks after the woman is mobile. Advise the use of alternative effective contraception during this time. In emergency procedures, the surgeon may consider the use of prophylactic anticoagulant measures, and early ambulation should be encouraged. 123 Sickle cell disease No data are available on the use of CICs by women who have sickle cell disease. Sickle cell trait is not a contraindication to the use of combined hormonal contraceptives, but women with homozygous sickle cell disease may be at increased risk of thrombosis. POIs are a more suitable choice than CICs for these women. 6.5 Counselling and information All CIC clients must receive appropriate counselling for the selection and use of CICs before starting this method of contraception. Encourage clients to ask all their questions so that any uncertainties and misunderstandings can be cleared up (See also chapter 2: Counselling). Selection of CICs as means of contraception Discuss the following points clearly with each client in language that she understands: • Advantages and disadvantages of CICs including effectiveness, risks and benefits, side-effects and cost. (Reassure clients about the lack of any conclusive evidence that CICs cause cancer, birth defects or future infertility). • Alternative family planning methods including information on effectiveness, risks and benefits, side-effects and cost as appropriate. • Remind clients who smoke that smoking increases the risk of serious circulatory disorders, and advise all women who intend to use CICs to stop smoking. • Timing of the injection: When the woman will receive the first injection, when the next injection will be due, and how often she will receive the injections. • The specific CIC to be used. Use of CICs See section 6.9 of this chapter. 6.6 Who can provide CICs? Any health care provider who has been trained in the education and counselling of clients and the administration of injectables may provide this method, depending on local regulations and practice. H O R M O N A L C O N TR AC EP TI O N 5 124 6.7 Health assessment The purpose of the health assessment is to determine the client's suitability for the use of the method. It should also be used as an opportunity to offer the client other available sexual and reproductive health services. The guidelines for COC assessment (see section 2.7) also apply to clients who receive CICs (compare sections 2.3 and 2.4 with sections 6.3 and 6.4). 6.8 CIC provision The initial injection Give the initial injection within the first 7 days of the menstrual cycle, preferably the first day. The client can also have the first injection at any other time, if it is reasonably certain that she is not pregnant. If it has been more than 7 days since menstrual bleeding started she will need to abstain from sex, or use additional contraceptive protection, for the next 7 days. For the amenorrhoeic client • The client can have the first injection at any time, if it is reasonably certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next 7 days. For the postpartum client • If the client is breast-feeding and she wishes to use an injectable contraceptive, recommend the progestogen-only injectable. CICs should not be used earlier than 6 months postpartum or before weaning. • If the client is not breast-feeding, she can receive the initial injection from 3-6 weeks postpartum. If the client wishes to start the CIC after the sixth week postpartum and she has not yet had the first postpartum period, rule ou
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