Improving access to quality care in family planning : medical eligibility criteria for contraceptive use, 2nd ed

Publication date: 2000

Acknowledgements This document is the result of collaboration between the World Health Organization's Department of Reproductive Health and Research and a large number of international agencies and organizations active in the field of family planning policies and programmes. These include: AVSC International; Centers for Disease Control and Prevention (CDC); Family Health International (FHI); Georgetown University Medical Center; International Planned Parenthood Federation (IPPF); Johns Hopkins University Center for Communication Program; National Institutes of Health (NIH); The Population Council; Program for International Training in Health (INTRAH); and the United Nations Population Fund (UNFPA). Representatives of these agencies and organizations, together with other individuals, served as experts at a meeting that achieved consensus on medical eligibility criteria for initiating and continuing use of the contraceptive methods dealt with in this report. We would like to express our deep appreciation to all of them for contributing their time and expertise towards the consensus building process. The evidence on which the decisions in this document were based was in large part obtained from a systematic review of the literature conducted and summarized by Dr KM Curtis and Ms CE Chrisman, who also provided substantial support to Secretariat. Additional evidence was provided in a background paper by Dr JJ Schlesselman and Dr TMM Farley. Dr H Peterson was overall coordinator of the project. We would like to express our deep appreciation to these individuals as well as to Dr J Shelton for his continuing support of this endeavour. The financial support towards the preparation and production of this document, provided by the Governments of the Netherlands, the United Kingdom of Great Britain and Northern Ireland (through the Department for International Development), and the United States of America (through the US Agency for International Development) is gratefully acknowledged. For any further information on this document, please contact Dr QM Islam, Acting Coordinator, Team on Development of Norms and Tools, Department of Reproductive Health and Research, World Health Organization, 1211 Geneva 27, Switzerland, direct fax: + 41 22 791 4189. Copies may be obtained from: Documentation Centre, direct fax:+ 41 22 791 4189; telephone: + 41 22 791 4447; e-mail: rhrpublications@who.int Document design & layout: C. Hamill Cover design: M. Ní Mhearáin Table of contents Executive summary and Overview Tables Low-dose combined oral contraceptives (COCs) Combined injectable contraceptives (CICs) Progestogen-only contraceptives (POCs) Emergency contraceptive pills (ECPs) Intrauterine devices (IUDs) Copper-IUD for emergency contraception (E-IUD) Barrier methods (BARR) Fertility awareness-based methods (FAB) Lactational amenorrhoea method (LAM) Coitus interruptus (CI) Surgical sterilization procedures (STER) Summary tables (SUMM) List of participants Table of contents Executive summary & Overview Executive summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Issues of service quality and access that affect method use . . . . . . . . . . . . . . . . . . . . . . . . . 3 Effectiveness of methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Conditions that expose a woman to increased risk as a result of unintended pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Return to fertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 STIs and contraception: Dual protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Method of work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Classification categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Clients with multiple risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 How to use this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Programmatic implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Clients with special needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Adolescents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Summary and conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Medical eligibility criteria for contraceptive use - Page 1 Executive summary This document is one important step in a process for improving access to quality of care in family planning by reviewing the medical eligibility criteria for selecting methods of contraception. It updates the first edition of Improving access to quality care in family planning: medical eligibility criteria for contraceptive use, published in 1996, and summarizes the main recommendations of a scientific Working Group meeting held at the World Health Organization, Geneva, 8-10 March 2000. (Please see Annex I for the list of participants.) The Working Group brought together 32 participants from 17 countries, including representatives of several agencies and organizations. The document provides recommendations for appropriate medical eligibility criteria based on the latest clinical and epidemiological data and is intended to be used by policy-makers, family planning programme managers and the scientific community. It aims to provide guidance to national family planning/reproductive health programmes in the preparation of guidelines for service delivery of contraceptives. It should not be seen or used as the actual guidelines but rather as a reference. The document covers the following family planning methods: low-dose combined oral contraceptives (COCs), combined injectable contraceptives (CICs), progestogen-only pills (POPs), depot medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN), Norplant implants I and II (NOR), emergency contraceptive pills (ECPs), copper intrauterine devices (Cu-IUDs), levonorgestrel-releasing IUDs (LNG-IUDs), copper-IUD for emergency contraception (E-IUD), barrier methods(BARR), fertility awareness-based methods (FAB), coitus interruptus (CI), lactational amenorrhoea method (LAM), and female and male sterilization (STER). Page 2 - Medical eligibility criteria for contraceptive use Overview “Reproductive rights embrace certain human rights that are already recognised in national laws, international human rights documents and other relevant consensus documents. These rights rest on the recognition of the basic right of all couples and individuals to decide freely and responsibly the number and spacing and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health.” (para. 95, Beijing Platform for Action, 1995) Reproductive and sexual health care including family planning services and information is recognized not only as a key intervention for improving the health of women and children but also as a human right. All individuals have the right to access, choice, and the benefits of scientific progress in the selection of family planning methods. A rights-based approach to the provision of contraceptives assumes a holistic view of clients, which includes taking into account clients’ sexual and reproductive health care needs and considering all appropriate eligibility criteria in helping clients choose and use a family planning method. Over the past 30 years, there have been significant advances in the development of new contraceptive technologies, including transitions from high-dose to low-dose estrogen combined oral contraceptives, and from inert to copper and levonorgestrel-releasing IUDs. However, current policies and health care practices in some countries are based on scientific studies of contraceptive products that are no longer in wide use, on long-standing theoretical concerns that have never been substantiated, or on the personal preference or bias of service providers. These outdated policies or practices many times result in limitations to both the quality of, and the access to, family planning services for clients. This document is intended to update the medical eligibility criteria used in the provision of all hormonal contraceptives, IUDs, barrier methods, fertility awareness-based methods, coitus interruptus, lactational amenorrhoea method, male and female sterilization, and emergency contraception. Advances in scientific knowledge, research and development in recent decades have resulted in an increasingly wider choice of new contraceptive methods and improvements in the safety and effectiveness of existing methods. However, the full range of modern family planning methods still remains unavailable to at least 350 million couples worldwide, many of whom wish to space or prevent another pregnancy, despite their individual right to the benefits of scientific progress. Even when family planning methods are accessible and individuals wish to space or limit births, family planning services are often under-used. Many factors contribute to the gap between access to, and use of, services. In addition to many logistic, social and behavioural obstacles to meeting the contraceptive needs and wishes of individuals and couples, there may be obstacles that stem from the structure, organization or procedures of the health system that can be immediately corrected. To meet people’s needs and close the existing large gap in quality services, reproductive health care providers, programmes and contraceptive suppliers will need to expand rapidly over the next several years, and information will need to be disseminated about new contraceptive developments, appropriateness of methods and introduction strategies. Thus, WHO is giving priority to improving access to high-quality care in family planning through a variety of strategies. These include: ensuring that women's and men’s rights and perspectives are taken into account in the planning, management and evaluation of services; promoting the widest availability of different contraceptive methods so that people may select what is most appropriate to their needs and circumstances; ensuring that contraceptive counselling and service delivery will Medical eligibility criteria for contraceptive use - Page 3 be based on eligibility criteria that are supported by a scientific rationale; and conducting research to develop new family planning methods, and improve existing ones. Delivery of care in accordance with the client’s human and reproductive rights is fundamental to quality of care. The development of international norms for the medical eligibility criteria for contraceptive methods is only one aspect of improving the quality of reproductive health care. Many family planning programmes have included screening, treatment and follow-up procedures that reflect high standards of public health and clinical practice but should not be seen as eligibility requirements for specific contraceptive methods. These procedures include the screening and treatment of cervical cancer, anaemia and sexually transmitted infections (STIs), and the promotion of breastfeeding and cessation of smoking. Such procedures should be strongly encouraged if the human and material resources are available to carry them out, but they should not be seen as prerequisites for the acceptance and use of family planning methods when they are not necessary to establish eligibility for the use or continuation of a particular method. While this document primarily addresses medical eligibility criteria for contraceptive use, considerations of social, behavioural, and other non-medical criteria, particularly client preference, must be taken into account. To provide contraceptive choices to clients in a way that respects and fulfils their human rights necessitates enabling clients to make informed choices for themselves. Women’s choices, however, are often imposed or limited by direct or indirect social, economic and cultural factors. From the women’s point of view, choices are made in a particular time, society and cultural context; choices are complex, multifactorial and subject to change. Decision-making for contraceptive methods usually requires the need to make trade-offs among the different methods, with advantages and disadvantages of specific contraceptive methods according to individual circumstances, perceptions, and interpretations. In the provision of high- quality family planning services, providers must respect client’s reproductive rights including facilitating choice and access through the promotion of contraceptive decision-making in the context of women’s lives. Issues of service quality and access that affect method use While this document chiefly addresses medical eligibility criteria, there are many other considerations in the appropriate provision of contraceptive methods. WHO will be examining, in depth, these programmatic and service delivery concerns, in various programme settings, during the next phase of this initiative. However, it is critical, even at this stage, to bear in mind the following service delivery criteria which are universally relevant to the initiation and follow-up of all contraceptive method use. a) Clients should be given adequate information in order to make an informed, voluntary choice of a contraceptive method. Information given to clients to help them make this choice should at least include: understanding of the relative effectiveness of the method; correct use of the method; how it works; common side-effects; health risks and benefits of the method; signs and symptoms that would necessitate a return to the clinic; information on return to fertility after discontinuing method use; and information on STI protection. b) For those methods that require surgical approaches, insertion, fitting and/or removal by a trained health provider (sterilization, Norplant implants, IUDs, diaphragms, cervical caps), appropriately trained personnel in adequately equipped facilities must Page 4 - Medical eligibility criteria for contraceptive use be available in order for those methods to be offered, and appropriate infection prevention procedures must be followed. c) Adequate and appropriate equipment and supplies need to be maintained and held in stock (for example, contraceptive commodities, equipment and supplies for infection prevention procedures). d) Service providers should be provided with guidelines (or client cards or other screening tools) to enable them to appropriately screen clients for conditions in which use of certain contraceptive methods would carry unacceptable health risks. e) Service providers must be trained in providing family planning counselling to help clients make informed and voluntary decisions about their fertility. Counselling is a key element in quality of care and is also an important part of both initiation and follow-up visits and should respond to clients needs not only in contraception but also related to sexuality and the prevention of STIs, including infection with the human immunodeficiency virus (HIV). Effectiveness of methods Contraceptive choice is in part dependent on the effectiveness of the contraceptive method in preventing unplanned pregnancy, which, in turn, is dependent for some methods not only on the protection afforded by the method itself, but also on how consistently and correctly it is used (Table 1). Both consistent and correct use can vary greatly with such characteristics as age, income, users' desire to prevent or delay pregnancy, and culture. Methods that depend on consistent and correct use by clients have a wide range of effectiveness. Most men and women tend to be more effective users as they become more experienced with a method. However, programmatic aspects also have a profound effect on how effectively the method will be used. Programmes must therefore ensure that the factors contributing to the effective use of contraceptive methods are adequately addressed. These include: # information for clients on consistent and correct use # technical competence, counselling and ongoing support by providers # accessibility, acceptability and affordability of services to ensure ongoing quality of care and availability of methods. In the context of contraceptive choice and method effectiveness, clients should be helped to understand: # the relative effectiveness of available methods to help them to make an informed choice of the method; and # the negative effects of unwanted pregnancies on the health and well-being of individuals and families and the potentially serious health risk of pregnancy for women with certain pre- existing medical conditions. Medical eligibility criteria for contraceptive use - Page 5 Table 1. Effectiveness of family planning methods† Pregnancies per 100 women in first 12 months of use Effectiveness group Family planning method As commonly Used correctly used & consistently Always very DMPA and NET-EN injectables 0.3 0.3 effective Norplant implants 0.1 0.1 Vasectomy 0.2 0.1 Combined injectables 0.3 0.3‡ Female sterilization 0.5 0.5 TCu-380A IUD 0.8 0.6 Progestogen-only oral contraceptives 1 0.5 (during breastfeeding) Effective as commonly used Very effective when used correctly and consistently Lactational amenorrhoea method 2 0.5 Combined oral contraceptives 6–8 0.1 Progestogen-only oral contraceptives 0.5 (not during breastfeeding) § §§ Only somewhat effective as commonly used Effective when used correctly and consistently. Male condoms 14 3 Coitus interruptus 19 4§§ Diaphragm with spermicide 20 6 Fertility awareness-based methods 20 1–9 Female condoms 21 5 Spermicides 26 6 Cap Nulliparous women 20 9 Parous women 40 26 No method 85 85 Key: 0–1 Very effective 2–9 Effective 10–30 Somewhat effective Notes: † Adapted from Hatcher RA, Rinehart W, Blackburn R, Geller JS and Shelton JD. The essentials of contraceptive technology. Baltimore, Johns Hopkins University School of Public Health, Population Information Program, 1997. ‡ UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. Facts about once-a-month injectable contraceptives: Memorandum from a meeting. Bulletin of the World Health Organization 1993; 70(6):677-689. § Outside the context of breastfeeding, progestogen-only contraceptives are somewhat less effective than combined oral contraceptives. See Hatcher RA, Trussell J, Stewart F, Cates Jr W, Stewart GK, Guest F, Kowal D. Contraceptive technology (17th edition). New York, Ardent Media Inc., 1998. Page 6 - Medical eligibility criteria for contraceptive use §§ Data source: Hatcher RA, Trussell J, Stewart F, Cates Jr W, Stewart GK, Guest F, Kowal D. Contraceptive technology (17th edition). New York, Ardent Media Inc., 1998. Medical eligibility criteria for contraceptive use - Page 7 Conditions that expose a woman to increased risk as a result of unintended pregnancy Women with conditions that may make pregnancy an unacceptable health risk should be advised that, because of their relatively higher typical-use failure rates, sole use of barrier methods for contraception, and behaviour-based methods of contraception may not be the most appropriate choice for them. These conditions are noted in Table 2. Table 2. Conditions that expose a woman to increased risk as a result of unintended pregnancy High blood pressure (systolic >160 mmHg or diastolic >100 mmHg)† Diabetes: insulin-dependent; with nephropathy/retinopathy/neuropathy or other vascular disease; or of > 20 years' duration Ischaemic heart disease Stroke Complicated valvular heart disease Breast cancer Endometrial or ovarian cancer STI HIV/AIDS Severe (decompensated) cirrhosis Malignant liver tumours (hepatoma) Malignant gestational trophoblastic disease Sickle cell disease Schistosomiasis with fibrosis of the liver Tuberculosis Note: † Throughout this document, blood pressure measurements are given in mm/Hg. 9To convert to kPa, multiply by 0.1333. For example, 120/80 mm Hg = 16.0/10.7 kPa. Return to fertility The use of contraceptive methods, with the exception of male and female sterilization, does not result in an irreversible change in fertility. Return to fertility is immediate with all methods, with the exception of DMPA and NET-EN; the median delay in return to fertility with these methods is 10 and 6 months respectively from the date of the last injection, regardless of the duration of their use. Male and female sterilization should be regarded as permanent methods. No other methods result in permanent infertility. Page 8 - Medical eligibility criteria for contraceptive use STIs and contraception: Dual protection While the development of international norms for contraceptive provision is essential for quality of care in services, the social and cultural context of each client must also be considered. In this regard, the problems of exposure to STIs, including HIV, deserve special consideration because of the equal importance of preventing pregnancy and preventing transmission of infection. When a risk of STI/HIV transmission exists, it is important that health care providers strongly recommend dual protection to all persons at significant risk, either through the simultaneous use of condoms with other methods or through the consistent and correct use of condoms alone for both pregnancy prevention and disease prevention. Women and men seeking contraceptive advice must always be reminded of the importance of condom use for preventing the transmission of STI/HIV. Male latex condoms are proven to protect against STI/HIV when used consistently and correctly. Method of work This document builds on a process initiated in 1994 that culminated in the 1996 publication of the document, Improving access to quality care in family planning: medical eligibility criteria for contraceptive use. In the initial process, which was created to reach agreement on appropriate eligibility criteria for widely used contraceptive methods, a number of agencies and organizations collaborated in an in-depth review of the epidemiological and clinical evidence relevant to medical eligibility criteria of well established contraceptive methods. The process involved comparing the eligibility criteria used by different agencies for various contraceptives, preparing summaries of published medical and epidemiological literature relevant to medical eligibility criteria, and preparing a draft classification for review by a larger group of experts and agencies. Two scientific Working Group meetings were organized by WHO, in March 1994 and May 1995, to review the background classifications and to formulate recommendations for revising medical eligibility criteria for all currently available contraceptive methods, and the document, Improving access to quality care in family planning: medical eligibility criteria for contraceptive use, followed in 1996. This first revision of the 1996 document is based on the recommendations of a scientific Working Group meeting held at WHO on 8–10 March 2000, that brought together 32 participants from 17 countries, including representatives of several agencies and organizations. The Working Group reviewed new evidence since the last Working Group meetings in 1994 and 1995. This new evidence was primarily obtained from a systematic review of the most recent literature, which was conducted to identify and summarize new evidence for medical eligibility criteria of contraceptive methods. A search of the MEDLINE database yielded all primary studies published in English, from January 1995 through January 2000, that described use of contraceptive methods among women with certain conditions (e.g., the risk of stroke for women with migraines who used COCs). The purpose of the systematic review was to identify direct evidence for the appropriateness of contraceptive method use by women with selected conditions. Information on indirect evidence or theoretical considerations was not obtained. There are a limited number of studies that specifically address use of a contraceptive method by women with the conditions of interest. Thus, most of the decisions regarding eligibility criteria using new evidence were often necessarily based on extrapolations from studies that primarily included healthy women, as well as on theoretical considerations and expert opinion. Evidence Medical eligibility criteria for contraceptive use - Page 9 was particularly limited for newer products and for those with limited usage. The total body of evidence considered by the Working Group included: # evidence based on direct studies or observations of the contraceptive method used by women (or men) with the condition; # evidence derived from effects of the contraceptive method used by women (or men) without the condition; # indirect evidence or theoretical concern based on studies of suitable animal models, human laboratory studies, or analogous clinical situations. Programmatic implications of the classification were also considered by the Working Group. The Working Group was charged with determining the eligibility criteria for each condition and method of contraception by selecting a category (1 through 4, as described below). Where changes in the eligibility criteria were made by the Working Group, the new evidence provided to the Group has been summarized and presented by the Secretariat under the heading “New evidence”, in the column labelled “New evidence/Comments”. Where changes in eligibility criteria were made based on considerations other than new evidence, the rationale for such changes has been summarized by the Secretariat under the heading “Comments”, in the column labelled “New evidence/Comments”. Comments also may have been provided by the Secretariat when the eligibility criteria for a condition did not change. These comments reflect key considerations, including programmatic implications. The present document is intended to be used by policy-makers, family planning programme managers and the scientific community. It aims to provide guidance to national family planning/reproductive health programmes in the preparation of guidelines for service delivery of contraceptives. It should not be seen or used as the actual guidelines but rather as a reference. Classification categories The medical eligibility criteria in this document were based on the approach described above and aim to ensure an adequate margin of safety. Each condition was defined as representing either an individual's characteristics (e.g., age, history of pregnancy) or a known pre-existing medical/pathological condition (e.g., diabetes, hypertension). It is expected that national and institutional health and service delivery environments will decide the most suitable means for screening for conditions according to their public health importance. Client history will often be the most appropriate approach. The conditions affecting eligibility for the use of each contraceptive method were classified under one of the following four categories: 1. A condition for which there is no restriction for the use of the contraceptive method. 2. A condition where the advantages of using the method generally outweigh the theoretical or proven risks. Page 10 - Medical eligibility criteria for contraceptive use 3. A condition where the theoretical or proven risks usually outweigh the advantages of using the method. 4. A condition which represents an unacceptable health risk if the contraceptive method is used. Categories 1 and 4 are self-explanatory. Classification of a method/condition as category 2 indicates the method can generally be used, but careful follow-up may be required. However, provision of a method to a woman with a condition classified as category 3 requires careful clinical judgement and access to clinical services; for such a woman, the severity of the condition and the availability, practicality, and acceptability of alternative methods should be taken into account. For a method/condition classified as category 3, use of that method is not usually recommended unless other more appropriate methods are not available or acceptable. Careful follow-up will be required. NA denotes a condition for which a ranking was not given by the Working Group but on which comments have been provided. The Working Group addressed medical criteria for the initiation and continuation of use of all methods evaluated. The discussion on continuation of use criteria included only those conditions where criteria for continuation of a method differed from criteria for initiation of the method and those conditions which may have the same classification for continuation and initiation, but a different rationale. The issue of continuation criteria is clinically relevant whenever a woman develops the condition while she is using the method. A difference in category between initiation and continuation is denoted in the columns 'I=Initiation' and 'C=Continuation'. On the basis of this classification system, the eligibility criteria for initiating and continuing use of a specific contraceptive method are presented in this document in a set of tables. The first column indicates the condition. Several conditions were subdivided to differentiate between varying degrees of the condition. The second column classifies the condition for initiation and/or continuation in one of the four categories described above. If necessary, the third column gives new evidence or comments regarding the classification, as described in the section above. ELIGIBILITY CRITERIA FOR USE OF A CONTRACEPTIVE METHOD TYPE OF CONTRACEPTIVE CONDITION CATEGORY NEW EVIDENCE/ I=Initiation COMMENTS C=Continuation Condition Condition classified New evidence/Comments on from 1 to 4 the classification The classifications for fertility awareness-based methods and surgical sterilization are described at the beginning of the relevant section. Medical eligibility criteria for contraceptive use - Page 11 A summary table is included at the end of the document covering medical eligibility criteria by condition for hormonal methods and IUDs. A summary of the conditions or categories that were revised for this edition is included at the end of this section. Clients with multiple risks When making decisions about contraception, both client and provider should assess thoroughly the client's general health and the presence of risk conditions. In the case of a client presenting more than one risk condition simultaneously, the category assigned to the risk conditions under each method may be changed to reflect the need for more caution. “Multiple cardiovascular risk factors” has been included as a specific condition. How to use this document This document is intended for adaptation at country and programme levels to reflect the diversity of situations and settings in which contraceptives are provided. In particular, the level of clinical knowledge and experience of various types of providers and the resources available at the service delivery point will have to be taken into consideration. Professionals who are developing family planning service delivery guidelines may wish to consider a variation of the classification system used in this document. Where clinical judgement resources are limited, such as in community-based services, the four-category classification framework can be simplified into two categories. Thus the framework can be used both in situations where clinical judgement can be provided and in those where it is not available. CLASSIFICATION CLINICAL JUDGEMENT CLINICAL JUDGEMENT WITH WITH LIMITED 1 Use method in any Yes circumstances (Use the method) 2 Generally use the method (Use the method) Yes 3 more appropriate methods are Use of method not usually recommended unless other not available or not acceptable No (Do not use the method) 4 Method not to be used (Do not use the method) No Page 12 - Medical eligibility criteria for contraceptive use Programmatic implications The goal of this document is to provide policy- and decision-makers and the scientific community with a set of recommendations that can be used for developing or revising national guidelines on medical eligibility criteria for contraceptive use. The document does not provide rigid guidelines but rather gives recommendations that provide a basis for rationalizing the provision of various contraceptives in view of the most up-to-date information available on the safety of the methods. Because country situations and programme environments vary so greatly, it is inappropriate to set firm international guidelines on criteria for contraceptive use. However, it is expected that national programmes will use these recommendations as a reference tool, adapting them to develop their own contraceptive eligibility guidelines in the light of their national health policies, needs, priorities and resources. The intent is to help improve access to, and quality of, family planning services. These improvements must be made within the context of users' informed choice and medical safety. Adaptation is not always an easy task and is best done by those well-acquainted with the prevailing health situation, habits and culture. Programmatic issues that need to be addressed include: C informed choice, C elements of quality of care, C essential screening procedures for administering the methods, C provider training and skills, C referral and follow-up for contraceptive use as appropriate. In the application of the eligibility criteria to programmes, service delivery practices that are essential for the safe use of the contraceptive should be distinguished from practices that may be appropriate for good health care but are not related to use of the method. The promotion of good health care practices unrelated to safe contraception should be considered neither as a prerequisite nor as an obstacle to the provision of a contraceptive method, but as complementary to it. As a next step, the recommendations on eligibility criteria need to be adapted so as to be applicable to providers at all levels of the service delivery system. Countries will need to determine how far and by what means it may be possible to extend their services to the more peripheral levels. This may involve upgrading both staff and facilities where feasible and affordable, or may require the extension of the skills of certain categories of health personnel or a modest addition of equipment and supplies, and redeployment of space. It will also be necessary to address questions of misperceptions sometimes held by providers and users on the risks and side-effects of the methods and to look closely at the needs and perspectives of women and men in the context of informed choice. Clients with special needs Medical eligibility criteria for contraceptive use - Page 13 Medical eligibility criteria address contraceptive use by people with specific medical conditions. In addition, contraceptive provision to people with special needs requires further consideration. Individuals with a physical disability represent such a group. Decisions on appropriate contraception must take into account the nature of the disability, the expressed desires of the individual and the nature of the method. Decisions must be based on informed choice. Similar considerations should be given to individuals with mental disability or with serious psychiatric disease. Where the nature of the condition does not allow for informed choice, contraceptives should be provided only after full discussion with all parties including guardians or care-givers. The reproductive rights of the individual must be considered in any such decisions. Adolescents In general, adolescents are eligible to use any method of contraception and must have access to a variety of contraceptive choices. Age alone does not constitute a medical reason for denying any method to adolescents. While some concerns have been expressed regarding the use of certain contraceptive methods in adolescents (e.g., the use of progestogen-only injectables by those below 18 years), these concerns must be balanced against the advantages of avoiding pregnancy. It is clear that many of the same eligibility criteria that apply to older clients apply to young people. However, some conditions (e.g., cardiovascular disorders) that may limit use of some methods in older women do not generally affect young people since these conditions are rare in this age group. Social and behavioural issues should be important considerations in the choice of contraceptive methods by adolescents. For example, in some settings, adolescents are also at increased risk for STIs, including HIV. While adolescents may choose to use any one of the contraceptive methods available in their communities, in some cases, using methods that do not require a daily regimen may be more appropriate. Adolescents, married or unmarried, have also been shown to be less tolerant of side-effects and therefore have high discontinuation rates. Method choice may also be influenced by factors such as sporadic patterns of intercourse and the need to conceal sexual activity and contraceptive use. For instance, sexually active adolescents who are unmarried have very different needs from those who are married and want to postpone, space or limit pregnancy. Expanding the number of method choices offered can lead to improved satisfaction, increased acceptance and increased prevalence of contraceptive use. Proper education and counselling both before and at the time of method selection can help adolescents address their specific problems and make informed and voluntary decisions. Every effort should be made to prevent service and method cost from limiting the options available. Summary and conclusions Updating knowledge and providing consistency among eligibility criteria will contribute to improvements in the quality of family planning services. Updated eligibility criteria improve the competence and confidence of service providers as they assist clients with their contraceptive choices. This, in turn, may contribute to increased satisfaction and confidence among clients. Individuals' access to quality contraceptive services may also be improved. On the basis of updated criteria, many persons who were previously prevented from using a particular contraceptive method might consider using it. Current contraceptive screening procedures may be simplified to include only those that are essential for the safe provision of contraceptive services. It is recognized that some of the eligibility criteria in this report will need to be reviewed in the light of new research findings from studies being completed and/or currently in progress. It is intended Page 14 - Medical eligibility criteria for contraceptive use that this document will be updated on a continual basis in order to reflect the latest scientific evidence and findings. A summary of the classification changes or major condition modifications from the first edition is given in Table 3. Medical eligibility criteria for contraceptive use - Page 15 Table 3. Summary of changes from the first edition (Conditions for which there was a classification change for one or more methods or a major modification to the condition description) CONDITION COC CIC POP DMPA NOR Cu-IUD LNG- NET-EN IUD I = Initiation, C = Continuation PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY NA NA NA NA NA 4 4 AGE Menarche Menarche Menarche Menarche Menarche Menarche Menarche to <40=1 to <40=1 to <18=1 to <18=2 to <18=1 to <20=2 to <20=2 >40=2 >40=2 18-45=1 18-45=1 18-45=1 >20=1 >20=1 >45=1 >45=2 >45=1 SMOKING a) Age < 35 2 2 1 1 1 1 1 b) Age > 35 (i) <15 cigarettes/day 3 2 1 1 1 1 1 (ii) >15 cigarettes/day 4 3 1 1 1 1 1 OBESITY 2 2 1 2 2 1 2 >30 kg/m body2 mass index (BMI) BLOOD PRESSURE NA NA NA NA NA NA NA MEASUREMENT UNAVAILABLE CARDIOVASCULAR DISEASE MULTIPLE RISK 3/4 3/4 2 3 2 1 2 FACTORS FOR ARTERIAL CARDIOVASCULAR DISEASE (such as older age, smoking, diabetes and hypertension) HYPERTENSION a) History of 3 3 2 2 2 1 2 hypertension where blood pressure CANNOT be evaluated (including hypertension during pregnancy) CONDITION COC CIC POP DMPA NOR Cu-IUD LNG- NET-EN IUD I = Initiation, C = Continuation Page 16 - Medical eligibility criteria for contraceptive use Hypertension (Cont’d) b) Adequately 3 3 1 2 1 1 1 controlled hypertension, where blood pressure CAN be evaluated c) Elevated blood pressure levels (properly taken measurements) (i) systolic 140-159 or 3 3 1 2 1 1 1 diastolic 90-99 (ii) systolic >160 or 4 4 2 3 2 1 2 diastolic >100 d) Vascular disease 4 4 2 3 2 1 2 HISTORY OF HIGH 2 2 1 1 1 1 1 BLOOD PRESSURE DURING PREGNANCY (where current blood pressure is measurable and normal) DEEP VENOUS THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE) a) History of DVT/PE 4 4 2 2 2 1 2 b) Current DVT/PE 4 4 3 3 3 1 3 c) Family history 2 2 1 1 1 1 1 (first-degree relatives) d) Major surgery (i) with prolonged 4 4 2 2 2 1 2 immobilization (ii) without prolonged 2 2 1 1 1 1 1 immobilization e) Minor surgery 1 1 1 1 1 1 1 without immobilization CONDITION COC CIC POP DMPA NOR Cu-IUD LNG- NET-EN IUD I = Initiation, C = Continuation Medical eligibility criteria for contraceptive use - Page 17 NEUROLOGIC CONDITIONS HEADACHES I C I C I C I C I C I C a) Non migrainous 1 2 1 2 1 1 1 1 1 1 1 1 1 (mild or severe) b) Migraine (i) without focal neurologic symptoms Age <35 2 3 2 3 1 2 2 2 2 2 1 2 2 Age >35 3 4 3 4 1 2 2 2 2 2 1 2 2 (ii) with focal 4 4 4 4 2 3 2 3 2 3 1 2 3 neurologic symptoms (at any age) REPRODUCTIVE TRACT INFECTIONS AND DISORDERS UNEXPLAINED VAGINAL BLEEDING (suspicious for serious condition) I C I C Before evaluation 2 2 2 3 3 4 2 4 2 CERVICAL 2 2 1 2 2 1 2 INTRAEPITHELIAL NEOPLASIA (CIN) CERVICAL CANCER I C I C (awaiting treatment) 2 2 1 2 2 4 2 4 2 BREAST DISEASE a) Undiagnosed 2 2 2 2 2 1 2 mass b) Benign breast 1 1 1 1 1 1 1 disease c) Family history 1 1 1 1 1 1 1 of cancer d) Cancer (i) current 4 4 4 4 4 1 4 (ii) past and no 3 3 3 3 3 1 3 evidence of current disease for 5 years CONDITION COC CIC POP DMPA NOR Cu-IUD LNG- NET-EN IUD I = Initiation, C = Continuation Barrier methods, especially condoms, are always recommended for prevention of STI/HIV/PID.1 Page 18 - Medical eligibility criteria for contraceptive use OVARIAN CANCER I C I C 1 1 1 1 1 3 2 3 2 UTERINE FIBROIDS a) Without distortion 1 1 1 1 1 2 2 of the uterine cavity b) With distortion of 1 1 1 1 1 4 4 the uterine cavity PELVIC INFLAMMATORY DISEASE (PID) a) Past PID (assuming no current risk factors of STIs) I C I C (i) with subsequent 1 1 1 1 1 1 1 1 1 pregnancy (ii) without subsequent 1 1 1 1 1 2 2 2 2 pregnancy b) PID-current or 1 1 1 1 1 4 3 4 3 within the last 3 months HIV/AIDS1 HIGH RISK OF HIV 1 1 1 1 1 3 3 HIV-POSITIVE 1 1 1 1 1 3 3 AIDS 1 1 1 1 1 3 3 GASTROINTESTINAL CONDITIONS GALL-BLADDER DISEASE a) Symptomatic (i) treated by 2 2 2 2 2 1 2 cholecystectomy (ii) medically treated 3 2 2 2 2 1 2 (iii) current 3 2 2 2 2 1 2 b) Asymptomatic 2 2 2 2 2 1 2 CONDITION COC CIC POP DMPA NOR Cu-IUD LNG- NET-EN IUD I = Initiation, C = Continuation Medical eligibility criteria for contraceptive use - Page 19 ANAEMIAS THALASSAEMIA 1 1 1 1 1 2 1 In addition, the following changes were made which are not included in the summary table: 1. Barrier methods For spermicides, the condition “HIV-positive” has moved from a category 1 rating to a category 2; and the condition “AIDS” has also moved from a category 1 rating to a category 2. For diaphragms, the condition “Urinary tract infection” has moved from a category 1 rating to a category 2. 2. Surgical sterilization The condition “Young age” has moved from a category A rating to a category C (see section on Surgical sterilization procedures). Page 20 - Medical eligibility criteria for contraceptive use Table of contents Low-dose combined oral contraceptives Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Postpartum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Past ectopic pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 History of pelvic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Blood pressure measurement unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Cardiovascular disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Neurologic conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Other infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Schistosomiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Malaria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Endocrine conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Gastrointestinal conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Drug interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Commonly used drugs which affect liver enzymes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Other antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Low-dose combined oral contraceptives - Page 1 LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY NA Comments: Use of COCs is not required. There is no known harm to the woman, the course of her pregnancy, or the fetus if COCs are accidentally used during pregnancy. AGE a) Menarche to 1 Comments: Theoretical concerns about the use of COCs < 40 years among young adolescents have not been substantiated by scientific evidence. b) > 40 years 2 Comments: The risk of cardiovascular disease increases with age and may also increase with COC use. In the absence of other adverse clinical conditions, COCs can be used until menopause. PARITY a) Nulliparous 1 Comments: There is no need for restriction of COC use based on parity. b) Parous 1 BREASTFEEDING a) < 6 weeks 4 Comments: There is some theoretical concern that the postpartum neonate may be at risk due to exposure to steroid hormones during the first 6 weeks postpartum. There is also some theoretical concern regarding the association between COC use up to 3 weeks postpartum and risk of thrombosis in the mother. b) > 6 weeks to 3 Comments: In the first 6 months postpartum, use of COCs < 6 months during breastfeeding diminishes the quantity of breast milk, postpartum (primarily decreases the duration of lactation, and may thereby breastfeeding) adversely affect the growth of the infant. c) > 6 months 2 postpartum POSTPARTUM (in non-breastfeeding women) a) < 21 days 3 Comments: Blood coagulation and fibrinolysis are b) > 21 days 1 essentially normalized by three weeks postpartum. LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 2 - Low-dose combined oral contraceptives POST-ABORTION a) First trimester 1 Comments: COCs may be started immediately post- b) Second trimester 1 c) Immediate post- 1 septic abortion abortion. PAST ECTOPIC 1 Comments: The risk of future ectopic pregnancy is PREGNANCY increased among women who have had an ectopic pregnancy in the past. COCs provide protection against ectopic pregnancy. HISTORY OF PELVIC 1 Comments: Prior pelvic surgery has no effect on COC use. SURGERY SMOKING a) Age < 35 years 2 Comments: Risk of cardiovascular events increases with increasing age and increasing number of cigarettes smoked per day.b) Age > 35 years (i) <15 cigarettes/day 3 (ii) >15 cigarettes/day 4 OBESITY > 30 kg/m body 2 Comments: Obesity is a risk factor for venous2 mass index (BMI) thromboembolism. BLOOD PRESSURE NA Comments: It is desirable to have blood pressure MEASUREMENT measurements taken before initiation of COC use. However, UNAVAILABLE in some settings blood pressure measurements are unavailable. In many of these settings pregnancy morbidity and mortality risks are high, and COCs are one of the few methods widely available. In such settings, women should not be denied use of COCs simply because their blood pressure cannot be measured. CARDIOVASCULAR DISEASE MULTIPLE RISK 3/4 Comments: When a woman has multiple major risk FACTORS FOR factors, any of which alone would substantially increase the ARTERIAL risk of cardiovascular disease, use of COCs may increase CARDIOVASCULAR her risk to an unacceptable level. However, a simple DISEASE addition of categories for multiple risk factors is not (such as older age, intended; for example, a combination of two risk factors smoking, diabetes and assigned a category 2 may not necessarily warrant a hypertension) higher category. LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Low-dose combined oral contraceptives - Page 3 HYPERTENSION a) History of 3 Comments: Evaluation of cause and level of hypertension hypertension, is recommended, as soon as feasible. For all categories of where blood hypertension, classifications are based on the assumption pressure CANNOT that no other risk factors for cardiovascular disease exist. be evaluated When multiple risk factors do exist, risk of cardiovascular (including disease may increase substantially. hypertension during pregnancy) b) Adequately 3 Comments: Women adequately treated for hypertension controlled are at reduced risk of acute myocardial infarction and hypertension, stroke as compared with untreated women. Although there where blood are no data, COC users with adequately controlled and pressure CAN be monitored hypertension should be at reduced risk of acute evaluated myocardial infarction and stroke compared with untreated hypertensive COC users. c) Elevated blood pressure levels (properly taken measurements) (i) systolic 140-159 or 3 New evidence: Among women with hypertension, COC diastolic 90-99 users are at increased risk of stroke and myocardial infarction compared with non-users. The risk1,2,3,4,5,6,7,8,9 increases with incremental rises in blood pressure. Comments: A single reading of blood pressure level 140-159/90-99 is not sufficient to classify a woman as hypertensive. (ii) systolic >160 or 4 diastolic >100 d) Vascular disease 4 Comments: Among women with underlying vascular disease, the increased risk of arterial thrombosis associated with COC use should be avoided. HISTORY OF HIGH 2 New evidence: Evidence suggests that women with a BLOOD PRESSURE history of high blood pressure in pregnancy, who use DURING PREGNANCY COCs, may have an increased risk of myocardial infarction (where current blood and venous thromboembolism, compared with COC users pressure is measurable who did not have a history of high blood pressure during and normal) pregnancy.6,9 LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 4 - Low-dose combined oral contraceptives DEEP VENOUS THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE) a) History of DVT/PE 4 Comments: The increased risk of venous thromboembolism associated with COCs should have little impact on healthy women, but may have substantial impact on women with a history of thromboembolism. b) Current DVT/PE 4 c) Family history of 2 Comments: Some conditions which increase the risk of DVT/PE (first-degree DVT/PE are heritable. relatives) d) Major surgery (i) with prolonged 4 Comments: The degree of risk of DVT/PE associated with immobilization major surgery depends on the length of time that a woman is immobilized. There is no need to stop COCs prior to female surgical sterilization.(ii) without prolonged 2 immobilization e) Minor surgery 1 without immobilization SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins 1 Comments: Varicose veins are not risk factors for DVT/PE. b) Superficial 2 thrombophlebitis CURRENT AND 4 Comments: Among women with underlying vascular HISTORY OF disease, the increased risk associated with COC use ISCHAEMIC HEART should be avoided. DISEASE STROKE 4 Comments: Among women with underlying vascular (history of disease, the increased risk associated with COC use cerebrovascular should be avoided. accident) KNOWN 2/3 Comments: Routine screening is not appropriate because HYPERLIPIDAEMIAS of the rarity of the conditions and the high cost of screening. While some types of hyperlipidaemias are risk factors for vascular disease, the category should be assessed according to the type, its severity, and the presence of other cardiovascular risk factors. LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Low-dose combined oral contraceptives - Page 5 VALVULAR HEART DISEASE a) Uncomplicated 2 b) Complicated 4 Comments: Among women with valvular heart disease, (pulmonary COC use may further increase the risk of arterial hypertension, atrial thrombosis; women with complicated valvular heart disease fibrillation, history of are at greatest risk. subacute bacterial endocarditis) NEUROLOGIC CONDITIONS HEADACHES I C a) Non migrainous 1 2 Comments: Classification depends on accurate diagnosis (mild or severe) of those severe headaches that are migrainous and those that are not. Any new headaches or marked changes in headaches should be evaluated. Classification is for women without any other risk factors for stroke. Risk of stroke increases with age, hypertension and smoking. b) Migraine New evidence: Among women with migraines, women who also have focal neurologic symptoms have a higher risk of stroke than those without focal neurologic symptoms. In addition, among women with migraines,10,11 those who use COCs have a 2 to 4-fold increased risk of stroke compared with women who do not use COCs.1,2,11,12,13 (i) without focal neurologic symptoms Age < 35 2 3 Age > 35 3 4 (ii) with focal 4 4 neurologic symptoms (at any age) EPILEPSY 1 Comments: If a woman is taking anti-epileptic medications, refer to the section on drug interactions. Certain anti-epileptic drugs lower COC efficacy. REPRODUCTIVE TRACT INFECTIONS AND DISORDERS VAGINAL BLEEDING PATTERNS a) Irregular pattern 1 Comments: Changes in menstrual bleeding patterns are without heavy common among healthy women. bleeding b) Heavy or prolonged 1 bleeding (includes regular and irregular patterns) LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 6 - Low-dose combined oral contraceptives UNEXPLAINED Comments: If pregnancy (or an underlying pathological VAGINAL BLEEDING condition such as pelvic malignancy) is suspected, it must (suspicious for serious be evaluated. There are no conditions that cause vaginal condition) bleeding that will be worsened in the short term by use of COCs. Before evaluation 2 ENDOMETRIOSIS 1 Comments: COCs do not worsen, and may alleviate, the symptoms of endometriosis. BENIGN OVARIAN 1 TUMOURS (including cysts) SEVERE 1 Comments: COC use may alleviate dysmenorrhoea. DYSMENORRHOEA TROPHOBLAST DISEASE a) Benign gestational 1 trophoblastic disease b) Malignant 1 gestational trophoblastic disease CERVICAL 1 Comments: Cervical ectropion is not a risk factor for ECTROPION cervical cancer, and there is no need for restriction of COC use. CERVICAL 2 Comments: There is some concern that COCs enhance INTRAEPITHELIAL the progression of CIN to invasive disease, particularly with NEOPLASIA (CIN) long-term use. CERVICAL CANCER 2 Comments: There is some theoretical concern that COC (awaiting treatment) use may affect prognosis of the existing disease. While awaiting treatment, women may use COCs. In general, treatment of this condition renders a woman sterile. BREAST DISEASE a) Undiagnosed mass 2 Comments: The vast majority of breast masses in women of reproductive age are benign. Evaluation should be pursued as early as possible. b) Benign breast 1 Comments: Eligibility for COC use is not affected by disease benign breast disease or a family history of breast disease. LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Low-dose combined oral contraceptives - Page 7 c) Family history of 1 cancer BREAST DISEASE (cont’d) d) Cancer Comments: Breast cancer is a hormonally sensitive tumour, and the prognosis of women with current or recent breast cancer may worsen with COC use. (i) current 4 (ii) past and no evidence 3 of current disease for 5 years ENDOMETRIAL 1 Comments: COC use reduces the risk of developing CANCER endometrial cancer. While awaiting treatment, women may use COCs. In general, treatment of this condition renders a woman sterile. OVARIAN CANCER 1 Comments: COC use reduces the risk of developing ovarian cancer. While awaiting treatment, women may use COCs. In general, treatment of this condition renders a woman sterile. UTERINE FIBROIDS a) Without distortion of 1 Comments: COCs do not appear to cause growth of the uterine cavity uterine fibroids. b) With distortion of the 1 uterine cavity PELVIC INFLAMMATORY DISEASE (PID) a) Past PID (assuming Comments: COCs may reduce the risk of PID among no current risk women with STIs, but do not protect against HIV or lower factors for STIs) genital tract STIs. (i) with subsequent 1 pregnancy (ii) without subsequent 1 pregnancy b) PID - current or 1 within the last 3 months LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 8 - Low-dose combined oral contraceptives STIs a) Current or within 1 Comments: COCs may reduce the risk of PID among 3 months (including women with STIs, but do not protect against HIV or lower purulent cervicitis) genital tract STIs. b) Vaginitis without 1 purulent cervicitis c) Increased risk of 1 STIs (e.g., multiple partners or partner who has multiple partners) HIV/AIDS HIGH RISK OF HIV 1 Comments: COCs may reduce the risk of PID among women with STIs, but do not protect against HIV or lower genital tract STIs. There is theoretical concern, but no consistent evidence, that COC use may increase the risk of HIV infection. HIV-POSITIVE 1 AIDS 1 OTHER INFECTIONS SCHISTOSOMIASIS a) Uncomplicated 1 b) Fibrosis of liver 1 (if severe, see cirrhosis) TUBERCULOSIS a) Non-pelvic 1 Comments: Prognosis of tuberculosis is not affected by b) Known pelvic 1 tuberculosis medications, refer to the section on drug the use of COCs. However, if a woman is taking interactions. Certain tuberculosis drugs lower COC efficacy. MALARIA 1 LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Low-dose combined oral contraceptives - Page 9 ENDOCRINE CONDITIONS DIABETES a) History of gestational 1 disease b) Non-vascular Comments: Although carbohydrate tolerance may change disease with COC use, the major concerns are vascular disease due to diabetes and additional risk of arterial thrombosis due to COC use.(i) non-insulin dependent 2 (ii) insulin dependent 2 c) Nephropathy/ 3/4 Comments: The category should be assessed according retinopathy/ to the severity of the condition. neuropathy d) Other vascular 3/4 Comments: The category should be assessed according disease or diabetes to the severity of the condition. of > 20 years' duration THYROID a) Simple goitre 1 Comments: The condition is not relevant for eligibility for b) Hyperthyroid 1 restriction of COC use. c) Hypothyroid 1 this contraceptive method, and there is no need for GASTROINTESTINAL CONDITIONS GALL-BLADDER DISEASE a) Symptomatic Comments: COCs may cause a small increased risk of gall-bladder disease. There is also concern that COCs may worsen existing gall-bladder disease.(i) treated by 2 cholecystectomy (ii) medically treated 3 (iii) current 3 b) Asymptomatic 2 HISTORY OF CHOLESTASIS a) Pregnancy-related 2 Comments: History of pregnancy-related cholestasis may predict an increased risk of developing COC-associated cholestasis. b) Past COC-related 3 Comments: History of COC-related cholestasis predicts an LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 10 - Low-dose combined oral contraceptives VIRAL HEPATITIS a) Active 4 Comments: COCs are metabolized by the liver, and their b) Carrier 1 already compromised. use may adversely affect women whose liver function is CIRRHOSIS a) Mild 3 Comments: COCs are metabolized by the liver and their (compensated) use may adversely affect women whose liver function is compromised. b) Severe 4 (decompensated) LIVER TUMOURS a) Benign 4 Comments: COCs are metabolized by the liver and their (adenoma) use may adversely affect women whose liver function is compromised. In addition, COC use may enhance the growth of tumours.b) Malignant 4 (hepatoma) ANAEMIAS THALASSAEMIA 1 Comments: There is anecdotal evidence from countries where thalassaemia is prevalent that COC use does not worsen the condition. SICKLE CELL 2 Comments: COC use may affect coagulation, blood DISEASE viscosity, or incidence or severity of painful sickle cell crises. IRON DEFICIENCY 1 Comments: COC use may decrease menstrual blood loss. ANAEMIA DRUG INTERACTIONS COMMONLY USED DRUGS WHICH AFFECT LIVER ENZYMES a) Certain antibiotics 3 Comments: Although the interaction between commonly- (rifampicin and used liver enzyme inducers and COCs is not harmful to griseofulvin) women, it is likely to reduce the efficacy of COCs. Use of other contraceptives should be encouraged for women who are long-term users of any of these drugs. Whether increasing the hormone dose of COCs is of benefit remains unclear. b) Certain anticonvulsants (phenytoin, carbamezapine, barbiturates, primidone) 3 LOW-DOSE COMBINED ORAL CONTRACEPTIVES (COCs) < 35 µg of ethinylestradiol COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 12 - Low-dose combined oral contraceptives OTHER ANTIBIOTICS 1 (excluding rifampicin and griseofulvin) Low-dose combined oral contraceptives - Page 11 1. Lidegaard O. Oral contraceptives, pregnancy and the risk of cerebral thromboembolism: the influence of diabetes, hypertension, migraine and previous thrombotic disease. British Journal of Obstetrics and Gynaecology 1995;102:153-159. 2. Lidegaard O. Oral contraceptives, pregnancy and the risk of cerebral thromboembolism: the influence of diabetes, hypertension, migraine and previous thrombotic disease. (Letter). British Journal of Obstetrics and Gynaecology 1996;103:94. 3. Heinemann LAJ, Lewis MA, Spitzer WO, Thorogood M, Guggenmoos-Holzmann I, Bruppacher R, and the Transnational Research Group on Oral Contraceptives and the Health of Young Women. Thromboembolic stroke in young women. Contraception 1998;57:29-37. 4. Sidney S, Siscovick DS, Petitti DB, Schwartz SM, Quesenberry CP, Psaty BM, Raghunathan TE, Kelaghan J, Koepsell TD. Myocardial infarction and use of low-dose oral contraceptives. A pooled analysis of 2 US studies. Circulation 1998;98:1058-1063. 5. Dunn N, Thorogood M, Faragher B, de Caestecker L, MacDonald TM, McCollum C, Thomas S, Mann R. Oral contraceptives and myocardial infarction: results of the MICA case-control study. British Medical Journal 1999;318:1579-1584. 6. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case- control study. Lancet 1995;346:1575-1582. 7. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Ischaemic stroke and combined oral contraceptives: results of an international, multicentre, case-control study. Lancet 1996;348:498-505. 8. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Haemorrhagic stroke, overall stroke risk, and combined oral contraceptives: results of an international, multicentre, case-control study. Lancet 1996;348:505-510. 9. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Acute myocardial infarction and combined oral contraceptives: results of an international multicentre case- control study. Lancet 1997;349:1202-1209. 10. Carolei A, Marini C, De Matteis G, and the Italian National Research Council Study Group on Stroke in the Young. History of migraine and risk of cerebral ischaemia in young adults. Lancet 1996;347:1503-1506. 11. Tzourio C, Tehindrazanarivelo A, Iglesias S, Alperovitch A, Chedru F, d’Anglejan-Catillon J, Bousser MG. Case-control study of migraine and risk of ischemic stroke in young women. British Medical Journal 1995;310:830-833. 12. Chang CL, Donaghy M, Poulter N, and the World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Migraine and stroke in young women: case-control study. British Medical Journal 1999;318:13-18. 13. Schwartz SM, Petitti DB, Siscovick DS, Longstreth WT, Sidney S, Raghunathan TE, Quesenberry CP Jr, Kelaghan J. Stroke and use of low-dose oral contraceptives in young women. A pooled analysis of two US studies. Stroke 1998;29:2277-2284. References for Low-Dose Combined Oral Contraceptives Table of contents Combined injectable contraceptives Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Postpartum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Past ectopic pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 History of pelvic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Blood pressure measurement unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Cardiovascular disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Neurologic conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Other infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Schistosomiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Malaria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Endocrine conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Gastrointestinal conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Drug interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Commonly used drugs which affect liver enzymes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Other antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Combined injectable contraceptives - Page 1 COMBINED INJECTABLE CONTRACEPTIVES (CICs) Combined injectable contraceptives (CICs) However, CICs are a relatively new contraceptive provide for the release of a natural estrogen plus method, and there are few epidemiological data a progestogen and act through the inhibition of on their long-term effects. There is also the ovulation. Two CIC formulations are considered concern that, while the effect of the hormonal here: load associated with COC and POP use can be 1) Cyclofem = Medroxyprogesterone acetate this is not the case with injectables, for which the 25mg plus estradiol cypionate 5mg effect continues for some time after the last 2) Mesigyna = Norethisterone enantate 50mg plus estradiol valerate 5mg The Working Group exercised some caution in Because the estrogens in CICs may be more a position somewhere between the categories for physiologic and may be less potent compared COCs and POPs. However, for severe with the synthetic estrogens of COCs, the type pathologies (e.g., ischaemic heart disease), the and magnitude of estrogen-related side-effects classification of conditions was the same as for associated with CICs may be different from those COCs. The assigned categories should, experienced by COC users. In fact, short-term therefore, be considered a preliminary, best studies of CICs have shown little effect on blood judgement, which will be re-evaluated as new pressure, haemostasis and coagulation, lipid data become available. metabolism, and liver function in comparison with COCs. In addition, the parenteral administration of CICs eliminates the first-pass effect of the hormones on the liver. reduced immediately by discontinuing their use, injection. assigning categories for CICs and generally took Page 2 - Combined injectable contraceptives COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY NA Comments: Use of CICs is not required. There is no known harm to the woman, the course of her pregnancy, or the fetus if CICs are accidentally used during pregnancy. AGE a) Menarche to 1 Comments: Theoretical concerns about the use of CICs < 40 years among young adolescents have not been substantiated by scientific evidence. b) > 40 years 2 Comments: The risk of cardiovascular disease increases with age and may also increase with CIC use. PARITY a) Nulliparous 1 b) Parous 1 BREASTFEEDING a) < 6 weeks 4 Comments: There is some theoretical concern that the postpartum neonate may be at risk due to exposure to steroid hormones during the first 6 weeks postpartum. There is also some theoretical concern regarding the association between CIC use up to 3 weeks postpartum and risk of thrombosis in the mother. b) > 6 weeks to 3 Comments: In the first 6 months postpartum, use of CICs < 6 months during breastfeeding diminishes the quantity of breast milk, postpartum (primarily decreases the duration of lactation, and may thereby breastfeeding) adversely affect the growth of the infant. c) > 6 months 2 postpartum POSTPARTUM (in non-breastfeeding women) a) < 21 days 3 Comments: Blood coagulation and fibrinolysis are essentially normalized by 3 weeks postpartum. b) > 21 days 1 POST-ABORTION Comments: CICs may be started immediately post- abortion. a) First trimester 1 b) Second trimester 1 c) Post-septic abortion 1 COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Combined injectable contraceptives - Page 3 PAST ECTOPIC 1 Comments: CIC use may, like COC use, provide PREGNANCY protection against ectopic pregnancy. HISTORY OF PELVIC 1 SURGERY SMOKING a) Age < 35 years 2 Comments: Risk of cardiovascular events increases with increasing age and increasing number of cigarettes smoked per day.b) Age > 35 years (i) <15 cigarettes/day 2 (ii) >15 cigarettes/day 3 OBESITY > 30 kg/m body 2 Comments: Obesity is a risk factor for venous2 mass index (BMI) thromboembolism. BLOOD PRESSURE NA Comments: It is desirable to have blood pressure MEASUREMENT measurements taken before initiation of CIC use. However, UNAVAILABLE in some settings blood pressure measurements are unavailable. In many of these settings, pregnancy morbidity and mortality risks are high, and CICs may be one of the few methods available. In such settings, women should not be denied use of CICs simply because their blood pressure cannot be measured. CARDIOVASCULAR DISEASE MULTIPLE RISK 3/4 Comments: When a woman has multiple major risk FACTORS FOR factors, any of which alone would substantially increase ARTERIAL the risk of cardiovascular disease, use of CICs may CARDIOVASCULAR increase her risk to an unacceptable level. However, a DISEASE simple addition of categories for multiple risk factors is not (such as older age, intended; for example, a combination of two risk factors smoking, diabetes and assigned a category ‘2' may not necessarily warrant a hypertension) higher category. HYPERTENSION a) History of 3 Comments: Evaluation of cause and level of hypertension hypertension, where is recommended as soon as feasible. For all categories of blood pressure hypertension, classifications are based on the assumption CANNOT be that no other risk factors for cardiovascular disease exist. evaluated (including When multiple risk factors do exist, risk of cardiovascular hypertension in disease may increase substantially. pregnancy) COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 4 - Combined injectable contraceptives b) Adequately 3 Comments: Women adequately treated for hypertension controlled are at reduced risk of acute myocardial infarction and hypertension, stroke as compared with untreated women. Although there where blood pressure are no data, CIC users with adequately controlled and CAN be evaluated monitored hypertension should be at reduced risk of acute myocardial infarction and stroke compared with untreated hypertensive CIC users. COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Combined injectable contraceptives - Page 5 HYPERTENSION (cont’d) c) Elevated blood Comments: Among women with hypertension, COC users pressure levels are at increased risk of stroke and myocardial infarction (properly taken compared with non-users. The risk increases with measurements) incremental rises in blood pressure. The extent to which risk with CICs is similar to COCs remains unclear. Comments: A single reading of blood pressure level 140-159/90-99 is not sufficient to classify a woman as hypertensive. (i) systolic 140-159 or 3 diastolic 90-99 (ii) systolic >160 or 4 diastolic >100 d) Vascular disease 4 Comments: Among women with underlying vascular disease, the increased risk of arterial thrombosis associated with COC use should be avoided. The extent to which risk with CICs is similar to COCs remains unclear. HISTORY OF HIGH 2 Comments: Evidence suggests that women with a history BLOOD PRESSURE of high blood pressure in pregnancy, who use COCs, may DURING PREGNANCY have an increased risk of myocardial infarction and venous (where current blood thromboembolism compared with COC users with no pressure is measurable history of high blood pressure during pregnancy. The extent and normal) to which risk with CICs is similar to COCs remains unclear. DEEP VENOUS THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE) a) History of DVT/PE 4 Comments: The increased risk of DVT/PE associated with COCs may also occur with CICs. b) Current DVT/PE 4 c) Family history of 2 DVT/PE (first-degree relatives) d) Major surgery (i) with prolonged 4 immobilization (ii) without prolonged 2 immobilization e) Minor surgery without 1 immobilization COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 6 - Combined injectable contraceptives SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins 1 Comments: Varicose veins are not risk factors for DVT/PE. b) Superficial 2 thrombophlebitis CURRENT AND 4 Comments: Among women with underlying vascular HISTORY OF disease or with a demonstrated predisposition to arterial ISCHAEMIC HEART thrombosis, the possible increased risk with COCs should DISEASE be avoided. The extent to which risk with CICs is similar to COCs remains unclear. STROKE 4 Comments: Among women with underlying vascular (history of disease or demonstrated predisposition to arterial cerebrovascular thrombosis, the possible increased risk of thrombosis with accident) COCs should be avoided. The extent to which risk with CICs is similar to COCs remains unclear. KNOWN 2/3 Comments: Routine screening is not appropriate because HYPERLIPIDAEMIAS of the rarity of the conditions and the high cost of screening. Some types of hyperlipidaemias are risk factors for vascular disease. The category should be assessed according to the type and its severity. VALVULAR HEART DISEASE a) Uncomplicated 2 b) Complicated 4 Comments: Among women with valvular heart disease, (pulmonary COC use may further increase the risk of arterial hypertension, risk of thrombosis; women with complicated valvular heart disease atrial fibrillation, are at greatest risk. The extent to which risk with CICs is history of subacute similar to COCs remains unclear. bacterial endocarditis) NEUROLOGIC CONDITIONS HEADACHES I C a) Non migrainous 1 2 Comments: Classification depends on accurate diagnosis (mild or severe) of those severe headaches that are migrainous and those that are not. Any new headaches or marked changes in headaches should be evaluated. Classification is for women without any other risk factors for stroke. Risk of stroke increases with age. COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Combined injectable contraceptives - Page 7 HEADACHES (cont’d) I C b) Migraine Comments: Among women with migraines, women who also have focal neurologic symptoms have a higher risk of stroke than those without focal neurologic symptoms. In addition, among women with migraines, those who use COCs have a 2 to 4 fold increased risk of stroke compared to women who do not use COCs. The extent to which risk with CICs is similar to COCs remains unclear. (i) without focal neurologic symptoms Age < 35 2 3 Age > 35 3 4 (ii) with focal neurologic 4 4 symptoms (at any age) EPILEPSY 1 Comments: The condition, as such, is not a concern. See section on drug interactions. REPRODUCTIVE TRACT INFECTIONS AND DISORDERS VAGINAL BLEEDING PATTERNS a) Irregular pattern 1 Comments: Changes in menstrual bleeding patterns are without heavy common among healthy women. CICs may decrease bleeding menstrual blood loss. Change in bleeding patterns with CICs may occur. b) Heavy or prolonged 1 bleeding (includes regular and irregular patterns) UNEXPLAINED Comments: If pregnancy or an underlying pathological VAGINAL BLEEDING condition (such as pelvic malignancy) is suspected, it must (suspicious for serious be evaluated. There are no conditions that cause vaginal condition) bleeding that will be worsened in the short term by use of CICs. Before evaluation 2 ENDOMETRIOSIS 1 BENIGN OVARIAN 1 TUMOURS (including cysts) SEVERE 1 Comments: CIC use may alleviate dysmenorrhoea. DYSMENORRHOEA COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 8 - Combined injectable contraceptives TROPHOBLAST DISEASE a) Benign gestational 1 trophoblastic disease b) Malignant gestational 1 trophoblastic disease CERVICAL 1 ECTROPION CERVICAL 2 Comments: There is some concern that combined INTRAEPITHELIAL hormonal methods enhance the progression of CIN to NEOPLASIA (CIN) invasive disease, particularly with long-term use. CERVICAL CANCER 2 Comments: There is some theoretical concern that (awaiting treatment) combined hormonal methods use may affect prognosis of the existing disease. While awaiting treatment, women may use CICs. In general, treatment of this condition renders a woman sterile. BREAST DISEASE a) Undiagnosed mass 2 Comments: The vast majority of breast masses in women of reproductive age are benign. b) Benign breast 1 disease c) Family history of 1 cancer d) Cancer (i) current 4 Comments: Breast cancer is a hormonally sensitive tumour, and the prognosis of women with current or recent breast cancer may worsen with CIC use. (ii) past and no evidence 3 of current disease for 5 years ENDOMETRIAL 1 Comments: It is not known whether CIC use reduces the CANCER risk of developing endometrial cancer, as is the case with COCs. While awaiting treatment, women may use CICs. In general, treatment of this condition renders a woman sterile. COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Combined injectable contraceptives - Page 9 OVARIAN CANCER 1 Comments: It is not known whether CIC use reduces the risk of developing ovarian cancer, as is the case with COCs. While awaiting treatment, women may use CICs. In general, treatment of this condition renders a woman sterile. UTERINE FIBROIDS a) Without distortion of 1 Comments: COCs do not appear to cause growth of the uterine cavity uterine fibroids and CICs are not expected to. b) With distortion of the 1 uterine cavity PELVIC INFLAMMATORY DISEASE (PID) a) Past PID (assuming Comments: CICs do not protect against STIs/HIV. no current risk factors of STIs) (i) with subsequent 1 pregnancy (ii) without subsequent 1 pregnancy b) PID - current or 1 within the last 3 months STIs a) Current or within the Comments: CICs do not protect against STIs/HIV. last 3 months (including purulent 1 cervicitis) b) Vaginitis without 1 purulent cervicitis c) Increased risk of 1 STIs (e.g., multiple partners, or partner who has multiple partners) HIV/AIDS HIGH RISK OF HIV 1 Comments: CICs do not protect against STIs/HIV. HIV-POSITIVE 1 COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 10 - Combined injectable contraceptives AIDS 1 OTHER INFECTIONS SCHISTOSOMIASIS a) Uncomplicated 1 b) Fibrosis of liver 1 (if severe, see cirrhosis) TUBERCULOSIS a) Non-pelvic 1 Comments: Prognosis of tuberculosis is not affected by b) Known pelvic 1 use of CICs (see Drug Interactions). MALARIA 1 ENDOCRINE CONDITIONS DIABETES a) History of gestational 1 disease b) Non-vascular disease (i) non-insulin dependent 2 Comments: Although carbohydrate tolerance may change with CIC use, the major concerns are vascular disease and additional risk of arterial thrombosis.(ii) insulin dependent 2 c) Nephropathy/ 3/4 Comments: The category should be assessed according retinopathy/ to the severity of the condition. neuropathy d) Other vascular 3/4 disease or diabetes of >20 years' duration THYROID a) Simple goitre 1 Comments: The condition is not relevant for eligibility for this contraceptive method, and there is no need for restriction of CIC use.b) Hyperthyroid 1 c) Hypothyroid 1 COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Combined injectable contraceptives - Page 11 GASTROINTESTINAL CONDITIONS GALL-BLADDER DISEASE a) Symptomatic (i) treated by 2 Comments: COCs may cause a small increased risk of cholecystectomy gall-bladder disease. There is also concern that COCs may worsen existing gall-bladder disease. However, unlike COCs, CICs have been shown to have a minimal effect on liver function in healthy women, and have no first-pass effect on the liver. (ii) medically treated 2 (iii) current 2 b) Asymptomatic 2 HISTORY OF CHOLESTASIS a) Pregnancy-related 2 Comments: Unlike COCs, CICs have been shown to have b) Past COC or 2 have no first-pass effect on the liver. However, past COC- CIC related related cholestasis may predict future estrogen-related a minimal effect on liver function in healthy women and cholestasis in a small group of susceptible women. VIRAL HEPATITIS a) Active 3/4 Comments: Unlike COCs, CICs have been shown to have a minimal effect on liver function in healthy women and have no first-pass effect on the liver. However, because CICs are metabolized by the liver, they could, in theory, lead to adverse effects on women whose liver function is already compromised. In women with symptomatic viral hepatitis, CICs should be withheld until liver function returns to normal or 3 months after the woman becomes asymptomatic. b) Carrier 1 CIRRHOSIS a) Mild 2 Comments: Unlike COCs, CICs have been shown to have (compensated) a minimal effect on liver function in healthy women and have no first-pass effect on the liver. However, because CICs are metabolized by the liver, they could, in theory, lead to adverse effects on women whose liver function is already compromised. b) Severe 3 (decompensated) LIVER TUMOURS COMBINED INJECTABLE CONTRACEPTIVES (CICs) CICs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation C=Continuation Page 12 - Combined injectable contraceptives a) Benign 3 Comments: Unlike COCs, CICs have been shown to have (adenoma) a minimal effect on liver function in healthy women and have no first-pass effect on the liver. However, because CICs are metabolized by the liver, they could, in theory, lead to adverse effects on women whose liver function is already compromised. b) Malignant 3/4 (hepatoma) ANAEMIAS THALASSAEMIA 1 SICKLE CELL 2 DISEASE IRON DEFICIENCY 1 Comments: CIC use may decrease menstrual blood loss. ANAEMIA DRUG INTERACTIONS COMMONLY USED DRUGS WHICH AFFECT LIVER ENZYMES a) Certain antibiotics 3 Comments: Commonly used liver enzyme inducers are (rifampicin and likely to reduce the efficacy of CICs. Use of other griseofulvin) contraceptives should be encouraged for women who are on long-term use of any of these drugs. b) Anticonvulsants 3 (phenytoin, carbamazepine, barbiturates, primidone) OTHER ANTIBIOTICS 1 (excluding rifampicin and griseofulvin) Table of contents Progestogen-only contraceptives Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Postpartum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Past ectopic pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 History of pelvic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Blood pressure measurement unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Cardiovascular disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Neurologic conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Other infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Schistosomiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Malaria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Endocrine conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Gastrointestinal conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Drug interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Commonly used drugs which affect liver enzymes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Other antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Progestogen-only contraceptives - Page 1 PROGESTOGEN-ONLY CONTRACEPTIVES P = Progestogen-only pill (POP) D/NE = Depot medroxyprogesterone acetate (DMPA)/norethisterone enantate (NET-EN) NOR = Norplant and Norplant II implants PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY NA Comments: Use of POCs is not required. There is no known harm to the woman, the course of her pregnancy, or the fetus if POCs are accidentally used during pregnancy. However, the relationship between DMPA use during pregnancy and its effects on the fetus remains unclear. AGE a) Menarche to 1 2 1 Comments: For women under 18 years of < 18 years age, there are theoretical concerns regarding hypo-estrogenic effect particularly due to DMPA use. New evidence: Three studies of Norplant use, one in adolescents and two in adult women, showed no decrease in bone density with long-term use compared with non- users. 1,2,3 b) 18 to 45 years 1 1 1 c) > 45 years 1 2 1 Comments: For women greater than age 45, there are theoretical concerns regarding hypo-estrogenic effect particularly due to DMPA use, and whether these women will regain lost bone mass after discontinuation of DMPA. PARITY a) Nulliparous 1 1 1 b) Parous 1 1 1 PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 2 - Progestogen-only contraceptives BREASTFEEDING a) < 6 weeks 3 3 3 Comments: There is concern that the postpartum neonate may be at risk of exposure to steroid hormones during the first 6 weeks postpartum. However, in many of these settings pregnancy morbidity and mortality risks are high, and access to services is limited. POCs may be one of the few types of methods widely available and accessible to breastfeeding women immediately postpartum. b) > 6 weeks to 1 1 1 Comments: No clinically measurable effects < 6 months on the health or growth of breast-fed babies postpartum (primarily of women using POCs beginning at 6 weeks breastfeeding) postpartum have been identified. c) > 6 months 1 1 1 postpartum POSTPARTUM (in non-breastfeeding women) a) < 21 days 1 1 1 Comments: POCs may be safely used by non-breastfeeding women immediately postpartum.b) > 21 days 1 1 1 POST-ABORTION a) First trimester 1 1 1 Comments: POCs may be safely used b) Second trimester 1 1 1 c) Immediate post- 1 1 1 septic abortion immediately post-abortion. PAST ECTOPIC 2 1 1 Comments: POPs have a higher absolute PREGNANCY rate of ectopic pregnancy compared with other POCs, but still less than using no method. HISTORY OF PELVIC 1 1 1 SURGERY PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Progestogen-only contraceptives - Page 3 SMOKING a) Age < 35 years 1 1 1 b) Age > 35 years (i) <15 cigarettes/day 1 1 1 (ii) >15 cigarettes/day 1 1 1 OBESITY 1 2 2 Comments: There may be some concern > 30 kg/m body mass regarding weight gain with some POCs,2 index (BMI) particularly for long-acting methods. BLOOD PRESSURE NA NA NA Comments: It is desirable to have blood MEASUREMENT pressure measurements taken before UNAVAILABLE initiation of POC use. However, in some settings blood pressure measurements are unavailable. In many of these settings, pregnancy morbidity and mortality risks are high, and POCs are one of the few types of methods widely available. In such settings, women should not be denied use of POCs simply because their blood pressure cannot be measured. CARDIOVASCULAR DISEASE MULTIPLE RISK 2 3 2 Comments: When multiple major risk factors FACTORS FOR exist, risk of cardiovascular disease may ARTERIAL increase substantially. Some POCs may CARDIOVASCULAR increase the risk of thrombosis, although this DISEASE increase is substantially less than with (such as older age, COCs. The effects of DMPA and NET-EN smoking, diabetes and may persist for some time after hypertension) discontinuation. HYPERTENSION a) History of 2 2 2 Comments: It is desirable to have blood hypertension where pressure measurements taken before blood pressure initiation of POC use. However, in some CANNOT be settings blood pressure measurements are evaluated (including unavailable. In many of these settings hypertension during pregnancy morbidity and mortality risks are pregnancy) high, and POCs are one of the few types of methods widely available. In such settings, women should not be denied use of POCs simply because their blood pressure cannot be measured. PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 4 - Progestogen-only contraceptives HYPERTENSION (cont’d) b) Adequately 1 2 1 controlled hypertension where blood pressure CAN be evaluated c) Elevated blood New evidence: Limited evidence pressure levels suggests that among women with (properly taken hypertension, those who use POPs or measurements) progestogen-only injectables may have an increased risk of cardiovascular events compared with women who do not use these methods.4 (i) systolic140-159 or 1 2 1 diastolic 90-99 (ii) systolic > 160 or 2 3 2 diastolic > 100 d) Vascular disease 2 3 2 Comments: There is concern about DMPA and NET-EN with regard to the potential hypo-estrogenic effect and decreasing HDL levels. However, there is little concern about these effects with regard to POPs or Norplant. The effects of DMPA and NET-EN may persist for some time after discontinuation. Comments: Theoretically, POCs may increase the risk of thrombosis although this increase is substantially less than with COCs. HISTORY OF HIGH 1 1 1 BLOOD PRESSURE DURING PREGNANCY (where current blood pressure is measurable and normal) DEEP VENOUS THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE) a) History of DVT/PE 2 2 2 Comments: Theoretically, POCs may increase the risk of thrombosis, although this increase is substantially less than with COCs. b) Current DVT/PE 3 3 3 PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Progestogen-only contraceptives - Page 5 c) Family history of 1 1 1 DVT/PE (first-degree relatives) PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 6 - Progestogen-only contraceptives DVT/PE (Cont’d) d) Major surgery (i) with prolonged 2 2 2 immobilization (ii) without prolonged 1 1 1 immobilization e) Minor surgery 1 1 1 without immobilization SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins 1 1 1 b) Superficial 1 1 1 thrombophlebitis CURRENT AND I C I C HISTORY OF ISCHAEMIC HEART DISEASE 2 3 3 2 3 Comments: There is concern regarding the hypo-estrogenic effect and reduced HDL levels, particularly among users of DMPA. The effects of DMPA and NET-EN may persist for some time after discontinuation. STROKE I C I C (history of cerebrovascular accident) 2 3 3 2 3 Comments: There is concern regarding reduced HDL levels among POC users. Some POCs may increase the risk of arterial thrombosis, although this increase is substantially less than with COCs. The effects of DMPA and NET-EN may persist for some time after discontinuation. KNOWN 2 2 2 Comments: Routine screening is not HYPERLIPIDAEMIAS appropriate because of the rarity of the conditions and the high cost of screening. Some types of hyperlipidaemias are risk factors for vascular disease. PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Progestogen-only contraceptives - Page 7 VALVULAR HEART DISEASE a) Uncomplicated 1 1 1 b) Complicated 1 1 1 (pulmonary hypertension, risk of atrial fibrillation, history of subacute bacterial endocarditis) NEUROLOGIC CONDITIONS HEADACHES I C I C I C a) Non migrainous 1 1 1 1 1 1 Comments: Classification depends on (mild or severe) accurate diagnosis of those severe headaches that are migrainous and those that are not. Any new headaches or marked changes in headaches should be evaluated. Classification is for women without any other risk factors for stroke. Risk of stroke increases with age. b) Migraine (i) without focal Comments: There is concern that severe neurologic symptoms headaches may increase in frequency with use of NET-EN, DMPA and Norplant: methods which cannot be discontinued immediately or whose effects persist for some time after discontinuation. In the case of headaches with focal neurologic symptoms, it may be prudent to attempt to improve the headache by discontinuing the progestogen. Age < 35 1 2 2 2 2 2 Age > 35 1 2 2 2 2 2 (ii) with focal neurologic 2 3 2 3 2 3 symptoms (at any age) EPILEPSY 1 1 1 Comments: If a woman is taking anti- epileptic medications, refer to the section on drug interactions. Certain anti-epileptic drugs lower POC efficacy. REPRODUCTIVE TRACT INFECTIONS AND DISORDERS VAGINAL BLEEDING PATTERNS PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 8 - Progestogen-only contraceptives a) Irregular pattern 2 2 2 Comments: Irregular menstrual bleeding without heavy patterns are common among healthy women, bleeding in particular among adolescents. VAGINAL BLEEDING PATTERNS (Cont’d) b) Heavy or prolonged 2 2 2 Comments: POC use may induce an bleeding (includes irregular bleeding pattern. Also, unusually regular and irregular heavy bleeding should raise the suspicion of patterns) serious underlying condition. Comments: Norplant use may induce irregular bleeding patterns, especially during the first 3-6 months, but these patterns may persist longer. The amount of blood loss is always reduced, which may be a desirable effect in many women. UNEXPLAINED Comments: If pregnancy or an underlying VAGINAL BLEEDING pathological condition (such as pelvic (suspicious for serious malignancy) is suspected, it must be underlying condition) evaluated and the category adjusted after evaluation. POCs may cause irregular bleeding patterns which may mask symptoms of underlying pathology. The effects of DMPA and NET-EN may persist for some time after discontinuation. Before evaluation 2 3 3 ENDOMETRIOSIS 1 1 1 BENIGN OVARIAN 1 1 1 TUMOURS (including cysts) SEVERE 1 1 1 DYSMENORRHOEA TROPHOBLAST DISEASE a) Benign gestational 1 1 1 trophoblastic disease b) Malignant 1 1 1 gestational trophoblastic disease CERVICAL 1 1 1 ECTROPION PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Progestogen-only contraceptives - Page 9 CERVICAL 1 2 2 Comments: There is some concern that long INTRAEPITHELIAL duration of POC use may enhance NEOPLASIA (CIN) progression of CIN. CERVICAL CANCER 1 2 2 Comments: There is some theoretical (awaiting treatment) concern that POC use may affect prognosis of the existing disease. This concern would be less for short duration of use. While awaiting treatment, women may use POCs. In general, treatment of this condition renders a woman sterile. BREAST DISEASE a) Undiagnosed mass 2 2 2 Comments: The vast majority of breast masses in women of reproductive age are benign. Evaluation should be pursued as early as possible. b) Benign breast 1 1 1 disease c) Family history of 1 1 1 cancer d) Cancer (i) current 4 4 4 Comments: Breast cancer is a hormonally sensitive tumour, and the prognosis of women with current or recent breast cancer may worsen with POC use. (ii) past and no evidence 3 3 3 of current disease for 5 years ENDOMETRIAL 1 1 1 Comments: While awaiting treatment, CANCER women may use POCs. In general, the treatment of this condition renders a woman sterile. OVARIAN CANCER 1 1 1 Comments: While awaiting treatment, women may use POCs. In general, the treatment of this condition renders a woman sterile. UTERINE FIBROIDS a) Without distortion of 1 1 1 Comments: POCs do not appear to cause the uterine cavity growth of uterine fibroids. b) With distortion of the 1 1 1 uterine cavity PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 10 - Progestogen-only contraceptives PELVIC INFLAMMATORY DISEASE (PID) a) Past PID (assuming Comments: POCs do not protect against no current risk HIV or STIs. factors of STIs) (i) with subsequent 1 1 1 pregnancy (ii) without subsequent 1 1 1 pregnancy b) PID - current or 1 1 1 within the last 3 months STIs a) current or within 3 1 1 1 Comments: POCs do not protect against months (including HIV or STIs. purulent cervicitis) b) Vaginitis without 1 1 1 purulent cervicitis c) Increased risk of 1 1 1 STIs (e.g., multiple partners or partner who has multiple partners) HIV/AIDS HIGH RISK OF HIV 1 1 1 Comments: POCs do not protect against HIV or STIs. Comments: While there are theoretical concerns based on animal models, data regarding the risks of HIV transmission in humans are inconsistent and data regarding disease progression are limited. HIV-POSITIVE 1 1 1 AIDS 1 1 1 OTHER INFECTIONS PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Progestogen-only contraceptives - Page 11 SCHISTOSOMIASIS a) Uncomplicated 1 1 1 b) Fibrosis of liver 1 1 1 (if severe, see cirrhosis) TUBERCULOSIS a) Non-pelvic 1 1 1 b) Known pelvic 1 1 1 MALARIA 1 1 1 ENDOCRINE CONDITIONS DIABETES a) History of gestational 1 1 1 disease b) Non-vascular disease (i) non-insulin dependent 2 2 2 Comments: POCs may slightly influence carbohydrate metabolism. (ii) insulin dependent 2 2 2 c) Nephropathy/ 2 3 2 Comments: There is concern about the retinopathy/ possible negative effect of DMPA and neuropathy NET-EN on lipid metabolism, possibly affecting the progression of nephropathy, retinopathy or other vascular disease. d) Other vascular 2 3 2 Comments: There is concern regarding the disease or diabetes potential hypo-estrogenic effect and of >20 years' decreasing HDL levels. Theoretically, POCs duration may increase the risk of thrombosis although this increase is substantially less than with COCs. The effects of DMPA and NET-EN may persist for some time after discontinuation. THYROID a) Simple goitre 1 1 1 b) Hyperthyroid 1 1 1 c) Hypothyroid 1 1 1 PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 12 - Progestogen-only contraceptives GASTROINTESTINAL CONDITIONS GALL-BLADDER DISEASE a) Symptomatic New evidence: Some POCs may cause a small increase in risk of gall-bladder disease. There is also concern that POCs may worsen existing gall-bladder disease.5 (i) treated by 2 2 2 cholecystectomy (ii) medically treated 2 2 2 (iii) current 2 2 2 b) Asymptomatic 2 2 2 HISTORY OF CHOLESTASIS a) Pregnancy-related 1 1 1 b) Past COC-related 2 2 2 Comments: Theoretically, a history of COC- related cholestasis may predict subsequent cholestasis with POC use. However, this has not been documented. VIRAL HEPATITIS a) Active 3 3 3 Comments: There is concern about the b) Carrier 1 1 1 hormonal load associated with POC use in active liver disease, but it is less than for COCs. Comments: Although progestogens are metabolized by the liver, they appear to have little effect on liver function. CIRRHOSIS a) Mild 2 2 2 Comments: There is concern about (compensated) hormonal load associated with POC use in b) Severe COCs. (decompensated) 3 3 3 active liver disease, but it is less than for LIVER TUMOURS a) Benign 3 3 3 Comments: POCs are metabolized by the (adenoma) liver and their use may adversely affect women whose liver function is compromised. In addition, POC use may enhance the growth of tumours. This concern is similar to, but less than, that with COCs. PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Progestogen-only contraceptives - Page 13 b) Malignant 3 3 3 (hepatoma) PROGESTOGEN-ONLY CONTRACEPTIVES (POCs) POCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS I=Initiation, C=Continuation P D/NE NOR Page 14 - Progestogen-only contraceptives ANAEMIAS THALASSAEMIA 1 1 1 SICKLE CELL 1 1 1 Comments: There is no need for restriction DISEASE of POC use; in fact, DMPA may have a beneficial effect on sickle cell crises. IRON DEFICIENCY 1 1 1 Comments: Changes in the menstrual ANAEMIA pattern associated with POC use have little effect on haemoglobin levels. DRUG INTERACTIONS COMMONLY USED DRUGS WHICH AFFECT LIVER ENZYMES a) Antibiotics 3 2 3 Comments: Commonly used liver enzyme (rifampicin and inducers are likely to reduce the efficacy of griseofulvin) POPs and NOR. Use of other contraceptives should be encouraged for women who are using any of these drugs long-term. Whether increasing the hormone dose of POPs alleviates this concern remains unclear. b) Anticonvulsants 3 2 3 (phenytoin, carbamazepine, barbiturates, primidone) OTHER ANTIBIOTICS 1 1 1 (excluding rifampicin and griseofulvin) Progestogen-only contraceptives - Page 15 1. Cromer BA, Smith RD, Blair JM, Dwyer J, Brown RT. A prospective study of adolescents who choose among levonorgestrel implant (Norplant), medroxyprogesterone acetate (Depo-Provera), or the combined oral contraceptive pill as contraception. Pediatrics 1994;94:687-694. 2. Naessen T, Olsson S-E, Gudmundson J. Differential effects on bone density of progestogen-only methods for contraception in premenopausal women. Contraception 1995,52:35-39. 3. Petitti D, Piaggio G, Mehta S, Cravioto M, Meirik O for the WHO Study of Hormonal Contraception and Bone Health. Hormonal contraception and bone density: a cross-sectional study in an international population. Obstetrics and Gynecology 2000,5:736-744. 4. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Contraception 1998;57:315-324. 5. Meirik O, Farley TMM, Sivin I, for the International Collaborative Post-Marketing Surveillance of Norplant. Obstetrics & Gynecology (submitted). Detailed papers to appear in Contraception. References for Progestogen-Only Contraception Emergency contraceptive pills - Page 1 EMERGENCY CONTRACEPTIVE PILLS (ECPs) For COCs: Use of estrogen-levonorgestrel/ For levonorgestrel pills: Use of levonorgestrel- norgestrel-containing oral contraceptives (which containing oral contraceptives (which total at total at least 100 µg ethinylestradiol per dose) least 750 µg levonorgestrel per dose) given as given as two doses, 12 hours apart. Pills should two doses, 12 hours apart. Pills should be be started within 72 hours of unprotected started within 72 hours of unprotected intercourse intercourse at any time* in the menstrual cycle to at any time* in the menstrual cycle to prevent prevent pregnancy. The contraceptive efficacy pregnancy. The contraceptive efficacy appears appears to decline with time. The earlier after to decline with time. The earlier after coitus the coitus the treatment is taken, the more effective treatment is taken, the more effective it seems to it seems to be. be, although the rate of decline in effectiveness cannot be precisely evaluated with available data. * Because ECPs are relatively benign and because of the difficulties in accurately calculating a woman's risk of pregnancy, ECPs are appropriate for use at any time during the menstrual cycle when a woman makes an informed choice to use them. Page 2 - Emergency contraceptive pills EMERGENCY CONTRACEPTION PILLS (ECPs) (including combined oral contraceptive pills and levonorgestrel contraceptive pills) ECPs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS PREGNANCY NA Comments: Although this method is not indicated for a woman with a known or suspected pregnancy, there is no known harm to the woman, the course of her pregnancy, or the fetus if ECPs are accidentally used. BREASTFEEDING 1 HISTORY OF ECTOPIC 1 PREGNANCY HISTORY OF SEVERE 2 Comments: The duration of use of ECPs is less than CARDIOVASCULAR that of regular use of COCs or POPs and thus would be COMPLICATIONS expected to have less clinical impact. (ischaemic heart disease, cerebrovascular attack, or other thromboembolic conditions) ANGINA PECTORIS 2 Comments: The duration of use of ECPs is less than that of regular use of COCs or POPs and thus would be expected to have less clinical impact. MIGRAINE 2 Comments: The duration of use of ECPs is less than that of regular use of COCs or POPs and thus would be expected to have less clinical impact. SEVERE LIVER DISEASE 2 Comments: The duration of use of ECPs is less than (including jaundice) that of regular use of COCs or POPs and thus would be expected to have less clinical impact. REPEATED ECP USE 1 Comments: Recurrent ECP use is an indication that the woman requires further counselling on other contraceptive options. Frequently repeated ECP use may be harmful for women with conditions classified as 2, 3 or 4 for COC, CIC or POC use. RAPE 1 Comments: There are no restrictions for use of ECPs in cases of rape. Table of contents Intrauterine devices Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Postpartum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Past ectopic pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 History of pelvic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Anatomical abnormalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Blood pressure measurement unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Cardiovascular disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Neurologic conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Other infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Schistosomiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Malaria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Endocrine conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Gastrointestinal conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Drug interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Commonly used drugs which affect liver enzymes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Other antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Intrauterine devices - Page 1 INTRAUTERINE DEVICES (IUDs) Cu = Copper-bearing IUD LNG = Levonorgestrel-releasing IUD (20 µg/24hours) INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY 4 4 Comments: The IUD is not indicated during pregnancy and should not be used because of the risk of serious pelvic infection and septic spontaneous abortion. AGE a) Menarche to 2 2 Comments: There is concern both about the risk < 20 years of expulsion due to nulliparity and risk of STIs due to sexual behaviour in younger age-groups. b) > 20 years 1 1 PARITY a) Nulliparous 2 2 Comments: Nulliparity is related to an increased risk of expulsion. b) Parous 1 1 POSTPARTUM (breastfeeding or non- breastfeeding, including post-caesarean section) a) < 48 hours 2 3 Comments: There is an increased risk of expulsion for IUD insertion done within the first 48 hours postpartum. Comments: There is a lack of data on the local effects of LNG-IUDs on uterine involution. Concern that the neonate may be at risk due to exposure to steroid hormones during the first 6 weeks postpartum is the same as for other POCs. b) 48 hours to 3 3 Comments: There is an increased risk of < 4 weeks perforation for IUD insertions done after 48 hours and up to 4 weeks postpartum. c) > 4 weeks 1 1 Comments: If breastfeeding, LNG-IUD is a category 3 until 6 weeks postpartum. d) Puerperal sepsis 4 4 Comments: Insertion of an IUD may substantially worsen the condition. INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Page 2 - Intrauterine devices POST-ABORTION a) First trimester 1 1 Comments: IUDs can be inserted immediately after first trimester spontaneous or induced abortion. b) Second trimester 2 2 Comments: There is some concern about the risk of expulsion after second trimester abortion. There is a lack of data on the local effects of LNG-IUD on uterine involution. c) Immediate post- 4 4 Comments: Insertion of an IUD may substantially septic abortion worsen the condition. PAST ECTOPIC 1 1 Comments: The absolute risk of ectopic PREGNANCY pregnancy is extremely low due to the high effectiveness of IUDs. However, when a woman becomes pregnant during IUD use the relative likelihood of ectopic pregnancy is increased. HISTORY OF 1 1 PELVIC SURGERY (see postpartum, including caesarean section) SMOKING a) Age < 35 years 1 1 b) Age > 35 years (i) < 15 cigarettes/day 1 1 (ii) > 15 cigarettes/day 1 1 OBESITY 1 2 > 30 kg/m body mass2 index (BMI) ANATOMICAL ABNORMALITIES a) Distorted uterine 4 4 Comments: In the presence of an anatomic cavity (any congenital abnormality that distorts the uterine cavity, proper or acquired uterine IUD placement may not be possible. abnormality distorting the uterine cavity in a manner that is incompatible with IUD insertion) INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Intrauterine devices - Page 3 ANATOMICAL ABNORMALITIES (Cont’d) b) Other abnormalities 2 2 (including cervical stenosis or cervical lacerations) not distorting the uterine cavity or interfering with IUD insertion BLOOD PRESSURE NA NA Comments: While a blood pressure measurement MEASUREMENT may be appropriate for good preventative health UNAVAILABLE care, it is not materially related to safe and effective IUD use. Women should not be denied use of IUDs simply because their blood pressure cannot be measured. CARDIOVASCULAR DISEASE MULTIPLE RISK 1 2 Comments: When multiple major risk factors FACTORS FOR exist, risk of cardiovascular disease may increase ARTERIAL substantially. Some progestogens may increase CARDIOVASCULAR the risk of thrombosis, although this increase is DISEASE substantially less than for COCs. (such as older age, smoking, diabetes and hypertension) HYPERTENSION a) History of 1 2 Comments: There is theoretical concern about the hypertension where effect of LNG on lipids. There is no restriction for blood pressure copper IUDs. CANNOT be evaluated (Including hypertension in pregnancy) b) Adequately controlled 1 1 hypertension where blood pressure CAN be evaluated INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Page 4 - Intrauterine devices HYPERTENSION (cont’d) c) Elevated blood pressure levels (properly taken measurements) (i) systolic 140-159 or 1 1 diastolic 90-99 (ii) systolic > 160 or 1 2 Comments: LNG use may decrease HDL levels. diastolic > 100 d) Vascular disease 1 2 Comments: LNG use may decrease HDL levels. HISTORY OF HIGH 1 1 BLOOD PRESSURE DURING PREGNANCY (where current blood pressure is measurable and normal) DEEP VENOUS THROMBOEMBOLISM (DVT)/ PULMONARY EMBOLISM (PE) a) History of DVT/PE 1 2 Comments: Some progestogens may increase the risk of venous thrombosis, although this increase is substantially less than for COCs. b) Current DVT/PE 1 3 c) Family history of 1 1 DVT/PE (first-degree relatives) d) Major surgery (i) with prolonged 1 2 immobilization (ii) without prolonged 1 1 immobilization e) Minor surgery without 1 1 immobilization INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Intrauterine devices - Page 5 SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins 1 1 b) Superficial 1 1 thrombophlebitis CURRENT AND I C Comments: LNG may reduce HDL levels. HISTORY OF ISCHAEMIC HEART 1 DISEASE 2 3 STROKE Comments: LNG may reduce HDL levels. Some (history of 1 2 progestogens may increase the risk of thrombosis, cerebrovascular although this increase is substantially less than for accident) COCs. KNOWN Comments: Routine screening is not appropriate HYPERLIPIDAEMIAS 1 2 because of the rarity of the condition. Some types of hyperlipidaemias are a risk factor for vascular disease, which may be affected by LNG. VALVULAR HEART DISEASE a) Uncomplicated 1 1 b) Complicated 2 2 Comments: Prophylactic antibiotics to prevent (pulmonary endocarditis are advised for insertion. hypertension, risk of arterial fibrillation, history of subacute bacterial endocarditis, on anti-coagulant treatment) NEUROLOGIC CONDITIONS HEADACHES I C a) Non migrainous 1 1 1 (mild or severe) INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Page 6 - Intrauterine devices Headaches (Cont’d) b) Migraine (i) without focal neurologic Comments: There is concern that migraine symptoms headaches may increase with use of LNG-IUDs, although there is less concern than with POCs. Some POCs may increase the risk of thrombosis, although this increase is substantially less than with COCs. Any new headaches or marked changes in headaches should be evaluated. Age < 35 1 2 2 Age > 35 1 2 2 (ii) with focal neurologic 1 2 3 symptoms (at any age) EPILEPSY 1 1 REPRODUCTIVE TRACT INFECTIONS AND DISORDERS VAGINAL BLEEDING I C PATTERNS a) Irregular pattern 1 1 1 without heavy bleeding b) Heavy or prolonged 2 1 2 Comments: Unusually heavy bleeding should bleeding (includes cause suspicion of a serious underlying pathology. regular and irregular LNG-IUD use may actually be indicated to correct patterns) heavy bleeding. LNG-IUD use may induce irregular bleeding patterns, especially during the first 3–6 months, but these patterns may persist longer. The amount of blood loss is always reduced, which may be a desirable effect in many women. UNEXPLAINED Comments: If pregnancy or an underlying VAGINAL BLEEDING pathological condition (such as pelvic malignancy) (suspicion for serious is suspected, it must be evaluated and the condition) category adjusted after evaluation. There is no need to remove the IUD before evaluation. I C I C Before evaluation 4 2 4 2 ENDOMETRIOSIS 2 1 Comments: Copper IUD use may worsen dysmenorrhoea associated with the condition. BENIGN OVARIAN 1 1 TUMOURS (including cysts) SEVERE 2 1 Comments: Dysmenorrhoea may intensify with DYSMENORRHOEA copper IUD use. LNG-IUD use has been associated with reduction of dysmenorrhoea. INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Intrauterine devices - Page 7 TROPHOBLAST DISEASE a) Benign gestational 3 3 trophoblastic disease b) Malignant gestational 4 4 Comments: There is an increased risk of trophoblastic disease perforation since the treatment for the condition may require multiple uterine curettages. CERVICAL ECTROPION 1 1 CERVICAL 1 2 Comments: There is some theoretical concern INTRAEPITHELIAL that LNG-IUDs may enhance progression of CIN. NEOPLASIA (CIN) CERVICAL CANCER I C I C (awaiting treatment) 4 2 4 2 Comments: There is concern about the increased risk of infection and bleeding at insertion, which may make the condition worse. The IUD will likely need to be removed at the time of treatment but, until then, the woman is at risk of pregnancy. BREAST DISEASE a) Undiagnosed mass 1 2 b) Benign breast 1 1 disease c) Family history of 1 1 cancer d) Cancer: Comments: Breast cancer is a hormonally sensitive tumour. Concerns about progression of the disease may be less with LNG-IUDs than with COCs or higher-dose POCs. (i) current 1 4 (ii) past and no evidence 1 3 of current disease for 5 years ENDOMETRIAL I C I C CANCER 4 2 4 2 Comments: There is concern about the increased risk of infection, perforation and bleeding at insertion, that may make the condition worse. The IUD will likely need to be removed at the time of treatment but, until then, the woman is at risk of pregnancy. INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Page 8 - Intrauterine devices OVARIAN CANCER 3 2 3 2 Comments: The IUD will likely need to be removed at the time of treatment but, until then, the woman is at risk of pregnancy. UTERINE FIBROIDS a) Without distortion of 2 2 the uterine cavity b) With distortion of the 4 4 Comments: Pre-existing uterine fibroids that uterine cavity distort the uterine cavity may be incompatible with IUD insertion. PELVIC INFLAMMATORY DISEASE (PID) I C I C a) Past PID (assuming Comments: Barrier methods, especially condoms, no known current risk are always recommended for prevention of factors for STIs) STI/HIV/PID. (i) with subsequent 1 1 1 1 pregnancy (ii) without subsequent 2 2 2 2 Comments: In women at low risk of STIs, IUD pregnancy insertion poses little risk of PID. Current risk of STIs and desire for future pregnancy are relevant considerations. b) PID - current or within 4 3 4 3 Comments: There is serious concern that IUD use the last 3 months may worsen current PID. Recent PID is a strong risk factor for subsequent PID. Continued use of an IUD depends on the client's current risk factors for STIs and PID and her informed choice. STIs a) Current or within 4 4 Comments: There is serious concern that IUD use 3 months (including increases risk of PID in women with current STIs, purulent cervicitis) or who are at high risk of acquiring these infections. b) Vaginitis without 2 2 Comments: Where background incidence of STIs purulent cervicitis is high, vaginitis may indicate an STI. c) Increased risk of STIs 3 3 (e.g., multiple partners or partner who has multiple partners) INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Intrauterine devices - Page 9 HIV/AIDS HIGH RISK OF HIV 3 3 Comments: Women at high risk of HIV are also at high risk of other STIs. HIV-POSITIVE 3 3 Comments: There are theoretical concerns about increased risks of STIs and PID and increased risks of transmission to uninfected partners, particularly for immunosuppressed women. AIDS 3 3 OTHER INFECTIONS SCHISTOSOMIASIS a) Uncomplicated 1 1 b) Fibrosis of the liver 1 1 (if severe, see cirrhosis) TUBERCULOSIS I C I C a) Non-pelvic 1 1 1 1 b) Known pelvic 4 3 4 3 Comments: Insertion of an IUD may substantially worsen the condition. MALARIA 1 1 ENDOCRINE CONDITIONS DIABETES a) History of gestational 1 1 Comments: LNG use may slightly influence disease carbohydrate and lipid metabolism. Whether the amount of LNG released by the IUD causes such change is unclear.b) Non-vascular disease (i) non-insulin dependent 1 2 (ii) insulin dependent 1 2 c) Nephropathy/ 1 2 retinopathy/ neuropathy d) Other vascular 1 2 Comments: Some progestogens may increase disease or diabetes of the risk of thrombosis, although this increase is >20 years' duration substantially less than for COCs. INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Page 10 - Intrauterine devices THYROID a) Simple goitre 1 1 b) Hyperthyroid 1 1 c) Hypothyroid 1 1 GASTROINTESTINAL CONDITIONS GALL-BLADDER DISEASE a) Symptomatic New evidence: Some progestogens may cause a small increase in risk of gall-bladder disease. There is also concern that progestogens may worsen existing gall bladder disease.1 (i) treated by 1 2 cholecystectomy (ii) medically treated 1 2 (iii) current 1 2 b) Asymptomatic 1 2 HISTORY OF CHOLESTASIS a) Pregnancy-related 1 1 b) Past COC-related 1 2 Comments: There is concern that history of COC- related cholestasis may predict subsequent cholestasis with LNG use. Whether there is any risk with use of LNG-IUD is unclear. VIRAL HEPATITIS a) Active 1 3 Comments: There is concern about hormonal load associated with LNG-IUD use in active liver disease, but it is less than for COCs. b) Carrier 1 1 CIRRHOSIS a) Mild 1 2 Comments: There is concern about hormonal load (compensated) associated with LNG-IUD use in active liver disease, but it is less than for COCs. b) Severe (decompensated) 1 3 INTRAUTERINE DEVICES (IUDs) IUDs do not protect against STI/HIV. If there is risk of STI/HIV (including the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE / COMMENTS I=Initiation, C=Continuation Cu LNG Intrauterine devices - Page 11 LIVER TUMOURS a) Benign 1 3 Comments: Progestogens are metabolized by the (adenoma) liver, and their use may adversely affect women whose liver function is compromised. In addition, progestogen use may enhance the growth of tumours. This concern is similar to, but less than, that for COCs. b) Malignant (hepatoma) 1 3 ANAEMIAS THALASSAEMIA 2 1 Comments: There is concern about an increased risk of blood loss with copper IUDs. SICKLE CELL DISEASE 2 1 Comments: There is concern about an increased risk of blood loss with copper IUDs. IRON DEFICIENCY 2 1 Comments: There is concern about an increased ANAEMIA risk of blood loss with copper IUDs. DRUG INTERACTIONS COMMONLY USED DRUGS WHICH AFFECT LIVER ENZYMES a) Certain antibiotics 1 1 Comments: LNG-IUDs function chiefly by local (rifampicin and levonorgestrel effect; systemic progestogen griseofulvin) metabolism will not affect local efficacy. b) Anticonvulsants 1 1 (phenytoin, carbamazepine, barbiturates, primidone) OTHER ANTIBIOTICS 1 1 (excluding rifampicin and griseofulvin) Page 12 - Intrauterine devices 1. Meirik O, Farley TMM, Sivin I, for the International Collaborative Post-Marketing Surveillance of Norplant. Obstetrics & Gynecology (submitted). Detailed papers to appear in Contraception. References for Intrauterine Devices Copper IUD for emergency contraception - Page 1 COPPER IUD FOR EMERGENCY CONTRACEPTION This method is highly effective for preventing pregnancy. A copper-releasing IUD (Cu-IUD) can be used within 5 days of unprotected intercourse as an emergency contraceptive. However, when the time of ovulation can be estimated, the Cu-IUD can be inserted beyond 5 days after intercourse, if necessary, as long as the insertion does not occur more than 5 days after ovulation. The eligibility criteria for interval Cu-IUD insertion also apply for the insertion of Cu-IUDs as emergency contraception. COPPER IUD FOR EMERGENCY CONTRACEPTION IUDs for emergency contraception do not protect against STI/HIV. If there is risk of STI/HIV, the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS PREGNANCY 4 Comments: The IUD is not indicated during pregnancy and should not be used because of the risk of serious pelvic infection and septic spontaneous abortion. RAPE Comments: There is serious concern that IUD use increases risk of PID in women with current STIs, or who are at high risk of acquiring these infections.High risk of STI 3 Low risk of STI 1 Page 2 - Copper IUD for emergency contraception Table of contents Barrier methods Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Past ectopic pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 History of pelvic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Anatomical abnormalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Blood pressure measurement unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Cardiovascular disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Neurologic conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Other infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Schistosomiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Malaria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 History of toxic shock syndrome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Urinary tract infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Endocrine conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Gastrointestinal conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Drug interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Commonly used drugs which affect liver enzymes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Other antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Allergy to latex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Barrier methods - Page 1 BARRIER METHODS C = Male latex condoms, male polyurethane condoms, female condoms S = Spermicide (film, tablets, foam, gel) D = Diaphragm (with spermicide), cervical cap BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY NA NA NA Comments: None of these methods are relevant for contraception during known pregnancy. However, for women who continue to be at risk of STI/HIV during pregnancy, the correct and consistent use of condoms is recommended. AGE a) Menarche to < 40 years 1 1 1 b) > 40 years 1 1 1 PARITY a) Nulliparous 1 1 1 b) Parous 1 1 2 Comments: There is a higher risk of failure than in nulliparous women. BREASTFEEDING a) < 6 weeks postpartum 1 1 NA Comments: Diaphragm and cap are unsuitable until uterine involution is complete. b) > 6 weeks to < 6 months 1 1 1 postpartum (primarily breastfeeding) c) > 6 months postpartum 1 1 1 POST-ABORTION a) First trimester 1 1 1 b) Second trimester 1 1 1 Comments: Diaphragm and cap are unsuitable until 6 weeks after second trimester abortion. c) Post-septic abortion 1 1 1 PAST ECTOPIC 1 1 1 PREGNANCY HISTORY OF 1 1 1 PELVIC SURGERY BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Page 2 - Barrier methods SMOKING a) Age < 35 1 1 1 b) Age > 35 (i) <15 cigarettes/day 1 1 1 (ii) >15 cigarettes/day 1 1 1 OBESITY 1 1 1 Comments: Severe obesity may make diaphragm > 30 kg/m and cap placement difficult.2 body mass index (BMI) ANATOMICAL 1 1 NA Comments: The diaphragm cannot be used in certain ABNORMALITIES cases of prolapse. Cap use is not appropriate for a client with a markedly distorted cervical anatomy. BLOOD PRESSURE NA NA NA Comments: While a blood pressure measurement MEASUREMENT may be appropriate for good preventative health care, UNAVAILABLE it is not required for safe and effective barrier method use. Women should not be denied use of barrier methods simply because their blood pressure cannot be measured. CARDIOVASCULAR DISEASE MULTIPLE RISK FACTORS 1 1 1 FOR ARTERIAL CARDIOVASCULAR DISEASE (such as older age, smoking, diabetes and hypertension) HYPERTENSION a) History of hypertension 1 1 1 where blood pressure CANNOT be evaluated (including hypertension in pregnancy) b) Adequately controlled 1 1 1 hypertension, where blood pressure CAN be evaluated BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Barrier methods - Page 3 HYPERTENSION (cont’d) c) Elevated blood pressure levels (properly taken 1 1 1 measurements) (i) systolic 140-159 or 1 1 1 diastolic 90-99 (ii) systolic >160 or 1 1 1 diastolic >100 d) Vascular disease 1 1 1 HISTORY OF HIGH BLOOD 1 1 1 PRESSURE DURING PREGNANCY (where current blood pressure is measurable and normal) DEEP VENOUS THROMBOSIS (DVT) PULMONARY EMBOLISM (PE) a) History of DVT/PE 1 1 1 b) Current DVT/PE 1 1 1 c) Family history of DVT/PE 1 1 1 (first degree relatives) d) Major surgery (i) with prolonged immobilization 1 1 1 (ii) without prolonged 1 1 1 immobilization e) Minor surgery without 1 1 1 immobilization SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins 1 1 1 b) Superficial 1 1 1 thrombophlebitis BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Page 4 - Barrier methods CURRENT AND HISTORY OF 1 1 1 ISCHAEMIC HEART DISEASE STROKE 1 1 1 (history of cerebrovascular accident) KNOWN 1 1 1 Comments: Screening is NOT necessary for safe HYPERLIPIDAEMIAS use of contraceptive methods. VALVULAR HEART DISEASE a) Uncomplicated 1 1 1 b) Complicated 1 1 2 Comments: Risk of urinary tract infection with the (pulmonary hypertension, diaphragm may increase risk in a client with sub- atrial fibrillation, history of acute bacterial endocarditis. subacute bacterial endocarditis) NEUROLOGIC CONDITIONS HEADACHES a) Non migrainous 1 1 1 (mild or severe) b) Migraine (i) without focal neurologic symptoms Age < 35 1 1 1 Age > 35 1 1 1 (ii) With focal neurologic 1 1 1 symptoms (at any age) EPILEPSY 1 1 1 REPRODUCTIVE TRACT INFECTIONS AND DISORDERS UNEXPLAINED VAGINAL Comments: The condition should be evaluated and BLEEDING (suspicious for treated. serious condition) Before evaluation 1 1 1 BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Barrier methods - Page 5 ENDOMETRIOSIS 1 1 1 BENIGN OVARIAN 1 1 1 TUMOURS (including cysts) SEVERE DYSMENORRHOEA 1 1 1 TROPHOBLAST DISEASE a) Benign gestational 1 1 1 trophoblastic disease b) Malignant gestational 1 1 1 trophoblastic disease CERVICAL ECTROPION 1 1 1 CERVICAL 1 1 1 Comments: Repeated and high-dose use of INTRAEPITHELIAL nonoxynol-9 can cause vaginal and cervical irritation NEOPLASIA (CIN) or abrasions. Comments: The cap is not recommended. There is no restriction for diaphragm use. CERVICAL CANCER 1 2 1 Comments: Repeated and high-dose use of (awaiting treatment) nonoxynol-9 can cause vaginal and cervical irritation or abrasions. Comments: The cap is not recommended. There is no restriction for diaphragm use. BREAST DISEASE a) Undiagnosed mass 1 1 1 b) Benign breast disease 1 1 1 c) Family history of cancer 1 1 1 d) Cancer (i) current 1 1 1 (ii) past and no evidence of 1 1 1 current disease for 5 years ENDOMETRIAL CANCER 1 1 1 OVARIAN CANCER 1 1 1 BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Page 6 - Barrier methods UTERINE FIBROIDS a) Without distortion of the 1 1 1 uterine cavity b) With distortion of the 1 1 1 uterine cavity PELVIC INFLAMMATORY DISEASE (PID) a) Past PID (assuming no current risk factors of STIs) (i) with subsequent pregnancy 1 1 1 (ii) without subsequent 1 1 1 pregnancy b) PID current or within the 1 1 1 last 3 months STIs a) Current or within 3 months 1 1 1 (including purulent cervicitis) b) Vaginitis without purulent 1 1 1 cervicitis c) Increased risk of STIs 1 1 1 (e.g., multiple partners or partner who has multiple partners) HIV/AIDS HIGH RISK OF HIV 1 2 1 Comments: Repeated and high-dose use of the spermicide nonoxynol-9 can cause vaginal and cervical irritation or abrasions which may increase risk of HIV transmission. HIV-POSITIVE 1 2 1 AIDS 1 2 1 BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Barrier methods - Page 7 OTHER INFECTIONS SCHISTOSOMIASIS a) Uncomplicated 1 1 1 b) Fibrosis of liver 1 1 1 TUBERCULOSIS a) Non-pelvic 1 1 1 b) Known pelvic 1 1 1 MALARIA 1 1 1 HISTORY OF TOXIC SHOCK 1 1 3 Comments: Toxic shock syndrome has been SYNDROME reported in association with contraceptive sponge and diaphragm use. URINARY TRACT 1 1 2 Comments: There is a potential increase of urinary INFECTION tract infection with diaphragms and spermicides. ENDOCRINE CONDITIONS DIABETES a) History of gestational 1 1 1 disease b) Non-vascular disease (i) non-insulin dependent 1 1 1 (ii) insulin dependent 1 1 1 c) Nephropathy/retinopathy/ 1 1 1 neuropathy d) Other vascular disease or 1 1 1 diabetes of > 20 years' duration THYROID a) Simple goitre 1 1 1 b) Hyperthyroid 1 1 1 c) Hypothyroid 1 1 1 BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Page 8 - Barrier methods GASTROINTESTINAL CONDITIONS GALL-BLADDER DISEASE a) Symptomatic (i) treated by cholecystectomy 1 1 1 (ii) medically treated 1 1 1 (iii) current 1 1 1 b) Asymptomatic 1 1 1 HISTORY OF CHOLESTASIS a) Pregnancy-related 1 1 1 b) Past COC-related 1 1 1 VIRAL HEPATITIS a) Active 1 1 1 b) Carrier 1 1 1 CIRRHOSIS a) Mild (compensated) 1 1 1 b) Severe (decompensated) 1 1 1 LIVER TUMOURS a) Benign (adenoma) 1 1 1 b) Malignant (hepatoma) 1 1 1 ANAEMIAS THALASSAEMIA 1 1 1 SICKLE CELL DISEASE 1 1 1 IRON DEFICIENCY ANAEMIA 1 1 1 BARRIER postpartum), the correct and consistent use of condoms should be METHODS If there is risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of their relatively-higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS C S D Barrier methods - Page 9 DRUG INTERACTIONS COMMONLY USED DRUGS WHICH AFFECT LIVER ENZYMES a) Certain antibiotics 1 1 1 (rifampicin and griseofulvin) b) Anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone OTHER ANTIBIOTICS 1 1 1 (excluding rifampicin and griseofulvin) ALLERGY TO LATEX 3 1 3 Comments: This does not apply to plastic condoms/diaphragms. Page 10 - Barrier methods Table of contents Fertility awareness-based methods Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Life stage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Postpartum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Use of drugs which affect cycle regularity, hormones and/or fertility signs . . . . . . . . . . . . . . . . . 3 Diseases which elevate body temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Fertility awareness-based methods - Page 1 FERTILITY AWARENESS-BASED METHODS Fertility awareness-based (FAB) methods of family planning involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time. If barrier methods are used, refer to the section on barrier methods (BARR) There are no medical conditions which become worse because of use of FAB methods. In general, these methods can be provided without concern for health effects to people who choose them. However, there are a number of conditions that make their use more complex. The existence of these conditions suggests that (1) use of these methods should be delayed until the condition is corrected or resolved or (2) they will require special counselling, and a more highly trained provider is generally necessary to ensure correct use. Definitions SYM Symptoms-based methods FAB methods based on observation of fertility signs (e.g., cervical secretions, basal body temperature) such as the Cervical Mucus Method, the Symptothermal Method, and the Two Day Method. CAL Calendar-based methods FAB methods based on calendar calculations such as the Calendar Rhythm Method and the Standard Days Method. A Accept There is no medical reason to deny the particular FAB method to a woman in this circumstance. C Caution The method is normally provided in a routine setting, but with extra preparation and precautions. For FAB methods, this usually means that special counselling may be needed to ensure correct use of the method by a woman in this circumstance. D Delay Use of this method should be delayed until the condition is evaluated or corrected. Alternative temporary methods of contraception should be offered. NA Not applicable Page 2 - Fertility awareness-based methods FERTILITY AWARENESS-BASED postpartum), the correct and consistent use of condoms should be METHODS Fertility awareness-based methods do not protect against STI/HIV. If there is a risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that fertility awareness-based methods may not be appropriate for them because of their relatively- higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS SYM CAL PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY NA Comments: FAB methods are not relevant during pregnancy. LIFE STAGE a) Post-menarche C C Comments: Menstrual irregularities are common in post-menarche and peri-menopause and may complicate the use of FAB methods.b) Peri-menopause C C BREASTFEEDING a) < 6 weeks postpartum D D Comments: Women who are primarily breastfeeding and are amenorrhoeic are unlikely to have sufficient ovarian function to produce detectable fertility signs and hormonal changes during the first 6 months postpartum. However, the likelihood of resumption of fertility increases with time postpartum and with substitution of breast milk by other foods. b) > C D 6 weeks c) After menses begin C C Comments: When the woman notices fertility signs (particularly cervical secretions), she can use a symptoms-based method. When she has had 3 postpartum menses, she can use a calendar-based method. Prior to that time, a barrier method should be offered if the woman plans to use a FAB method later. Comments: FAB methods during breastfeeding may be less effective than when not breastfeeding. POSTPARTUM (in non-breastfeeding women) a) < 4 weeks D D Comments: Non-breastfeeding women are not likely to have sufficient ovarian function to either require a FAB method or to have detectable fertility signs or hormonal changes prior to 4 weeks postpartum. Although the risk of pregnancy is low, a method appropriate for the postpartum period should be offered. FERTILITY AWARENESS-BASED postpartum), the correct and consistent use of condoms should be METHODS Fertility awareness-based methods do not protect against STI/HIV. If there is a risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that fertility awareness-based methods may not be appropriate for them because of their relatively- higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS SYM CAL Fertility awareness-based methods - Page 3 Postpartum (Cont’d) b) > 4 weeks A D Comments: Non-breastfeeding women are likely to have sufficient ovarian function to produce detectable fertility signs and/or hormonal changes at this time; likelihood increases rapidly with time postpartum. Women can use calendar-based methods as soon as they have completed 3 postpartum menses. Methods appropriate for the postpartum period should be offered prior to that time. POST-ABORTION C D Comments: Post-abortion women are likely to have sufficient ovarian function to produce detectable fertility signs and/or hormonal changes at this time; likelihood increases rapidly with time post-abortion. Women can use calendar-based methods as soon as they have completed 3 post-abortion menses. Methods appropriate for the postabortion period should be offered prior to that time. REPRODUCTIVE TRACT INFECTIONS AND DISORDERS IRREGULAR VAGINAL D D Comments: Presence of this condition makes FAB BLEEDING methods unreliable. Therefore, barrier methods should be recommended until the bleeding pattern is compatible with proper method use. The condition should be evaluated and treated as necessary. VAGINAL DISCHARGE D A Comments: Because vaginal discharge makes recognition of cervical secretions difficult, the condition should be evaluated and treated if needed prior to providing methods based on cervical secretions. OTHER USE OF DRUGS WHICH C/D C/D Comments: Use of certain mood-altering drugs such AFFECT CYCLE as lithium, tricyclic antidepressants, and anti-anxiety REGULARITY, HORMONES therapies, as well as certain antibiotics and anti- AND/OR FERTILITY SIGNS inflammatory drugs, may alter cycle regularity or affect fertility signs. The condition should be carefully evaluated and a barrier method offered until the degree of effect has been determined or the drug is no longer being used. FERTILITY AWARENESS-BASED postpartum), the correct and consistent use of condoms should be METHODS Fertility awareness-based methods do not protect against STI/HIV. If there is a risk of STI/HIV (including during pregnancy or recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that fertility awareness-based methods may not be appropriate for them because of their relatively- higher typical-use failure rates. CONDITION CATEGORY NEW EVIDENCE/COMMENTS SYM CAL Page 4 - Fertility awareness-based methods DISEASES WHICH ELEVATE BODY TEMPERATURE a) Chronic diseases C A Comments: Elevated temperature levels may make basal body temperature difficult to interpret, but there is no effect on cervical secretions. Thus the use of a method that relies on temperature should be delayed until the acute disease abates. Temperature-based methods are not appropriate for women with chronically-elevated temperatures. In addition, some chronic diseases interfere with cycle regularity, making calendar-based methods difficult to interpret. b) Acute diseases D A Lactational amenorrhoea method - Page 1 LACTATIONAL AMENORRHOEA METHOD The lactational amenorrhoea method does not protect against STI/HIV. If there is a risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms should be recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions which make pregnancy an unacceptable risk should be advised that the lactational amenorrhoea method may not be appropriate for them because of its relatively higher typical-use failure rates. The Bellagio Consensus provided the scientific basis for defining the conditions under which breastfeeding can be used safely and effectively for birth-spacing purposes, and programmatic guidelines were developed for the use of lactational amenorrhoea in family planning. These guidelines include the following three criteria, all of which must be met to ensure adequate protection from an unplanned pregnancy: 1) Amenorrhoea; 2) Fully or nearly fully breastfeeding; and 3) Less than six months postpartum. The main indications for breastfeeding remain the need to provide an ideal food for the infant and to protect it against disease. There are no medical conditions in which the use of lactational amenorrhoea is restricted and there is no documented evidence of its negative impact on maternal health. However, certain conditions or obstacles which affect breastfeeding may also affect the duration of amenorrhoea, making this a less useful choice for family planning purposes. These include: HIV infection Breastfeeding should be promoted, protected, and supported in all populations, for all women who are HIV-negative or of unknown HIV status. Women who are known to be HIV-positive should be counselled about all infant feeding methods and the risks involved, make an informed choice, and be supported in their choice. Medication used during breastfeeding In order to protect infant health, breastfeeding is not recommended for women using such drugs as: anti-metabolites, bromocriptine, certain anticoagulants, corticosteroids (high doses), cyclosporin, ergotamine, lithium, mood-altering drugs, radioactive drugs, and reserpine. Conditions affecting the newborn Congenital deformities of the mouth, jaw or palate; newborns who are small-for-date or premature and needing intensive neonatal care; and certain metabolic disorders of the infant all can make breastfeeding difficult. Page 2 - Lactational amenorrhoea method Coitus interruptus - Page 1 COITUS INTERRUPTUS Coitus interruptus does not protect against STI/HIV. If there is a risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms should be recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. Women with conditions that make pregnancy an unacceptable risk should be advised that coitus interruptus may not be appropriate for them because of its relatively higher typical-use failure rates Coitus interruptus (CI), also known as withdrawal, is a traditional family planning method in which the man completely removes his penis from the vagina, and away from the external genitalia of the female partner, before he ejaculates. CI prevents sperm from entering the woman’s vagina, thereby preventing contact between spermatozoa and the ovum. This method may be appropriate for couples: C who are highly motivated and able to use this method effectively; C with religious or philosophical reasons for not using other methods of contraception; C who need contraception immediately and have entered into a sexual act without alternative methods available; C who need a temporary method while awaiting the start of another method; C who have intercourse infrequently. Some benefits of CI are that the method, if used correctly, does not affect breastfeeding and is always available for primary use or use as a back-up method. In addition, CI involves no economic cost or use of chemicals. There are no health risks associated directly with CI. Men and women who are at high risk of STI/HIV infection should use a condom with each act of intercourse. CI is unforgiving of incorrect use, and its effectiveness depends on the willingness and ability of the couple to use withdrawal with every act of intercourse. Page 2 - Coitus interruptus Table of contents Surgical sterilization procedures A. Female surgical sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Personal characteristics and reproductive history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Young age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Postpartum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Post-abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Past ectopic pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Cardiovascular disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Neurologic conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Reproductive tract infections and disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Other infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Schistosomiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Malaria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Endocrine conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Gastrointestinal conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Other conditions relevant only for female surgical sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Local infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Coagulation disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Respiratory diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Systemic infection or gastroenteritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Fixed uterus due to previous surgery or infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Abdominal wall or umbilical hernia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Diaphragmatic hernia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Kidney disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Severe nutritional deficiencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Sterilization concurrent with abdominal surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Sterilization concurrent with caesarean section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 B. Male surgical sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Local infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Previous scrotal injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Systemic infection or gastroenteritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Large varicocele . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Large hydrocele . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Filariasis; elephantiasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Intrascrotal mass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Cryptorchidism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Inguinal hernia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Sickle cell disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Coagulation disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Surgical sterilization procedures - Page 1 SURGICAL STERILIZATION PROCEDURES Considering the irreversibility or permanence of There is no medical condition that would sterilization procedures, special care must be absolutely restrict a person's eligibility for taken to assure a voluntary informed choice of sterilization. Some conditions and the method by the client. Particular attention circumstances indicate that certain must be given in the case of young people, precautions should be taken. nulliparous women, and men who have not yet been fathers, and in clients with mental health The classification of conditions into the different problems, including depressive conditions. All categories is based on an in-depth review of the women should be counselled about the epidemiological and clinical evidence relevant to permanence of sterilization and the availability of medical eligibility. The programmatic alternative, long-term, highly effective methods; implications of these updated medical criteria this is of extra concern for young people. The are still to be addressed taking into account the national laws and existing norms for the delivery various levels of service delivery. However, for the of sterilization procedures must be considered in particular case of sterilization procedures, the the decision process. following category definitions were developed. DEFINITIONS A Accept There is no medical reason to deny sterilization to a person with this condition. C Caution The procedure is normally conducted in a routine setting, but with extra preparation and precautions. D Delay The procedure is delayed until the condition is evaluated and/or corrected. Alternative temporary methods of contraception should be provided. S Special The procedure should be undertaken in a setting with an experienced surgeon and staff, equipment needed to provide general anaesthesia, and other back-up medical support. For these conditions, the capacity to decide on the most appropriate procedure and anaesthesia regimen is also needed. Alternative temporary methods of contraception should be provided, if referral is required or there is otherwise any delay. Page 2 - Surgical sterilization procedures A. Female surgical sterilization FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY PREGNANCY D YOUNG AGE C New evidence: Studies show that up to 20% of women sterilized at a young age later regret this decision, and that young age is the strongest predictor of regret that can be identified before sterilization. 1,2 Comments: All women should be counselled about the permanency of sterilization and the availability of alternative, long-term, highly effective methods. This is of extra concern for young women. PARITY a) Nulliparous A Comments: Counselling requires special care to ensure that an informed choice is being made. b) Parous A BREASTFEEDING A Comments: There is no impact on lactation if local anaesthesia is used and separation of mother and child is minimized. POSTPARTUM a) < 7 days A Comments: Sterilization can be safely performed immediately postpartum. 7 to < 42 days D Comments: There is an increased risk of complications when the uterus has not fully involuted. > 42 days A b) Pre-eclampsia/ eclampsia (i) mild pre-eclampsia A (ii) severe pre-eclampsia/ D Comments: There are increased anaesthesia-related eclampsia risks. c) Prolonged rupture of D Comments: There are increased risks of postoperative membranes: 24 hours or infection. more d) Puerperal sepsis, D Comments: This may indicate systemic or local intrapartum or puerperal infection; there is an increased risk of postoperative fever infection. e) Severe antepartum or D Comments: The woman may be anaemic and unable postpartum haemorrhage to tolerate further blood loss (see section below). FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Surgical sterilization procedures - Page 3 POSTPARTUM (Cont’d) f) Severe trauma to the D Comments: There may have been significant blood genital tract: cervical or loss and anaemia. The procedure may be very painful. vaginal tear at time of delivery g) Uterine rupture or S Comments: There may have been significant blood perforation loss or damage to abdominal contents, which may increase the risk of infection. If exploratory surgery or laparoscopy is conducted and the patient is stable, repair of the problem and tubal sterilization may be performed concurrently if no additional risk is involved. POST-ABORTION a) Uncomplicated A b) Post-abortal sepsis or D Comments: This condition may substantially increase fever the risk of post-sterilization infection. c) Severe post-abortal D Comments: The woman may be anaemic and unable haemorrhage to tolerate further blood loss. d) Severe trauma to the D Comments: The woman may be anaemic and unable genital tract: cervical or to tolerate further blood loss. The procedure may be vaginal tear at time of more painful. abortion e) Uterine perforation S Comments: There may have been significant blood loss or damage to abdominal contents, thereby increasing the risk of infection. If exploratory surgery or laparoscopy is conducted, repair of the problem and tubal sterilization may be performed concurrently if no additional risk is involved. f) Acute haematometra D Comments: The woman may be anaemic and unable to tolerate further blood loss. PAST ECTOPIC A PREGNANCY SMOKING a) Age < 35 years A b) Age > 35 years (i) <15 cigarettes/day A (ii) >15 cigarettes/day A FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Page 4 - Surgical sterilization procedures OBESITY C Comments: The procedure may be more difficult. > 30 kg/m There is an increased risk of wound infection and2 body mass index (BMI) disruption. The condition may require general anaesthesia and may limit respiratory function. CARDIOVASCULAR DISEASE MULTIPLE RISK S Comments: The woman may be at high risk for FACTORS FOR ARTERIAL complications associated with anaesthesia and CARDIOVASCULAR surgery. DISEASE (such as older age, smoking, diabetes and hypertension) HYPERTENSION a) History of hypertension, C Comments: Blood pressure should be controlled where blood pressure before surgery. CANNOT be evaluated (including hypertension Comments: There are increased anaesthesia-related during pregnancy) risks and an increased risk of cardiac arrhythmia. Blood pressure may be very labile and difficult to control in the early postpartum period. Appropriate monitoring of blood pressure intraoperatively is necessary. b) Adequately controlled C hypertension, where blood pressure CAN be evaluated c) Elevated blood pressure levels (properly taken measurements) (i) systolic 140-159 or C diastolic 90-99 (ii) systolic >160 or S diastolic >100 d) Vascular disease S HISTORY OF HIGH BLOOD A PRESSURE DURING PREGNANCY (where current blood pressure is measurable and normal) FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Surgical sterilization procedures - Page 5 DEEP VENOUS THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE) a) History of DVT/PE A Comments: To reduce the risk of DVT/PE, early ambulation is recommended. b) Current DVT/PE D c) Family history of A DVT/PE (first-degree relatives) d) Major surgery (i) with prolonged D immobilization (ii) without prolonged A immobilization e) Minor surgery without A immobilization SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins A b) Superficial A thrombophlebitis CURRENT AND HISTORY OF ISCHAEMIC HEART DISEASE a) Current ischaemic heart D Comments: The woman is at high risk for disease complications associated with anaesthesia and surgery. b) History of ischaemic C heart disease STROKE C (history of cerebrovascular accident) KNOWN Comments: Routine screening is not appropriate HYPERLIPIDAEMIAS A because of the rarity of the conditions and the high cost of screening. Some types of hyperlipidaemias are risk factors for vascular disease. The category should be assessed according to the type and its severity. FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Page 6 - Surgical sterilization procedures VALVULAR HEART DISEASE a) Uncomplicated C Comments: The woman requires prophylactic antibiotics. b) Complicated S Comments: The woman is at high risk for (pulmonary complications associated with anaesthesia and hypertension, atrial surgery. If she has unstable atrial fibrillation or current fibrillation, history of subacute bacterial endocarditis, the procedure should subacute bacterial be delayed. endocarditis) NEUROLOGIC CONDITIONS HEADACHES a) Non migrainous A (mild or severe) b) Migraine (i) without focal neurologic symptoms Age < 35 A Age > 35 A (ii) with focal neurologic A symptoms (at any age) EPILEPSY C REPRODUCTIVE TRACT INFECTIONS AND DISORDERS VAGINAL BLEEDING PATTERNS a) Irregular pattern without A heavy bleeding b) Heavy or prolonged A bleeding (includes regular and irregular patterns) UNEXPLAINED VAGINAL Comments: The condition must be evaluated before BLEEDING (suspicious for the procedure is performed. serious condition) Before evaluation D ENDOMETRIOSIS S FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Surgical sterilization procedures - Page 7 BENIGN OVARIAN A TUMOURS (including cysts) SEVERE A DYSMENORRHOEA TROPHOBLAST DISEASE a) Benign gestational A trophoblastic disease b) Malignant gestational D trophoblastic disease CERVICAL ECTROPION A CERVICAL A INTRAEPITHELIAL NEOPLASIA (CIN) CERVICAL CANCER D Comments: In general, the treatment renders a woman (awaiting treatment) sterile. BREAST DISEASE a) Undiagnosed mass A b) Benign breast disease A c) Family history of cancer A d) Cancer (i) current C (ii) past and no evidence of A current disease for 5 years ENDOMETRIAL CANCER D Comments: In general, the treatment renders a woman sterile. OVARIAN CANCER D Comments: In general, the treatment renders a woman sterile. UTERINE FIBROIDS Comments: Depending on the size and location of the fibroids, it might be difficult to localize the tubes and mobilize the uterus.a) Without distortion of the C uterine cavity b) With distortion of the C uterine cavity FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Page 8 - Surgical sterilization procedures PELVIC INFLAMMATORY DISEASE (PID) a) Past PID (assuming no Comments: A careful pelvic examination must be current risk factors for performed to rule out recurrent or persistent infection STIs) and to determine the mobility of the uterus. (i) with subsequent A pregnancy (ii) without subsequent C pregnancy b) PID - current or within D Comments: PID can lead to an increased risk of post- the last 3 months sterilization infection or adhesions. STIs a) Current (including D Comments: There is an increased risk of postoperative purulent cervicitis) infection. Comments: If no symptoms persist following treatment, sterilization may be performed. b) Within the last 3 months A c) Vaginitis without purulent A cervicitis d) Increased risk of STIs A HIV/AIDS HIGH RISK OF HIV A Comments: No routine screening is needed. Appropriate infection prevention procedures, including universal precautions, must be carefully observed with all surgical procedures. The use of condoms is recommended following sterilization. HIV-POSITIVE A AIDS S Comments: If the woman is currently suffering an AIDS-related illness, the procedure should be delayed. OTHER INFECTIONS SCHISTOSOMIASIS a) Uncomplicated A b) Fibrosis of liver C Comments: Liver function may need to be evaluated. TUBERCULOSIS a) Non-pelvic A b) Known pelvic S MALARIA A FEMALE SURGICAL STERILIZATION Sterilization does not protect against STI/HIV, if there is risk of STI/HIV (including during the postpartum period), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV. CONDITION CATEGORY NEW EVIDENCE/COMMENTS Surgical ster

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