SELECTING FERTILITY REGULATION
METHODS FOR INTRODUCTION

Existing contraceptive methods are of five types- hormonal, intrauterine devices, sterilization, barrier, and natural or traditional methods. Both surgical and medical techniques exist for inducing abortion.

Each method has intrinsic characteristics which must be considered when governments or agencies choose a method for particular countries or programmes. Women's health advocates emphasized, however, that the selection process must also take into account the sexual, reproductive, social and economic realities of women's lives; their health; and the quality of family planning and health services in particular settings. That is, the technologies should not be selected in isolation from the conditions in which they are to be used.

Women are concerned that, in many in stances, this principle has not been followed. As a result, methods that should, in women's view, be provided only by well-trained personnel in settings with strong health infrastructure that can ensure informed choice have been misused or abused. Scientists usually consider that they are contributing to knowledge about a particular technology and that they rarely have the possibility of influencing how and where a method is used.

Participants discussed at length the standards that should be set for selection and use of contraceptives, and the efforts needed to encourage adoption of these standards. It was agreed that women's health advocates and scientists, working together, might design more appropriate standards and also monitor selection and use, at least in some settings.

The participants agreed that a woman's selection of a method of fertility regulation is affected by many considerations. These include such personal circumstances as her health, sexual relationship(s) and point in her reproductive life cycle; the societal conditions that affect her sexuality such as her status in society, risk of violence, and possible exposure to infected partners; her prior experience with fertility regulation methods; and her access to information. Her choice will also be affected by the availability of health and family planning services, their quality and accessibility, the mix of methods offered as well as the availability of safe abortion.

"Access is not only a question of how distant her home is, or how much the transportation costs or who will take care of the baby if she goes to the clinic. We have to ask what is the attitude of the husband what is the attitude of the mother-in-law what is the attitude of the neighborhood, of the family, of the city, of the society at large with respect to that woman using that method? What are the sources of information? ...Much more emphasis should be put on this field". - Anibal Faundes

It was also agreed that no one method can work for all women at all times in their lives, and that therefore, the broadest possible number of fertility regulation methods should be offered. Some scientists see greater hope for improving choice through development of highly effective, reversible, long-acting methods. Many women's health advocates see a greater need for the promotion of already existing methods that have minimal side effects, are user-controlled, and are protective against infection, such as barrier methods. Behind these preferences lie differences in the definitions and relative weight assigned to four fundamental characteristics of fertility regulation technologies: safety, efficacy, acceptability and availability.

Safety, efficacy, acceptability and availability

Safety

Scientists want to ensure that a method they develop causes no dangerous or permanent side effects. Through toxicological and clinical studies they assess whether a method might be carcinogenic, or might have severe effects on physiological functions such as those of the heart, the kidneys or the reproductive organs, or might have other potentially severe outcomes. The women who use methods that have passed these tests are also concerned about how these methods might affect their overall health, including their sexual interest, physical stamina, or emotional well-being - aspects of health that generally have been given lower priority by researchers and service providers. Side effects such as menstrual bleeding disturbances, which scientists consider unimportant medically, can be of extreme concern to women, and may affect how they perceive the safety of any method. For a woman, safety of use of a method during lactation, and the long-term effects of method use, are of particular concern, and her concept of safety may also require that the method is immediately reversible. Because safety is impossible to measure in absolute terms, and accurate technical information is still insufficient, a broad spectrum of society, certainly women, should participate in the process of weighing risks and benefits of technologies to be introduced.

Some women feel that certain natural substances, such as herbs and plants used as contraceptives may be safer than modern methods and some women's health advocates felt that more emphasis should be put on researching traditional herbs and plants. Scientists pointed out that the Special Programme had funded a major international research programme in this area, albeit restricted to plants alleged to have properties preventing implantation of a fertilized egg in the uterus or to inhibit male fertility. No new chemical entities suitable for method development were identified. However, this area of research has by no means been exhausted. *

"Natural" is not always simple and safe. On the other hand, there are many traditional methods which I'm sure haven't been adequately explored and could very well turn out to have the advantage of simplicity and safety". - Henry Gabelnick

Women's health advocates felt that attention needs to be given to the safety of particular methods in settings where disease and malnutrition are very substantial. They emphasized the need to examine interactions between fertility regulation methods and sexually transmitted diseases, especially AIDS. They suggested, for example, that a community with endemic reproductive tract infections, especially where they are undiagnosed and untreated, is an inappropriate environment in which to introduce IUDs. Scientists pointed out that some agencies do carry out studies on the wider health implications of method use. The Special Programme, for example, is conducting cross-cultural research in more than 20 countries to examine the effect of various contraceptives on a range of problems including HIV transmission, neoplasia, infant development, anemia, hepatitis B and cardiovascular diseases. It was recognized, however, that more needs to be done, and that the results of such studies need to be made available much more widely than is presently the case.

Scientists indicated that they need to know more about how clients perceive and define safety. However, they also urged that what is known medically about safety should be more adequately conveyed to women. For instance, a once-a-month injectable contraceptive sold over the counter in Latin American countries has been very popular among women because bleeding remains regular. However, the drug contains a high dose of estrogen which increases the risk of metabolic and cardiovascular diseases - a long-term problem which is not noticed on a daily basis by the user. This example underlines the essential need for communication between scientists and users. As a result of this situation the Special Programme has supported the development of an alternative, once a-month injectable with a lower dose of estrogen, which is currently being introduced into six countries.

Both scientists and women's health advocates agreed that cultural and service delivery factors influence the actual safety of any method. The safety of sterilization or IUDs, for instance, depends largely on the care with which they are delivered. Furthermore, for certain methods, the service provider determines a dimension of safety critical to most women: immediate and effective reversibility on demand.

A fundamental difference in perspectives on the relative safety of methods remains. Scientists tend to argue that the health risks of any method should be measured against the risks of a clandestine abortion or of a full-term pregnancy (wanted or unwanted). Their priority is to develop the most effective contraceptive methods to reduce the likelihood that women will resort to dangerous abortions or go through a high-risk pregnancy. Women's health advocates, on the other hand, often see the risks of some methods, whether inherent or caused by poor services, to be too high. Many argue for the provision of methods that have minimal side effects, along with safe abortion as a back-up. They also point out that emphasis on family planning services should not detract from efforts to improve pregnancy and delivery care.

Efficacy

Scientists measure the efficacy of a contraceptive method by quantifying how often it fails to prevent pregnancy. The measures applied are rates of "method failure" and of "user failure". Women, however, may define efficacy by how well a method "works for them in their lives". Their measures include not only pregnancy prevention but also "satisfaction". The latter may encompass the effects the method has on the woman's sexual relationship, her sense of control over the method, the freedom to use it when she pleases, and its efficacy in preventing infection. For many women, these aspects of effectiveness, along with safety as defined above, may be as or more important than contraceptive efficacy. Women's health advocates felt that the scientific community tends to give too much weight to contraceptive efficacy. Scientists stressed that safety is their first concern and indicated that women's perception of their priorities in this regard is incorrect. Scientists and women's health advocates agreed that this is evidence of a serious communication gap that should be closed through continuing dialogue.

Women's health advocates questioned scientists' bias toward systemic or provider-dependent methods that have less likelihood of user failure. They suggested that this emphasis has led researchers to overlook low user acceptability or significant dissatisfaction with the method which may be masked by high continuation rates when assessing the efficacy of methods such as the IUD or subdermal implants. At the same time, what appears to be the lower effectiveness of barrier methods may be due not so much to the methods them selves as to failure to provide adequate information and support to women who use them. Furthermore, service providers have often simply asserted that the diaphragm is inappropriate for low income women who do not have privacy, water, education or other resources. It has been assumed, rightly or wrongly, that instruction in the proper use of barrier methods places undue demands on understaffed, overworked clinics. The meeting participants agreed that such assumptions need to be tested and the use-effectiveness of barrier methods further studied. They also agreed that clinical studies of effectiveness are not sufficient, since efficacy also depends on the social and health environment, on service providers, and on users, not just on the method itself. Women's health advocates also suggested that the safety-efficacy balance of barrier methods, backed up by safe abortion facilities, should be compared to the safety efficacy balance of systemic, provider dependent methods.

Acceptability

This concept permeated discussions throughout the meeting. The measures commonly used by scientists and policy makers are rates of acceptance (agreeing to start using a contraceptive method) and rates of continuing a method. Women's health advocates argued for indicators of acceptability that also measure in formed choice and user satisfaction. Research on the reasons not only for acceptance, but also for satisfaction and dissatisfaction, could help to increase understanding of what acceptability really means to women. Scientists pointed out that the Special Programme carries out research on these and other aspects of acceptability, particularly on reasons for discontinuation.

It was agreed that acceptance and acceptability are influenced by many factors. For example, if health service providers judge one method better than another, then the counseling and information they provide is likely to reflect that bias and affect acceptance and use of that method. Similarly, policy-makers and providers may make incorrect assumptions about what is acceptable to women and men. A common assumption is that women will not touch their genitals. In Thailand, a clinical trial of a vaginal ring run by clinicians was unsuccessful be cause of this assumption on the part of the male clinicians, whereas a trial of a similar ring run by midwives met with considerable success, because they spent time demonstrating how the method works. A similar experience occurred in the Dominican Republic. In Brazil, donors, health authorities and gynecologists have regarded the diaphragm as in effective and unusable, particularly for low-income women. Yet, a feminist health centre in Sao Paulo has shown that, if women are given information and counseling about a range of methods including the diaphragm, many of them, regardless of income level, choose the diaphragm and find it easy to use. In an other instance, in Turkey, family planning officials assumed that women were their primary clients, even though the main method used up to that time was withdrawal. Early family planning efforts failed because men, who control contraceptive practice in Turkey, were not fully involved.

Women's health advocates indicated that women's definitions of acceptability change over time with changes in their circumstances. As women become more concerned with their rights and have more knowledge of their bodies, for example, they may be less willing to accept methods that can adversely affect their health. Many of the participants felt strongly that not only risks but also more responsibility for fertility regulation should be shared by men and that resources for the development of male methods should be increased. Some participants nonetheless expressed concern that even women in stable relationships may not trust their partners to use contraceptives effectively and, therefore, female methods should continue to have priority.

Finally, acceptability is also conditioned by the availability of methods. The participants agreed that if only one or two methods are available, it is not meaningful to speak of acceptability because there is no choice.

Availability

For a method to be truly "available", a number of conditions must be met, including easily accessible distribution points (clinics, commercial outlets, etc.), where the supplies are consistent, staff are properly trained, and opening hours are convenient for clients. A key aspect of availability discussed at length is afford ability, both for the service provider (e.g., a national government programme) and for the consumer. Participants expressed considerable concern that some recently developed methods, such as implants, are costly. This also raised the question of manufacture. Participants from Africa and Asia in particular, stressed that many countries in their regions have no control over manufacture and supply of fertility regulation products, and that this affects availability.

Other critical factors in selection of methods

Health and family planning infrastructure

Women's health advocates and scientists agreed that, in an ideal world, women and men should have the freedom to choose any method, the right to change methods, and the ability to afford any method. This requires properly staffed and maintained health and family planning services and the provision of safe abortion services. In reality, health and family planning services tend to be over worked, understaffed and under financed. Adding fertility regulation methods, especially those that require sophisticated delivery and follow-up, may simply compound existing service weaknesses.

"We get the feeling now and then that the method gets the blame whilst it is the services that should be the target of complaints". - Olav Meirik

There was general agreement that the health and family planning infrastructure has a very significant impact on the safety and efficacy of fertility regulation methods. Those responsible for selecting methods therefore must determine whether the infrastructure is well enough staffed and equipped to ensure safety and efficacy. Are necessary supplies available consistently, along with trained staff who have both the skills and the time required to deliver the various methods safely? Can the staff ensure informed choice, provide counseling and follow up clients? Are services readily available to deal adequately with method complications, method removal, side effects or unwanted pregnancy?

There were different views on the criteria that might be used in answering these questions. Some participants argued that certain methods should simply not be selected by countries with very weak infrastructure. Others suggested that methods dependent on sophisticated facilities should perhaps be provided first (or only) at higher levels of the health system or in urban areas. Clearly, this is an area of on going debate which may be best resolved in particular countries through dialogue among policy makers, service providers and women's health advocates.

Quality of services

Women's health advocates suggested that qualitative aspects of existing health and family planning programmes should be taken into account in selecting fertility regulation methods to introduce into those systems. A service that emphasizes quantitative targets is unlikely to provide or reward counseling, may have coercive elements (e.g., denies women abortions unless they agree to accept a particular method of contraception or sterilization), and may not maintain privacy or treat clients with respect.

"Any type of new technology that we introduce in any country of the world will fail if you don't have good service delivery and good counseling". - Kerstin Hagenfeld

Such systems will not provide any method appropriately, but especially those that are not reversible (sterilization), are reversible only with the cooperation of the service provider (IUDs, implants) or are not immediately reversible (e.g. long-acting injectables).

Many of these aspects of quality of care could be improved at little or no cost by adjusting objectives to emphasize choice among methods and respect for the client. Others, like counseling, demand time from already over-worked staff - a demand that will increase with the introduction of each additional method. One way to address this problem is to broaden personnel to include non-physicians in the delivery of services - an approach that has proved to be very successful in a number of countries. Participants generally agreed that, regardless of the method to be selected or introduced, family planning services must do more to ensure respect for the user and for her or his cultural, sexual and religious values.

Government and donor criteria for method selection

Women's health advocates expressed a need for more information on the definition and application of criteria for method selection at national levels. Since many countries are dependent upon supplies from donors, the criteria used by the donors are especially important. For example, a recent attempt to manufacture diaphragms in Brazil has been thwarted by lack of donor support, while in Bangladesh, until very recently, only high-dose contraceptive pills have been available.

Government policies can also be very restrictive. Natural methods of fertility regulation are often not included in the official list of contraceptive methods and thus services are not provided. Health ministries sometimes set supply quotas for certain methods such as condoms, and this can result in serious shortages. Although some public sector agencies are beginning to accept the need for barrier methods, a general prejudice still exists among donors and government programmes against providing methods that require spermicides be cause of the difficulty of maintaining supplies of spermicides in developing countries.

Unwanted pregnancy and abortion

The primary purpose of very large investments in contraceptive technologies and services to date has been to prevent unwanted, ill-timed or otherwise inappropriate pregnancies. In some countries, nonetheless, induced abortions equal or surpass the number of live births. Worldwide, it is estimated that between 36 and 53 million induced abortions occur every year, and as many as 200,000 women may die each year due to unsafe abortion. Clearly, as yet contraceptive technologies and services neither meet the needs of, nor are accessible to, millions of women who want to control their fertility.

"Abortion has to be seen as an important integral aspect of reproductive rights which cannot be neglected. In my two years as coordinator of the women's health programme in Sao Paulo, I have been involved in research in 25 municipal hospitals in poor areas and have seen the increase in abortion and abortion complications as a great issue. The total number of complicated abortions presented at the hospital in 1989 exceeded the number of births. It is therefore impossible for researchers not to involve themselves publicly in the abortion issue in their countries". - Maria Jose Araujo

Recognizing that it will be some time be fore all women's contraceptive needs can be met, and that some women will always need safe abortion services, most participants felt strongly that women's groups and scientists should actively collaborate to encourage understanding of unwanted pregnancy and to prevent and eliminate unsafe abortion.

A limited number of institutions and organizations (such as the Special Programme) currently support research activities on particular aspects of abortion, including the very serious health effects of unsafe abortion, the factors that lead to unwanted pregnancy and unsafe abortion, and assessment of new technologies for safe induced abortion. These and other aspects of abortion urgently need more research, on which scientists and women's health advocates should collaborate.

Women's health advocates also emphasized that public education and advocacy are needed to decriminalize abortion. Women's health advocacy groups usually work for safe and accessible abortion services, but initiatives are needed from others as well. In a number of countries, physicians and other health professionals have taken the lead, some times in alliance with women's organizations. It was suggested that researchers could provide an additional strong and effective voice in national and international efforts to ensure women's access to safe services in all countries.

It was pointed out that the World Health Organization, as an inter-governmental organization, serves the needs of its Member States, who have divergent policies on the issue of abortion. In accordance with the recommendation of the 1984 International Conference on Population, WHO does not promote abortion as a method of family planning, but is concerned with the health aspects, particularly of unsafe abortion.

Suggested actions



The availability of methods and the reality of choice:
Bangladesh and Brazil

In theory, a wide range of fertility regulation methods is available in Bangladesh but, at most, one third of reproductive age couples use a contraceptive method, and many women resort to abortion. The methods available through governmental and non-governmental channels include high dose oral contraceptives, condoms, vaginal foam tablets, IUDs (copper T380A), two- and three-month injectables, Norplant subdermal implants, tubal ligation and vasectomy, and menstrual regulation. Other methods used include natural family planning, breast feeding, withdrawal, ayurvedic and homeopathic methods.

Most women in Bangladesh do not have the wide choices that this list implies. The majority have no access to information about methods and only limited access to services, which are of poor quality. Many women are compelled to obey their husbands and in-laws, and, as a result, practice fertility regulation in secret, if at all. Consequently, methods requiring male cooperation are difficult or impossible for many women to adopt. Injectable contraceptives have become increasingly popular, in part because women can obtain them under the guise of taking their children to a clinic for immunization. Methods which cause menstrual disruption are problematic, however, because bleeding interferes with praying, fasting, sexual intercourse, and a woman's feeling of health and well-being. Women also want to avoid methods believed to cause cancer and methods which might cause infections such as an IUD inserted under unsterile conditions.

Given all these limitations, along with problems of service delivery, it is estimated that every year 750,000 women in Bangladesh have an abortion. Perhaps one-fifth of these have access to safe menstrual regulation through Government clinics; the rest risk their lives in clandestine procedures. For many women, a vasectomy for their partner is the ideal choice, but most men reject it. Most sterilization in Bangladesh is there fore undertaken by women, even though vasectomy is easier, safer and less expensive than tubal ligation.

In Brazil, though the range of legal fertility regulation methods is extremely narrow, about two-thirds of women in marital or consensual unions use some method of contraception or are sterilized. Although the government has adopted an integrated women's health programme which mandates the provision of a wide range of contraceptive methods, in fact, the only fertility regulation methods accessible to most women are oral contraceptives provided through the private sector, clandestine abortion (legal abortion is severely restricted), and tubal ligation. The lack of choice of contraceptive methods and the legal restrictions on abortion mean that women pay a very high price for fertility regulation.

For low-income women, the recurring cost of pills, along with costs of obtaining them, such as transportation, loss of earnings, and child care are deterrents to oral contraceptive use. Side effects of oral contraceptives, such as menstrual disturbances, weight gain, headaches, or loss of libido are reported often, and these kinds of effects frequently result in incorrect use, discontinuation of the method and, ultimately, unwanted pregnancy.

It is estimated that three million abortions occur each year in the country, compared to four million births. In a survey of low-income women in the state of Santa Catarina, 18 methods to induce abortion were reported, including catheters and knitting needles. In 1989, the number of cases with complications from induced abortion in the municipal hospital of Sao Paulo exceeded the number of deliveries.

With no temporary means of contraception available to them, many women undergo tubal ligation. Not surprisingly, studies show that up to 50 percent of Brazilian women sterilized before 25 years of age regret it. Tubal ligation is not officially provided in the public sector, but it is frequently done clandestinely at the time of Cesarean section. This helps explain the extremely high rate of "unnecessary" Cesarean sections and associated complications in Brazil.

Given the negative experience many Brazilian women have had with hormonal methods and with the service system, the greatest weight should perhaps now be given to methods that have minimal health risks or side effects, are reversible, inexpensive and easy to use. Careful introduction of barrier methods and the IUD may be more appropriate than the introduction of new methods which have systemic effects, require a physician's involvement, and therefore are not under the user's control.

By comparison, an ideal contraceptive in Bangladesh would be one that is easy to use with privacy, is inexpensive, and is not connected with sexual intercourse. It would not require leaving the home, would have minimal side effects and would be socially and culturally acceptable. But the issue in Bangladesh may be less selection of additional methods than improvement in service quality and availability along with broader changes in women's lives that would enable them to make choices for themselves.

This text is based on presentations by Sandra Kabir and Maria Jose Araujo


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