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10th Postgraduate Course for Training in Reproductive Medicine and Reproductive Biology

Executive Summary

Understanding people’s reproductive health needs and perspectives

P. Van Look
WHO Department of Reproductive Health and Research

Men’s involvement in reproductive health

The paucity of information in developing countries on men's roles in and perspectives towards reproductive health led the Programme to launch, in 1995, a social science research initiative to address this problem. A total of 17 studies were supported. In general, the studies have shown that, while there may be high levels of awareness and approval of contraception among men, in practice prevailing attitudes conspire to reduce contraceptive use. For example, a study of 714 Jamaican men between the ages of 15-40 years indicated that there were high overall levels of awareness, approval and use of contraception. Yet study participants expressed concerns about the side-effects and low effectiveness of certain female contraceptive methods. And while 30% of the men in the study favoured condom use for disease prevention, they considered female contraception more appropriate when they were in a "bona fide" relationship with a trusted partner. On the other hand, men were strongly opposed to permanent methods. Eighty-nine per cent of the men disapproved of tubal ligations for their partners and 96% would not consider a vasectomy for themselves. For many men, the uncertainty of relationships made vasectomy too final an option.

A study of 200 Mexican men examined which factors influenced men's choice of vasectomy as a method of contraception. Factors supporting the use of vasectomy included: having three or more children; prior experience with withdrawal; predominant use of traditional methods; and a high level of communication with partners on contraception. Men who had no intention of getting a vasectomy reported either that it was not easily accessible or that they were opposed to family planning. Based on the results of the study, the authors suggested that family planning programmes should emphasize that vasectomy had no impact on virility or pleasure during sexual intercourse.

Ten focus group discussions with married men and women were conducted in Umraniye, one of the most densely populated districts in Istanbul, Turkey, to determine their attitudes towards contraception. There was a sustained willingness among the men to use certain types of male contraceptive methods, withdrawal being the most common (25% of participants); far fewer used condoms (7-8%). Men favoured withdrawal because of poor knowledge of other methods, negative experiences with modern contraceptive methods, and rumours about the side-effects of modern methods. Several factors appeared to contribute to the reluctance of men to use condoms. Almost all study participants said they would be embarrassed to buy condoms in public. There was also the perception that condoms are intended for disease prevention.

Four other studies also examined men's attitudes towards condom use. In two studies in Shanghai, China, 2266 male clinic attendees diagnosed with a sexually transmitted infection (STI) were randomly assigned to three groups and received: routine clinical services; routine services and an educational video about STIs; or routine services, educational video plus opportunity to participate in a discussion group. Knowledge and attitudes were determined 2-3 weeks later in a follow-up interview. Men in the video and video-plus-discussion groups correctly answered questions about condoms more frequently, and had more a positive attitude towards condoms, than men in the group that obtained standard clinical services only. The results of this study underscore the need for education to improve the chances of successfully introducing condoms, and other contraceptive methods, into a culture.

Another study in China was designed to understand providers' perspectives of clients, counselling and condom promotion in STI clinics. Clinic attendees were also interviewed in-depth to ascertain their attitudes towards condom use. Embarrassment about telling one's spouse about the STI was the main reason for not using a condom. The results also revealed that 80% of the clients feared visiting public STI clinics because they expected providers to express negative attitudes. The physicians on the other hand, did not always understand clients' fears and perceived themselves as having good attitudes towards clients. Moreover, while most physicians recognized the importance of counselling for prevention of STIs and human immunodeficiency virus (HIV) infection, doctors lacked the time to provide adequate consultations.

The Programme is also supporting studies in South Africa and Thailand on the acceptability of a non-latex male condom. The results will provide information about the background characteristics of men and women who are likely to accept the latex or non-latex condom, and ascertain reasons for discontinuing condom use.

Family planning and sexual behaviour in the era of HIV/STIs

The Programme's six-country study, entitled Family Planning and Sexual Behaviour in the Era of HIV/AIDS, was launched to ascertain the perspectives of sexually active individuals on the dual risks of unwanted pregnancy and HIV/STIs. In addition, the study also investigated practical and effective ways of coping with these risks, and explored opportunities for changing people's behaviour, with particular emphasis on communication between partners. In Phase I of the study, focus groups collected qualitative data on community attitudes towards family planning and sexual health.

The Phase I findings showed that the focus group participants had high levels of knowledge about STIs and HIV/AIDS, and many felt that using methods for preventing both STIs and unwanted pregnancy made sense. However, male opposition to family planning was a major barrier not just to the use of condoms for dual protection, but to contraceptive methods generally. Many participants in the study felt that attitudes towards condom use would have to change, particularly among men, before condom use would be more widely taken up. Misconceptions regarding AIDS were also noted by the study, such as the belief that AIDS could be cured by sleeping with a child under 10 years of age. The Phase I results are being used in Phase II as the basis of a survey to quantify people's perspectives on reproductive health.

Sexual and reproductive health needs and perspectives of adolescents

Over one billion young people live in developing countries and yet there is insufficient information to develop evidence-based strategies for meeting their sexual and reproductive health needs. To help combat this knowledge gap, since 1990 the Programme has supported 34 studies in 20 developing countries on the reproductive health needs of young people. In 1999, the Programme reviewed the findings from these studies and found that, while substantial numbers of youth in all regions were sexually active, there were major gender differences in attitudes towards sex and this influenced risk perception and behaviour. Males, in particular, were consistently more likely to engage in risky sexual practices and consistently less likely to use condoms with regular partners. Compounding this problem was the fact that sexually active females usually deferred to male partners for contraceptive decisions. Not surprisingly, the The Programme also launched a major initiative to identify factors that contribute to positive sexual and reproductive health among adolescents. Three regional workshops, designed to develop research proposals, were held in Brazil, Kenya and Thailand during 1998-1999, and 27 studies were selected for support. In addition, two Programme-supported multicentre studies are under way in China. The first is an exploratory study that has been examining the reproductive health needs of young female migrant workers. The study found that, despite widespread sexual activity, the women lacked knowledge about their bodies, reproduction and reproductive health. The second study investigated the unmet needs of sexually active, unmarried, young adults and the barriers that inhibited them from obtaining sexual and reproductive health services. The investigators found that unmarried youth generally lack knowledge of safe sex, contraceptives and reproductive health. All involved in the study, that is the young people themselves, their families and family planning providers, agreed on the need for systematic sex education. Condoms, pills and spermicides were identified as suitable contraceptive methods for young adults.

The Programme is also supporting projects to evaluate and improve reproductive health services for adolescents, including an ongoing study in six sub-Saharan countries Benin, Burkina Faso, Cameroon, Côte d'Ivoire, Guinea and Senegal. In 1999, the first phase of the study, to profile adolescent users, was completed in Côte d'Ivoire. Results showed that half of all adolescents attending general health facilities were sexually experienced, with their sexual debut occurring at an average age of 15 years; and one-third of all women requiring delivery services were adolescents. The study identified four priority areas for intervention. First, parents and influential community members need to be provided with information and communication skills. Second, fees for reproductive health services should be reduced or waived for adolescents. Third, youth-friendly health services need to be developed, including reorientation training for existing providers, separate waiting areas for adolescents and ensuring the availability of supplies, including contraceptives. Finally, the mass media should also be involved in providing useful and acceptable messages about sex to adolescents.

Gender and human rights issues in reproductive health

Initiative in gender and reproductive health

This is an innovative training project, initiated in 1996, to help programme managers understand and implement a gender-equality and rights-based approach to reproductive health planning. Following a 1997 pilot course in South Africa, the curriculum was run in 1999 in four regional centres in Argentina, Australia, China and Kenya. The final curriculum will be published in 2001.

Understanding the informed consent process in human reproduction research

Guidelines by which potential research subjects are informed about a study and give their consent to participate are well-developed and accepted. How these guidelines are translated into practice is less well understood, however. In 1997, the Programme launched a pilot initiative to examine this issue. Two studies, in Brazil and Chile, were completed in 1998; the third is ongoing in Mexico. The results of the two completed studies indicated that research subjects and investigators had very different understandings about the research process and the information given, as well as about the rights and obligations of the two groups.

Discriminatory laws and policies that affect women's reproductive health

During 1999, the Programme began a process of consultation to understand how existing laws and regulations could be reviewed, with the aim of understanding which laws or policies adversely affect women's reproductive health. With the help of advice from outside experts it was concluded that it would not be useful to create an inventory of laws, since this would duplicate previous and ongoing efforts by other organizations. Instead, it was decided that existing information in this area should be utilized. It was also decided that a detailed analysis was needed to determine what would be feasible and appropriate in this area; what the purpose of such an undertaking would be; and what the comparative advantage of WHO would be for undertaking this work. The Department of Reproductive Health and Research has therefore begun drafting a strategy for work on human rights, which would include attention to discriminatory laws and policies, and which can serve as a basis for consultation.

DEVELOPING NEW METHODS OF FERTILITY REGULATION

To meet the need for a wider range of fertility regulation methods, the Programme has supported the development of improved versions of existing technologies, to make them safer and more effective, as well as the development of new methods.

New and improved contraceptive methods for women

A three-monthly injectable contraceptive – levonorgestrel butanoate

Working with the Contraceptive Development Branch of the US National Institute of Child Health and Human Development, the Programme identified levonorgestrel butanoate for further development, as a better alternative to the existing three-monthly injectable, depot medroxyprogesterone acetate (DMPA). Studies over the past two years have focused on improving the formulation of a clinically-acceptable preparation of the compound. Once such a formulation is developed, pharmacokinetic and tolerance studies in animal models will be carried out, as well as Phase I and II clinical trials in humans.

A six/twelve-monthly immunocontraceptive

In this area, the Programme has focused on a contraceptive directed against human chorionic gonadotrophin (hCG). A prototype hCG immunocontraceptive entered Phase II clinical trials in 1994, but the study was stopped when the first few volunteers developed unexpected injection-site pain and tissue reactions. Research in 1997-1998 led to the development of an advanced prototype which did not produce the unacceptable injection-site reactions in animal models. In 1999, a batch of this prototype was produced according to Good Manufacturing Practice and used in pre-Phase I toxicity studies in rabbits to determine the highest dose of the standard immunocontraceptive formulation that would not produce muscle irritation at the site of injection. These studies are ongoing and, if successful, a new Phase I clinical trial application will be made.

Emergency contraception

In 1992, the Programme showed that a single 600 mg dose of mifepristone was effective as an emergency contraceptive. Based on subsequent work indicating that lower doses of mifepristone might also be effective, the Programme compared the efficacy of 50 mg and 10 mg doses of mifepristone with the 600 mg dose in women within five days of unprotected coitus. The results showed that the failure rates in the three groups were comparable, ranging from 1.1% to1.3% for all groups. A comparison of the number of expected and actually observed pregnancies indicated that each dose prevented 85% of the pregnancies. A common side-effect was delay in onset of the next menses, which increased with increasing mifepristone dose. These results have practical implications since the lower dose of mifepristone will be cheaper, a significant consideration particularly in developing countries.

In 1993, Programme-supported research suggested that levonorgestrel was as effective as the Yuzpe regimen of emergency contraception, but had fewer side-effects. To confirm this, the Programme supported a double-blind, randomized study that included 1998 women in 14 countries. The results showed that levonorgestrel treatment was more effective than the Yuzpe regimen, and that fewer women receiving levonorgestrel reported side-effects, such as nausea, vomiting, dizziness and fatigue. Another important finding was that pregnancy rates for both treatment regimens increased with increasing time between unprotected coitus and receiving treatment. These findings, which were published in 1998, have had a major impact on emergency contraception services, with authorities in several countries expressing interest in registering the levonorgestrel method.

An important question remaining is whether mifepristone is a better emergency contraceptive than levonorgestrel. A trial to answer this question is under way.

Natural family planning

The "rhythm" or "calendar" method is the most commonly used method of natural family planning worldwide. The Institute for Reproductive Health (IRH) at Georgetown University, Washington, DC, USA has derived a blanket rule by which women with regular cycles abstain on days 8-19 of the menstrual cycle; a bead collar is used to help the women keep track of cycle days. IRH is initiating a multicentre project to study the effectiveness and acceptability of the 8-19 day rule method, and the Programme is considering potential support to save centres in sub-Saharan Africa.

Lactational amenorrhoea

In the past two years, several papers were published reporting the results from a large multinational programme study that investigated the relationship between lactational amenorrhoea and breastfeeding practices and whether there were significant differences in the period of lactational amenorrhoea between different populations with similar breastfeeding practices. Ten factors were found to be related to the duration of amenorrhoea, seven of which had to do with infant breastfeeding characteristics. Among other factors, the risk that menses would return was reduced by: a shorter interval between birth and the first breastfeed; delaying supplementation of breastfeeding with food or drink; and by increasing the duration and frequency of breastfeeds. The results supported the Bellagio Consensus and confirmed that the lactational amenorrhoea method is a viable approach to postpartum contraception.

Non-surgical abortion with mifepristone plus misoprostol

There is a need to improve the efficacy of the sequential regimen for non-surgical abortion (mifepristone followed by a prostaglandin such as misoprostol or gemeprost), and to reduce the post-abortion bleeding associated with its use. A study of 1589 women in the first trimester of pregnancy was carried out to compare the efficacy of a single dose of either 200 mg or 600 mg of mifepristone followed, 48 h later, by a 0.4 mg oral dose of misoprostol. The results showed that the lower dose was as effective as the higher dose. This finding is important because the costs of 600 mg of mifepristone may be prohibitive in developing countries.

A problem with the above regimen is that the effectiveness of the mifepristone-misoprostol combination is too low to justify its use by women with menstrual delays of more than 21 days (49 days' gestation). Higher doses of mifepristone do not increase efficacy in this regard. Hence, the Programme is focusing on the prostaglandin component to see if a regimen can be identified that would be suitable for pregnancies of up to 63 days' gestation. For example, an ongoing study is comparing the efficacy and side-effects of repeated doses of misoprostol, given after 200 mg of mifepristone.

Hormonal contraceptives for men

Testosterone buciclate

Testosterone buciclate shows promise as a three-monthly injectable contraceptive for men. In 1998, Programme-supported research led to the formulation of a stable, 400 mg/ml suspension of the compound, that would be suitable for preclinical and clinical trials. Meanwhile, discussions have been held with the US National Institutes of Health and a potential industrial partner concerning the licensing of testosterone buciclate, both as a male contraceptive and for androgen replacement therapy in hypogonadal men.

Testosterone undecanoate

Testosterone undecanoate has shown promise as a six-weekly injectable contraceptive for men. During the biennium, the Programme has been supporting a multicentre study in China to see how quickly and to what extent this androgen suppresses spermatogenesis, and for how long sperm production remains suppressed. This study is still ongoing. A concurrent study, to assess the acceptability of testosterone undecanoate as a male contraceptive, is also ongoing and involves the participants of the efficacy study and their partners.

Basic research into human reproduction

The Programme continues to support basic research to identify new leads for regulating male fertility; for contraceptive methods that could be used once a month by women; and for improving the performance and acceptability of progestogen-based methods of fertility regulation.

Endometrial bleeding

Many of the approximately 20 million women who use progestogen-only methods of contraception endure irregularities in vaginal bleeding caused by these methods, but options to alleviate this problem are few. Thus, the Programme has supported research into the mechanism of normal menstruation, and particularly into understanding how contraceptive steroids, such as progestogens, affect this process.

Results of this work suggest that normal menstruation is an inflammatory response to the withdrawal of progesterone, rather than a vasoconstrictive event as had previously been thought, and that this leads to destruction of the endometrial tissue by cells of the immune system. On the other hand, progestogen-induced endometrial bleeding is intermittent, unpredictable and occurs from superficial veins and capillaries. Work supported by the Programme confirmed that progestogen-induced bleeding was associated with vascular frailty and abnormal angiogenesis, and provided further evidence that progestogen-induced bleeding was associated with abnormal levels of enzymes involved in the destruction of connective tissue.

In 1998, two studies were launched to see if different treatments could ameliorate the effects of progestogen-induced bleeding. These studies are expected to be completed by mid-2001.

Male reproductive physiology

Triptolide is a compound isolated from the roots of the Chinese medicinal plant, Tripterygium wilfordii, that causes infertility in male rats and mice and in men. Programme-supported research during the biennium found that triptolide induced no signs of clinical toxicity or mortality in the test animals and no alterations in chromosome structure or number. Studies are ongoing to examine the mechanisms underlying the antifertility effects of this compound.

In 1998, a three-year project to study the mechanisms of spermatogenesis was completed. The results show that a truncated form of the receptor, c-kit, is able to activate oocytes to undergo parthenogenetic cell division. The normal protein receptor is found in sperm cytoplasm, and the research suggests it may be involved in oocyte activation and subsequent egg development. Thus, it may offer a novel target for male contraception. Research is ongoing in mice to see if animals lacking the truncated version of the receptor exhibit normal spermatogenesis and whether the spermatozoa they produce are capable of fertilization and egg activation.

Mechanisms of implantation - The WHO/Rockefeller Foundation initiative on implantation research

As a result of discussions in 1997 between the Programme and the Rockefeller Foundation a joint research initiative in the area of implantation was established. Anti-implantation and menses-inducing agents have long been seen as attractive options for fertility regulation. During 1999, six proposals were funded that cover three broad areas of research: (i) basic research in vitro and in vivo, mainly at the molecular level; (ii) research using animal models; and (iii) clinical research on the mechanisms of action of putative anti-implantation agents and menses inducers.

EXPANDING FAMILY PLANNING OPTIONS

Emergency contraception

In 1998, the Programme published the results of a large, multinational study comparing levonorgestrel with the Yuzpe regimen for emergency contraception. The study demonstrated that levonorgestrel treatment was clearly superior to the older Yuzpe regimen and had fewer side-effects. This had a major impact on the provision of emergency contraception and authorities in at least 20 countries have registered the levonorgestrel-only method. This study also helped make emergency contraception better known and more available to women in several parts of the world.

The Programme continues to play an important role in the Consortium on Emergency Contraception. The Consortium is dedicated to making the levonorgestrel method of emergency contraception available to developing countries. The Programme has lead responsibility for assessing the introduction of this product in two Asian countries, Indonesia and Sri Lanka, and participates in disseminating a package of informational materials that cover a variety of emergency contraception issues. The package, prepared by the Consortium, is targeted to both policy-makers and service providers, and is now produced in English, French and Spanish.

The female condom

In a collaboration with UNAIDS and the WHO Initiative on HIV/AIDS/Sexually Transmitted Infections, the Programme is continuing its activities to make the female condom more widely available and utilized. In 1999, for example, the in-house Condom Working Group developed a detailed planning and programming guide for integrating the female condom into existing national family planning and other reproductive health programmes. Stage II research projects are continuing in South Africa and Zambia to study the introduction of the female condom, and close links are being maintained with several southern African countries involved in introducing and marketing the product.

A series of studies continued to examine the feasibility and safety of re-using the female condom, since it is well-documented that some women do wash and re-use them to save money. In one small study in South Africa, the majority of respondents found the idea of washing and re-using the female condom to be acceptable. Another study found that household detergent effectively removed microbial contaminants from female condoms for up to 10 washes, and that this treatment did not impair the structural integrity of the condom. Also, even though handling the condoms, washed or not, caused some microbial contamination this was not considered to pose a health risk.

The diaphragm

A study of the diaphragm effectiveness and women's attitudes towards its use was completed during the biennium. The investigators concluded that private clinics, where client-provider interaction is more personal, might be better starting points for introducing the diaphragm, although a small proportion of women at all clinics would be interested in the method. As a result of the study, the Turkish Ministry of Health agreed to make the diaphragm available in Turkey.

EVALUATING REPRODUCTIVE HEALTH CARE

Steroid hormone contraception and the risk of cardiovascular disease

In 1998, the WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (CVD) published additional results on the cardiovascular risks associated with the use of progestogen-only pills, progestogen-only injectables and combined (estrogen plus progestogen) injectables. The data showed there was little or no increase in the risk of stroke, venous thromboembolism, or acute myocardial infarction associated with the use of oral or injectable progestogen-only or of combined injectable contraceptives.

A supplementary questionnaire conducted as part of the CVD study examined whether migraine headaches were a risk factor for stroke in women using oral contraceptives. The results of the questionnaire confirmed that for women with a history of migraine but not for women without such a history oral contraceptives increased the risk of ischaemic stroke. In general, the results from this study underscored the conclusions from the full CVD study, that women who do not have a history of cardiovascular risk factors are not at increased risk of ischaemic stroke if they use low-dose oral contraceptives.

To place the cardiovascular risks associated with using hormonal contraception in the context of overall risk for women, the Programme developed a model that incorporates age, smoking, contraceptive use and the presence of other risk factors. The analysis concluded that oral contraceptive use did not significantly increase mortality rates (through cardiovascular disease) in women under 35 years of age, even among smokers. The minimal risks posed by using oral contraceptives must therefore be weighed against the advantages of a convenient, rapidly reversible and highly effective method. However, the risks are different for women over age 35.

The influence of hormonal contraception on bone mineral density

Bone fractures associated with osteoporosis are a major cause of mortality, morbidity and medical expense worldwide. To investigate whether hormonal contraceptives affect bone mass and promote osteoporosis, the Programme supported a study in Bangladesh, Brazil, China, Egypt, Mexico, Thailand and Zimbabwe. The results showed there was a small loss of bone mass shortly after the women started taking progestogen-only contraceptives, but this reversed when they stopped taking the contraceptives.

A five-year longitudinal study is under way in Durban, South Africa, to evaluate the impact of the progestogens, DMPA and norethisterone enantate, and combined oral contraceptives, on bone density in young and older women. The younger women were included in the study because bone mass may reach a peak at about 20 years of age; and peak bone mass may be an indicator of osteoporosis risk later in life. For women approaching menopause, there might be an advantage to using a contraceptive that maintains bone mass, or does not accelerate the rate at which bone mass is lost in the decade or so before menopause.

Post-marketing surveillance of Norplant

In conjunction with Family Health International and the Population Council, the Programme supported a multicentre, post-marketing study of Norplant in eight developing countries. The study showed that malignant neoplastic diseases or cardiovascular events did not occur more frequently in women who used Norplant, compared with users of other methods. The large study confirmed the high efficacy of Norplant for preventing unwanted pregnancies and suggested that the method is safe and well tolerated. Several papers based on this study will be published in 2000.

The long-term safety and efficacy of intrauterine devices

Intrauterine devices (IUDs) are used by some 130 million women worldwide. Between 1989 and 1993, the Programme initiated three large-scale, multicentre studies to investigate the safety and efficacy of the copper IUDs commonly used in family planning programmes in developing countries.

A study to compare the Multiload 375 and TCu380A IUDs in eight countries is following the subjects for 10 years. Interim results show that from the second year onwards there is a significantly higher pregnancy rate with the Multiload 375 compared with the TCu380A.

A randomized controlled trial is comparing an IUD that releases 20 mg/day of levonorgestrel with the TCu380A in 20 centres worldwide. After five years of study, interim results show that, although the pregnancy rate with the levonorgestrel IUD is low, nearly 20% of the women discontinued use because of amenorrhoea.

A prototype of the "frameless" IUD was compared with the TCu380A in over 2000 women, since the main side-effects causing women to stop using IUDs are believed to be related to the size of the IUD frame and its shape.

However, the expulsion rates with the prototype frameless IUD were no better than with TCu380A and the study was closed down in 1997.

HIV and steroid hormone contraception

The Programme has developed a study to determine whether steroid hormone contraceptives influence the progression of HIV, by comparing HIV-infected women taking steroid contraceptives with HIV-infected women not taking steroid contraceptives. A pilot study to test instruments and logistics was completed in four countries in 1999 and the main phase of the study will begin in 2000. The Programme also initiated a study to examine the effects of steroid contraceptives on HIV shedding in the cervical-vaginal secretions of HIV-infected women who do not have AIDS-defining conditions. A pilot study was completed in 1999 and the main study will start in early 2000.

Primate studies have shown that simian immunodeficiency virus can be transmitted through the vaginal epithelium, and that progesterone administration leads to a thinning of the vaginal epithelium and increased susceptibility to infection with this virus. Consequently, the Programme sponsored a study in Sweden of women using the oral contraceptives, Norplant and DMPA, and a comparison group not using hormonal contraceptives. Results from this study are expected in 2000.

Prostate cancer and vasectomy

Studies performed in the USA in the 1980s and early 1990s raised questions as to whether vasectomy increased the risk of prostate cancer. In developing countries where vasectomy and prostate cancer are common, these concerns were particularly germane. Thus, the Programme undertook a multicentre study in China, Nepal, and the Republic of Korea to study the relationship between vasectomy and prostate cancer. The results showed that the risk of prostate cancer in vasectomized men was slightly greater, compared with non-vasectomized men. However, the number of extra cases attributable to the increased risk was only one in 100 000 vasectomized men.

Research into pregnancy and delivery care

The Programme completed a trial involving 24 703 women in Argentina, Cuba, Saudi Arabia and Thailand to evaluate the effects of a new antenatal care programme on the health of mothers and newborns. Data collection was completed in 1999 and, in 2000, the efficacy of the new programme will be analysed in comparison with the standard care programme, based on the outcomes for the mothers and newborns. In conjunction with this trial, an evaluation was done whether the new programme of antenatal care is more cost-effective than existing services.

Postpartum heamorrhage is a leading cause of maternal death. The use of agents such as oxytocin and ergometrine help reduce the bleeding, but they need to be administered by injection and sometimes require refrigeration. In contrast, the prostaglanding analogue misoprostol is stable at room temperature and can be administered orally. In 1997, the Programme launched a multicentre trial to see if an oral dose of misoprostol was more effective in preventing postpartum haemorrhage than oxytocin. First results from this study will be published in 2000.

Anticonvulsants are given to women with pre-eclampsia in the belief that they reduce the risk of eclampsia and improve the outcome for mother and infant. But there are few hard data about the overall hazards and benefits of such treatment. The Programme is co-sponsoring a trial to evaluate whether magnesium sulfate given as an anticonvulsant improves the outcome for mother and newborn. It is anticipated that a total of nearly 10 000 women will eventually be enrolled.

The Programme is also collaborating with centres in Latin America in a trial to evaluate the effectiveness of a systematic second opinion in reducing Caesarean sections. The goal is to reduce Caesarean sections in maternity units by 25%, without adversely affecting the mothers and their babies. The intervention part of the study started in Cuba in 1999 and the results from some 140 000 deliveries are expected to be available in 2000.

ASSESSING AND IMPROVING REPRODUCTIVE HEALTH SERVICES

To help governments broaden both their technology base and their options for delivering health care services, the Programme developed, in the early 1990s, a "strategic approach" for introducing methods of fertility regulation. The strategic approach considers not only whether there is a need to improve the provision of existing methods, or whether there are new contraceptive methods that need to be introduced, but also whether current methods that may be unsafe or inappropriate should be withdrawn. Until the end of 1996, the emphasis of the strategic approach was on contraceptive introduction, but since 1997 the scope has been broadened to address a range of reproductive health matters.

The strategic approach has three stages. Stage I consists of an assessment of users' needs and perspectives, available technologies and services, and the capabilities of the service delivery system. These issues are all considered within the broader context of the reproductive health, sociocultural, political and resource settings. Stage II involves action research to design and test optimal models for introducing technologies and services, while improving the overall quality of care. The purpose of Stage III is to disseminate the information and apply the research findings to policy development and wider implementation.

Country activities during the biennium

In Brazil, a Stage II research project was completed in one municipality, and results showed there was a considerable improvement in the quantity and quality of reproductive health services provided. A Stage III project was designed to test if results could be replicated in four other municipalities with less intensive technical support. An evaluation of the project is under way.

A workshop in China on the use of the strategic approach was organized by the Programme, in collaboration with the International Council on the Management of Population Programmes and the University of Michigan, Ann Arbor, Michigan, USA. The workshop was designed for policy-makers, technical experts and women's groups and will be followed up by a Stage I assessment to investigate the potential for introducing different types of IUDs in the national family planning programme.

In Ethiopia, a Stage I assessment was undertaken in 1997 to help the Ministry of Health evaluate broad reproductive health needs in the country. In 1998, a dissemination workshop was held to review the findings of the assessment, and planning for Stage II research began in 1999 in collaboration with UNFPA.

In the Lao People's Democratic Republic, the Programme has also provided assistance to the Mother and Child Health Institute to implement a comprehensive assessment of reproductive health needs. Following a review of the reproductive health care situation in Laos, field work for the Stage I strategic assessment was undertaken in early 1999, and the findings were discussed at a national dissemination workshop in June 1999. The assessment report made a series of specific recommendations about the development of a comprehensive reproductive health policy, focusing on issues related to contraception, maternal health, RTIs including HIV, and adolescent reproductive health.

In Myanmar, the major objectives of the Stage II research project initiated include: improving the availability of hormonal contraceptives; discouraging the use of hormonal contraceptives that are of low efficacy or of unproven safety; reintroducing the use of IUDs; streamlining the process of tubal ligation for women who request sterilization; promoting the idea of dual protection against pregnancy and STIs; and increasing the involvement of men in reproductive health.

In Romania, the Programme supported a study to examine the perspectives of both users and providers towards adding non-surgical abortion, using mifepristone and misoprostol, to the surgical abortion services already offered. The study also investigated the service delivery adaptations necessary to add non-surgical abortion.

In South Africa, a Stage II project was undertaken in an attempt to expand contraceptive options. The project focused on the introduction of female condoms and emergency contraception, the promotion of the male condom for both contraception and prevention of STIs/HIV and the development of an improved referral mechanism for sterilization services. The project assisted in the development of national policy and technical guidelines, of messages and materials to support community education campaigns, and of a package for training health staff in reproductive health issues. While activities were ongoing, the donation of a million female condoms has led to the expansion of the project from the initial three provinces to an additional six provinces. This expansion is part of the effort to develop strategies for the national introduction of the female condom.

In Viet Nam, a Stage II study to develop strategies for introducing DMPA and for strengthening reproductive health services was completed in 1998. The project developed training curricula and IEC materials for service providers and leaders of community organizations, and focused on ways of strengthening management and supervision of services. The Stage II work demonstrated that introducing DMPA enhanced the contraceptive choice for women, and that good counselling and follow-up care increased the continuation rates for DMPA use. In 1999, a project to facilitate a wider introduction of DMPA, and activities to improve the quality of care in providing all contraceptive methods, began in 34 of the 53 provinces of Viet Nam.

In the Copperbelt region of Zambia, based on the results of an assessment, a Stage II project was implemented in 11 rural health centres. The project introduced DMPA and emergency contraception as a means of expanding contraceptive choice, and also trained providers in all the contraceptive options available. In mid-1999, the impact of the project on the quality of care was evaluated. The results suggested that key factors in ensuring client satisfaction with their method of contraception, including DMPA, were the quality of service provided and a broad choice of contraceptive options.

Evaluation of the strategic approach for introducing methods of fertility regulation

During the biennium, the three-stage strategic approach was evaluated to see if it did improve the delivery of contraceptive methods, and how it could be strengthened. The report concluded that the strategic approach had been successful in broadening the approach to introducing contraceptives. In countries where the strategic approach had been used, it was found to be invaluable for developing policies that expanded contraceptive choice, and helped strengthen the quality of care in family planning and other reproductive health services. But the report also found that the strategic approach was complex, time-consuming and relied heavily on technical assistance, and it was suggested that more attention be given to resource and sustainability issues throughout the process.

Product management

During the past two years the Programme continued work on product management, to ensure the quality of contraceptive products. For instance, in 1998, the Programme supported activities to examine quality-control problems with several public-sector contraceptives in Bangladesh. Advice was given to the Government to help it develop procedures for assessing and maintaining the quality of contraceptives.

Mapping the best reproductive health practices

The best practices and policies for health care are based upon sound scientific evidence. In 1998, the Programme decided that a systematic review be conducted of all planned interventions before selecting them for further research and certainly before introducing them into practice. To accomplish this, access to evidence-based scientific information is a prerequisite and, consequently, the Programme has supported the dissemination of systematic reviews.

The main tool within the Programme for disseminating information is The WHO reproductive health library (RHL). This annual electronic journal is based on Cochrane Reviews. RHL was launched in earley 1998 and, in 1999, RHL No. 2 was published that included an additional 13 Cochrane Reviews, bringing the total number of reviews to 40. A Spanish translation of RHL number 2 was also published in 1999. Negotiations were initiated in 1999 to prepare a Chinese version in 2000.

BUILDING NATIONAL RESEARCH CAPABILITY IN REPRODUCTIVE HEALTH RESEARCH

The main strategy for building research capacity in developing countries has been to award research grants to train scientists and support staff at research institutions, as well as to strengthen infrastructure such as research facilities and equipment. During the biennium, 47 institutions in developing countries received support from the Programme and, in 1999, there were 54 designated WHO Collaborating Centres for Research in Human Reproduction.

Africa and the Eastern Mediterranean region

Twenty-four countries in Africa and the Eastern Mediterranean region collaborated with the Programme during the biennium. Seven institutions in these countries received Long-term Institutional Development Grants, three received Resource Maintenance Grants and 16 were awarded grants for library support and the purchase of consumable laboratory supplies. Two of the three priority research areas identified earlier continued to be developed.

Female genital mutilation (FGM)

In 1998, a wide-ranging proposal, developed by the Programme and the former Women's Health Unit, to prevent FGM in sub-Saharan countries was selected for support by the United Nations Foundation, Inc. The proposed research will be conducted in Burkina Faso, Cameroon, Gambia, Ghana, Kenya, Nigeria and the Sudan. The main study is expected to last three years and the results will contribute substantially to the world-wide information on the subject.

Improving reproductive health services for adolescents

The research project to evaluate and improve reproductive health services for adolescents was developed further in six French-speaking sub-Saharan countries: Benin, Burkina Faso, Cameroon, Côte d'Ivoire, Guinea and Senegal. To strengthen the ability of the teams to carry out the project the Programme conducted: (i) a five-day workshop to derive a consensus on methods of data analysis and to carry out an analysis of the pilot study data; (ii) a three-day workshop on how to use research to influence policies and programmes; and (iii) a one-week workshop in Côte d'Ivoire to discuss how to choose, execute and monitor interventions.

The Programme has also supported a number of training courses and workshops on identifying reproductive health priorities and on mechanisms for disseminating information. Other workshops trained epidemiologists in research methodology, and developed outlines for studying infertility, STIs and the management of postpartum haemorrhaging.

The Americas region

A total of 12 countries in the Americas region collaborated with the Programme during the biennium. During 1998, of the 163 studies conducted in regional centres collaborating with the Programme, 15 were implemented with support from the Programme's capacity building grants and another 17 with support from other Programme grants. The remaining studies received financial support from national sources (68 projects) or international agencies other than who (63 projects).

There are three regional research networks in the Americas region - clinical/epidemiological research (involving centres in Argentina, Brazil, Cuba, Guatemala and Mexico); social science research (supported by the Programme through the Centre for Population Studies in Buenos Aires, Argentina); and basic research into reproductive biology (involving centres in Argentina, Chile and Mexico). All the projects undertaken within these networks aim to strengthen regional cooperation and focus on regional research needs in reproductive health. They also foster increased linkages between more developed and lesser-developed institutions in the region. For instance, three institutions in Bolivia, Mexico and Peru, which had not formerly received support, are now being supported and benefit from the technical know-how of the more-developed institutions that are part of the networks.

In 1998-1999, eight scientists were trained in intraregional programmes in reproductive epidemiology, reproductive medicine and social sciences.

To evaluate the status of ethical review mechanisms in the 25 institutions supported by the Programme, a survey of the composition and modus operandi of their ethical review committees was conducted by questionnaire in 1998. The results showed that 88% of the centres had ethical review committees and 32% of these committees were directly affilitated to the research centre itself. The results highlighted the need for improvement, and in 1999 the Programme assisted regional institutions to improve their ethical review mechanisms.

Asia and the Western Pacific region

Over the period 1990-1997, the Programme provided technical and financial support to 22 institutions in 11 countries in the region, including the two most populated countries in the world, China and India. In order to be able to use the limited resources available more effectively in meeting the needs of the countries, the Regional Advisory Panel meeting in 1998 endorsed the following four regional strategies:

(i) concentrate collaborative efforts on selected institutions and countries and emphasize results;

(ii) draft a new strategy for building research capacity and adjust financial support accordingly, focusing on the following activities:

research projects of regional/national importance.

initiatives for joint research programmes in the region.

research training oriented to specific and attainable objectives.

national and regional cooperation and communication mechanisms.

networking in the region.

(iii) encourage regional research initiatives and networking;

(iv) seek partnerships and generate additional support for strengthening research capacities.

Also in 1998, the Asia and Pacific Symposium on Intraregional Cooperation in Reproductive Health Research was held in Shanghai, China. It was attended by 24 directors or representatives of research institutes from 13 countries in the region, who agreed that:

(i) In nearly all countries of the region more research into reproductive health was needed and research capacity needed to be strengthened.

(ii) A high priority was to initiate joint regional research programmes. The top five regional research priorities were:

RTIs, HIV/AIDS and cervical cancer

fertility regulation

adolescent reproductive health

safe motherhood

unsafe abortion.

(iii) Networking will be important for developing countries to be able to exploit the strengths of more mature countries and expand their reproductive health research capacity.

Eastern European region

In response to the reproductive health issues identified in the region, the Programme has supported a number of research projects. In Romania, a study was initiated on the determinants of contraceptive choice, to try to understand why some women do not use modern contraceptive methods. A study in Szeged evaluated the efficacy of daily doses of mifepristone (0.5mg) as an oral contraceptive. This study was stopped before completion because an unacceptably high number of the women became pregnant. A third study tested a model for classifying perinatal deaths in three newly independent states and Russia.