Events

WHO Call for research proposals/concept papers on Medical Abortion

WORLD  HEALTH  ORGANIZATION

 Department of Reproductive Health and Research, including
UNDP/UNFPA/WHO/WORLD BANK
Special Programme of Research, Development
and Research Training in Human Reproduction

Social Science and Operations Research in Sexual and Reproductive Health
 

CALL FOR RESEARCH PROPOSALS/CONCEPT PAPERS

ON MEDICAL ABORTION

Each year, some 205 million women throughout the world become pregnant and nearly one in five (20%) chooses to terminate the pregnancy. Of these 42 million induced abortions, approximately 19 to 20 million are estimated to be unsafe. To increase choice and access to safe abortion services and to reduce morbidity and mortality from unsafe abortions, non-surgical methods of abortion, known as medical abortion, have been developed which use safe and effective drug-based methods to terminate an unwanted pregnancy. Much progress has been made in developing effective and acceptable regimens and in the registration and affordability of drugs, all of which contribute to making medical abortion a safe, viable alternative to surgical abortion procedures such as vacuum aspiration, sharp curettage, and intra-uterine injections. Despite these significant advances, medical abortion remains under-utilized and inaccessible for many women, particularly in developing countries. Gaps remain in understanding and overcoming the social, behavioural, financial, legal, policy and programmatic obstacles that would make medical abortion available to those women who desire to use it.

Recognizing these gaps in knowledge, the Special Programme of Research, Development and Research Training in Human Reproduction at the World Health Organization (WHO) is launching a research initiative specifically focusing on medical abortion. The Special Programme is inviting social science and operations research proposals or concept papers which seek to provide an in-depth understanding of issues related to improving access to medical abortion in low-income settings. Investigators are encouraged to identify and develop a research topic that is of high priority in their local context and that will have a significant impact on programme and policy development. Suggested research topics are elaborated below and include, but are not limited to, the following areas: perspectives of women seeking abortion and of providers; strategies for training and retaining new providers and expanding the pool of trained providers in public-sector facilities; identifying barriers to access; testing interventions to improve pre- and post-abortion care provided to women who use medical abortion; and introducing medical abortion into public and private sector abortion and reproductive health services.

Background

Medical abortion was introduced in France in 1989 and, for nearly twenty years, safe, effective, and acceptable regimens of an antiprogestin (mifepristone) followed by a prostaglandin analogue (usually misoprostol) have provided an alternative to surgical abortion methods.

Despite growing access to these drugs, the full potential of medical abortion remains untapped for women with limited access to health care services in low-income settings. Mifepristone is registered in over 35 countries, most of which are in the industrialized world. As of 2007, in developing countries and countries of the former Soviet Union the drug is available in Albania, Armenia, Azerbaijan, Belarus, China, Estonia, Georgia, Guyana, Hungary, India, Latvia, Moldova, Mongolia, South Africa (in the private sector only), Tunisia, Uzbekistan, and Vietnam. Misoprostol is available in over 90 countries for the prevention and treatment of gastric ulcers and is widely used off-label for gynaecological indications. Medical abortion provides women with a safe alternative to the limitations of surgical abortion, including a lack of providers trained in surgical procedures and the need for specialized equipment. Moreover, when given the choice, studies have shown that many women prefer medical abortion.

A number of regimens for medical abortion have been investigated and refined since the introduction of the method some twenty years ago. Most commonly used is a combination of mifepristone and misoprostol, considered the gold standard, although there are increasing uses of misoprostol-alone regimens particularly in settings where mifepristone is unavailable or very expensive. Mifepristone, an antiprogestin, works synergistically with a prostaglandin (usually misoprostol) to terminate the pregnancy at up to 24 weeks gestation. Mifepristone blocks the ability of the uterus to sustain the growth of the embryo and dilates the cervix. Once the embryo has stopped growing, the prostaglandin causes the uterus to contract and expel the products of conception. In early pregnancy, medical abortion produces a complete abortion in 96% of women.

Different regimens of these two drugs have been used in different settings. The original regimen that is licensed for use in the first trimester in many countries is 600 mg of mifepristone orally followed by 0.4 mg of misoprostol orally two days later, but ongoing modifications to this regimen often produce superior results. The WHO and other expert bodies currently recommend the use of 200mg of mifepristone orally followed 36-48 hours later by 0.8mg misoprostol administered vaginally.  The feasibility, safety, and effectiveness of home use of misoprostol by the woman herself have been shown in a number of countries including the USA and Tunisia, where this is standard practice.

Medical abortion requires considerable communication between the woman and the provider. Regardless of the regimen employed or location of the administration of the drugs, medical abortion providers must give appropriate counselling about the method as common side effects, such as cramps and nausea, may cause discomfort. Counselling should also ensure that women know to seek care in the event of complications or continuing pregnancy. Thus, the quality of the provider-patient interaction plays an important role in safety and satisfaction with the procedure.

Research challenges

The beliefs, perspectives, and experiences of women, providers, and society regarding medical abortion influence the use of this method. Research is encouraged that addresses locally-identified gaps in knowledge about medical abortion. Below, topics are presented as guidelines, recognizing that the issues outlined vary significantly by country and service delivery context. The list of topics is illustrative and is not binding; other relevant research topics may be submitted with appropriate justification, including the potential of the research for impact on policies and programmes. Innovative approaches to the study design and use of research methods are encouraged.

Perspectives and acceptability of medical abortion among women in developing countries: beyond healthy, wealthy, urban women.

There has been considerable research on the acceptability of medical abortion among women in countries where abortion is legal; however, in developing countries, many of the studies interviewed women participating in clinical or introductory trials. Research is needed to explore the perspectives of users and potential users from vulnerable and underserved populations who may raise different issues from women participating in preliminary studies. To better meet the needs of all women, research is needed to fill the gaps on the perspectives and acceptability of medical abortion among poor women, rural women, women with little or no education, adolescents/youth, unmarried women, women living with HIV/AIDS, victims of domestic violence or rape, women having experienced female genital mutilation for whom the safety of medical abortion is a primary issue, migrants, and displaced persons.

Social, cultural, financial, and religious preferences for various types of regimens (route of administration, number of clinic visits, type of preferred provider, at-home administration, etc.) need to be documented. Other research questions include, how do women rate the various attributes of medical and surgical abortion in arriving at their choice of method? What barriers do women perceive in terms of access, affordability (including both formal and informal payments), and availability?  The concept of "safe" abortion has different meanings in different contexts for different constituencies. How does the perceived quality and safety of surgical abortion services influence the choice of medical abortion methods? Studies are needed to explore women’s perceptions of “safe” abortion (both clinically and socially) in legally restricted settings and the ways these perceptions influence preferences for surgical versus medical abortion.

Provider perspectives

Research is needed to explore provider perspectives on medical abortion in different settings. Topics include provider knowledge of medical abortion, exploring provider preferences for type of method (i.e. surgical versus medical), and understanding provider perspectives on client compliance. Specifically, to what extent do providers believe that women of all socioeconomic backgrounds are able to comply with the regimen?  

There is a need to investigate the role of financial renumeration on the providers’ decision-making process to offer women medical verses surgical abortion. What are the important incentives (monetary or non-monetary) that influence whether a provider includes medical abortion in their practice? What are the actual cost differences to health systems and providers for providing vacuum aspiration versus medical abortion?  To what extent does medical abortion enhance or limit income generation for providers?  

Quality of care

Research is also needed on providers’ and users’ perspectives on quality of care and counselling for medical abortion. How do providers and/or users define quality provision of medical abortion based on their own experiences? Independent observations of provider-patient interactions would also shed light on practices and perceptions of quality of care.

The effect of medical abortion on unsafe abortion practice

Increasing access to medical abortion has the potential to reduce morbidity and mortality from unsafe abortion. Documenting the impact of the availability of misoprostol on abortion-related morbidity and mortality where abortion is restricted by law (i.e. Africa, Asia, and Latin America), would provide evidence of the impact of the method on reducing unsafe abortion. Research is also needed to specifically document types of morbidity among women who have used medical abortion outside clinical settings, due to legal restrictions on abortion, and who seek hospital care for incomplete medical abortion. In settings where medical abortion is permissible by law, studies are needed to assess both self-reported and clinically measured morbidities associated with the procedure in different health service settings, as these may affect compliance and acceptability of medical abortion by both providers and women.

Research is needed on women's experiences where abortion is legally restricted. How do women hear about, obtain and use medical abortion drugs? How early (and how late) in pregnancy do they seek and use the drug(s)? How many use the drug(s) alone, or involve their partner or a close woman friend or family member? Do they stay at home until the abortion is complete or carry on with their lives as normal? How do they determine whether the abortion is complete and what is the decision-making process if they think the pregnancy is ongoing and/or experience complications and seek care?

Expanding the MA provider base to include mid-level providers

Research is needed to assess the potential for expanded provision of medical abortion through different types of providers (including midwives, nurses, pharmacy personnel) in all settings, especially decentralized, low-income settings, In settings where a physician provides medical abortion, studies to test strategies for provision by trained nurses or midwives, including family planning personnel, would provide valuable evidence for increasing access and conserving resources.

The role of medical abortion counselling on contraceptive uptake.

Compared to surgical abortion, there has been little research about perceptions, acceptability, and use of contraception following medical abortion. Does the type and greater frequency of counselling required for medical abortion have greater potential to break a cycle of repeat abortions and increase post-abortion contraceptive uptake compared to surgical abortion? Should contraceptive counselling be introduced during Day 3, when misoprostol is introduced, or earlier, or at every clinic visit? What is the most effective counselling strategy for postabortion contraception uptake for surgical versus medical abortion? An under-explored area of research related to counselling is that of comparative contraceptive uptake, continuation of use, and the incidence of repeat unintended pregnancy and abortion by type of abortion method (surgical verses medical).

Legal barriers to the provision of medical abortion

In the absence of laws specifically designed for medical abortion, many countries continue to apply laws designated for surgical abortion. Studies are needed to review and assess the appropriateness, impact, and necessity of applying laws designed for surgical abortion to medical abortion, including the impact of mandated waiting periods and additional provider consent, on eligibility for medical abortion. Information on how national law influences institutional policies and provider behaviour is also needed (e.g., to the extent permitted by law, do all health care systems provide medical abortion, and, if the facility allows medical abortion, do all physicians provide it equally?). Finally, case studies to identify the most appropriate forms of law and policy for making medical abortion accessible would provide valuable guidelines for policy makers.

Strategies for introducing medical abortion to medical communities and to reproductive health services.

Medical communities may be wary of introducing a new abortion method without sufficient clinical, financial, and social support. Research is needed on the best strategies for increasing awareness of medical abortion among medical professionals and for introducing the method into clinics. To this end, studies of medical students and faculty on their knowledge of the legal status of medical abortion, their attitudes towards medical abortion and abortion generally, their familiarity with procedures, and their training in medical abortion are necessary.  Studies are needed to conduct an education and information based intervention and follow-up with a post-intervention survey in the medical community. It would be also be helpful to explore strategies for increasing receptiveness to medical abortion in medical communities.

Research is needed to best determine how to introduce medical abortion to existing surgical abortion services, as well as to services where surgical abortion is not provided, i.e. primary care settings. Evidence from a situation analysis of the feasibility of implementing medical abortion in selected clinics, including cost and infrastructure considerations, would be valuable. Information on the range of incentives and disincentives that influence provider uptake of medical abortion in their medical practices is needed, both of a monetary and non-monetary nature.

Eligibility/Conditions

1. Developing country scientists or those in countries in economic transition working in local institutions are eligible to apply. Collaboration with scientists in developed countries can be proposed, but financial support is provided only to institutions in developing countries or countries in economic transition. Collaboration between researchers, policy-makers and programme managers of abortion or reproductive health services is encouraged.
2. Support may be requested for the analysis of available secondary data or for collecting new data, if needed.  New data collection should be proposed only when no data exist to meet the objectives of the proposed study.
3. Studies proposing to use qualitative or quantitative research methods or both are eligible for support.
4. Cross-sectional, panel studies or longitudinal data collection may be proposed.  However, longitudinal studies should normally limit follow-up visits to no more than 12-18 months.
5. Large national or longitudinal studies are beyond the scope of this small grant programme.
6. Research proposals testing specific interventions for improving access to medical abortion are encouraged.
7. The support is limited to research or research interventions and does not cover service provision or other items unrelated to research.

Procedures

All submissions are first reviewed by the HRP Specialist Panel on Social Science and Operations Research in Sexual and Reproductive Health.  The Panel is composed of independent experts from around the world with multidisciplinary expertise and research experience.  Proposals recommended by the Panel are reviewed by the HRP Scientific and Ethical Review Group and by the WHO Research Ethical Review Committee. Concept papers are reviewed by the Panel for relevance, scientific design, feasibility, ethical considerations, timetable and budget and those selected are then requested to develop full proposals.  The research projects are selected on a competitive basis, using criteria of scientific rigour, justification and programmatic relevance of the proposed research topic.

Submission

Researchers are invited to submit full proposals or a 6-8 page concept paper addressing one or more of the priority research topics with a focus on developing countries or countries in economic transition. The proposals should be prepared in accordance with the format and guidelines described in the booklet entitled "Preparing a Research Project Proposal - Guidelines and Forms".  This document contains all the necessary forms and instructions, and is available on request from Ms. Sabatini-Fox at sabatinifoxn@who.int.

Should you decide to first submit a concept paper, please include the following:

• Title of the research study
• Objectives
• Rationale/justification of the proposed study
• Design and methods, including overall project design, conceptual framework, main variables (both independent and outcome), sampling procedures, analysis plans, and description of proposed intervention (if applicable).
• Ethical considerations
• Timetable and budget
• CV (abridged)

Deadline

All submissions should be made electronically on or before 15 February 2008 for a review by the Specialist Panel in March 2008. The proposals should be sent to Ms Nicky Sabatini-Fox at the email address: sabatinifoxn@who.int. Concept papers or proposals received after 15 February 2008 will be reviewed at the meeting of the Specialist Panel in October 2008.

Further information

Should you need any further information or wish to obtain a copy of the Guidelines for Preparing Project Proposals, please write or email to Ms Nicky Sabatini-Fox, using the email address sabatinifoxn@who.int or the following mailing address:

Nicky Sabatini-FoxDepartment of Reproductive Health and ResearchWorld Health Organization
1211 Geneva 27
Switzerland

Telephone: +41-22-791.33.75
Facsimile: +41-22-791.41.71