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In this section you will find information about Gynuity's work to improve medical abortion services in four ways:

 
>

By introducing medical abortion in developing countries

> By improving medical abortion regimens
> By decreasing use of routine sonography
> By developing misoprostol alone regimens for early termination of pregnancy

Complications of abortion are among the most important causes of maternal death globally. In Africa, it is estimated that there are 22 unsafe abortions per 1,000 women; nearly one-fifth of all maternal deaths in the region are linked to unsafe abortion practices.

In many low resource countries with limited access to health care services and few trained surgical abortion providers, medical methods of abortion promise to help reduce maternal morbidity and mortality. Furthermore, many women prefer abortion induced by drugs to surgery. Enabling women to choose an alternate method of abortion will improve access to safe services and increase satisfaction.

Medical abortion is a good method for low resource countries because:

> It is a simple, easy-to-use method that can be adapted for low resource settings;

> The drugs used are stable at ambient temperatures and do not require special storage facilities;

> Surgical skills are not needed, so medical abortion can be safely delivered by a larger pool of providers; and

> Women and providers may prefer this non-surgical option.

Gynuity Health Projects tracks the approval of the medical abortion drugs, mifepristone and misoprostol, throughout the world. To download maps that reflect our latest information about the registration of these medications follow the link below.

> Maps of mifepristone and misoprostol availability

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Introduction of Medical Abortion in Developing Countries
Mifepristone medical abortion requires the use of two drugs: mifepristone and misoprostol. Mifepristone is an antiprogestin taken orally during the first trimester of pregnancy. It blocks receptors of the hormone progesterone. As a result, the lining of the uterus can no longer sustain the growing embryo. The drug also increases prostaglandin levels and dilates the cervix, facilitating abortion. Misoprostol is a prostaglandin analog that is marketed worldwide in over 60 countries for treatment and prevention of gastric ulcers. It is widely used “off-label” for a number of reproductive tract indications.

One tablet of mifepristone is swallowed first, causing the embryo to stop growing. Two days later, the woman takes misoprostol, causing contractions of the uterus and expelling the uterine products. The timing, dose, and route of administration of misoprostol often vary slightly. Studies have shown that these drugs effectively terminate more than 9 out of 10 pregnancies in the early first trimester.


To date, mifepristone has been registered in 35 countries, but most of these are in the industrialized world. (The notable exceptions are China, one of the first countries to use the drug and the one with the most widespread use, Tunisia, South Africa, India, and Vietnam.) Fewer developing countries have made this drug available in part because of more restrictive abortion laws, the expense of the drug, and reluctance to allow the pill on the market (sometimes fostered by current providers of abortion services). Even doing clinical testing of the acceptability and feasibility of the use of the drug can be daunting because of unclear regulatory requirements and political controversies.

Current or planned Gynuity activities in this area include:

> Demonstration projects using medical abortion regimens to introduce the technology in new settings, particularly in places with limited access to legal abortion services;

> Studies to inform service delivery protocols for low resource settings
> Collaboration with pharmaceutical companies to facilitate the registration of the drugs internationally;
>

Partnering with large nongovernmental organization service providers to introduce medical abortion;

>

Creation of policy, sharing of information, and advocacy for medical abortion technologies; and

> Organization of seminars, educational opportunities, and training courses to share information and stimulate interest in the technology’s potential among service providers and other interested colleagues.


Download "Introduction of Medical Abortion in Developing Countries" in PDF

Gynuity produced a tool for providers and policy makers who are interested in introduction of medical methods for safe termination of early pregnancy. Providing Medical Abortion in Developing Countries: An Introductory Guidebook is now available in Arabic, English, French, Portuguese, Romanian, Russian, Spanish, and Vietnamese in PDF format.  Please contact Gynuity to obtain the print version of the guidebook in English, Russian or Spanish.

Follow this link to download the guidebook in various languages.

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Improvements in Medical Abortion Regimens
Medical abortion regimens using mifepristone with misoprostol and misoprostol alone are quickly gaining support worldwide as safe and effective alternatives to surgical abortion.

However, it is widely believed that the most frequently registered regimen may not be ideal for use in a range of settings. Refinements to the standard regimen of mifepristone and misoprostol promise to increase access to this method while sustaining high safety, efficacy, and acceptability profiles. Each of these refinements also may lower the costs of providing safe abortion services.

Gynuity has helped to support a report that analyzes ways in which early medical abortion services in the United Kingdom can be improved. The report, produced by the Family Planning Association of the United Kingdom, summarizes a framework for action. The Executive Summary of “Early abortions: Promoting real choice for women” is provided below.

> Download the Executive Summary in PDF format


Ways to improve the regimen:

> Reduce doses of mifepristone, thereby lowering the cost of the method;

>

Offer home administration of misoprostol, entailing fewer clinic visits;


> Implement improvements to misoprostol dosage, timing, and route of administration that may increase efficacy and decrease time to completion of abortion; and

> Create simplified alternatives to management of follow-up.

 

Current or planned Gynuity activities in this area include:

> Studies testing home use of misoprostol with mifepristone medical abortion in a range of settings;
> Clinical trials of variants in dosage and route of misoprotol administration with mifepristone medical abortion;
> Clinical trials to investigate use of medical abortion at later gestational ages;
 
> Policy meetings in the United States and internationally to share information about clinical refinements to the methods; and
> Information-sharing via creation and dissemination of an Instructions for Use document on misoprostol alone for medical abortion.

Download "Improvements in Medical Abortion Regimens" in PDF

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Decreased Use of Routine Sonography

Mifepristone medical abortion has been rapidly accepted in the United States since its 2000 approval. Yet the technology has not yet been able fully to deliver on its promise to offer American women a new, widely available alternative to surgical abortion for a number of reasons, among them the requirement that women come in to a clinic for a minimum of two visits and the tendency of those offering medical abortion to insist on pre- and post-procedure sonography as part of treatment. These two factors render medical abortion more burdensome and expensive than it might otherwise be and limit its provision to practitioners who have sonography machines and the skills to use them.

Gynuity Health Projects has launched a project to lay the groundwork for decreasing both the number of clinic visits and the use of sonography in medical abortion. The project involves more than 4,000 women recruited from four clinics providing medical abortion. The study aims to determine if the simplified approach to medical abortion is as successful as current practice of routine sonography at diagnosing ongoing pregnancies. The study also seeks to discover whether or not symptoms, examination, and a low-sensitivity pregnancy test can, without recourse to sonographic data, in most cases adequately determine duration of pregnancy, likelihood of ectopic pregnancy, and presence of ongoing pregnancy or other post-abortion complications.

For more information about this study contact Wesley Clark (wclark@gynuity.org).

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Misoprostol Alone for Early Termination of Pregnancy
A wealth of evidence in the scientific literature indicates that misoprostol alone can be used safely and effectively for early pregnancy termination. However, no formal drug development strategy or authoritative advice on appropriate regimens existed for use of misoprostol for this indication—until now.

To address the need for clinical guidelines for early abortion with misoprostol alone, Gynuity Health Projects and the Reproductive Health Technologies Project convened a small expert meeting in July 2003. Prominent researchers and experts on use of misoprostol for early abortion, training and advocacy organizations, and leading obstetrician-gynecologists attended this gathering. They carefully reviewed the medical literature, discussed the clinical aspects of various regimens, and agreed on clinical advice for use of misoprostol alone for early pregnancy termination.

That advice can be found in “Instructions for Use: Abortion Induction with Misoprostol in Pregnancies through 9 Weeks LMP.” The information in this document can be used as the basis for training manuals, fact sheets, and leaflets for providers and advocates.

Follow this link to download this document in Arabic, English, French, Portuguese, Russian and Spanish. A reference list and annotated bibliography in support of these instructions are also available.

Other documents available on this topic include:

> "Route of misoprostol administration"

> "Misoprostol and teratogenicity: Reviewing the evidence"

    This document is available in English and Spanish

> "Misoprostol: An emerging technology for women's health"


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