Medical Abortion Overview

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 health 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.

Introduction of Medical Abortion in Developing Countries

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.

To date, mifepristone has been registered in over 35 countries, but most of these are in the industrialized world. 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. 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. Gynuity works in low resource settings to help support introduction of this promising technology.

Medical Abortion Regimens Improvement

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 conducts a significant amount of clinical research with the goal of refining medical abortion regimens in order to increase efficacy and acceptability, and reduce side effects and costs associated with the method.

Decrease in Use of Routine Sonography

Mifepristone medical abortion has been rapidly accepted in the US 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 are the requirement that women come in to a clinic for a minimum of two visits and the tendency to require pre- and post-procedure sonography as part of treatment. These two factors render medical abortion more burdensome and expensive and limit its provision to practitioners who have sonography machines and the skills to use them.

Gynuity has launched a project to lay the groundwork for decreasing 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 a 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.

Misoprostol Alone Regimens 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.

To address the need for clinical guidelines for early abortion with misoprostol alone, Gynuity and the Reproductive Health Technologies Project convened a small expert meeting in July 2003 to review the medical literature, discuss the clinical aspects of various regimens, and agree on clinical advice for use of misoprostol for this indication. That advice can be found in a brochure entitled “Instructions for Use: Abortion Induction with Misoprostol in Pregnancies through 9 Weeks LMP.”

Gynuity also conducts clinical research to help refine misoprostol alone regimens for early pregnancy termination with the goal of increasing efficacy and acceptability, and reducing side effects and costs associated with provision of this method.

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