Medical Abortion Program Brief

MEDICAL ABORTION

For over two decades, medical abortion using mifepristone and misoprostol has proven to be a safe, effective, and acceptable option for terminating pregnancies. Millions of women have chosen to have medical abortions because they wish to avoid surgery or because they feel the method seems more natural and affords greater autonomy and privacy. Medical abortion is an important choice to offer all women; in low-resource settings and where access to surgical methods is limited, it could potentially dramatically reduce maternal morbidity and mortality from the estimated 19 million unsafe abortions that occur each year.1

Why is medical abortion a good method for low resource settings?

Our primary goal is to increase access to medical abortion, especially in resource-poor environments.

We achieve this by:

Summary of clinical and operations research studies

Topic * Rationale * Studies * Results

Home administration of mifepristone * Although no medical reason exists to take mifepristone in the clinic, the medical abortion process almost everywhere requires that ingestion occur under the direct supervision of a clinician. Allowing women to take mifepristone at home would grant them greater flexibility in determining the time of their bleeding. * We recently conducted a study in the United States, Moldova, and Nepal that allowed women to choose where they took mifepristone, and documented the safety and acceptability of this new option. * Between 46-98% of women in the three countries chose to take mifepristone at home, and were very satisfied with their experience. Women were able to follow instructions about when to take the two medications. Providers did not feel this option posed an undue burden on their service.

Exploring oral routes of misoprostol administration * Regimens using 800 mcg vaginal misoprostol have been highly successful ending pregnancies up to 63 days since LMP, but many women prefer to take medication orally. Establishing equally successful oral misoprostol regimens would increase women’s satisfaction with the method. * Studies have examined regimens of 200 mg mifepristone followed by:; 800 mcg buccal misoprostol (pills are held in the cheek); 400 mcg sublingual misoprostol (pills are held under the tongue); 400 mcg buccal misoprostol * All three regimens have proven highly effective for terminating pregnancies up to 63 days since LMP. Due in part to the strong evidence provided by Gynuity’s study of 800 mcg buccal misoprostol, Planned Parenthood Federation of America revised their guidelines to recommend this regimen through 63 days since LMP.

Extending the gestational age limit * Medical abortion conducted on an outpatient basis is safe and highly effective through 63 days since LMP. Women who narrowly miss this cutoff often wish to use medical abortion but clinicians are uncomfortable given the lack of data to support its use past 63 days since LMP. * We tested the effectiveness and acceptability of medical abortion at 64-70 days since LMP versus 57-63 days since LMP in the U.S. (using a mifepristone + 800 mcg buccal misoprostol regimen) and in India, Tunisia, the Republic of Georgia, and Ukraine (using a mifepristone +400 mcg sublingual misoprostol regimen). * Success rates did not differ significantly in the two groups (94% for 57-63 days since LMP vs. 93% for 64-70 days since LMP in the U.S.; and 95% vs 92%, respectively, for international sites. Acceptability was high and similar in both groups, with 81%- 88% reporting their experience was either very satisfactory or satisfactory.

Exploring optimal pain management options for early medical abortion * Medical abortion causes pain and cramping in almost all patients, which can sometimes be intense. However, data on the effectiveness of medication to control or prevent pain during medical abortion are scant. * We are currently conducting a randomized trial at two sites in the United States comparing an oral analgesic therapeutic regimen to a prophylactic regimen in women undergoing first trimester medical abortion with mifepristone and misoprostol. * The study is ongoing. The primary study outcome is experience of pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, and overall satisfaction with the abortion procedure.

Reducing reliance on ultrasonography and introducing new technologies for follow-up after medical abortion * While ultrasound is a valuable diagnostic tool, medical abortion providers may become overly reliant on this technology pre- and post-procedure to date the pregnancy and confirm complete abortions. For the 90-95% of patients who complete their medical abortion successfully with only one dose of mifepristone and misoprostol, this unnecessary use of ultrasound can lead to increased costs, unnecessary surgical intervention and prevents lower level facilities from offering the method. Since the vast majority of patients abort successfully with medical abortion and do not require in-person follow-up, it is important to explore ways to determine which patients need to come back and which do not. * Gynuity conducted a study in the U.S. of the feasibility and efficacy of an approach that promotes a more selective use of ultrasound and seeks to eliminate the need for a follow-up visit in the clinic by developing low-tech screening alternatives.; Our current studies evaluate a semi-quantitative urine pregnancy test (SQPT) that gauges hCG levels. This test gives clinicians and women rapid and accurate information about hCG levels with no office visits, no laboratory tests, and no long waits for results.; Another trial is being conducted in collaboration with the British Pregnancy Advisory Service (bpas) in the United Kingdom examining the use of technologies including text messaging and email to communicate with women after their medical abortions. * The study results suggest that algorithms based on factors noted by women – or by women and clinicians (without sonography) – can flag almost all post-abortion problems, and almost all ongoing pregnancies. * In Vietnam we found that the SQPT accurately detected all ongoing pregnancies. We are now carrying out three RCTs in Vietnam, Moldova, and Uzbekistan comparing standard medical abortion follow-up with clinic-based care to alternative follow-up schemes using the SQPT together with a symptom checklist.

Comparison of mifepristone-misoprostol and buccal misoprostol-alone regimens for first trimester medical abortion * The limited availability and high cost of mifepristone in many countries has prompted a search for alternative regimens. Misoprostol-alone regimens for early abortion have been tested for over a decade, but a confusing array of doses and dosing schedules have been used with widely varying results. * A first double-blinded, placebo-controlled study in Vietnam and Tunisia evaluated a regimen of 200 mg mifepristone followed by 800 mcg buccal misoprostol compared to 2 doses of buccal misoprostol alone taken 24 hours apart. A follow-up study was conducted in both countries with a reduced time interval of 3 hours between repeat doses of buccal misoprostol. * The results from the first and second study and second confirmed that the combined regimen was significantly more effective than the misoprostol-alone regimen studied for early medical abortion. (study 1: 96.5% mifepristone-misoprostol vs. 76.2% misoprostol only; study 2: 92.9% mifepristone-misoprostol vs. 78.0% misoprostol only)

Second-trimester medical abortion * To date no standard internationally agreed upon regimen exists for medical abortion for 2nd trimester gestations. There is renewed interest in systematically comparing combined mifepristone + misoprostol regimens to misoprostol alone due to higher efficacy rates and a shorter time to complete evacuation. * We have conducted a series of studies evaluating 200 mg mifepristone administered 24 hours before repeat buccal misoprostol doses (400 mcg) every 3 hours for a maximum of 5 doses compared to misoprostol alone on the same dosing schedule. * Pre-treatment with mifepristone resulted in over twice the chance of a complete uterine evacuation versus misoprostol alone and significantly reduced the mean induction-to-abortion interval. Based on these results, a modified protocol allowing for additional misoprostol doses up to 48 hours is being implemented in Moldova and Tunisia.

Highlights of operations research and technical support activities

Operations research: In addition to research on clinical innovations, Gynuity also conducts operational research that aims to enhance the quality, effectiveness and/or coverage of programs. For example, in recent years Gynuity has been working with the Tunisian Office Nationale de la Famille et de la Population to carry out operations research to extend the method nationally. In 2009, medical abortion was available in 10 of 24 regions; currently medical abortion is available in 22 regions. Medical abortion accounts for approximately two-thirds of abortions performed in the public sector today.

Influencing clinical guidelines on medical abortion: Gynuity provides technical support to international and national public and private sector entities to encourage inclusion of evidence-based regimens for medical abortion into clinical guidelines. At the country-level, we work to influence national guidelines on mifepristone medical abortion and to introduce new opportunities for use of this technology. Often national abortion guidelines do not contemplate the use of medicines as a treatment option and thus practical considerations such as level of care and provider type restrict health systems because services are organized around surgical procedures. In recent years we have worked to support health systems to adopt clinical and practical considerations relevant to medical abortion provision. These efforts, in part, have led to updated clinical guidelines in Armenia, the Republic of Georgia, Mexico, Moldova and Ukraine.

GYNUITY PUBLICATIONS

Since 2003 Gynuity has been producing informational resources for health care providers and women’s health advocates on the topic of medical abortion, including our most popular resource Providing Medical Abortion in Low-resource Settings: An Introductory Guidebook, 2nd Edition (2009), available in 10 languages. For more information or for copies of our publications, please contact pubinfo@gynuity.org. Summaries of over two dozen peer-reviewed articles, annotated bibliographies, service delivery guidelines and other resources on this topic can be found at www.gynuity.org

Projects in this program area are funded by the David and Lucile Packard Foundation and an anonymous donor.

June 2012

1 Organización Mundial de la Salud, 2004. “Unsafe abortion: Global and regional estimates of the incidence of unsafe abortion and associated mortality in 2000.” (Aborto inseguro: cálculos globales y regionales sobre la prevalencia del aborto inseguro y la mortalidad derivada del mismo en 2000). Cuarta edición.