Outpatient mifepristone-misoprostol medical abortion through 77 days of gestation
ESC Congress Library. Dzuba I. May 4, 2016; 126854; A-028
Ilana Dzuba
Ilana Dzuba
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The published literature demonstrates that medical abortion effectiveness decreases slightly as gestational age increases. Current evidence supports outpatient medical abortion through 70 days of gestation. The efficacy of medical abortion 71-77 days of gestation has not been rigorously explored in outpatient settings and without repeat doses of misoprostol. This open label, non-inferiority, multi-country study compares the efficacy, side effects, and acceptability of a mifepristone and buccal misoprostol regimen for pregnancy termination among women with pregnancies 64-70 days and 71-77 days of gestation.

A total of 691 women are required to determine non-inferiority of success in women 71-77 days' LMP (one-sided margin of 6%, 90% power, α=0.05). Women with intrauterine pregnancies 64-77 days gestational age by abdominal ultrasound seeking abortion services in study sites in five countries and who meet standard eligibility criteria for medical abortion are invited to participate in the study. All consenting participants take 200 mg mifepristone followed 24-48 hours later by 800 mcg buccal misoprostol and return one week after to determine abortion status by ultrasound. Women keep a home diary to record drug administration, pregnancy expulsion (if observed), daily bleeding and pain score.

The primary outcome is rate of successful medical abortion without surgical intervention. Data collection is currently ongoing. To date, more than 520 women have been enrolled, and recruitment should be completed in the first quarter of 2016. Data will be analyzed prior to the meeting and final results will be presented.

Increasingly, providers are offering outpatient medical abortion to clients through 70 days' LMP. Due to a lack of evidence and provider concerns of reduced efficacy, increased complications, or challenges with managing the expulsion at home, women are typically denied medical abortion if the estimated gestational ages of their pregnancies exceed 70 days. The results of this study will contribute much-needed information on medical abortion through 77 days of gestation and guide a more informed selection of the most appropriate pregnancy termination method.


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