Misoprostol for Treatment of Incomplete Abortion in Madagascar

P. Blumenthal, J. P. Rakotovao, A. Diop, B. Winikoff

Objective: 600 mcg oral dose misoprostol for treatment of incomplete abortion is highly effective. Pharmacokinetic studies show that oral and sublingual routes of administration produce the shortest time to peak serum levels of misoprostol, but sublingual administration results in prolonged high serum levels. This study aims to show that sublingual misoprostol may permit lowering the dose to treat incomplete abortion.

Materials and Methods: 200 women < 12 weeks LMP seeking treatment for clinically diagnosed incomplete abortions, were randomized to either receive 600 or 400 mcg misoprostol orally or sublingually respectively. Success was defined as a completed abortion without surgical intervention. Women returned for follow-up and evaluation of abortion status after 7 days. Women with a continued incomplete abortion were offered an extended follow-up visit (up to 15 days) or immediate surgical evacuation. Exit interviews were conducted once the abortion was completed.

Results: Preliminary results show high success rates for both routes: 96.3% for sublingual, n= 57 (95% CI 89.8%, 98.5%); 94.7% for oral, n= 54, (95% CI 85.4%, 98.9%). 96.4% (95% CI 90.7%, 98.8%) of women in both groups reported being either satisfied or very satisfied with the treatment. The majority of women also reported side effects to be tolerable (93.7%, 95% CI 87.3%, 97.1%)). Over 83% (N=114) correctly self-assessed their abortion status, compared to clinician assessment.

Conclusion: 400 mcg sublingual misoprostol appears to have a safety and efficacy profile comparable to the 600 mcg oral dose for the treatment of incomplete abortion. This reduced dose may have important implications in terms of cost and availability.