The Potential of Two Non-vaginal Routes of Misoprostol Administration Following Mifepristone for Medical Abortion up to 63 Days Gestation (poster)

I. Dzuba, C. Shannon, T. Britton, M.D. Creinin, A. Goldberg, R. Hanson, M. Howe, E.S. Lichtenberg, M. Molaei, L. Prine, B. Winikoff

Introduction: To avoid vaginal administration of misoprostol following mifepristone, some U.S. providers are restricting medical abortion to women with pregnancies less than 57 days’ gestational age. This multi-site randomized study explores if misoprostol 800 mcg oral and 800 mcg buccal 24-36 hours following mifepristone 200 mg are safe, effective, and acceptable regimens for terminating pregnancy up to 63 days’ gestation.

Materials and Methods: Approximately 1000 women will be enrolled in the study and randomized to take either buccal or oral misoprostol 800 mcg at home 24-36 hours following clinic administration of mifepristone 200 mg. Participants return for follow-up 7-14 days after mifepristone to determine their abortion status. Each woman completes a diary of bleeding and side effects and responds to a satisfaction questionnaire prior to exit from the study. Data collection is expected to end in May 2007.

Results: Of 468 women treated to date, complete abortion occurred in 217/224 (96.8%) women receiving buccal misoprostol and 206/218 (94.5%) of women receiving oral misoprostol (p=0.2). Surgical completion was required for ongoing pregnancy in 3 (1.3%) and 7 (3.2%) participants, respectively. Differences between study arms will be examined by gestational age and analysis will be conducted to explore the side effects profile of each treatment arm and the acceptability of the regimens to women.

Conclusion: Mifepristone followed by 800 mcg misoprostol buccally or orally may be feasible and effective medical abortion options for women up to 63 days gestation.