A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

Completed 1200 enrolled Gynuity Health Projects

RandomizedSingle-groupOpen-labelTreatment

Summary

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.

Timeline

Start: 2006-10
Primary completion: —
Completion: 2007-03

Outcome

Met primary endpoint

paper Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; PMID 19037040 ↗

Publications

Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Misoprostol	Other / unclassified	800 ug	Oral

Indications

No indication recorded.