NCT02708446

A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Detailed description

Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Conditions

• Legally Induced Abortion Without Mention of Complication

Interventions

Type	Name	Description
DRUG	Mifepristone	200mg oral mifepristone to both study arms
DRUG	Buccal misoprostol	doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
DRUG	Sublingual misoprostol	doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-03-15
• Last updated: 2016-07-14

Locations

4 sites across 4 countries: Armenia, Nepal, Tunisia, Uzbekistan