NCT02342002

Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

Detailed description

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Conditions

• Missed Abortion
• Pregnancy

Interventions

Type	Name	Description
DRUG	Mifepristone	Mifepristone for treatment of missed abortion
DRUG	Misoprostol	Misoprostol for treatment of missed abortion

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2015-01-19
• Last updated: 2019-01-15

Locations

4 sites across 4 countries: Argentina, Gabon, Mexico, Pakistan