NCT02633761

Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death

Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.

Detailed description

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening 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 repeated doses of 200mcg buccal misoprostol given every 3 hours; 2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.

Conditions

• Fetal Death

Interventions

Type	Name	Description
DRUG	Mifepristone	200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
DRUG	Placebo	placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
DRUG	Misoprostol 200mcg	Buccal misoprostol 200mcg

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2015-12-17
• Last updated: 2019-02-11

Locations

3 sites across 2 countries: Mexico, Vietnam