Clinical Trial: Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial
Brief 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 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. 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:
- STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;
- STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
Sponsor: Gynuity Health Projects
Current Primary Outcome: Complete uterine evacuation of the fetus and placenta without surgical intervention [ Time Frame: 48 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Gynuity Health Projects
Dates:
Date Received: December 8, 2015
Date Started: April 2015
Date Completion: June 2017
Last Updated: July 15, 2016
Last Verified: July 2016
