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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Gynuity Health Projects

Current Primary Outcome: Rate of successful evacuation of the uterus [ Time Frame: 1 week after treatment ]

uterine evacuation without the need for uterine aspiration or other surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of successful evacuation without any additional intervention [ Time Frame: 1 week after treatment ]
    uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
  • Excessive bleeding or a complication for which a woman received treatment [ Time Frame: 30 days after treatment ]
  • Induction expulsion interval after misoprostol administration [ Time Frame: one week follow-up ]
    time interval between misoprostol administration and the expulsion
  • Acceptability of assigned method to women [ Time Frame: one week follow-up ]


Original Secondary Outcome: Same as current

Information By: Gynuity Health Projects

Dates:
Date Received: January 9, 2015
Date Started: January 2015
Date Completion: January 2017
Last Updated: July 15, 2016
Last Verified: July 2016