Clinical Trial: Mifepristone Induction for Fetal Demise
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Mifepristone Induction for Fetal Demise, a Randomized Control Trial
Brief Summary:
Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational age or greater.
Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when compared to placebo, and in conjunction with other pharmacologic methods for induction of labor.
Expected outcomes: The addition of a progesterone receptor modulator will expedite time to delivery of the fetus and ultimately improve the experience associated with induction of labor for fetal demise.
Detailed Summary:
The investigators propose a double blinded, randomized, placebo-controlled clinical trial at the time of initiation of induction of labor for fetal demise at 20 weeks gestational age or greater.
- Diagnose fetal demise: confirm absence of fetal heart motion by attending physician as per the institutional standards and protocols.
- Confirm gestational age at presentation to labor and delivery based on available medical records and/or ultrasonography as per standard practice and institutional protocols.
- Based on inclusion and exclusion criteria potential participants will be informed about the research, offered the opportunity to contribute, and trained research staff will complete the informed consent process. After documentation of consent and discussion of the research as indicated the participants will be randomized to the intervention or control arm. Both groups will receive emotional and physical support with induction of labor as per practice guidelines and standard of care by Montefiore physicians, faculty and staff irrespective of participation or assignment.
- Interventional Arm: Ingest 200mg tab of mifepristone orally. This will coincide with or be implemented prior to the initiation of the induction of labor plan as delineated by the attending physician. The timing will be sensitive to the needs of the participant and the labor and delivery room staff.
- Control Arm: Ingest a placebo tab orally with similar physical properties. This will coincide with or be implemented prior to the initiation of the induction of labor plan as delineated by the attending physician. The timing will be sensitive to the needs of the participant and the labor and delivery room staff.
- Mont
Sponsor: Montefiore Medical Center
Current Primary Outcome: time to delivery of fetus [ Time Frame: from the initiation of medical therapy for induction to delivery of fetus ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Montefiore Medical Center
Dates:
Date Received: December 1, 2015
Date Started: February 2016
Date Completion: January 2019
Last Updated: October 14, 2016
Last Verified: December 2015
