Trial Outcomes & Findings for Mifepristone Induction for Fetal Demise (NCT NCT02620904)

Last Updated: 2021-02-18

Results Overview

From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

Results posted on

2021-02-18

Participant milestones
Measure	Mifepristone following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery Mifepristone	Placebo Pill following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery placebo
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Mifepristone n=4 Participants following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery Mifepristone	Placebo Pill n=5 Participants following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery placebo	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	5 Participants n=5 Participants	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	5 Participants n=5 Participants	9 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	5 participants n=5 Participants	9 participants n=9 Participants

Timeframe: From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

Outcome measures
Measure	Mifepristone n=4 Participants following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery Mifepristone	Placebo Pill n=5 Participants following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery placebo
Time to Delivery of Fetus	14 hours Interval 3.0 to 27.0	20 hours Interval 2.0 to 25.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Montefiore Einstein

Phone: 7184058260