drugset / Trial / NCT02620904

Mifepristone Induction for Fetal Demise

NCT02620904 ↗

Phase 4 Terminated 9 enrolled Montefiore Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-07-14
Primary completion
2019-10
Completion
2020-01

Outcome

Outcome not reported

Stopped (Enrollment): “unable to recruit. Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mifepristone Small molecule 200 mg Oral