Mifepristone Induction for Fetal Demise
NCT02620904 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2021-02-18
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.
Conditions
- Intrauterine Fetal Demise
- Fetal Death
Interventions
- DRUG
- DRUG
Sponsors & Collaborators
-
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Jessica Atrio, MD · Montefiore Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-07-14
- Primary Completion
- 2019-10-31
- Completion
- 2020-01-31
Countries
- United States
Study Locations
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