Mifepristone Induction for Fetal Demise
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Intrauterine Fetal Demise, Fetal Death
In brief
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.
Key facts
- Study ID
- NCT02620904
- Run by
- Montefiore Medical Center
- People needed
- 9
- Starts
- 2016-07-14
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2021-02-18
Who can join
Age: 16 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by Attending physician at the time of admission to the hospital.
- Estimated gestational age greater than 20 weeks
- Hemodynamically stable and appropriate for induction of labor as per primary clinical health team in house
- Women with one prior low transverse cesarean delivery
You may not qualify if…
- History of 2 or more low transverse cesarean deliveries
- Prior classical cesarean delivery
- History of abdominal myomectomy
- Known or suspected allergic reaction to mifepristone
- Known or suspected adrenal gland disease
- Known or suspected bleeding diatheses or coagulopathies
- Known or suspected use of QTc-prolonging medication
- Known maternal medical or physical conditions that prohibits vaginal delivery
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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