Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial

202202144

When time allows, administration of mifepristone prior to second trimester induction of labor decreases total labor time. However, in the setting of many pregnancy complications, decreasing time from diagnosis of nonviable pregnancy to delivery is of utmost importance to decrease risk of maternal complications. Previous data has shown that total abortion time is longer in the group receiving mifepristone owing to the delay between mifepristone administration and initiation of misoprostol induction of labor. Thus, the investigators aim to investigate whether simultaneous mifepristone and misoprostol has benefits over misoprostol alone when labor induction of a nonviable second trimester cannot be delayed.

2022-07-01

2024-12-01

2025-12-01

Recruiting

Early phase I

30

Inclusion Criteria: * 18 years or older * 14 and 28 weeks' gestation * Singleton gestation * Nonviable fetus (i.e. fetal demise or previable gestational age/weight or lethal fetal anomaly) * Requires induction of labor * If fetal cardiac motion, abortion being performed for medical emergency per MO laws and consents completed Exclusion Criteria: * Contraindication to mifepristone * Plan for surgical evacuation of uterus * Contraindication to vaginal delivery * Plan to initiate induction with any medication or device except misoprostol * Declines participation

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-04-24