At a glance
ClinicalIndex Comparison Record- ✓Rupture of membranes ≤24 hours prior with no evidence of labor
- ✓Gestational age at least 36 weeks
- ✓Nulliparous (no prior vaginal or cesarean delivery)
- ✓Singleton pregnancy in vertex (head-down) presentation
- ✕Prior cesarean section or other contraindication to vaginal delivery
- ✕Intrauterine fetal demise
- ✕Major congenital anomaly
- ✕Intraamniotic infection (chorioamnionitis) at time of admission
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
POM PROM: Pitocin or Oral Misoprostol for PROM IOL in Nulliparous Women With Unfavorable Cervical Exams
In Brief
A Phase 4 clinical trial evaluating Misoprostol and Oxytocin for PROM. Completed, enrolled 108 participants across 1 site.
Detailed Summary
Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.
Study Details
Timeline
Interventions
Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol