drugset / Trial / NCT04028765

Pitocin or Oral Misoprostol for PROM IOL

NCT04028765

Phase 4 Completed 108 enrolled University of Pennsylvania
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-08-12
Primary completion
2022-12-08
Completion
2023-01-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Misoprostol Other / unclassified 50 ug Oral
Comparator Oxytocin Peptide 2 unknown Intravenous