drugset / Trial / NCT02825641

Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

NCT02825641

Completed 458 enrolled Rambam Health Care Campus
RandomizedParallel-groupOpen-labelTreatment

Summary

The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes. The means of labor induction and cervical ripening are either oxytocin or dinoprostone. Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition. The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.

Timeline

Start
2016-08-01
Primary completion
2021-11-01
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified Other
Subject Oxytocin Peptide Intravenous