drugset / Trial / NCT02684305

Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction

NCT02684305

Phase 3 Unknown 320 enrolled Tel-Aviv Sourasky Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today. 1. During the past years there has been an additional rise due to elective inductions 2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks of induced delivery, particularly those associated with post-term pregnancy, rupture of membranes, oligohydramnios and additional fetal and maternal conditions that pose risks to mother and fetus. In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score \<7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.

Timeline

Start
2016-04
Primary completion
2018-04
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified 10 mg Other
Subject Oxytocin Peptide 4 iu Intravenous

Indications

No indication recorded.