drugset / Trial / NCT01866488

The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor

NCT01866488

Phase 2 Unknown 200 enrolled University of Arizona
RandomizedParallel-groupTriple-blindTreatment

Summary

The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity. The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.

Timeline

Start
2013-04
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 50 ug Oral

Indications

No indication recorded.