drugset / Trial / NCT02777190

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

NCT02777190

Phase 4 Terminated 34 enrolled Milton S. Hershey Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.

Timeline

Start
2017-11-01
Primary completion
2019-04-23
Completion
2019-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 25 ug Oral

Indications