NCT02777190

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Labor; Forced or Induced, Affecting Fetus or Newborn
• Pregnancy

Interventions

Type	Name	Description
DRUG	Misoprostol	Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-04-23
• Completion: 2019-04-23
• First posted: 2016-05-19
• Last updated: 2022-10-13
• Results posted: 2022-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study