Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

Phase 2

Completed

• Conditions: Premature Birth; Cervical Ripening

• Registration Number: NCT00325026
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Detailed Description

Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Study Completion: 2007-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• singleton gestation, gestational age 23-35 weeks, indication for induction

Exclusion Criteria

• multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to vaginal delivery

Secondary Outcome Measures

Name	Time	Method
Rate of chorioamnionitis
Incidence of abnormal fetal heart rate tracings
Rate of postpartum hemorrhage
Incidence of NICU admissions

Trial Locations

Locations (1)

Shands Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States