Combined Agent Randomized Trial of Induction of Labor

Not Applicable

Completed

• Conditions: Labor Induction; Cervical Ripening

• Registration Number: NCT00504465
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.

Detailed Description

This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: \>36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score \<6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery \<24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.

Study Timeline

• Study Start: 2002-05
• Study Completion: 2007-04
• Status Verified: 2007-07
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-19
• Last Update Submitted: 2007-07-19
• Study First Posted: 2007-07-20
• Last Update Posted: 2007-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• > or = to 36 weeks of gestation
• Singleton fetus
• Cephalic presentation
• Intact membranes and an unripe cervix (Bishop score <6)

Exclusion Criteria

• Multifetal gestation
• Rupture of membranes
• Ripe cervix (Bishop score >6)
• Active labor
• Contraindication to vaginal delivery
• Previous uterine surgery
• Non-cephalic presentation
• Fetal macrosomia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of vaginal delivery <24 hours

Secondary Outcome Measures

Name	Time	Method
Randomization to delivery interval
Rate of cesarean delivery for non reassuring fetal status
Rate of uterine hyperstimulation

Trial Locations

Locations (3)

New York Hospital Medical Center of Queens; 🇺🇸 Flushing, New York, United States

The Brooklyn Hospital Center; 🇺🇸 Brooklyn, New York, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States