NCT00504465

Combined Agent Randomized Trial of Induction of Labor

Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (planned)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Labor Induction
• Cervical Ripening

Interventions

Type	Name	Description
DRUG	dinoprostone

Timeline

• Start date: 2002-05-01
• Completion: 2007-04-01
• First posted: 2007-07-20
• Last updated: 2007-07-20

Locations

3 sites across 1 country: United States