Combined Agent Randomized Trial of Induction of Labor

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504465
• Other study ID #: 0402-264
• Status: Completed
• Phase: N/A
• First received: July 19, 2007
• Last updated: July 19, 2007
• Start date: May 2002
• Est. completion date: April 2007

Study information

• Verified date: July 2007
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Labor Induction

Intervention

Drug:
• dinoprostone

Locations

Country	Name	City	State
United States	The Brooklyn Hospital Center	Brooklyn	New York
United States	New York Hospital Medical Center of Queens	Flushing	New York
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of vaginal delivery <24 hours
Secondary	Randomization to delivery interval
Secondary	Rate of cesarean delivery for non reassuring fetal status
Secondary	Rate of uterine hyperstimulation