Skip to main content
OpenTrials
Completed

NCT Number: NCT00504465

Combined Agent Randomized Trial of Induction of Labor

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Induction Cervical Ripening

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Brooklyn Hospital Center, Brooklyn, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dinoprostone

Drug

Primary outcomes

  1. Rate of vaginal delivery <24 hours

Secondary outcomes

  1. Randomization to delivery interval

  2. Rate of cesarean delivery for non reassuring fetal status

  3. Rate of uterine hyperstimulation

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2007
First posted
Jul 20, 2007
Registry last updated
Jul 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.