Combined Agent Randomized Trial of Induction of Labor

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00504465
First received: July 19, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Labor Induction
Cervical Ripening
Drug: dinoprostone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Rate of vaginal delivery <24 hours

Secondary Outcome Measures:
  • Randomization to delivery interval
  • Rate of cesarean delivery for non reassuring fetal status
  • Rate of uterine hyperstimulation

Estimated Enrollment: 210
Study Start Date: May 2002
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504465

Locations
United States, New York
The Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
New York Hospital Medical Center of Queens
Flushing, New York, United States, 11355
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Daniel W Skupski, MD Weill Medical College of Cornell University
Principal Investigator: Michael Cabbad, MD The Brooklyn Hospital Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504465     History of Changes
Other Study ID Numbers: 0402-264
Study First Received: July 19, 2007
Last Updated: July 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Labor
Labor induction
Cervical ripening
Dinoprostone
Fetal safety
Oxytocin
Cesarean delivery

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014