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Combined Agent Randomized Trial of Induction of Labor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00504465
First Posted: July 20, 2007
Last Update Posted: July 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Weill Medical College of Cornell University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00504465     History of Changes
Other Study ID Numbers: 0402-264
First Submitted: July 19, 2007
First Posted: July 20, 2007
Last Update Posted: July 20, 2007
Last Verified: July 2007

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

Additional relevant MeSH terms:
Oxytocin
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs