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Combined Agent Randomized Trial of Induction of Labor

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.
 
ClinicalTrials.gov Identifier: NCT00504465
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : July 20, 2007
Sponsor:
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE July 19, 2007
First Posted Date  ICMJE July 20, 2007
Last Update Posted Date July 20, 2007
Study Start Date  ICMJE May 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2007)		 Rate of vaginal delivery <24 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
  • Randomization to delivery interval
  • Rate of cesarean delivery for non reassuring fetal status
  • Rate of uterine hyperstimulation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Agent Randomized Trial of Induction of Labor
Official Title  ICMJE Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Labor Induction
  • Cervical Ripening
Intervention  ICMJE Drug: dinoprostone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 19, 2007)		 210
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00504465
Other Study ID Numbers  ICMJE 0402-264
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Weill Medical College of Cornell University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel W Skupski, MD Weill Medical College of Cornell University
Principal Investigator: Michael Cabbad, MD The Brooklyn Hospital Center
PRS Account Weill Medical College of Cornell University
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP