- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504465
Combined Agent Randomized Trial of Induction of Labor
July 19, 2007 updated by: Weill Medical College of Cornell University
Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Brooklyn, New York, United States, 11201
- The Brooklyn Hospital Center
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Flushing, New York, United States, 11355
- New York Hospital Medical Center of Queens
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of vaginal delivery <24 hours
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Secondary Outcome Measures
Outcome Measure |
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Randomization to delivery interval
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Rate of cesarean delivery for non reassuring fetal status
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Rate of uterine hyperstimulation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel W Skupski, MD, Weill Medical College of Cornell University
- Principal Investigator: Michael Cabbad, MD, The Brooklyn Hospital Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
July 19, 2007
First Submitted That Met QC Criteria
July 19, 2007
First Posted (Estimate)
July 20, 2007
Study Record Updates
Last Update Posted (Estimate)
July 20, 2007
Last Update Submitted That Met QC Criteria
July 19, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0402-264
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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