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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00504465 |
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 |
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Labor Induction Cervical Ripening |
Drug: dinoprostone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin. |
Estimated Enrollment: | 210 |
Study Start Date: | May 2002 |
Study Completion Date: | April 2007 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 | |
New York Hospital Medical Center of Queens | |
Flushing, New York, United States, 11355 | |
The Brooklyn Hospital Center | |
Brooklyn, New York, United States, 11201 |
Principal Investigator: | Daniel W Skupski, MD | Weill Medical College of Cornell University |
Principal Investigator: | Michael Cabbad, MD | The Brooklyn Hospital Center |
Study ID Numbers: | 0402-264 |
Study First Received: | July 19, 2007 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00504465 |
Health Authority: | United States: Institutional Review Board |
Labor Labor induction Cervical ripening Dinoprostone |
Fetal safety Oxytocin Cesarean delivery |
Dinoprostone Oxytocin |
Oxytocics Therapeutic Uses Physiological Effects of Drugs Reproductive Control Agents Pharmacologic Actions |