Combined Agent Randomized Trial of Induction of Labor
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor Induction; Cervical Ripening
Intervention: dinoprostone (Drug)
Sponsored by: Weill Medical College of Cornell University
Official(s) and/or principal investigator(s):
Daniel W Skupski, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University
Michael Cabbad, MD, Principal Investigator, Affiliation: The Brooklyn Hospital Center
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.
Official title: Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of vaginal delivery <24 hours
Randomization to delivery interval
Rate of cesarean delivery for non reassuring fetal status
Rate of uterine hyperstimulation
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.
Minimum age: 18 Years.
Maximum age: 45 Years.
- > or = to 36 weeks of gestation
- Singleton fetus
- Cephalic presentation
- Intact membranes and an unripe cervix (Bishop score <6)
- Multifetal gestation
- Rupture of membranes
- Ripe cervix (Bishop score >6)
- Active labor
- Contraindication to vaginal delivery
- Previous uterine surgery
- Non-cephalic presentation
- Fetal macrosomia
Locations and Contacts
Weill Medical College of Cornell University, New York, New York 10021, United States
New York Hospital Medical Center of Queens, Flushing, New York 11355, United States
The Brooklyn Hospital Center, Brooklyn, New York 11201, United States
Starting date: May 2002
Ending date: April 2007
Last updated: July 19, 2007