Trial | NCT00504465  Report issue

Title

Combined Agent Randomized Trial of Induction of Labor
Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    210
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.
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 Started
May 31
2002
Study Completion
Apr 30
2007
Last Update
Jul 20
2007
Estimate

Drug dinoprostone

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
No Results Posted