Combined Agent Randomized Trial of Induction of Labor

Condition(s) targeted: Labor Induction; Cervical Ripening

Intervention: dinoprostone (Drug)

Phase: N/A

Status: Completed

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

Secondary outcome:

Randomization to delivery interval

Rate of cesarean delivery for non reassuring fetal status

Rate of uterine hyperstimulation

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

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