Combined Agent Randomized Trial of Induction of Labor

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Cervical Ripening

Labor Induction

Treatments

Drug: dinoprostone

Study type

Interventional

Funder types

Other

Identifiers

NCT00504465

0402-264

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria