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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504465

Enrollment

210

Registered

2007-07-20

Start date

2002-05-31

Completion date

2007-04-30

Last updated

2007-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening, Labor Induction

Keywords

Labor, Labor induction, Cervical ripening, Dinoprostone, Fetal safety, Oxytocin, Cesarean delivery

Brief summary

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.

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.

Interventions

DRUGdinoprostone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Rate of vaginal delivery <24 hours	—

Secondary

Measure	Time frame
Randomization to delivery interval	—
Rate of cesarean delivery for non reassuring fetal status	—
Rate of uterine hyperstimulation	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026