Comparing Oxytocin and Prostaglandins for Labor Induction in Women with an Unfavorable Cervix After 24 Hours of Cervical Ripening
Led by University Hospital, Tours · Updated on 2026-07-27
1494
Participants Needed
14
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare two strategies for managing women who have an unfavorable cervix after 24 hours of cervical ripening during labor induction. It focuses on pregnant women who have not yet gone into labor despite cervical ripening and evaluates whether induction with oxytocin is as safe and effective as repeating cervical ripening with prostaglandins. The goal is to find the best approach that lowers risks for both mother and baby while also improving maternal satisfaction.
Participants are divided into two groups one group receives induction of labor with intravenous oxytocin and early amniotomy following French guidelines, with oxytocin doses not exceeding 10 UI. The other group undergoes a second cervical ripening lasting up to 24 hours using one of three prostaglandin methods, chosen based on local protocols a vaginal slow-releasing dinoprostone system, oral misoprostol tablets, or vaginal dinoprostone gel. Women who remain not in labor after this second ripening then receive induction with oxytocin.
During the study, researchers will monitor delivery outcomes, including cesarean delivery rates up to 2 days after intervention, time from intervention to delivery, and maternal satisfaction one month after delivery using a childbirth experience questionnaire. They will also assess various maternal and newborn health outcomes such as infections, hemorrhage, instrumental delivery, and intensive care admissions. The study is randomized and open-label, with participation expected from labor induction until shortly after delivery for assessment purposes.
CONDITIONS
Brief Title
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Research Team
C
Caroline DIGUISTO, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Singleton pregnancy with baby in head-down position
At least 37 weeks of gestation
Gestational age confirmed by first trimester ultrasound
Underwent 24 hours of prior cervical ripening
Bishop score 6 or less indicating unfavorable cervix
Holder of French health insurance
Provided written informed consent
You will not qualify if you...
Under any legal protection measures
Previous cesarean section or uterine scar
Contraindications to vaginal delivery
Fetus suspected of severe congenital abnormalities
Abnormal fetal heart rate
Contraindications to oral misoprostol (ANGUSTA4), vaginal dinoprostone slow-release system (PROPESS4), or vaginal dinoprostone gel (PROSTINE4)
Contraindications to oxytocin
Already in labor
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 2 days
Participants are randomly assigned to receive either induction of labor with intravenous oxytocin and early amniotomy or a second cervical ripening using prostaglandins. If not in labor after second ripening, oxytocin induction follows.
1 to 2 visits depending on labor progress
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Randomized Study Comparing Membrane Stripping, Double Balloon Catheter, and PGE2 for Cervical Ripening in Women Undergoing Labor Induction
Early Safety and Performance Study of the INGA Catheter Compared to Standard Balloon Catheter for Labor Induction in Pregnant Women
Comparing Oxytocin and Prostaglandins for Labor Induction in Women with an Unfavorable Cervix After 24 Hours of Cervical Ripening
Comparing Labor Induction Methods Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone for Women With Term Premature Rupture of Membranes and an Unfavorable Cervix
Evaluating the Safety and Ease of Use of the INGA Balloon Catheter for Cervical Ripening in Labor Induction of Pregnant Women at Term
The SWEEP Trial Comparing Serial Membrane Sweeping to No Sweeping to Promote Spontaneous Labor in Pregnant Women at Term
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial.
Marion De Berti, Amélie Le Gouge, Fanny Monmousseau...