Comparing oxytocin and prostaglandins for labor induction in women with an unfavorable cervix
Official title: Oxytocine Versus Prostaglandines Pour le déclenchement du Travail Des Femmes Dont le Col Est défavorable après 24 Heures de Maturation Cervicale : Essai Multicentrique randomisé de Non infériorité
Run by University Hospital, Tours · NCT04949633 · Data updated 2026-11-12
This study is testing whether using oxytocin or more prostaglandins is better for inducing labor in women whose cervix isn't ready after 24 hours, to see which option leads to safer deliveries and happier moms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1494 (estimated) |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 14 sites (Angers and 13 other locations) |
| Status | Recruiting |
| Started | September 28, 2021 |
| Main results expected | September 2027 |
| Study ends | November 2027 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT04949633 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 18 and older, with a singleton cephalic pregnancy, who have undergone 24 hours of cervical ripening and have a Bishop score of 6 or less.
✕Probably not a fit
Patients who have had a prior cesarean section, contraindications to vaginal delivery, or severe fetal abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine the most effective management strategy for women with an unfavorable cervix after 24 hours of cervical ripening. It compares the use of oxytocin for labor induction against repeated cervical ripening with prostaglandins. The study focuses on minimizing maternal and perinatal morbidity while maximizing maternal satisfaction. Participants will be monitored to assess outcomes related to cesarean delivery rates and overall labor progression.
Why it matters
Potential benefit: If successful, this study could lead to improved labor induction practices, reducing the need for cesarean deliveries and enhancing maternal satisfaction.
How similar studies have gone: Other studies have explored similar approaches to labor induction, but this specific comparison of oxytocin versus prostaglandins in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant woman * ≥ 18 years old * With a singleton cephalic pregnancy * ≥37+0 weeks of gestation * Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation) * With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours * Bishop score ≤ 6 at inclusion (unfavorable cervix) * French health insurance policy holder * Written informed consent Exclusion Criteria: * Any measures of legal protection * Prior caesarean section or uterine scar * Contra-indications to a vaginal delivery * Foetus with suspected severe congenital abnormalities * Pathological foetal heart rate * Contra-indications to ANGUSTA® (oral misoprostol, cervical ripening agent) * Contra-indications to PROPESS® (vaginal slow releasing system of dinoprostone, cervical ripening agent) * Contra-indications to PROSTINE® (vaginal gel of dinoprostone, cervical ripening agent) * Contra-indications for using oxytocin * Woman in labor
Where it's running
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Gynaecology-obstetrics, University Hospital, Angers
Angers, France Recruiting -
Gynaecology-obstetrics, University Hospital, Brest
Brest, France Recruiting -
Gynaecology-obstetrics, University Hospital, Nancy
Nancy, France Recruiting -
Gynaecology-obstetrics, University Hospital, Nantes
Nantes, France Recruiting -
Gynaecology-obstetrics, University Hospital, Orléans
Orléans, France Recruiting -
Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris
Paris, France Recruiting
Show 8 more locations
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Gynaecology-obstetrics, University Hospital, Saint Etienne
Saint-Etienne, France Recruiting -
Gynaecology-obstetrics, University Hospital, Tours
Tours, France Recruiting -
Gynaecology-obstetrics, University Hospital, Bordeaux
Bordeaux, France Terminated -
Gynaecology-obstetrics, University Hospital, Clermont-Ferrand
Clermont-Ferrand, France Terminated -
Gynaecology-obstetrics, Hospital St Joseph, Marseille
Marseille, France Terminated -
Gynaecology-obstetrics, University Hospital, Poitiers
Poitiers, France Terminated -
Gynaecology-obstetrics, Hospital, Pontoise
Pontoise, France Not yet recruiting -
Gynaecology-obstetrics, University Hospital, Strasbourg
Strasbourg, France Not yet recruiting
Study contacts
- Study coordinator: Caroline DIGUISTO, MD
- Email: carolinediguisto@gmail.com
- Phone: 02 47 47 47 39
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PGE2 then oxytocin versus oxytocin for starting labor after your water breaks at term.
This test will see whether giving a 6-hour vaginal dinoprostone (PGE2) insert before oxytocin or starting oxytocin right away works better for women 18 and older with a single baby whose water breaks at 37–42 weeks and whose cervix isn't ready.
-
Serial membrane sweeping to encourage spontaneous labor at term
This trial will try serial membrane sweeping in people with low-risk, singleton pregnancies at term to see if it makes spontaneous labor happen before 41+3 weeks more often than no sweeping.
-
Evaluating membrane stripping for cervical ripening in labor induction
This study tests whether a method called membrane stripping works better than a double balloon catheter for helping women get ready for labor.
-
Cervical ripening balloon left in place for 3 hours vs 12 hours during labor induction
This study tests whether keeping the cervical ripening balloon in for 3 hours works as well as the standard 12 hours to shorten time to delivery in pregnant people induced for labor.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.