Comparing oxytocin and prostaglandins for labor induction in women with an unfavorable cervix
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
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 |
| Enrollment | 1494 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT04949633 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored similar approaches to labor induction, but this specific comparison of oxytocin versus prostaglandins in this context is relatively novel.
Eligibility criteria
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 this trial is running
Angers and 11 other locations
- Gynaecology-obstetrics, University Hospital, Angers — Angers, France (Recruiting)
- Gynaecology-obstetrics, University Hospital, Bordeaux — Bordeaux, France (Terminated)
- Gynaecology-obstetrics, University Hospital, Brest — Brest, France (Recruiting)
- Gynaecology-obstetrics, University Hospital, Clermont-Ferrand — Clermont-Ferrand, France (Terminated)
- Gynaecology-obstetrics, Hospital St Joseph, Marseille — Marseille, France (Terminated)
- Gynaecology-obstetrics, University Hospital, Nancy — Nancy, France (Not_yet_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)
- Gynaecology-obstetrics, University Hospital, Poitiers — Poitiers, France (Terminated)
- Gynaecology-obstetrics, University Hospital, Saint Etienne — Saint-Etienne, France (Recruiting)
- Gynaecology-obstetrics, University Hospital, Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Caroline DIGUISTO, MD
- Email: carolinediguisto@gmail.com
- Phone: 02 47 47 47 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.