Clinical trial Recruiting at 8 sites Phase 3 Interventional Ages 18 and up Women only

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.

More Cervical Ripening trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment1494 (estimated)
SponsorUniversity Hospital, Tours
Academic / other
Locations14 sites (Angers and 13 other locations)
StatusRecruiting
StartedSeptember 28, 2021
Main results expectedSeptember 2027
Study endsNovember 2027
Registry record updatedJuly 27, 2026
Trial IDNCT04949633 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.