Ireland
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Recruiting Phase 3

Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening

NCT04949633 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2021-09-28
Last updated
2026-07-27

Condition(s) studied

Cervical RipeningUnfavorable Cervix

Investigational drug(s) / intervention(s)

ProstaglandinsOxytocin →

Prostaglandins: Second cervical ripening lasting a maximum of 24 hours

Oxytocin: Induction of labor with oxytocin.

Study summary

Twenty-two percent of deliveries in France are induced. In cases where labor is induced and cervix is unfavorable, cervical ripening prior oxytocin administration is advised in order to reduce the risk of cesarean delivery. Cervical ripening agents, pharmacological (prostaglandins) or mechanical are administered during 24 hours. After 24 hours, most women will be either delivered or in labor but 25% of women will require further induction of labor. For 16% of women who undergo cervical ripening, whatever the cervical ripening method, the cervix remains unchanged after 24 hours. The management of these women is not consensual and depends on the maternity unit where women are cared for.

This study seeks to identify the most appropriate strategy for the management of women with an unfavorable cervix after 24 hours of cervical ripening, a strategy which would be associated with the lowest maternal and perinatal morbidity but also with the best maternal satisfaction. Because both strategies are practiced in France, the trial would compare: induction of labor with oxytocin and repeated cervical ripening. The aim is to show that repeating cervical ripening is an unnecessary procedure. And more specifically that oxytocin administration is not associated with a higher caesarean delivery rate and that it reduces the time to delivery in comparison with cervical ripening with prostaglandins.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Cesarean delivery rate — Up to 2 days after intervention
    The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery

Trial sites (14)

FacilityCityRegionStatus
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 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, Hospital, Pontoise Pontoise France Not Yet Recruiting
Gynaecology-obstetrics, University Hospital, Saint Etienne Saint-Etienne France Recruiting
Gynaecology-obstetrics, University Hospital, Strasbourg Strasbourg France Not Yet Recruiting
Gynaecology-obstetrics, University Hospital, Tours Tours France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04949633 on ClinicalTrials.gov ↗ ← All trials in France