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Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Sponsor: University Hospital, Tours
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1494
Start Date
2021-09-28
Completion Date
2026-11
Last Updated
2025-12-01
Healthy Volunteers
Yes
Conditions
Interventions
Prostaglandins
Second cervical ripening lasting a maximum of 24 hours
Oxytocin
Induction of labor with oxytocin.
Locations (12)
Gynaecology-obstetrics, University Hospital, Angers
Angers, France
Gynaecology-obstetrics, University Hospital, Bordeaux
Bordeaux, France
Gynaecology-obstetrics, University Hospital, Brest
Brest, France
Gynaecology-obstetrics, University Hospital, Clermont-Ferrand
Clermont-Ferrand, France
Gynaecology-obstetrics, Hospital St Joseph, Marseille
Marseille, France
Gynaecology-obstetrics, University Hospital, Nancy
Nancy, France
Gynaecology-obstetrics, University Hospital, Nantes
Nantes, France
Gynaecology-obstetrics, University Hospital, Orléans
Orléans, France
Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris
Paris, France
Gynaecology-obstetrics, University Hospital, Poitiers
Poitiers, France
Gynaecology-obstetrics, University Hospital, Saint Etienne
Saint-Etienne, France
Gynaecology-obstetrics, University Hospital, Tours
Tours, France