Actively Recruiting
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Led by University Hospital, Tours · Updated on 2025-12-01
1494
Participants Needed
12
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman
- At least 18 years old
- Carrying a single baby in head-down position
- Pregnancy of 37 weeks or more
- Gestational age confirmed by first trimester ultrasound between 11+0 and 13+6 weeks
- Medical reason for labor induction with prior 24 hours of pharmacological or mechanical cervical ripening
- Bishop score of 6 or less at study entry (unfavorable cervix)
- Holder of French health insurance
- Provided written informed consent
You will not qualify if you...
- Under any legal protection measures
- Previous cesarean section or uterine scar
- Any reason preventing vaginal delivery
- Baby with suspected severe birth defects
- Abnormal fetal heart rate
- Contraindications to oral misoprostol (ANGUSTA�), vaginal dinoprostone slow-release system (PROPESS�), or vaginal dinoprostone gel (PROSTINE�)
- Contraindications to oxytocin
- Already in labor
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Gynaecology-obstetrics, University Hospital, Angers
Angers, France, 49033
Actively Recruiting
2
Gynaecology-obstetrics, University Hospital, Bordeaux
Bordeaux, France, 33076
Terminated
3
Gynaecology-obstetrics, University Hospital, Brest
Brest, France, 29609
Actively Recruiting
4
Gynaecology-obstetrics, University Hospital, Clermont-Ferrand
Clermont-Ferrand, France, 63001
Terminated
5
Gynaecology-obstetrics, Hospital St Joseph, Marseille
Marseille, France, 13008
Terminated
6
Gynaecology-obstetrics, University Hospital, Nancy
Nancy, France, 54000
Not Yet Recruiting
7
Gynaecology-obstetrics, University Hospital, Nantes
Nantes, France, 44093
Actively Recruiting
8
Gynaecology-obstetrics, University Hospital, Orléans
Orléans, France, 45100
Actively Recruiting
9
Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris
Paris, France, 75014
Actively Recruiting
10
Gynaecology-obstetrics, University Hospital, Poitiers
Poitiers, France, 86000
Terminated
11
Gynaecology-obstetrics, University Hospital, Saint Etienne
Saint-Etienne, France, 42270
Actively Recruiting
12
Gynaecology-obstetrics, University Hospital, Tours
Tours, France, 37044
Actively Recruiting
Research Team
C
Caroline DIGUISTO, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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