Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
Healthy Volunteers
NCT04949633

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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