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

NCT ID: NCT04949633

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2026-11-30

Brief 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.

Detailed Description

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. In some units, women are admitted into labor ward for induction of labor with oxytocin. Elsewhere cervical ripening is repeated in order to obtain a favorable cervix and to reduce the risk of caesarean delivery.

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 policy of induction of labor with oxytocin, being the simpler strategy, would be acceptable if it did not lead to a substantially proportion of women with caesarean deliveries compared with a second cervical ripening. This multicenter non inferiority randomized trial will recruit women with an unfavorable cervix (bishop score ≤ 6) after 24 hours of cervical ripening (pharmacological or mechanical) and randomize them to either induction of labor with oxytocin or to a second cervical ripening with prostaglandins. 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

Unfavorable Cervix; Cervical Ripening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction of labor

women randomized in the experimental group will be admitted to the labor ward to undergo induction of labor with intra-veinous oxytocin and early amniotomy. Oxytocin will be administered according to the French guidelines for induction of labor. Maximum oxytocin used should not exceed 10 UI.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Induction of labor with oxytocin.

Second cervical ripening

women randomized in the control group will undergo a second cervical ripening lasting a maximum of 24 hours with either:

• Vaginal slow releasing system of dinoprostone PROPESS® which is inserted in the vagina, against the cervix and left in place during 24 hours.
• Oral misoprostol (ANGUSTA®) 25 µg every 2 hours, 8 times (maximum dosage should not exceed 200µg). Tablets will be given one at the time by midwives.
• Vaginal gel of dinoprostone (2 mg PROSTINE®) every 6 hours, maximum dose of 6 mg.

The choice of the cervical ripening agent will depend of the local protocol of the participating maternity unit. The choice between ANGUSTA®, PROPESS® and PROSTINE® will be made by investigators of each participating unit at the beginning of the trial.

At the end of the second cervical ripening procedure women not in labor will be transferred to the labor ward for induction of labor with oxytocin.

Group Type: ACTIVE_COMPARATOR

Prostaglandins

Intervention Type: DRUG

Second cervical ripening lasting a maximum of 24 hours

Oxytocin

Intervention Type: DRUG

Induction of labor with oxytocin.

Interventions

Prostaglandins

Second cervical ripening lasting a maximum of 24 hours

Intervention Type: DRUG

Oxytocin

Induction of labor with oxytocin.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline DIGUISTO, MD

Role: STUDY_DIRECTOR

Locations

Gynaecology-obstetrics, University Hospital, Angers

Angers, , France

Site Status: RECRUITING

Gynaecology-obstetrics, University Hospital, Bordeaux

Bordeaux, , France

Site Status: TERMINATED

Gynaecology-obstetrics, University Hospital, Brest

Brest, , France

Site Status: RECRUITING

Gynaecology-obstetrics, University Hospital, Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: TERMINATED

Gynaecology-obstetrics, Hospital St Joseph, Marseille

Marseille, , France

Site Status: TERMINATED

Gynaecology-obstetrics, University Hospital, Nancy

Nancy, , France

Site Status: NOT_YET_RECRUITING

Gynaecology-obstetrics, University Hospital, Nantes

Nantes, , France

Site Status: RECRUITING

Gynaecology-obstetrics, University Hospital, Orléans

Orléans, , France

Site Status: RECRUITING

Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris

Paris, , France

Site Status: RECRUITING

Gynaecology-obstetrics, University Hospital, Poitiers

Poitiers, , France

Site Status: TERMINATED

Gynaecology-obstetrics, University Hospital, Saint Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Gynaecology-obstetrics, University Hospital, Tours

Tours, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Caroline DIGUISTO, MD

Role: CONTACT

carolinediguisto@gmail.com

02 47 47 47 39 ext. +33

Facility Contacts

Guillaume LEGENDRE, MD-PhD

Role: primary

Jordan POZZY, MD

Role: primary

Charline BERTHOLDT, MD

Role: primary

Norbert WINER, MD-PhD

Role: primary

Floranne MEUNIER, MD

Role: primary

François GOFFINET, MD

Role: primary

Tiphaine BARJAT, MD

Role: primary

Franck PERROTIN, MD-PhD

Role: primary

References

De Berti M, Le Gouge A, Monmousseau F, Gallot D, Sentilhes L, Winer N, Legendre G, Desbriere R, Girault A, Pozzi J, Gachon B, Barjat T, Perrotin F, Brunet-Houdard S, Diguisto C; Groupe de Recherche en Gynecologie Obstetrique. Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial. BMJ Open. 2023 Apr 17;13(4):e058282. doi: 10.1136/bmjopen-2021-058282.

Reference Type: DERIVED

PMID: 37068892 (View on PubMed)

Other Identifiers

2021-000989-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DR200090

Identifier Type: -

Identifier Source: org_study_id