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

NCT04949633 | Recruiting Phase 3

• 2 other identifiers: DR2000902021-000989-15
• Study Type: interventional
• Target: 1,494
• Locations: 1 country
• Sites: 12

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.

Conditions

Cervical Ripening; Unfavorable Cervix

Keywords

cervical ripening; oxytocin; prostaglandin; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery rate

  The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery

  Up to 2 days after intervention

Secondary Outcomes (14)

• Time from intervention to delivery in hours

  Up to 2 days after intervention

• The proportion of women who delivered within 12 hours of the intervention

  Up to 12 hours after intervention

• Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE)

  1 month

• The proportion of women who require induction with oxytocin (for women in the control group)

  Up to 2 days after intervention

• The indications of caesarean in case of caesarean delivery

  Up to 2 days after intervention

Other Outcomes (5)

• Number and rate of children with an Apgar score under 7

  Up to 2 days after intervention

• Number and rate of children with neonatal acidosis defined as umbilical arterial pH <7,00

  Up to 2 days after intervention

• Number and rate of children with early neonatal infection

  Up to 7 days after delivery

Study Arms (2)

Induction of labor

EXPERIMENTAL

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.

Drug: Oxytocin

Second cervical ripening

ACTIVE COMPARATOR

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.

Drug: Prostaglandins; Drug: Oxytocin

Interventions

Prostaglandins DRUG

Second cervical ripening lasting a maximum of 24 hours

Second cervical ripening

Oxytocin DRUG

Induction of labor with oxytocin.

Induction of labor; Second cervical ripening

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• French health insurance policy holder
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (12)

Gynaecology-obstetrics, University Hospital, Angers

Angers, 49033, France

RECRUITING

Gynaecology-obstetrics, University Hospital, Bordeaux

Bordeaux, 33076, France

TERMINATED

Gynaecology-obstetrics, University Hospital, Brest

Brest, 29609, France

RECRUITING

Gynaecology-obstetrics, University Hospital, Clermont-Ferrand

Clermont-Ferrand, 63001, France

TERMINATED

Gynaecology-obstetrics, Hospital St Joseph, Marseille

Marseille, 13008, France

TERMINATED

Gynaecology-obstetrics, University Hospital, Nancy

Nancy, 54000, France

NOT YET RECRUITING

Gynaecology-obstetrics, University Hospital, Nantes

Nantes, 44093, France

RECRUITING

Gynaecology-obstetrics, University Hospital, Orléans

Orléans, 45100, France

RECRUITING

Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris

Paris, 75014, France

RECRUITING

Gynaecology-obstetrics, University Hospital, Poitiers

Poitiers, 86000, France

TERMINATED

Gynaecology-obstetrics, University Hospital, Saint Etienne

Saint-Etienne, 42270, France

RECRUITING

Gynaecology-obstetrics, University Hospital, Tours

Tours, 37044, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37068892 DERIVED

MeSH Terms

Interventions

Prostaglandins; Oxytocin

Intervention Hierarchy (Ancestors)

Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Caroline DIGUISTO, MD

  STUDY DIRECTOR

Central Study Contacts

Caroline DIGUISTO, MD

CONTACT

02 47 47 47 39; carolinediguisto@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: July 2, 2021
• Study Start: September 28, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available immediately following publication and ending in 5 years
• Access Criteria: Contact with the corresponding author

Locations

FR (12)