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

Cervical Ripening Clinical Trial

— OPIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949633
• Other study ID #: DR200090
• Secondary ID: 2021-000989-15
• Status: Recruiting
• Phase: Phase 3
• Start date: September 28, 2021
• Est. completion date: November 2025

Study information

• Verified date: November 2022
• Source: University Hospital, Tours
• Contact: Caroline DIGUISTO, MD
• Phone: 02 47 47 47 36
• Email: C.DIGUISTO[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1494
• Est. completion date: November 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman
• = 18 years old
• With a singleton cephalic pregnancy
• Between =37+0 weeks and = 42+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 or with more than 3 contractions / 10 minutes

Related Conditions & MeSH terms

• Cervical Ripening
• Unfavorable Cervix

Intervention

Drug:
• Prostaglandins
Second cervical ripening lasting a maximum of 24 hours
• Oxytocin
Induction of labor with oxytocin.

Locations

Country	Name	City	State
France	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, Nantes	Nantes
France	Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris	Paris
France	Gynaecology-obstetrics, University Hospital, Poitiers	Poitiers
France	Gynaecology-obstetrics, University Hospital, Saint Etienne	Saint-Étienne
France	Gynaecology-obstetrics, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and rate of children with an Apgar score under 7		Up to 2 days after intervention
Other	Number and rate of children with neonatal acidosis defined as umbilical arterial pH <7,00		Up to 2 days after intervention
Other	Number and rate of children with early neonatal infection		Up to 7 days after delivery
Other	Number and rate of children admitted in an intensive care unit		Up to 7 days after delivery
Other	Proportion of incremental cost-effect pairs	Health economic outcome	Up to 8 weeks
Primary	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	Time from intervention to delivery in hours		Up to 2 days after intervention
Secondary	The proportion of women who delivered within 12 hours of the intervention		Up to 12 hours after intervention
Secondary	Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE)		1 month
Secondary	The proportion of women who require induction with oxytocin (for women in the control group)		Up to 2 days after intervention
Secondary	The indications of caesarean in case of caesarean delivery		Up to 2 days after intervention
Secondary	The proportion of women with an instrumental delivery		Up to 2 days after intervention
Secondary	The indications for the use of instruments in case of instrumental delivery		Up to 2 days after intervention
Secondary	The proportion of women suspected of per-partum infection		Up to 2 days after intervention
Secondary	The proportion of women with post-partum haemorrhage		Up to 1 day after delivery
Secondary	The proportion of women with severe Post-partum haemorrhage		Up to 2 days after intervention
Secondary	The proportion of women with anal sphincter injury at delivery		Up to 2 days after intervention
Secondary	The proportion of women who need blood transfusion		Up to 2 days after intervention
Secondary	The proportion of women who need for antibiotics		Up to 2 days after intervention
Secondary	The proportion of women admitted to intensive care unit		Up to 2 days after intervention