Oxytocin versus Prostaglandins for labor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening: a multicenter non inferiority randomized trial

Oxytocin versus Prostaglandins for labor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening: a multicenter non inferiority randomized trial - OPIC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000989-15-FR

Enrollment

1494

Registered

2021-03-01

Start date

2021-07-28

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening MedDRA version: 20.0 Level: LLT Classification code 10023540 Term: Labor induced System Organ Class: 100000004868

Interventions

Trade Name: OXYTOCINE PANPHARMA Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: OXYTOCIN CAS Number: 50-56-6 Concentration unit: IU/mg international unit(s)/milligram Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1494 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To show that, among women with an unfavorable cervix after a first cervical ripening, induction of labor with oxytocin is not associated with an increased risk of caesarean delivery in comparison with repeating cervical ripening with prostaglandins.;Secondary Objective: Clinical objectives: To show that, among women with an unfavorable cervix after a first cervical ripening, induction of labor with oxytocin in comparison with repeated cervical ripening is associated with a reduced time to delivery and increased satisfaction of women. Also to show that maternal morbidity (instrumental delivery, infection, post-partum haemorrhage, sphincter injury, blood transfusion, admission in an intensive care unit) and neonatal morbidity (neonatal infection, neonatal acidosis, admission in an intensive care unit) are similar for these two strategies. Health-economic objective: To evaluate, in a joint analysis, that inducing labor with oxytocin is clinically not inferior in terms of caesarean delivery rate and not more expensive (economic non inferiority) in comparison with repeated cervical ripening. ;Primary end point(s): The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery;Timepoint(s) of evaluation of this end point: At delivery	—

Measure

Time frame

Main Objective: To show that, among women with an unfavorable cervix after a first cervical ripening, induction of labor with oxytocin is not associated with an increased risk of caesarean delivery in comparison with repeating cervical ripening with prostaglandins.;Secondary Objective: Clinical objectives: To show that, among women with an unfavorable cervix after a first cervical ripening, induction of labor with oxytocin in comparison with repeated cervical ripening is associated with a reduced time to delivery and increased satisfaction of women. Also to show that maternal morbidity (instrumental delivery, infection, post-partum haemorrhage, sphincter injury, blood transfusion, admission in an intensive care unit) and neonatal morbidity (neonatal infection, neonatal acidosis, admission in an intensive care unit) are similar for these two strategies. Health-economic objective: To evaluate, in a joint analysis, that inducing labor with oxytocin is clinically not inferior in terms of caesarean delivery rate and not more expensive (economic non inferiority) in comparison with repeated cervical ripening. ;Primary end point(s): The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery;Timepoint(s) of evaluation of this end point: At delivery

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Secondary

Measure	Time frame
Secondary end point(s): Clinical outcomes: • Time from intervention to delivery in hours • Delivery within 12 hours • Maternal satisfaction • Need for induction with oxytocin (for women in the control group) • Indication of caesarean in case of caesarean delivery • Instrumental delivery • Indication for the use of instruments in case of instrumental delivery • Suspicion of per-partum infection • Post-partum haemorrhage • Severe post-partum haemorrhage • Anal sphincter injury • Blood transfusion • Need for antibiotics • Admission to intensive care unit • Neonatal morbidity o An APGAR score at 5 minutes under 7 o Neonatal acidosis defined as umbilical arterial pH <7,00 o Early neonatal infection o Admission in an intensive care unit Health-economic outcome: Proportion of incremental cost-effect pairs that lies into the non-inferiority area, for various values of economic non–inferiority margin, and for a constant clinical non-inferiority margin (7%). ;Timepoint(s) of evaluation of this end point: From inclusion to discharge of the mother and child. Women's satisfaction will be assessed at 4 weeks postpartum.	—

Measure

Time frame

Secondary end point(s): Clinical outcomes: • Time from intervention to delivery in hours • Delivery within 12 hours • Maternal satisfaction • Need for induction with oxytocin (for women in the control group) • Indication of caesarean in case of caesarean delivery • Instrumental delivery • Indication for the use of instruments in case of instrumental delivery • Suspicion of per-partum infection • Post-partum haemorrhage • Severe post-partum haemorrhage • Anal sphincter injury • Blood transfusion • Need for antibiotics • Admission to intensive care unit • Neonatal morbidity o An APGAR score at 5 minutes under 7 o Neonatal acidosis defined as umbilical arterial pH <7,00 o Early neonatal infection o Admission in an intensive care unit Health-economic outcome: Proportion of incremental cost-effect pairs that lies into the non-inferiority area, for various values of economic non–inferiority margin, and for a constant clinical non-inferiority margin (7%). ;Timepoint(s) of evaluation of this end point: From inclusion to discharge of the mother and child. Women's satisfaction will be assessed at 4 weeks postpartum.

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Countries

France

Contacts

Public ContactYoann DESVIGNES, CRA coordinator

University Hospital, Tours

cpcq@chu-tours.fr+330247474632

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026