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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
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517675-20-00
Acronym
DR200090
Enrollment
1494
Registered
2024-12-10
Start date
2021-09-28
Completion date
Unknown
Last updated
2025-10-08

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

Brief summary

Rate of caesarean delivery, whatever the indication of the caesarean delivery

Detailed description

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, Oxytocin augmentation, Uterine hyperstimulation, Suspicion of per-partum infection, Post-partum haemorrhage, Severe post-partum haemorrhage, Anal sphincter injury, Blood transfusion, Need for antibiotics, Length of hospital stay, Cardiorespiratory arrest, Damage to internal organs, Hysterectomy for any complications resulting from birth, Pulmonary embolus, Stroke, Admission to intensive care unit, Maternal death, Neonatal morbidity: birth trauma, Neonatal morbidity: hypoxic ischaemic encephalopathy, Neonatal morbidity: need for therapeutic hypothermia, Neonatal morbidity: meconium aspiration syndrome, Neonatal morbidity: need for respiratory support, Neonatal morbidity: neonatal seizures, Neonatal morbidity: neonatal acidosis, Neonatal morbidity: Early neonatal infection, Neonatal morbidity: Admission in an intensive care unit, Neonatal morbidity: death of the baby, 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%).

Interventions

DRUGPROPESS 10 mg
DRUGsystème de diffusion vaginal
DRUGOXYTOCINE PANPHARMA 5 UI/1 ml
DRUGsolution injectable
DRUGANGUSTA 25 microgrammes
DRUGcomprime
DRUGPROSTINE E2 2 mg/3 g
DRUGgel vaginal

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Rate of caesarean delivery, whatever the indication of the caesarean delivery

Secondary

MeasureTime frame
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, Oxytocin augmentation, Uterine hyperstimulation, Suspicion of per-partum infection, Post-partum haemorrhage, Severe post-partum haemorrhage, Anal sphincter injury, Blood transfusion, Need for antibiotics, Length of hospital stay, Cardiorespiratory arrest, Damage to internal organs, Hysterectomy for any complications resulting from birth, Pulmonary embolus, Stroke, Admission to intensive care unit, Maternal death, Neonatal morbidity: birth trauma, Neonatal morbidity: hypoxic ischaemic encephalopathy, Neonatal morbidity: need for therapeutic hypothermia, Neonatal morbidity: meconium aspiration syndrome, Neonatal morbidity: need for respiratory support, Neonatal morbidity: neonatal s

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026