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)

简要总结

主要结局

次要结局

• Delivery within 12 hours
• Neonatal morbidity: death of the baby
• Time from intervention to delivery in 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
• 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%).