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

niversity Hospital, Tours0 个研究点目标入组 1,494 人开始时间: 2021年3月1日最近更新: 2024年7月15日

试验速览

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•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

•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

发起方

niversity Hospital, Tours