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

Phase 1

Conditions: abor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening
MedDRA version: 20.0Level: LLTClassification code 10023540Term: Labor inducedSystem Organ Class: 100000004868
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2021-000989-15-FR

Lead Sponsor: niversity Hospital, Tours

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 1494

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

•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