Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Dinoprostone; Oxytocin

Criteria

Inclusion Criteria:

• Pregnant women

• 18 years old With a singleton live cephalic pregnancy ≥ 37+0 weeks Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) PROM without spontaneous labour in the 12 hours after the rupture. The diagnostic of PROM is clinic or biologic (ActimProm® test).

Unfavourable cervix (Bishop's score < 6) Agreement of the patient after clear, loyal and appropriate information Subject covered by or having the rights to the French Social Security system

Exclusion Criteria:

• Vaginal infection by B streptococcus or in urinary sample during actual or anterior pregnancy Meconium fluid amniotic Contraindication of vaginal delivery (placenta praevia, …) Temperature > 38,2°C Suspicion of chorio-amnionitis among Newton requirements Intra-uterine growth restriction < 3rd percentile with Doppler abnormalities History of cesarean and uterine scare Suspected genital herpes infection Known VIH seropositivity (confirmed by blood serology) Fetus with suspected severe congenital abnormalities Pathological fetal heart rate (see appendix 1) Contra-indications to Propess®, Cook® Cervical Ripening Balloon, Oxytocin Women under guardianship or trusteeship