Status:
UNKNOWN
Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
PROM (Premature Rupture Of Foetal Membrane)
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ti...
Detailed Description
The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning. If the cervix i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03310333
Start Date
February 14 2018
End Date
July 1 2020
Last Update
February 19 2018
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003