PROM (Premature Rupture Of Foetal Membrane) Clinical Trial
— RUBAPROOfficial title:
Comparison Between Two Strategies of Induction in Case of Unfavourable Cervix After 12 Hours of Premature Rupture of Membranes (PROM) at Term: Cook Cervical Ripening + Oxytocine From 6 Hours Versus Dinoprostone Vaginal Insert
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | April 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time between the beginning of the induction of labor and the delivery | at day 1 | ||
| Secondary | Time limits between the PROM and the beginning of induction | at day 1 | ||
| Secondary | Rate of delivery in the first 24 hours | at day 1 | ||
| Secondary | Application time of Cook® balloon | at day 1 | ||
| Secondary | Application time of Propess® | at day 1 | ||
| Secondary | Time between labour induction and vaginal delivery | at day 1 | ||
| Secondary | Rate of vaginal delivery with and without extraction | at day 1 | ||
| Secondary | Rate of cesarean | at day 1 | ||
| Secondary | Rate of delivery hemorrhage | at day 1 | ||
| Secondary | Bischop score when Cook balloon is fallen or retry | at day 1 | ||
| Secondary | Rate of balloon present after 12 hours | at day 1 | ||
| Secondary | Rate of anomaly of fetal heart rate leading stop of dinoprostone | at day 1 | ||
| Secondary | Rate of epidural analgesia | at day 1 | ||
| Secondary | Time to obtain active labour | at day 1 | ||
| Secondary | Time to obtain complete cervix dilatation | at day 1 | ||
| Secondary | Rate of fever during the labour | at day 1 | ||
| Secondary | Rate of uterine hyperkinesias | at day 1 | ||
| Secondary | Rate of clinic chorio-amnionitis defined by Newton criteria | at day 1 |