PROM (Premature Rupture Of Foetal Membrane) Clinical Trial
Official 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.
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 is unfavourable (cervical Bishop's score <6), the information of the study is
given to the patient and the consent collected.
An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in
case of allergy of amoxicillin) to prevent choroamnionitis.
After randomization, the patient is included in one of the two groups: Cook ® balloon or
Propess ®.
- In the Cook cervical ripening balloon group: the device is introduced by a resident or a
doctor. No traction on the probe was done. It is left in place for maximum 12 hours.
Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural
analgesia can be started before or after the installation of oxytocin
- In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for
maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be
introduce if the cervix stayed unfavourable.
After 24 hours, it is removed. If they are any contraction, oxytocin is started with or
without epidural analgesic.
- The fetal heart rate is monitoring 30 minutes before and after the insertion of the
device. After, the patient has a monitoring each 6 hours.
- Since the oxytocin is started, the monitoring is registered in continue until the
delivery.
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