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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
• 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.
CHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGTime between the beginning of the induction of labor and the delivery
Time frame: at day 1
Time limits between the PROM and the beginning of induction
Time frame: at day 1
Rate of delivery in the first 24 hours
Time frame: at day 1
Application time of Cook® balloon
Time frame: at day 1
Application time of Propess®
Time frame: at day 1
Time between labour induction and vaginal delivery
Time frame: at day 1
Rate of vaginal delivery with and without extraction
Time frame: at day 1
Rate of cesarean
Time frame: at day 1
Rate of delivery hemorrhage
Time frame: at day 1
Bischop score when Cook balloon is fallen or retry
Time frame: at day 1
Rate of balloon present after 12 hours
Time frame: at day 1
Rate of anomaly of fetal heart rate leading stop of dinoprostone
Time frame: at day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rate of epidural analgesia
Time frame: at day 1
Time to obtain active labour
Time frame: at day 1
Time to obtain complete cervix dilatation
Time frame: at day 1
Rate of fever during the labour
Time frame: at day 1
Rate of uterine hyperkinesias
Time frame: at day 1
Rate of clinic chorio-amnionitis defined by Newton criteria
Time frame: at day 1