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About
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.
Full 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 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 ®.
After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Pregnant women
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
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
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Central trial contact
Patrick LACARIN
Data sourced from clinicaltrials.gov
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