To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.
Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.
Del Ponte Hospital
Varese, Italy
Vaginal delivery within 24 hours
Time frame: 24 hours from start of cervical ripening
Cesarean section rate
Time frame: 48 hours from start of ripening
Onset of active labor
Active labor is defined as at least 4 uterine contractions in a 30 minutes interval with a totally effaced cervix and a cervical dilatation ≥3 cm
Time frame: 36 hours from start of ripening
Uterine hyperstimulation
Time frame: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening
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