A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.
Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day. The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Number of Participants with Bishop score ≥6 or spontaneous labour
Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention
Time frame: 24 hours
Mean of gain in Bishop score
Mean of gain in Bishop score from intervention to hospital admission
Time frame: 24 hours
Time frame between intervention and active phase of labour
Time frame between intervention and active phase of labour (min)
Time frame: 1-2 days
Time of Vaginal Delivery
Delivery time frame in mins from intervention
Time frame: 2-4days
Number of Participants with vaginal delivery within 24hrs
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Time frame: 1-2days
Vaginal delivery within 48hrs
Rate of vaginal deliveries within 48 hours since admission to hospital (%)
Time frame: 1-2days
Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Time frame: 1-2days
Operative deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
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Time frame: 1-4days
Cesarean deliveries
Proportion of patients that delivered by cesarean (%).
Time frame: 1-4days
Analgesia requirement
Rate of women who require any analgesia during cervical ripening process (%)
Time frame: 24 hours
Vaginal bleeding
Rate of women who had vaginal bleeding during cervical ripening process (%)
Time frame: 24 hours
Reduced fetal movements
Rate of women who had reduced fetal movements during cervical ripening process (%)
Time frame: 24 hours
Non reassuring fetal status
Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)
Time frame: 24 hours
Patient Satisfaction: questionnaire
Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire
Time frame: 1-4days