Status:
COMPLETED
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Cervical Ripening
Labor Induction
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- singleton gestation
- gestational age greater than 34 weeks
- cephalic presentation
- intact membranes
- Bishop score of ≤4
- reactive fetal heart rate (FHR) pattern on admission
Exclusion
- any condition precluding vaginal delivery
- any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
- previous cesarean section or other uterine incision
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01170819
Start Date
June 1 2010
End Date
December 1 2011
Last Update
December 13 2011
Active Locations (1)
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1
Del Ponte Hospital
Varese, Italy, 21100