Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

Phase 4

Completed

• Conditions: Labor Induction; Cervical Ripening
• Interventions: Device: Double balloon catheter; Drug: Dinoprostone 10 mg controlled-release vaginal insert

• Registration Number: NCT01170819
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2011-09
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-09
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Balloon Catheter	Double balloon catheter	-
Dinoprostone Vaginal Insert	Dinoprostone 10 mg controlled-release vaginal insert	-

Primary Outcome Measures

Name	Time	Method
Vaginal delivery within 24 hours	24 hours from start of cervical ripening

Secondary Outcome Measures

Name	Time	Method
Cesarean section rate	48 hours from start of ripening
Uterine hyperstimulation	12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening
Onset of active labor	36 hours from start of ripening	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

Trial Locations

Locations (1)

Del Ponte Hospital; 🇮🇹 Varese, Italy