Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

Università degli Studi dell'Insubria

Status and phase: Completed; Phase 4

Conditions: Cervical Ripening; Labor Induction

Treatments: Device: Double balloon catheter; Drug: Dinoprostone 10 mg controlled-release vaginal insert

Study type: Interventional

Funder types: Other

Identifiers

NCT01170819

1229

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Dinoprostone Vaginal Insert

Active Comparator group

Treatment:

Drug: Dinoprostone 10 mg controlled-release vaginal insert

Double Balloon Catheter

Experimental group

Treatment:

Device: Double balloon catheter