Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert

Medical University of Graz

Status and phase: Unknown; Phase 4

Conditions: Cervical Ripening; Induction of Labor

Treatments: Device: Cervical Ripening Balloon, Cook Medical Inc.; Drug: Dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT01720394

MUG-CRB-2012

Details and patient eligibility

About

The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not greater than 6) compared to medical treatment using a dinoprostone slow-release-vaginal-insert.

Enrollment: 253 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• medical indication for induction of labor
• 18 years of age
• signed informed consent
• cephalic presentation
• no PROM
• 37+0 - 42+0 weeks of gestation
• Bishop-Score ≤ 6
• no contra-indication for medical induction of labor
• no clinical signs of infection

Exclusion criteria

• fetal anomalies
• contra-indications for medical induction of labor
• placental pathologies
• St.p. surgery with opening the uterine cavity (incl. caesarean section)
• PROM
• multiple gestations
• < 37-0 weeks of gestation
• St.p. cervical tear

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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253 participants in 2 patient groups

Cervical ripening balloon

Experimental group

Description:

primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3.

Treatment:

Device: Cervical Ripening Balloon, Cook Medical Inc.

Propess

Active Comparator group

Description:

Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)

Treatment:

Drug: Dinoprostone