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

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

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.

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