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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborators: Hospital Braunau, Austria; Hospital Hartberg, Austria; Klinikum Klagenfurt am Wörthersee; Medical University Innsbruck; Medical University of Vienna; University of Salzburg
• Treatments: Dinoprostone

Criteria

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