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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.
Details
| Lead sponsor | Medical University of Graz |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 253 |
| Start date | 2013-11 |
| Completion | 2019-12 |
Conditions
- Cervical Ripening
- Induction of Labor
Interventions
- Cervical Ripening Balloon, Cook Medical Inc.
- Dinoprostone
Primary outcomes
- time interval from primary treatment to delivery — maximum of 72 hours
the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured
Countries
Austria