Trials / Unknown
UnknownNCT01720394
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 253 (estimated)
- Sponsor
- Medical University of Graz · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cervical Ripening Balloon, Cook Medical Inc. | Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1. |
| DRUG | Dinoprostone | Application of Propess-vaginal-insert, (Dinoprostone 10mg - Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria) for labor induction on day 1-3 in therapy arm 2. |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2019-07-01
- Completion
- 2019-12-01
- First posted
- 2012-11-02
- Last updated
- 2018-09-11
Locations
7 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT01720394. Inclusion in this directory is not an endorsement.