Trials / Completed
CompletedNCT01170819
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (actual)
- Sponsor
- Università degli Studi dell'Insubria · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Double balloon catheter | The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred. |
| DRUG | Dinoprostone 10 mg controlled-release vaginal insert | Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours. |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2011-09-01
- Completion
- 2011-12-01
- First posted
- 2010-07-27
- Last updated
- 2011-12-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01170819. Inclusion in this directory is not an endorsement.