Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01170819|
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : December 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cervical Ripening Labor Induction||Device: Double balloon catheter Drug: Dinoprostone 10 mg controlled-release vaginal insert||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
|Active Comparator: Dinoprostone Vaginal Insert||
Drug: Dinoprostone 10 mg controlled-release vaginal insert
Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.
Other Name: PROPESS®, Ferring Pharmaceuticals
|Experimental: Double Balloon Catheter||
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.
Other Name: COOK CERVICAL BALLOON, COOK UROLOGICAL INC. US
- Vaginal delivery within 24 hours [ Time Frame: 24 hours from start of cervical ripening ]
- Cesarean section rate [ Time Frame: 48 hours from start of ripening ]
- Onset of active labor [ Time Frame: 36 hours from start of ripening ]Active labor is defined as at least 4 uterine contractions in a 30 minutes interval with a totally effaced cervix and a cervical dilatation ≥3 cm
- Uterine hyperstimulation [ Time Frame: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170819
|Del Ponte Hospital|
|Varese, Italy, 21100|