Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Antonella Cromi, Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT01170819

First received: July 23, 2010

Last updated: December 9, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 23, 2010
Last Updated Date	December 9, 2011
Start Date ^ICMJE	June 2010
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 26, 2010)	Vaginal delivery within 24 hours [ Time Frame: 24 hours from start of cervical ripening ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01170819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 26, 2010)	Cesarean section rate [ Time Frame: 48 hours from start of ripening ] [ Designated as safety issue: Yes ] Onset of active labor [ Time Frame: 36 hours from start of ripening ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
Official Title ^ICMJE	Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cervical Ripening Labor Induction
Intervention ^ICMJE	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 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
Study Arm (s)	Active Comparator: Dinoprostone Vaginal Insert Intervention: Drug: Dinoprostone 10 mg controlled-release vaginal insert Experimental: Double Balloon Catheter Intervention: Device: Double balloon catheter
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	210
Completion Date	December 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: singleton gestation gestational age greater than 34 weeks cephalic presentation intact membranes Bishop score of ≤4 reactive fetal heart rate (FHR) pattern on admission Exclusion Criteria: any condition precluding vaginal delivery any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease previous cesarean section or other uterine incision
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01170819
Other Study ID Numbers ^ICMJE	1229
Has Data Monitoring Committee	No
Responsible Party	Antonella Cromi, Università degli Studi dell'Insubria
Study Sponsor ^ICMJE	Università degli Studi dell'Insubria
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Università degli Studi dell'Insubria
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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