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Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170819
First Posted: July 27, 2010
Last Update Posted: December 13, 2011
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.
Information provided by (Responsible Party):
Antonella Cromi, Università degli Studi dell'Insubria
  Purpose
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.

Condition Intervention Phase
Cervical Ripening Labor Induction Device: Double balloon catheter Drug: Dinoprostone 10 mg controlled-release vaginal insert Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.

Resource links provided by NLM:


Further study details as provided by Antonella Cromi, Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • Vaginal delivery within 24 hours [ Time Frame: 24 hours from start of cervical ripening ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 210
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Italy
Del Ponte Hospital
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
  More Information

Responsible Party: Antonella Cromi, PhD, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01170819     History of Changes
Other Study ID Numbers: 1229
First Submitted: July 23, 2010
First Posted: July 27, 2010
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Antonella Cromi, Università degli Studi dell'Insubria:
Cervical ripening
Induction of labor
Prostaglandins
Mechanical methods
Balloon catheter

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs