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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Vaginal delivery within 24 hours [ Time Frame: 24 hours from start of cervical ripening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170819

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

No publications provided

Responsible Party: Antonella Cromi, PhD, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01170819     History of Changes
Other Study ID Numbers: 1229
Study First Received: July 23, 2010
Last Updated: December 9, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by 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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013