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Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

This study has been completed.
Information provided by (Responsible Party):
Antonella Cromi, Università degli Studi dell'Insubria Identifier:
First received: July 23, 2010
Last updated: December 9, 2011
Last verified: December 2011
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: 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.


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

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
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Please refer to this study by its identifier: NCT01170819

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 Identifier: NCT01170819     History of Changes
Other Study ID Numbers: 1229
Study First Received: July 23, 2010
Last Updated: December 9, 2011

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

Additional relevant MeSH terms:
Reproductive Control Agents
Physiological Effects of Drugs processed this record on May 25, 2017