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. Identifier: NCT01170819
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):
Antonella Cromi, Università degli Studi dell'Insubria

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.

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
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.
Study Start Date : June 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Cesarean section rate [ Time Frame: 48 hours from start of ripening ]
  2. 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

  3. Uterine hyperstimulation [ Time Frame: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01170819

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

Responsible Party: Antonella Cromi, PhD, Università degli Studi dell'Insubria Identifier: NCT01170819     History of Changes
Other Study ID Numbers: 1229
First Posted: July 27, 2010    Key Record Dates
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
Mechanical methods
Balloon catheter

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