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

July 23, 2010
December 9, 2011
June 2010
September 2011   (final data collection date for primary outcome measure)
Vaginal delivery within 24 hours [ Time Frame: 24 hours from start of cervical ripening ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01170819 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Ripening
  • Labor Induction
  • 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
  • Active Comparator: Dinoprostone Vaginal Insert
    Intervention: Drug: Dinoprostone 10 mg controlled-release vaginal insert
  • Experimental: Double Balloon Catheter
    Intervention: Device: Double balloon catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01170819
1229
No
Antonella Cromi, Università degli Studi dell'Insubria
Università degli Studi dell'Insubria
Not Provided
Not Provided
Università degli Studi dell'Insubria
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP