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A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

This study has been completed.
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00501033
First received: July 12, 2007
Last updated: May 2, 2008
Last verified: May 2008
History of Changes

July 12, 2007
May 2, 2008
January 2006
February 2008   (final data collection date for primary outcome measure)
Success of labor induction [ Time Frame: Postpartum period ]
Same as current
Complete list of historical versions of study NCT00501033 on ClinicalTrials.gov Archive Site
  • Postpartum endometritis rate [ Time Frame: The postpartum period ]
  • Cesarean section rate [ Time Frame: Delivery ]
Same as current
Not Provided
Not Provided
 
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Induction of Labor
  • Cesarean
  • Endometritis
  • Device: Mechanical induction of labor
  • Device: Double Balloon
  • Device: Foley Catheter
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term pregnancy
  • Parturients candidates for mechanical induction of labor

Exclusion Criteria:

  • Suspected amnionitis
  • Vaginal discharge
  • Pre induction pyrexia
  • Immunocompromised parturients
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00501033
4
No
Professor Jacob Bornstein, Western Galilee Hospital
Western Galilee Hospital-Nahariya
Not Provided
Principal Investigator: Ido Solt, MD Western Galilee Hospital
Western Galilee Hospital-Nahariya
May 2008

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