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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
  Purpose

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.


Condition Intervention
Induction of Labor
Cesarean
Endometritis
Device: Mechanical induction of labor
Device: Double Balloon
Device: Foley Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Success of labor induction [ Time Frame: Postpartum period ]

Secondary Outcome Measures:
  • Postpartum endometritis rate [ Time Frame: The postpartum period ]
  • Cesarean section rate [ Time Frame: Delivery ]

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term pregnancy
  • Parturients candidates for mechanical induction of labor

Exclusion Criteria:

  • Suspected amnionitis
  • Vaginal discharge
  • Pre induction pyrexia
  • Immunocompromised parturients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501033

Locations
Israel
Western Galilee Hospital
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Ido Solt, MD Western Galilee Hospital
  More Information

No publications provided

Responsible Party: Professor Jacob Bornstein, Western Galilee Hospital
ClinicalTrials.gov Identifier: NCT00501033     History of Changes
Other Study ID Numbers: 4
Study First Received: July 12, 2007
Last Updated: May 2, 2008
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Western Galilee Hospital-Nahariya:
Induction of labor
Cesarean
Endometritis
Foley
Infections

Additional relevant MeSH terms:
Endometritis
Adnexal Diseases
Genital Diseases, Female
Pelvic Inflammatory Disease
Uterine Diseases

ClinicalTrials.gov processed this record on November 20, 2014