Back to resultsA Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Primary Purpose
Induction of Labor, Cesarean, Endometritis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mechanical induction of labor
Double Balloon
Foley Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Induction of Labor focused on measuring Induction of labor, Cesarean, Endometritis, Foley, Infections
Eligibility Criteria
Inclusion Criteria:
- Term pregnancy
- Parturients candidates for mechanical induction of labor
Exclusion Criteria:
- Suspected amnionitis
- Vaginal discharge
- Pre induction pyrexia
- Immunocompromised parturients
Sites / Locations
- Western Galilee Hospital
Outcomes
Primary Outcome Measures
Success of labor induction
Secondary Outcome Measures
Postpartum endometritis rate
Cesarean section rate
Full Information
NCT ID
NCT00501033
First Posted
July 12, 2007
Last Updated
May 2, 2008
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT00501033
Brief Title
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Official Title
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of Labor, Cesarean, Endometritis
Keywords
Induction of labor, Cesarean, Endometritis, Foley, Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Mechanical induction of labor
Intervention Type
Device
Intervention Name(s)
Double Balloon
Intervention Type
Device
Intervention Name(s)
Foley Catheter
Primary Outcome Measure Information:
Title
Success of labor induction
Time Frame
Postpartum period
Secondary Outcome Measure Information:
Title
Postpartum endometritis rate
Time Frame
The postpartum period
Title
Cesarean section rate
Time Frame
Delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Term pregnancy
Parturients candidates for mechanical induction of labor
Exclusion Criteria:
Suspected amnionitis
Vaginal discharge
Pre induction pyrexia
Immunocompromised parturients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ido Solt, MD
Organizational Affiliation
Western Galilee Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
31185762
Citation
Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1034-1041. doi: 10.1080/14767058.2019.1623776. Epub 2019 Jun 11.
Results Reference
derived
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A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
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