Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder (ECVBLADDER)
Primary Purpose
Breech Presentation; Before Labor
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
external cephalic version
Sponsored by
About this trial
This is an interventional treatment trial for Breech Presentation; Before Labor focused on measuring breech; ECV; version
Eligibility Criteria
Inclusion Criteria:
- non-cephalic presentation,
- singleton pregnancy,
- term gestation,
- No previous attempt at ECV in this pregnancy,
- signed informed consent.
Exclusion Criteria:
• Any contraindication for vaginal delivery
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ECV with Full urinary bladder
ECV with empty urinary bladder
Arm Description
ECV with Full urinary bladder
ECV with empty urinary bladder
Outcomes
Primary Outcome Measures
ECV success rate
ECV success rate
Secondary Outcome Measures
Full Information
NCT ID
NCT04118465
First Posted
October 5, 2019
Last Updated
February 9, 2021
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT04118465
Brief Title
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
Acronym
ECVBLADDER
Official Title
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2002 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.
Detailed Description
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation; Before Labor
Keywords
breech; ECV; version
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECV with Full urinary bladder
Arm Type
Active Comparator
Arm Description
ECV with Full urinary bladder
Arm Title
ECV with empty urinary bladder
Arm Type
Active Comparator
Arm Description
ECV with empty urinary bladder
Intervention Type
Procedure
Intervention Name(s)
external cephalic version
Intervention Description
external cephalic version
Primary Outcome Measure Information:
Title
ECV success rate
Description
ECV success rate
Time Frame
immediate
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-cephalic presentation,
singleton pregnancy,
term gestation,
No previous attempt at ECV in this pregnancy,
signed informed consent.
Exclusion Criteria:
• Any contraindication for vaginal delivery
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After study completion and publishing
IPD Sharing Access Criteria
IPD will be supplied to interested research colleagues.
Learn more about this trial
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
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