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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
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation; Before Labor focused on measuring breech; ECV; version

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
October 5, 2019
Last Updated
February 9, 2021
Sponsor
Hadassah Medical Organization
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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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