Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
ECVBLADDER
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 5, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 10, 2021
February 1, 2021
19 years
October 5, 2019
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ECV success rate
ECV success rate
immediate
Study Arms (2)
ECV with Full urinary bladder
ACTIVE COMPARATORECV with Full urinary bladder
ECV with empty urinary bladder
ACTIVE COMPARATORECV with empty urinary bladder
Interventions
external cephalic version
Eligibility Criteria
You may qualify if:
- non-cephalic presentation,
- singleton pregnancy,
- term gestation,
- No previous attempt at ECV in this pregnancy,
- signed informed consent.
You may not qualify if:
- Any contraindication for vaginal delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Center
Jerusalem, 91120, Israel
Related Publications (1)
Kabiri D, Haj Yahya R, Yahalomi S, Ezra Y. Impact of full vs empty urinary bladder on external cephalic version success: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100991. doi: 10.1016/j.ajogmf.2023.100991. Epub 2023 Apr 30.
PMID: 38236701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Medical Unit, OB/GYN
Study Record Dates
First Submitted
October 5, 2019
First Posted
October 8, 2019
Study Start
January 1, 2002
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After study completion and publishing
- Access Criteria
- IPD will be supplied to interested research colleagues.