Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder

Not Applicable

Completed

• Conditions: Breech Presentation; Before Labor

• Registration Number: NCT04118465
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2019-10-05
• Study First Submitted QC: 2019-10-05
• Study First Posted: 2019-10-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ECV success rate	immediate	ECV success rate

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel