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

Breech Presentation; Before Labor Clinical Trial

— ECVBLADDER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118465
• Other study ID #: ECVBLAD-HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: January 2002
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breech Presentation
• Breech Presentation; Before Labor

Intervention

Procedure:
• external cephalic version
external cephalic version

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECV success rate	ECV success rate	immediate