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

Hadassah Medical Center

Status: Completed

Conditions: Breech Presentation; Before Labor

Treatments: Procedure: external cephalic version

Study type: Interventional

Funder types: Other

Identifiers

NCT04118465

ECVBLAD-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

ECV with Full urinary bladder

Active Comparator group

Description:

ECV with Full urinary bladder

Treatment:

Procedure: external cephalic version

ECV with empty urinary bladder

Active Comparator group

Description:

ECV with empty urinary bladder

Treatment:

Procedure: external cephalic version