Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
- Conditions
- Breech Presentation; Before Labor
- Interventions
- Procedure: external cephalic version
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
- non-cephalic presentation,
- singleton pregnancy,
- term gestation,
- No previous attempt at ECV in this pregnancy,
- signed informed consent.
• Any contraindication for vaginal delivery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ECV with Full urinary bladder external cephalic version ECV with Full urinary bladder ECV with empty urinary bladder external cephalic version ECV with empty urinary bladder
- Primary Outcome Measures
Name Time Method ECV success rate immediate ECV success rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hadassah Medical Center
🇮🇱Jerusalem, Israel