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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Procedure: external cephalic version
    • external cephalic version

Arms, Groups and Cohorts

  • Active Comparator: ECV with Full urinary bladder
    • ECV with Full urinary bladder
  • Active Comparator: ECV with empty urinary bladder
    • ECV with empty urinary bladder

Clinical Trial Outcome Measures

Primary Measures

  • ECV success rate
    • Time Frame: immediate
    • ECV success rate

Participating in This Clinical Trial

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

Gender Eligibility: Female

pregnant women

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ezra Yosi, Director of Medical Unit, OB/GYN – Hadassah Medical Organization
  • Overall Contact(s)
    • Yossef Ezra, Prof., 00972507874243, ezrayossi69@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.