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Completed

NCT Number: NCT04118465

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

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.

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Key information

Conditions

Breech Presentation; Before Labor Breech Presentation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, 91120, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

external cephalic version

Procedure

external cephalic version

Primary outcomes

  1. ECV success rate

    Time frame: immediate

    ECV success rate

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Acronym: ECVBLADDER

Important dates

Study start
2002
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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