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CompletedNCT04118465ECVBLADDERUpdated Feb 10, 2021

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

An interventional study of external cephalic version in Breech Presentation; Before Labor, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 17 years 9 months after the study started (first participant enrolled Jan 2002, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breech Presentation; Before Labor

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Keywords

  • breech; ECV; version
03

In context

Breech Presentation

41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.

This study's enrollment of 70 is below the median of 119 across 31 interventional studies indexed under Breech Presentation.

Browse Breech Presentation studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • non-cephalic presentation,
  • singleton pregnancy,
  • term gestation,
  • No previous attempt at ECV in this pregnancy,
  • signed .

Exclusion criteria

Exclusion Criteria:

  • Any for vaginal delivery
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    ECV with Full urinary bladder

    ECV with Full urinary bladder

    Procedure: external cephalic version

  • Active comparator
    ECV with empty urinary bladder

    ECV with empty urinary bladder

    Procedure: external cephalic version

Interventions

  • Procedureexternal cephalic version

    external cephalic version

06

What researchers measure

Primary outcomes

  1. ECV success rate

    ECV success rate

    Time frame: immediate

07

Study locations

1 site
  • Hadassah Medical Center
    Jerusalem, 91120, Israel
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: After study completion and publishing

Access criteria: IPD will be supplied to interested research colleagues.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04118465
Responsible party
Ezra Yosi (Director of Medical Unit, OB/GYN, Hadassah Medical Organization) — Principal investigator
First posted
Oct 8, 2019
Start date
Jan 2002
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Feb 10, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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