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

NCT ID: NCT04118465

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Breech Presentation; Before Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECV with Full urinary bladder

ECV with Full urinary bladder

Group Type ACTIVE_COMPARATOR

external cephalic version

Intervention Type PROCEDURE

external cephalic version

ECV with empty urinary bladder

ECV with empty urinary bladder

Group Type ACTIVE_COMPARATOR

external cephalic version

Intervention Type PROCEDURE

external cephalic version

Interventions

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external cephalic version

external cephalic version

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Ezra Yosi

Director of Medical Unit, OB/GYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Kabiri D, Haj Yahya R, Yahalomi S, Ezra Y. Impact of full vs empty urinary bladder on external cephalic version success: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100991. doi: 10.1016/j.ajogmf.2023.100991. Epub 2023 Apr 30.

Reference Type DERIVED
PMID: 38236701 (View on PubMed)

Other Identifiers

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ECVBLAD-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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