Prospective Randomized Controlled Trial Comparing ECV Suc... | NCT04118465

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

NCT04118465

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Feb 10, 2021Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Breech Presentation; Before Labor

Interventions

external cephalic version

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Oct 5, 2019

First Submission Date that Met QC Criteria

Oct 5, 2019

First Posted Date

Oct 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ezra Yosi, Director of Medical Unit, OB/GYN, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECV with Full urinary bladder	Active Comparator	ECV with Full urinary bladder	Procedure: external cephalic version
ECV with empty urinary bladder	Active Comparator	ECV with empty urinary bladder	Procedure: external cephalic version

Interventions

Name	Type	Description	Arm Group Labels	Other Names
external cephalic version	Procedure	external cephalic version	ECV with Full urinary bladder ECV with empty urinary bladder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ECV success rate	ECV success rate	immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem		91120	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38236701	Derived	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.

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative