Twin A Breech External Cephalic Version Intervention Tria... | NCT04579835

Studies
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

NCT04579835

Sponsor

Charite University, Berlin, Germany

Status

Recruiting

Last Update Posted

Feb 6, 2024Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Breech Presentation
Twin; Complicating Pregnancy

Interventions

External Cephalic Version

Countries

Germany

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 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2020Actual

Primary Completion Date

Sep 28, 2025Estimated

Completion Date

Sep 28, 2026Estimated

First Submitted Date

Sep 28, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 8, 2020Actual

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 5, 2024

Last Update Posted Date

Feb 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Larry Hinkson, Lead Consultant in Obstetrics, Deputy Director, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

Detailed Description

The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
External Cephalic Version	Other	External Cephalic Version Twin A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of external cephalic version Twin A	Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants	4 hours after external cephalic version

Secondary Outcomes

Measure	Description	Time Frame
Fetal weight	Measurement in grams	30 Minutes before external cephalic version
Fetal Doppler Umbilical Pulsatility Index	Index mesurent /Ratio

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of the written consent of the patients.
The patients must be over 18 years old .
No limit in the ability to consent.

Exclusion Criteria:

Age under 18
Limited ability to consent
Placenta previa
Fetal abnormalities

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients presenting with Twin A breech presentation to the antenatal clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Larry Hinkson, FRCOG	Contact	004930450664710		Larry.Hinkson@charite.de

Overall Officials

Name	Affiliation	Role
Larry Hinkson, FRCOG	Charité University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University Hospital	Recruiting	Mitte		10117	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001946	Breech Presentation
D011248	Pregnancy Complications

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014710	Version, Fetal

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided