- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579835
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT) (TWEXIT)
February 5, 2024 updated by: Larry Hinkson, Charite University, Berlin, Germany
Twin A Breech External Cephalic Version Intervention Trial
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Larry Hinkson, FRCOG
- Phone Number: 004930450664710
- Email: Larry.Hinkson@charite.de
Study Locations
-
-
-
Berlin-Mitte, Germany, 10117
- Recruiting
- Charité University Hospital
-
Contact:
- Larry Hinkson, FRCOG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
All patients presenting with Twin A breech presentation to the antenatal clinic
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of external cephalic version Twin A
Time Frame: 4 hours after external cephalic version
|
Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants
|
4 hours after external cephalic version
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal weight
Time Frame: 30 Minutes before external cephalic version
|
Measurement in grams
|
30 Minutes before external cephalic version
|
Fetal Doppler Umbilical Pulsatility Index
Time Frame: 30 Minutes before external cephalic version
|
Index mesurent /Ratio
|
30 Minutes before external cephalic version
|
Fetal Doppler Umbilical Resistance Index
Time Frame: 30 Minutes before external cephalic version
|
Index mesurent /Ratio
|
30 Minutes before external cephalic version
|
Incidence of pathological cardiotocogramm
Time Frame: 60 Minutes after external cephalic version
|
Numerical percentage
|
60 Minutes after external cephalic version
|
Incidence of emergency delivery
Time Frame: 60 Minutes after external cephalic version
|
Numerical percentage
|
60 Minutes after external cephalic version
|
Incidence of bleeding
Time Frame: 60 Minutes after external cephalic version
|
Numerical percentage
|
60 Minutes after external cephalic version
|
Incidence of contractions
Time Frame: 60 Minutes after external cephalic version
|
Numerical percentage
|
60 Minutes after external cephalic version
|
Incidence of rupture of membranes
Time Frame: 60 Minutes after external cephalic version
|
Numerical percentage
|
60 Minutes after external cephalic version
|
Pain scores
Time Frame: 60 Minutes after external cephalic version
|
Numerical score: Pain scale Linkert score.
(0-10 with 10 being extremely painful)
|
60 Minutes after external cephalic version
|
Mode of Delivery
Time Frame: 6 weeks after delivery
|
Type of delivery (vaginal or caesarean)
|
6 weeks after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Larry Hinkson, FRCOG, Charité University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2020
Primary Completion (Estimated)
September 28, 2025
Study Completion (Estimated)
September 28, 2026
Study Registration Dates
First Submitted
September 28, 2020
First Submitted That Met QC Criteria
October 1, 2020
First Posted (Actual)
October 8, 2020
Study Record Updates
Last Update Posted (Actual)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA2/116/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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