Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579835
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Larry Hinkson, Charite University, Berlin, Germany

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

Condition or disease Intervention/treatment
Breech Presentation Twin; Complicating Pregnancy Other: External Cephalic Version

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Twin A Breech External Cephalic Version Intervention Trial
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : September 28, 2025
Estimated Study Completion Date : September 28, 2026
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: External Cephalic Version
    External Cephalic Version Twin A

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Fetal weight [ Time Frame: 30 Minutes before external cephalic version ]
    Measurement in grams

  2. Fetal Doppler Umbilical Pulsatility Index [ Time Frame: 30 Minutes before external cephalic version ]
    Index mesurent /Ratio

  3. Fetal Doppler Umbilical Resistance Index [ Time Frame: 30 Minutes before external cephalic version ]
    Index mesurent /Ratio

  4. Incidence of pathological cardiotocogramm [ Time Frame: 60 Minutes after external cephalic version ]
    Numerical percentage

  5. Incidence of emergency delivery [ Time Frame: 60 Minutes after external cephalic version ]
    Numerical percentage

  6. Incidence of bleeding [ Time Frame: 60 Minutes after external cephalic version ]
    Numerical percentage

  7. Incidence of contractions [ Time Frame: 60 Minutes after external cephalic version ]
    Numerical percentage

  8. Incidence of rupture of membranes [ Time Frame: 60 Minutes after external cephalic version ]
    Numerical percentage

  9. Pain scores [ Time Frame: 60 Minutes after external cephalic version ]
    Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful)

  10. Mode of Delivery [ Time Frame: 6 weeks after delivery ]
    Type of delivery (vaginal or caesarean)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting with Twin A breech presentation to the antenatal clinic
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579835


Contacts
Layout table for location contacts
Contact: Larry Hinkson, FRCOG 004930450664710 Larry.Hinkson@charite.de

Locations
Layout table for location information
Germany
Charité University Hospital Recruiting
Berlin-Mitte, Germany, 10117
Contact: Larry Hinkson, FRCOG         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Principal Investigator: Larry Hinkson, FRCOG Charité University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Larry Hinkson, Lead Consultant in Obstetrics, Deputy Director, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04579835    
Other Study ID Numbers: EA2/116/20
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breech Presentation
Pregnancy Complications
Obstetric Labor Complications