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NCT04579835 Clinical Trial

Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

Breech Presentation Clinical Trial

— TWEXIT  

Official title:
Twin A Breech External Cephalic Version Intervention Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04579835
Other study ID # EA2/116/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 28, 2020
Est. completion date September 28, 2026

Study information
Verified date February 2024
Source Charite University, Berlin, Germany
Contact Larry Hinkson, FRCOG
Phone 004930450664710
Email Larry.Hinkson@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date September 28, 2026
Est. primary completion date September 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• External Cephalic Version
External Cephalic Version Twin A

Locations
Country Name City State
Germany Charité University Hospital Berlin-Mitte

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Fetal weight Measurement in grams 30 Minutes before external cephalic version
Secondary Fetal Doppler Umbilical Pulsatility Index Index mesurent /Ratio 30 Minutes before external cephalic version
Secondary Fetal Doppler Umbilical Resistance Index Index mesurent /Ratio 30 Minutes before external cephalic version
Secondary Incidence of pathological cardiotocogramm Numerical percentage 60 Minutes after external cephalic version
Secondary Incidence of emergency delivery Numerical percentage 60 Minutes after external cephalic version
Secondary Incidence of bleeding Numerical percentage 60 Minutes after external cephalic version
Secondary Incidence of contractions Numerical percentage 60 Minutes after external cephalic version
Secondary Incidence of rupture of membranes Numerical percentage 60 Minutes after external cephalic version
Secondary Pain scores Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful) 60 Minutes after external cephalic version
Secondary Mode of Delivery Type of delivery (vaginal or caesarean) 6 weeks after delivery
See also
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Completed NCT00516555 - EBIS: The Eindhoven Breech Intervention Study N/A
Completed NCT01487590 - Cephalic Version by Acupuncture-Moxibustion for Breech Presentation N/A
Completed NCT00890474 - Moxibustion for Fetus in Breech Presentation Phase 3
Terminated NCT00119184 - Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version Phase 1
Completed NCT05827627 - Simulation Techniques Used in Breech Birth Management Training N/A
Terminated NCT04538261 - Elevation of the Fetal Buttocks Prior to External Cephalic Version N/A
Recruiting NCT02801201 - Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation Phase 3
Completed NCT02331160 - Rebozo and External Cephalic Version in Breech Presentation. N/A
Completed NCT00901758 - Intravenous (IV) Nitroglycerin for Versions in Multiparous Women N/A
Completed NCT00896311 - Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women N/A
Not yet recruiting NCT02167841 - Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation. N/A
Completed NCT01048398 - Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions. Phase 3
Recruiting NCT04613778 - Correction of Breech Presentation With Laser Acupuncture N/A
Completed NCT01708018 - Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy N/A
Terminated NCT00465712 - Effect of Amnioinfusion on External Cephalic Version Successful Rate N/A
Recruiting NCT03827226 - Breech External Cephalic Version Intervention Trial
Completed NCT00813683 - Cephalic Version by Acupuncture for Breech Presentation N/A
Recruiting NCT06187948 - An Informative Video Before Planned External Cephalic Version N/A
Completed NCT00141687 - Early External Cephalic Version (ECV) 2 Trial N/A