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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


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
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Completed NCT05827627 - Simulation Techniques Used in Breech Birth Management Training N/A
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Completed NCT00813683 - Cephalic Version by Acupuncture for Breech Presentation N/A
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Completed NCT00141687 - Early External Cephalic Version (ECV) 2 Trial N/A