Charité University Hospital
Mitte, 10117, Germany
Location status: Recruiting
Location contact
Larry Hinkson, FRCOG
CONTACT
Recruiting
NCT Number: NCT04579835
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
External Cephalic Version
OtherExternal Cephalic Version Twin A
Primary outcomes
-
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 outcomes
-
Fetal weight
Time frame: 30 Minutes before external cephalic version
Measurement in grams
-
Fetal Doppler Umbilical Pulsatility Index
Time frame: 30 Minutes before external cephalic version
Index mesurent /Ratio
-
Fetal Doppler Umbilical Resistance Index
Time frame: 30 Minutes before external cephalic version
Index mesurent /Ratio
-
Incidence of pathological cardiotocogramm
Time frame: 60 Minutes after external cephalic version
Numerical percentage
-
Incidence of emergency delivery
Time frame: 60 Minutes after external cephalic version
Numerical percentage
-
Incidence of bleeding
Time frame: 60 Minutes after external cephalic version
Numerical percentage
-
Incidence of contractions
Time frame: 60 Minutes after external cephalic version
Numerical percentage
-
Incidence of rupture of membranes
Time frame: 60 Minutes after external cephalic version
Numerical percentage
-
Pain scores
Time frame: 60 Minutes after external cephalic version
Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful)
-
Mode of Delivery
Time frame: 6 weeks after delivery
Type of delivery (vaginal or caesarean)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Charite University, Berlin, Germany
Other
Registry information
Official study title
Twin A Breech External Cephalic Version Intervention Trial
Acronym: TWEXIT
Important dates
- Study start
- 2020
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Oct 8, 2020
- Registry last updated
- Feb 6, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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