Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

Recruiting

• Conditions: Twin; Complicating Pregnancy; Breech Presentation

• Registration Number: NCT04579835
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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 Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-09-28
• Study Completion: 2026-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of external cephalic version Twin A	4 hours after external cephalic version	Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants

Secondary Outcome Measures

Name	Time	Method
Fetal Doppler Umbilical Resistance Index	30 Minutes before external cephalic version	Index mesurent /Ratio
Incidence of emergency delivery	60 Minutes after external cephalic version	Numerical percentage
Incidence of bleeding	60 Minutes after external cephalic version	Numerical percentage
Incidence of contractions	60 Minutes after external cephalic version	Numerical percentage
Fetal Doppler Umbilical Pulsatility Index	30 Minutes before external cephalic version	Index mesurent /Ratio
Fetal weight	30 Minutes before external cephalic version	Measurement in grams
Incidence of pathological cardiotocogramm	60 Minutes after external cephalic version	Numerical percentage
Pain scores	60 Minutes after external cephalic version	Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful)
Mode of Delivery	6 weeks after delivery	Type of delivery (vaginal or caesarean)
Incidence of rupture of membranes	60 Minutes after external cephalic version	Numerical percentage

Trial Locations

Locations (1)

Charité University Hospital; 🇩🇪 Berlin-Mitte, Germany