Breech External Cephalic Version Intervention Trial

Recruiting

• Conditions: Breech Presentation

• Registration Number: NCT03827226
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

The primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks.

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-02-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of external cephalic version	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
Incidence of fetal extended legs	30 Minutes before external cephalic version	Numerical percentage
Fetal Doppler Indices middle cerebral	30 Minutes before external cephalic version	Index Measurements/Ratios
Maternal Doppler Indices Uterine artery Left	30 Minutes after external cephalic version	Index Measurements/Ratios
Bladder volume	30 Minutes before external cephalic version	Volume measurement
Distance Symphysis to Breech	30 Minutes before external cephalic version	mm
Depression and Anxiety Stress scale score	120 Minutes after external cephalic version	A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)
Fetal reflexes	30 Minutes before external cephalic version	Percentage
Mode of delivery	6 weeks after delivery	Type of delivery Vaginal or Caesarean
Incidence of bleeding	30 minutes after external cephalic version	Numerical percentage
Sonographic Fetal Parameters: Amniotic Fluid	30 Minutes before external cephalic version	Measurements in mm
Sonographic Fetal Parameters: Head Circumference	30 Minutes before external cephalic version	Measurements in mm
Sonographic Fetal Parameters: Abdominal Circumference	30 Minutes before external cephalic version	Measurements in mm
Sonographic Fetal Parameters: Femur length	30 Minutes before external cephalic version	Measurements in mm
Fetal Doppler Indices Umbilical Pulsatility Index	30 Minutes before external cephalic version	Index Measurements/Ratios
Fetal Doppler Indices Umbilical Resistance Index	30 Minutes after external cephalic version	Index Measurements/Ratios
Maternal Doppler Indices Uterine artery Right	30 Minutes before external cephalic version	Index Measurements/Ratios
Incidence of pathological Cardiotocogram	30 minutes after external cephalic version	Numerical percentage
Incidence of ruptured membranes	30 minutes after external cephalic version	Numerical percentage
Incidence of emergency delivery	30 minutes after external cephalic version	Numerical percentage
Pain scores	30 minutes after external cephalic version	Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)
Incidence of umbilical cord looping	30 Minutes before external cephalic version	Numerical percentage
Incidence of tocolysis	30 minutes after external cephalic version	Numerical percentage

Trial Locations

Locations (1)

Charité University Hospital; 🇩🇪 Berlin-Mitte, Germany