Breech External Cephalic Version Intervention Trial

Breech Presentation Clinical Trial

— BREXIT  

Official title:

Breech External Cephalic Version Intervention Trial- A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827226
• Other study ID #: EA2/241/18
• Status: Recruiting
• Start date: February 5, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Larry Hinkson, FRCOG
• Phone: 0049 (0)30450564015
• Email: Larry.Hinkson[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• 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

Related Conditions & MeSH terms

• Breech Presentation

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, 

References & Publications (3)

American College of Obstetricians and Gynecologists' Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 161: External Cephalic Version. Obstet Gynecol. 2016 Feb;127(2):e54-61. doi: 10.1097/AOG.0000000000001312. — View Citation

External Cephalic Version and Reducing the Incidence of Term Breech Presentation: Green-top Guideline No. 20a. BJOG. 2017 Jun;124(7):e178-e192. doi: 10.1111/1471-0528.14466. Epub 2017 Mar 16. No abstract available. — View Citation

Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of external cephalic version	Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,	4 hours after external cephalic version
Secondary	Sonographic Fetal Parameters: Head Circumference	Measurements in mm	30 Minutes before external cephalic version
Secondary	Sonographic Fetal Parameters: Abdominal Circumference	Measurements in mm	30 Minutes before external cephalic version
Secondary	Sonographic Fetal Parameters: Femur length	Measurements in mm	30 Minutes before external cephalic version
Secondary	Sonographic Fetal Parameters: Amniotic Fluid	Measurements in mm	30 Minutes before external cephalic version
Secondary	Fetal Doppler Indices middle cerebral	Index Measurements/Ratios	30 Minutes before external cephalic version
Secondary	Fetal Doppler Indices Umbilical Pulsatility Index	Index Measurements/Ratios	30 Minutes before external cephalic version
Secondary	Fetal Doppler Indices Umbilical Resistance Index	Index Measurements/Ratios	30 Minutes after external cephalic version
Secondary	Maternal Doppler Indices Uterine artery Right	Index Measurements/Ratios	30 Minutes before external cephalic version
Secondary	Maternal Doppler Indices Uterine artery Left	Index Measurements/Ratios	30 Minutes after external cephalic version
Secondary	Bladder volume	Volume measurement	30 Minutes before external cephalic version
Secondary	Distance Symphysis to Breech	mm	30 Minutes before external cephalic version
Secondary	Depression and Anxiety Stress scale score	A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)	60 minutes before external cephalic version
Secondary	Depression and Anxiety Stress scale score	A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)	120 Minutes after external cephalic version
Secondary	Fetal reflexes	Percentage	30 Minutes before external cephalic version
Secondary	Mode of delivery	Type of delivery Vaginal or Caesarean	6 weeks after delivery
Secondary	Incidence of fetal extended legs	Numerical percentage	30 Minutes before external cephalic version
Secondary	Incidence of bleeding	Numerical percentage	30 minutes after external cephalic version
Secondary	Incidence of ruptured membranes	Numerical percentage	30 minutes after external cephalic version
Secondary	Incidence of pathological Cardiotocogram	Numerical percentage	30 minutes after external cephalic version
Secondary	Incidence of emergency delivery	Numerical percentage	30 minutes after external cephalic version
Secondary	Pain scores	Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)	30 minutes after external cephalic version
Secondary	Incidence of tocolysis	Numerical percentage	30 minutes after external cephalic version
Secondary	Incidence of umbilical cord looping	Numerical percentage	30 Minutes before external cephalic version