Breech External Cephalic Version Intervention Trial (BREXIT)

Breech External Cephalic Version Intervention Trial- A Prospective Study

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

Study Overview

• Status: Recruiting
• Conditions: Breech Presentation

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Larry Hinkson, FRCOG; Phone Number: 0049 (0)30450564015; Email: Larry.Hinkson@charite.de

Study Locations

• Germany
  • Berlin-Mitte, Germany, 10117
    • Recruiting
    • Charité University Hospital
    • Contact: Larry Hinkson, FRCOG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with breech presentation to the antenatal clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Larry Hinkson, FRCOG, Consultant in Obstetrics

Publications and helpful links

General Publications

• Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083.
• 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.
• 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.
• Schauer M, Latartara E, Alonso-Espias M, Rossetti E, Gebert P, Henrich W, Hinkson L. Depression, anxiety and stress in women with breech pregnancy compared to women with cephalic presentation-a cross-sectional study. Arch Gynecol Obstet. 2023 Feb;307(2):409-419. doi: 10.1007/s00404-022-06509-0. Epub 2022 Mar 27.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breech Presentation
• Other Study ID Numbers: EA2/241/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No