Breech External Cephalic Version Intervention Trial
BREXIT
1 other identifier
observational
200
1 country
1
Brief Summary
A prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
February 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedFebruary 6, 2024
February 1, 2024
5.9 years
January 29, 2019
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (23)
Sonographic Fetal Parameters: Head Circumference
30 Minutes before external cephalic version
Sonographic Fetal Parameters: Abdominal Circumference
30 Minutes before external cephalic version
Sonographic Fetal Parameters: Femur length
30 Minutes before external cephalic version
Sonographic Fetal Parameters: Amniotic Fluid
30 Minutes before external cephalic version
Fetal Doppler Indices middle cerebral
30 Minutes before external cephalic version
- +18 more secondary outcomes
Eligibility Criteria
All patients presenting with breech presentation to the antenatal clinic
You may qualify if:
- Presence of the written consent of the patients.
- The patients must be over 18 years old .
- No limit in the ability to consent.
You may not qualify if:
- Age under 18
- Limited ability to consent
- Placenta previa
- Fetal abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité University Hospital
Mitte, 10117, Germany
Related Publications (4)
Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083.
PMID: 10796122BACKGROUNDAmerican 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.
PMID: 26942387RESULTExternal 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.
PMID: 28299867RESULTSchauer 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.
PMID: 35344082DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Larry Hinkson, FRCOG
Consultant in Obstetrics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 29, 2019
First Posted
February 1, 2019
Study Start
February 5, 2019
Primary Completion
January 1, 2025
Study Completion
June 1, 2025
Last Updated
February 6, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share