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Breech External Cephalic Version Intervention Trial (BREXIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827226
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Larry Hinkson, Charite University, Berlin, Germany

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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breech External Cephalic Version Intervention Trial- A Prospective Study
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2022



Primary Outcome Measures :
  1. Success rate of external cephalic version [ Time Frame: 4 hours after external cephalic version ]
    Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,


Secondary Outcome Measures :
  1. Sonographic Fetal Parameters: Head Circumference [ Time Frame: 30 Minutes before external cephalic version ]
    Measurements in mm

  2. Sonographic Fetal Parameters: Abdominal Circumference [ Time Frame: 30 Minutes before external cephalic version ]
    Measurements in mm

  3. Sonographic Fetal Parameters: Femur length [ Time Frame: 30 Minutes before external cephalic version ]
    Measurements in mm

  4. Sonographic Fetal Parameters: Amniotic Fluid [ Time Frame: 30 Minutes before external cephalic version ]
    Measurements in mm

  5. Fetal Doppler Indices middle cerebral [ Time Frame: 30 Minutes before external cephalic version ]
    Index Measurements/Ratios

  6. Fetal Doppler Indices Umbilical Pulsatility Index [ Time Frame: 30 Minutes before external cephalic version ]
    Index Measurements/Ratios

  7. Fetal Doppler Indices Umbilical Resistance Index [ Time Frame: 30 Minutes after external cephalic version ]
    Index Measurements/Ratios

  8. Maternal Doppler Indices Uterine artery Right [ Time Frame: 30 Minutes before external cephalic version ]
    Index Measurements/Ratios

  9. Maternal Doppler Indices Uterine artery Left [ Time Frame: 30 Minutes after external cephalic version ]
    Index Measurements/Ratios

  10. Bladder volume [ Time Frame: 30 Minutes before external cephalic version ]
    Volume measurement

  11. Distance Symphysis to Breech [ Time Frame: 30 Minutes before external cephalic version ]
    mm

  12. Depression and Anxiety Stress scale score [ Time Frame: 60 minutes before external cephalic version ]
    A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)

  13. Depression and Anxiety Stress scale score [ Time Frame: 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)

  14. Fetal reflexes [ Time Frame: 30 Minutes before external cephalic version ]
    Percentage

  15. Mode of delivery [ Time Frame: 6 weeks after delivery ]
    Type of delivery Vaginal or Caesarean

  16. Incidence of fetal extended legs [ Time Frame: 30 Minutes before external cephalic version ]
    Numerical percentage

  17. Incidence of bleeding [ Time Frame: 30 minutes after external cephalic version ]
    Numerical percentage

  18. Incidence of ruptured membranes [ Time Frame: 30 minutes after external cephalic version ]
    Numerical percentage

  19. Incidence of pathological Cardiotocogram [ Time Frame: 30 minutes after external cephalic version ]
    Numerical percentage

  20. Incidence of emergency delivery [ Time Frame: 30 minutes after external cephalic version ]
    Numerical percentage

  21. Pain scores [ Time Frame: 30 minutes after external cephalic version ]
    Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)

  22. Incidence of tocolysis [ Time Frame: 30 minutes after external cephalic version ]
    Numerical percentage

  23. Incidence of umbilical cord looping [ Time Frame: 30 Minutes before external cephalic version ]
    Numerical percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting with breech presentation to the antenatal clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827226


Contacts
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Contact: Larry Hinkson, FRCOG 0049 (0)30450564015 Larry.Hinkson@charite.de

Locations
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Germany
Charité University Hospital Recruiting
Berlin-Mitte, Germany, 10117
Contact: Larry Hinkson, FRCOG         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Larry Hinkson, FRCOG Consultant in Obstetrics
Publications of Results:
Other Publications:
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Responsible Party: Larry Hinkson, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03827226    
Other Study ID Numbers: EA2/241/18
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications