<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03827226</url>
  </required_header>
  <id_info>
    <org_study_id>EA2/241/18</org_study_id>
    <nct_id>NCT03827226</nct_id>
  </id_info>
  <brief_title>Breech External Cephalic Version Intervention Trial</brief_title>
  <acronym>BREXIT</acronym>
  <official_title>Breech External Cephalic Version Intervention Trial- A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective study assessing the use of external cephalic version for the management of&#xD;
      breech presentation in pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the study is to determine the success rate of external cephalic version&#xD;
      for breech presentation from 36 gestational weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of external cephalic version</measure>
    <time_frame>4 hours after external cephalic version</time_frame>
    <description>Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sonographic Fetal Parameters: Head Circumference</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Measurements in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic Fetal Parameters: Abdominal Circumference</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Measurements in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic Fetal Parameters: Femur length</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Measurements in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic Fetal Parameters: Amniotic Fluid</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Measurements in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Doppler Indices middle cerebral</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Index Measurements/Ratios</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Doppler Indices Umbilical Pulsatility Index</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Index Measurements/Ratios</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Doppler Indices Umbilical Resistance Index</measure>
    <time_frame>30 Minutes after external cephalic version</time_frame>
    <description>Index Measurements/Ratios</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Doppler Indices Uterine artery Right</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Index Measurements/Ratios</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Doppler Indices Uterine artery Left</measure>
    <time_frame>30 Minutes after external cephalic version</time_frame>
    <description>Index Measurements/Ratios</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder volume</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Volume measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Symphysis to Breech</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and Anxiety Stress scale score</measure>
    <time_frame>60 minutes before external cephalic version</time_frame>
    <description>A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and Anxiety Stress scale score</measure>
    <time_frame>120 Minutes after external cephalic version</time_frame>
    <description>A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal reflexes</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>6 weeks after delivery</time_frame>
    <description>Type of delivery Vaginal or Caesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fetal extended legs</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bleeding</measure>
    <time_frame>30 minutes after external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ruptured membranes</measure>
    <time_frame>30 minutes after external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of pathological Cardiotocogram</measure>
    <time_frame>30 minutes after external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of emergency delivery</measure>
    <time_frame>30 minutes after external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>30 minutes after external cephalic version</time_frame>
    <description>Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of tocolysis</measure>
    <time_frame>30 minutes after external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of umbilical cord looping</measure>
    <time_frame>30 Minutes before external cephalic version</time_frame>
    <description>Numerical percentage</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breech Presentation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presenting with breech presentation to the antenatal clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of the written consent of the patients.&#xD;
&#xD;
          -  The patients must be over 18 years old .&#xD;
&#xD;
          -  No limit in the ability to consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  Limited ability to consent&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  Fetal abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Larry Hinkson, FRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant in Obstetrics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Larry Hinkson, FRCOG</last_name>
    <phone>0049 (0)30450564015</phone>
    <email>Larry.Hinkson@charite.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Charité University Hospital</name>
      <address>
        <city>Berlin-Mitte</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Larry Hinkson, FRCOG</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>10796122</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>26942387</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>28299867</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Larry Hinkson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breech Presentation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03827226
org study id: EA2/241/18
nct id: NCT03827226
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective study assessing the use of external cephalic version for the management of
      breech presentation in pregnancy.
The primary aim of the study is to determine the success rate of external cephalic version
      for breech presentation from 36 gestational weeks.
observational model: Cohort
time perspective: Prospective
measure: Success rate of external cephalic version
time frame: 4 hours after external cephalic version
description: Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,
measure: Sonographic Fetal Parameters: Head Circumference
time frame: 30 Minutes before external cephalic version
description: Measurements in mm
measure: Sonographic Fetal Parameters: Abdominal Circumference
time frame: 30 Minutes before external cephalic version
description: Measurements in mm
measure: Sonographic Fetal Parameters: Femur length
time frame: 30 Minutes before external cephalic version
description: Measurements in mm
measure: Sonographic Fetal Parameters: Amniotic Fluid
time frame: 30 Minutes before external cephalic version
description: Measurements in mm
measure: Fetal Doppler Indices middle cerebral
time frame: 30 Minutes before external cephalic version
description: Index Measurements/Ratios
measure: Fetal Doppler Indices Umbilical Pulsatility Index
time frame: 30 Minutes before external cephalic version
description: Index Measurements/Ratios
measure: Fetal Doppler Indices Umbilical Resistance Index
time frame: 30 Minutes after external cephalic version
description: Index Measurements/Ratios
measure: Maternal Doppler Indices Uterine artery Right
time frame: 30 Minutes before external cephalic version
description: Index Measurements/Ratios
measure: Maternal Doppler Indices Uterine artery Left
time frame: 30 Minutes after external cephalic version
description: Index Measurements/Ratios
measure: Bladder volume
time frame: 30 Minutes before external cephalic version
description: Volume measurement
measure: Distance Symphysis to Breech
time frame: 30 Minutes before external cephalic version
description: mm
measure: Depression and Anxiety Stress scale score
time frame: 60 minutes before external cephalic version
description: A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)
measure: Depression and Anxiety Stress scale score
time frame: 120 Minutes after external cephalic version
description: A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)
measure: Fetal reflexes
time frame: 30 Minutes before external cephalic version
description: Percentage
measure: Mode of delivery
time frame: 6 weeks after delivery
description: Type of delivery Vaginal or Caesarean
measure: Incidence of fetal extended legs
time frame: 30 Minutes before external cephalic version
description: Numerical percentage
measure: Incidence of bleeding
time frame: 30 minutes after external cephalic version
description: Numerical percentage
measure: Incidence of ruptured membranes
time frame: 30 minutes after external cephalic version
description: Numerical percentage
measure: Incidence of pathological Cardiotocogram
time frame: 30 minutes after external cephalic version
description: Numerical percentage
measure: Incidence of emergency delivery
time frame: 30 minutes after external cephalic version
description: Numerical percentage
measure: Pain scores
time frame: 30 minutes after external cephalic version
description: Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)
measure: Incidence of tocolysis
time frame: 30 minutes after external cephalic version
description: Numerical percentage
measure: Incidence of umbilical cord looping
time frame: 30 Minutes before external cephalic version
description: Numerical percentage
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Larry Hinkson, FRCOG
role: Principal Investigator
affiliation: Consultant in Obstetrics
last name: Larry Hinkson, FRCOG
phone: 0049 (0)30450564015
email: Larry.Hinkson@charite.de
facility: 
status: Recruiting
contact: 
country: Germany
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.
PMID: 10796122
citation: 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.
PMID: 26942387
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.
PMID: 28299867
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Larry Hinkson
investigator title: Principal Investigator
mesh term: Breech Presentation
sharing ipd: No