<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/NCT03834805</url>
  </required_header>
  <id_info>
    <org_study_id>API/2018/95</org_study_id>
    <nct_id>NCT03834805</nct_id>
  </id_info>
  <brief_title>Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks</brief_title>
  <acronym>ELASTOPULM</acronym>
  <official_title>Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>No</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>
      The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver&#xD;
      Elastography ratio) during normal pregnancy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">March 4, 2021</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea</measure>
    <time_frame>measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA)</time_frame>
    <description>Evolution of the fetal lung elasticity coefficient measured in kilopascals (kPa) compared to the fetal liver elasticity</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Pregnant Woman</condition>
  <arm_group>
    <arm_group_label>Pregnant women with a normal pregnancy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assesment of fetal lung and liver stiffness with 2D Ultrasounds Shear Wave Elastography</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lung and liver elastography measurement of fetus</intervention_name>
    <description>Other: lung and liver elastography measurement of fetus</description>
    <arm_group_label>Pregnant women with a normal pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  major pregnant women&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        foetus:&#xD;
&#xD;
          -  fetal pulmonary disease&#xD;
&#xD;
          -  fetal liver disease&#xD;
&#xD;
          -  chromosome fetal abnormalities&#xD;
&#xD;
          -  fetal growth restriction&#xD;
&#xD;
        mother:&#xD;
&#xD;
          -  BMI&gt;30 in beginning of pregnancy&#xD;
&#xD;
          -  premature ruptured membranes&#xD;
&#xD;
          -  high blood pressure&#xD;
&#xD;
          -  pre-eclampsia&#xD;
&#xD;
          -  gestational diabetes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <state>Doubs</state>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03834805
org study id: API/2018/95
nct id: NCT03834805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver
      Elastography ratio) during normal pregnancy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea
time frame: measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA)
description: Evolution of the fetal lung elasticity coefficient measured in kilopascals (kPa) compared to the fetal liver elasticity
arm group label: Pregnant women with a normal pregnancy
arm group type: Experimental
description: Assesment of fetal lung and liver stiffness with 2D Ultrasounds Shear Wave Elastography
intervention type: Other
intervention name: lung and liver elastography measurement of fetus
description: Other: lung and liver elastography measurement of fetus
arm group label: Pregnant women with a normal pregnancy
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No