<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/NCT04432805</url>
  </required_header>
  <id_info>
    <org_study_id>2020-30</org_study_id>
    <secondary_id>2020-A01303-36</secondary_id>
    <nct_id>NCT04432805</nct_id>
  </id_info>
  <brief_title>Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19</brief_title>
  <acronym>LUSCOVIDPREG</acronym>
  <official_title>Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Cohort prospective study.&#xD;
&#xD;
      Objectives :&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed&#xD;
      COVID-19&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan)&#xD;
           lesions&#xD;
&#xD;
        -  To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant&#xD;
           women&#xD;
&#xD;
        -  To evaluate predictive value of different lung ultrasound lesions for intensive care&#xD;
           unit admission of pregnant women with suspected or confirmed COVID-19&#xD;
&#xD;
        -  To describe the pregnancy issues of the study population&#xD;
&#xD;
      Course of the study:&#xD;
&#xD;
        -  Inclusion of pregnant suspected of having COVID-19 and cared following the service&#xD;
           protocol&#xD;
&#xD;
        -  Performing of lung ultrasound at bedside in labor ward or in COVID unit&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      Lung ultrasound lesions (and corresponding score) at the moment of the initial management of&#xD;
      pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse&#xD;
      Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment issues&#xD;
  </why_stopped>
  <start_date type="Actual">October 13, 2020</start_date>
  <completion_date type="Actual">January 2, 2021</completion_date>
  <primary_completion_date type="Actual">January 2, 2021</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>Description of the lesions</measure>
    <time_frame>4 months</time_frame>
    <description>Description of the lesions in each of the 6 pulmonary quadrants on the right and left. Establishment of the ultrasound score corresponding to the sum of the scores attributed to each type of lesion in each quadrant (0: normal, 1: spaced comet tails, 2: curtain comet tails, 3: consolidation).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pregnant Women Suspected of COVID-19</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women suspected of COVID-19</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Performing of lung ultrasound</intervention_name>
    <description>Performing of lung ultrasound at bedside in labor ward or in COVID unit</description>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Gestational age greater than or equal to 22 weeks of gestation&#xD;
&#xD;
          -  Pregnant women suspected of COVID-19 :&#xD;
&#xD;
          -  already having a nasopharyngeal RT-PCR for the SARS-CoV-2&#xD;
&#xD;
          -  AND having a chest CT-scan or waiting for this exam&#xD;
&#xD;
          -  Women giving a writing consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women giving an opposition to participate&#xD;
&#xD;
          -  Women not enough fluent in French to benefit from clear and intelligible information&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Olivier ARNAUD, Director</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04432805
org study id: 2020-30
secondary id: 2020-A01303-36
nct id: NCT04432805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cohort prospective study.

      Objectives :

      Primary objective:

      To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed
      COVID-19

      Secondary objectives:

        -  To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan)
           lesions

        -  To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant
           women

        -  To evaluate predictive value of different lung ultrasound lesions for intensive care
           unit admission of pregnant women with suspected or confirmed COVID-19

        -  To describe the pregnancy issues of the study population

      Course of the study:

        -  Inclusion of pregnant suspected of having COVID-19 and cared following the service
           protocol

        -  Performing of lung ultrasound at bedside in labor ward or in COVID unit

      Primary outcome:

      Lung ultrasound lesions (and corresponding score) at the moment of the initial management of
      pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse
      Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Description of the lesions
time frame: 4 months
description: Description of the lesions in each of the 6 pulmonary quadrants on the right and left. Establishment of the ultrasound score corresponding to the sum of the scores attributed to each type of lesion in each quadrant (0: normal, 1: spaced comet tails, 2: curtain comet tails, 3: consolidation).
arm group label: Pregnant women
arm group type: Experimental
description: Pregnant women suspected of COVID-19
intervention type: Device
intervention name: Performing of lung ultrasound
description: Performing of lung ultrasound at bedside in labor ward or in COVID unit
arm group label: Pregnant women
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Olivier ARNAUD, Director
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No