<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/NCT04441866</url>
  </required_header>
  <id_info>
    <org_study_id>NP3574</org_study_id>
    <nct_id>NCT04441866</nct_id>
  </id_info>
  <brief_title>Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound</brief_title>
  <acronym>Auto-2T</acronym>
  <official_title>Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Brescia</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>
      This study aims to evaluate the effect of the use of automated algorithms for the measurement&#xD;
      of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared&#xD;
      with the standard ultrasound technique, during the second trimester ultrasound scan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years in many ultrasound equipment were fitted with automated algorithms for&#xD;
      measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy.&#xD;
      Although there are studies that have assessed the application of these algorithms in terms of&#xD;
      repeatability of the measurements made, or of possibility of acquiring diagnostic planes,&#xD;
      there are no randomized controlled studies that evaluated their impact on the second&#xD;
      trimester ultrasound scan.&#xD;
&#xD;
      The aim of the study is to evaluate the effect of the use of automated algorithms for the&#xD;
      measurement of fetal biometry, and for the reconstruction of standard planes of fetal&#xD;
      anatomy, compared with the standard ultrasound technique, in terms of:&#xD;
&#xD;
        -  duration of the ultrasound scan&#xD;
&#xD;
        -  quality of biometric measurements&#xD;
&#xD;
        -  quality of the diagnostic planes&#xD;
&#xD;
        -  operator satisfaction&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of ultrasound examination</measure>
    <time_frame>During ultrasound examination</time_frame>
    <description>Duration of ultrasound examination in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality score of fetal biometry</measure>
    <time_frame>During ultrasound examination</time_frame>
    <description>Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality score of fetal diagnostic planes</measure>
    <time_frame>During ultrasound examination</time_frame>
    <description>Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator satisfaction</measure>
    <time_frame>During ultrasound examination</time_frame>
    <description>Visual analogue scale: from 0 (worst) to 32 (best)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Ultrasonography, Prenatal</condition>
  <arm_group>
    <arm_group_label>Automated algorithms</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard technique</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard 2D assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Automated algorithms</intervention_name>
    <description>Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy</description>
    <arm_group_label>Automated algorithms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard technique</intervention_name>
    <description>Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy</description>
    <arm_group_label>Standard technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy 19+0-21+6 weeks&#xD;
&#xD;
          -  Live fetus&#xD;
&#xD;
          -  No fetal abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Intrauterine fetal death&#xD;
&#xD;
          -  Fetal abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Spedali Ciivli</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Brescia</investigator_affiliation>
    <investigator_full_name>Federico Prefumo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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/NCT04441866
org study id: NP3574
nct id: NCT04441866
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of the use of automated algorithms for the measurement
      of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared
      with the standard ultrasound technique, during the second trimester ultrasound scan.
In recent years in many ultrasound equipment were fitted with automated algorithms for
      measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy.
      Although there are studies that have assessed the application of these algorithms in terms of
      repeatability of the measurements made, or of possibility of acquiring diagnostic planes,
      there are no randomized controlled studies that evaluated their impact on the second
      trimester ultrasound scan.

      The aim of the study is to evaluate the effect of the use of automated algorithms for the
      measurement of fetal biometry, and for the reconstruction of standard planes of fetal
      anatomy, compared with the standard ultrasound technique, in terms of:

        -  duration of the ultrasound scan

        -  quality of biometric measurements

        -  quality of the diagnostic planes

        -  operator satisfaction
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Duration of ultrasound examination
time frame: During ultrasound examination
description: Duration of ultrasound examination in minutes
measure: Quality score of fetal biometry
time frame: During ultrasound examination
description: Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)
measure: Quality score of fetal diagnostic planes
time frame: During ultrasound examination
description: Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best)
measure: Operator satisfaction
time frame: During ultrasound examination
description: Visual analogue scale: from 0 (worst) to 32 (best)
arm group label: Automated algorithms
arm group type: Active Comparator
description: Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes
arm group label: Standard technique
arm group type: Placebo Comparator
description: Standard 2D assessment
intervention type: Diagnostic Test
intervention name: Automated algorithms
description: Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
arm group label: Automated algorithms
intervention type: Diagnostic Test
intervention name: Standard technique
description: Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
arm group label: Standard technique
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Brescia
investigator full name: Federico Prefumo
investigator title: Associate Professor
sharing ipd: No