<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/NCT03002246</url>
  </required_header>
  <id_info>
    <org_study_id>H-39343</org_study_id>
    <nct_id>NCT03002246</nct_id>
  </id_info>
  <brief_title>Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume</brief_title>
  <official_title>Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samsung Medison Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Obstetrics and Gynecology Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Frauenklinik der Diakonischen Dienste Hannover</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is a collaborative study between 4 sites worldwide. A total of 600 research&#xD;
      subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software&#xD;
      to improve on estimated fetal weight predictions over a broad range of gestational ages. The&#xD;
      purpose is to compare the accuracy and precision of birth weight predictions based on this&#xD;
      new technology as compared to the current 2D birth weight prediction models.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound has been used for over 20 years to estimate fetal weight prior to birth. Sometimes&#xD;
      this estimation is not always similar to what the baby actually weighs. In addition to the&#xD;
      regular measurements taken at routine ultrasound exams, 3D ultrasound of the baby's arm and&#xD;
      leg soft tissue may give us more precise information on how much the baby weighs. This&#xD;
      measurement is called fractional limb volume. Fractional limb volume (FLV) is a soft tissue&#xD;
      measurement of the arm or thigh that can be used to evaluate body composition. This&#xD;
      measurement mostly reflects the fat and muscle development with a small amount of bone.&#xD;
&#xD;
      The recent introduction of 5D Limb Volume software (Samsung, Seoul, Korea) now makes it&#xD;
      possible to efficiently and reproducibly measure semi-automated FLV using a computer guided&#xD;
      technique.&#xD;
&#xD;
      Subjects will receive one ultrasound scan 4-7 days before their delivery. Both 2D and 3D&#xD;
      measurements will be taken. These measurements will then be used to estimate fetal weight. We&#xD;
      will compare estimated weight to actual birth weight in order to determine the accuracy and&#xD;
      precision of the 5D Limb Volume technology. This data may also be used to develop new weight&#xD;
      estimation models that could provide better accuracy and/or precision than what is currently&#xD;
      provided using published methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>Comparison Between 5D Limb Vol and 2D Birth weight Prediction</measure>
    <time_frame>Feb 2017 -Feb 2018</time_frame>
    <description>Compare the accuracy and precision of BW predictions based on 5D Limb Vol technology in pregnant women as compared to 2D BW prediction models</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Birth weight Predictions in Suspected Growth Abnormalities</measure>
    <time_frame>Feb 2017 - Feb 2018</time_frame>
    <description>Characterize the performance of BW predictions based on 5D Limb Vol technology in pregnant women with suspected growth abnormalities.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">330</enrollment>
  <condition>Birth Weight</condition>
  <condition>Fetal Growth Retardation</condition>
  <condition>Fetal Weight</condition>
  <condition>Fetal Macrosomia</condition>
  <arm_group>
    <arm_group_label>Average for Gestational Age</arm_group_label>
    <description>This cohort will include a sample size of 90 subjects. Fetuses will have an estimated fetal weight greater than 10th percentile and less than 90th percentile based on clinical ultrasound assessment. This cohort will receive an ultrasound examination 4-7 days before their delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Large for Gestational Age</arm_group_label>
    <description>This cohort will include a sample size of 30 subjects. Fetuses will have an estimated fetal weight greater than 90th percentile based on clinical ultrasound assessment.This cohort will receive an ultrasound examination 4-7 days before their delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Small for Gestational Age</arm_group_label>
    <description>This cohort will include a sample size of 30 subjects. Fetuses will have an estimated fetal weight less than 10th percentile based on clinical ultrasound assessment.This cohort will receive an ultrasound examination 4-7 days before their delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound Examination</intervention_name>
    <description>Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.</description>
    <arm_group_label>Average for Gestational Age</arm_group_label>
    <arm_group_label>Large for Gestational Age</arm_group_label>
    <arm_group_label>Small for Gestational Age</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women between 28-42 weeks gestation. Fetuses will be either small for gestational&#xD;
        age (estimated fetal weight &lt; 10%), average for gestational age, or large for gestational&#xD;
        age (estimated fetal weight &gt; 90%).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women (28-42 weeks) within 4-7 days of delivery&#xD;
&#xD;
          2. Planned delivery at the collaborating hospital where the fetal US scan was performed&#xD;
&#xD;
          3. Body mass index at first official prenatal appointment below 35.0 kg/M2&#xD;
&#xD;
          4. Firm US dating criteria (early crown-rump length &lt; 14 weeks gestational age)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of technical factors (e.g. obesity) that make it difficult to visualize fetal&#xD;
             structures&#xD;
&#xD;
          2. Oligohydramnios determined by amniotic fluid index less than 5cm&#xD;
&#xD;
          3. Fetal distress or unstable maternal condition&#xD;
&#xD;
          4. Structural or chromosomal fetal anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wesley Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Wesley Lee</investigator_full_name>
    <investigator_title>Dr. Wesley Lee</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
    <mesh_term>Fetal Macrosomia</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Birth Weight</mesh_term>
    <mesh_term>Fetal Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03002246
org study id: H-39343
nct id: NCT03002246
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This trial is a collaborative study between 4 sites worldwide. A total of 600 research
      subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software
      to improve on estimated fetal weight predictions over a broad range of gestational ages. The
      purpose is to compare the accuracy and precision of birth weight predictions based on this
      new technology as compared to the current 2D birth weight prediction models.
Ultrasound has been used for over 20 years to estimate fetal weight prior to birth. Sometimes
      this estimation is not always similar to what the baby actually weighs. In addition to the
      regular measurements taken at routine ultrasound exams, 3D ultrasound of the baby's arm and
      leg soft tissue may give us more precise information on how much the baby weighs. This
      measurement is called fractional limb volume. Fractional limb volume (FLV) is a soft tissue
      measurement of the arm or thigh that can be used to evaluate body composition. This
      measurement mostly reflects the fat and muscle development with a small amount of bone.

      The recent introduction of 5D Limb Volume software (Samsung, Seoul, Korea) now makes it
      possible to efficiently and reproducibly measure semi-automated FLV using a computer guided
      technique.

      Subjects will receive one ultrasound scan 4-7 days before their delivery. Both 2D and 3D
      measurements will be taken. These measurements will then be used to estimate fetal weight. We
      will compare estimated weight to actual birth weight in order to determine the accuracy and
      precision of the 5D Limb Volume technology. This data may also be used to develop new weight
      estimation models that could provide better accuracy and/or precision than what is currently
      provided using published methods.
observational model: Cohort
time perspective: Prospective
measure: Comparison Between 5D Limb Vol and 2D Birth weight Prediction
time frame: Feb 2017 -Feb 2018
description: Compare the accuracy and precision of BW predictions based on 5D Limb Vol technology in pregnant women as compared to 2D BW prediction models
measure: Birth weight Predictions in Suspected Growth Abnormalities
time frame: Feb 2017 - Feb 2018
description: Characterize the performance of BW predictions based on 5D Limb Vol technology in pregnant women with suspected growth abnormalities.
arm group label: Average for Gestational Age
description: This cohort will include a sample size of 90 subjects. Fetuses will have an estimated fetal weight greater than 10th percentile and less than 90th percentile based on clinical ultrasound assessment. This cohort will receive an ultrasound examination 4-7 days before their delivery.
arm group label: Large for Gestational Age
description: This cohort will include a sample size of 30 subjects. Fetuses will have an estimated fetal weight greater than 90th percentile based on clinical ultrasound assessment.This cohort will receive an ultrasound examination 4-7 days before their delivery.
arm group label: Small for Gestational Age
description: This cohort will include a sample size of 30 subjects. Fetuses will have an estimated fetal weight less than 10th percentile based on clinical ultrasound assessment.This cohort will receive an ultrasound examination 4-7 days before their delivery.
intervention type: Other
intervention name: Ultrasound Examination
description: Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.
arm group label: Average for Gestational Age
arm group label: Large for Gestational Age
arm group label: Small for Gestational Age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Wesley Lee, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Wesley Lee
investigator title: Dr. Wesley Lee
mesh term: Fetal Growth Retardation
mesh term: Fetal Macrosomia
mesh term: Body Weight
mesh term: Birth Weight
mesh term: Fetal Weight
sharing ipd: Yes