<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/NCT04443205</url>
  </required_header>
  <id_info>
    <org_study_id>PO20090</org_study_id>
    <nct_id>NCT04443205</nct_id>
  </id_info>
  <brief_title>Relevance of Ultrasound Screening for Foetal Macrosomia</brief_title>
  <acronym>USmacro</acronym>
  <official_title>Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before&#xD;
      birth). This management is an artificial induction of labour for an earlier delivery and&#xD;
      therefore a lower fetal weight gain. Several studies have already shown that ultrasound&#xD;
      performed during the third trimester of pregnancy was not a perfect tool for this screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to describe management of women whose child is macrosomal but has not&#xD;
      been screened g using ultrasound during the third trimester of pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>Foetal macrosomia</measure>
    <time_frame>Baseline</time_frame>
    <description>estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>no macrosomy</arm_group_label>
    <description>pregnant women whose child is not macrosomal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>screened macrosomy</arm_group_label>
    <description>pregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no screened macrosomy</arm_group_label>
    <description>pregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data record</intervention_name>
    <description>Data record</description>
    <arm_group_label>no macrosomy</arm_group_label>
    <arm_group_label>no screened macrosomy</arm_group_label>
    <arm_group_label>screened macrosomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria : Patients (consecutive inclusions) :&#xD;
&#xD;
        Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of&#xD;
        Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.&#xD;
&#xD;
        Women for which the delivery is planned in the gynaecology and obstetrics department of the&#xD;
        Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en&#xD;
        Champagne General Hospital.&#xD;
&#xD;
        Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women&#xD;
        having a contraindication to labour or vaginal delivery Women with a scarred uterus Women&#xD;
        having a history of shoulder dystocia or obstetric trauma Women having a history of urinary&#xD;
        or fecal incontinence Women having a history of bad birth experience with high&#xD;
        psychological impact Women with maternal pathologies (excluding gestational diabetes) Women&#xD;
        whose fetus is breech Women with twin pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Uzma ISHAQUE</last_name>
    <phone>03 10 73 62 88</phone>
    <phone_ext>0033</phone_ext>
    <email>uishaque@chu-reims.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Damien JOLLY</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Uzma ISHAQUE</last_name>
      <phone>03 10 73 62 88</phone>
      <phone_ext>0033</phone_ext>
      <email>uishaque@chu-reims.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fetal Macrosomia</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Shoulder Dystocia</keyword>
  <keyword>induction of labour</keyword>
  <keyword>Cesarean</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Macrosomia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04443205
org study id: PO20090
nct id: NCT04443205
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before
      birth). This management is an artificial induction of labour for an earlier delivery and
      therefore a lower fetal weight gain. Several studies have already shown that ultrasound
      performed during the third trimester of pregnancy was not a perfect tool for this screening.
The aim of the study is to describe management of women whose child is macrosomal but has not
      been screened g using ultrasound during the third trimester of pregnancy.
observational model: Cohort
time perspective: Prospective
measure: Foetal macrosomia
time frame: Baseline
description: estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound
arm group label: no macrosomy
description: pregnant women whose child is not macrosomal
arm group label: screened macrosomy
description: pregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy
arm group label: no screened macrosomy
description: pregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy
intervention type: Other
intervention name: Data record
description: Data record
arm group label: no macrosomy
arm group label: no screened macrosomy
arm group label: screened macrosomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Uzma ISHAQUE
phone: 03 10 73 62 88
phone ext: 0033
email: uishaque@chu-reims.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Fetal Macrosomia