<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/NCT03261245</url>
  </required_header>
  <id_info>
    <org_study_id>MARIET AOI 2016</org_study_id>
    <nct_id>NCT03261245</nct_id>
  </id_info>
  <brief_title>Relationship Between Multi-exposure to Noise and Air Pollution and the Onset of Hypertension Disorders During Pregnancy</brief_title>
  <acronym>HTA-BQuA</acronym>
  <official_title>Hypertension Disorders During Pregnancy and Multi-exposure to Environmental Noise and Atmospheric Pollution in an Urban Setting: Case-control Study in Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      This retrospective study aimed to analyse the relationship between multi-exposure to noise&#xD;
      and air pollution the onset of hypertension disorders during pregnancy&#xD;
&#xD;
      It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and&#xD;
      2009 split into two groups:&#xD;
&#xD;
        -  530 cases (women who experienced hypertension disorders during pregnancy&#xD;
&#xD;
        -  2120 controls (women who did not experience a hypertension disorder during pregnancy)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Onset of a hypertension disorder during pregnancy</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2650</enrollment>
  <condition>Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009</condition>
  <arm_group>
    <arm_group_label>Cas</arm_group_label>
    <description>Onset of a hypertension disorder during pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>No hypertension disorder during pregnancy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women who gave birth at Dijon and Besançon CHU between 2005 and 2009&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women living in Besançon or one of the 15 communes of the Dijon conurbation&#xD;
&#xD;
          -  Who gave birth at Dijon or Besançon CHU&#xD;
&#xD;
          -  Between 1st January 2005 and 31st December 2009&#xD;
&#xD;
        Criterion for the inclusion of cases:&#xD;
&#xD;
          -  Onset of a hypertension disorder during pregnancy defined according to expert&#xD;
             recommendations&#xD;
&#xD;
        Criterion for the inclusion of controls:&#xD;
&#xD;
          -  No hypertension disorder during pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical termination of pregnancy&#xD;
&#xD;
          -  Opposition to the use of their data&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne-Sophie MARIET</last_name>
    <phone>03.80.29.55.74</phone>
    <phone_ext>+33</phone_ext>
    <email>anne-sophie.mariet@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de BESANCON</name>
      <address>
        <city>Besancon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>frédéric MAUNY</last_name>
      <phone>03.81.21.94.94</phone>
      <phone_ext>+33</phone_ext>
      <email>frederic.mauny@univ-fcomte.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Sophie MARIET</last_name>
      <phone>03 80 29 55 74</phone>
      <phone_ext>+33</phone_ext>
      <email>anne-sophie.mariet@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</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>Hypertension</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/NCT03261245
org study id: MARIET AOI 2016
nct id: NCT03261245
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This retrospective study aimed to analyse the relationship between multi-exposure to noise
      and air pollution the onset of hypertension disorders during pregnancy

      It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and
      2009 split into two groups:

        -  530 cases (women who experienced hypertension disorders during pregnancy

        -  2120 controls (women who did not experience a hypertension disorder during pregnancy)
observational model: Case-Control
time perspective: Retrospective
measure: Onset of a hypertension disorder during pregnancy
time frame: at baseline
arm group label: Cas
description: Onset of a hypertension disorder during pregnancy
arm group label: Controls
description: No hypertension disorder during pregnancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne-Sophie MARIET
phone: 03.80.29.55.74
phone ext: +33
email: anne-sophie.mariet@chu-dijon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Hypertension