<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/NCT03233984</url>
  </required_header>
  <id_info>
    <org_study_id>PREVED</org_study_id>
    <nct_id>NCT03233984</nct_id>
  </id_info>
  <brief_title>Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition</brief_title>
  <official_title>Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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>
      Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major&#xD;
      foetal pathology and impact growth.&#xD;
&#xD;
      Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and&#xD;
      water.&#xD;
&#xD;
      Through a prevention program, the investigators tried to warned pregnant women on endocrine&#xD;
      disruptors exposition risks. The goal here is to assess the effectiveness of this program on&#xD;
      their fresh products consumption.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2017</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>program effectivness</measure>
    <time_frame>During the pregnancy (second and third trimester)</time_frame>
    <description>Assessing the Effectiveness of the Prevention Program &quot;My Home, My Health Environment&quot; (consists of a series of workshop in the second and third trimesters of pregnancy) in an immersive environment or not, to evaluate the consumption of fresh products according to exposure endocrine disruptors (cans or industrial products).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>psychosocial aspects</measure>
    <time_frame>During the pregnancy (second and third trimester)</time_frame>
    <description>Assess if the program impact any psychosocial aspects, this outcome will be determine with a psychosocial questionary (to do before and after the intervention for compare the results)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine concentration</measure>
    <time_frame>During the pregnancy (second and third trimester)</time_frame>
    <description>Assess if the program has an impact on the urinary endocrine disruptors's concentrations, this outcome will be determine with samples of urine (to do before and after the intervention for comparate the results)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Milk concentration</measure>
    <time_frame>After the birth of the child (first year)</time_frame>
    <description>Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>foetal growth</measure>
    <time_frame>After the birth of the child (first year)</time_frame>
    <description>Study the relation between endocrine disruptors expositions and foetal growth by merging PREVED and EDDS (a previous trial) datas.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">267</enrollment>
  <condition>Pregnancy</condition>
  <condition>Endocrine System</condition>
  <condition>Prevention Program</condition>
  <arm_group>
    <arm_group_label>Leaflet only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women will only receive a leaflet about endocrine disruptor at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non immersive program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>immersive program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>sensibilisation program &quot;Ma maison, mon environnement santé&quot;</intervention_name>
    <description>The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.</description>
    <arm_group_label>immersive program</arm_group_label>
    <arm_group_label>non immersive program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18&#xD;
&#xD;
          -  Patients living in Poitiers or city around (near the immersive environment)&#xD;
&#xD;
          -  Patients on pregnancy and who declared their pregnancy to the authority&#xD;
&#xD;
          -  Patients who planned to give birth in Poitiers's hospital, Châtellerault's hospital or&#xD;
             Clinique Fief de Grimoire, in Poitiers.&#xD;
&#xD;
          -  Patients giving her agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients planning to move during the study&#xD;
&#xD;
          -  Patients under legal protection&#xD;
&#xD;
          -  Patients expecting twins&#xD;
&#xD;
          -  Patients unable to speak french&#xD;
&#xD;
          -  Patients willing to give birth in another hospital than those mentionned before&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bisphenol-A</keyword>
  <keyword>prevention</keyword>
  <keyword>endocrine disruptors</keyword>
  <!-- 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/NCT03233984
org study id: PREVED
nct id: NCT03233984
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major
      foetal pathology and impact growth.

      Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and
      water.

      Through a prevention program, the investigators tried to warned pregnant women on endocrine
      disruptors exposition risks. The goal here is to assess the effectiveness of this program on
      their fresh products consumption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: program effectivness
time frame: During the pregnancy (second and third trimester)
description: Assessing the Effectiveness of the Prevention Program "My Home, My Health Environment" (consists of a series of workshop in the second and third trimesters of pregnancy) in an immersive environment or not, to evaluate the consumption of fresh products according to exposure endocrine disruptors (cans or industrial products).
measure: psychosocial aspects
time frame: During the pregnancy (second and third trimester)
description: Assess if the program impact any psychosocial aspects, this outcome will be determine with a psychosocial questionary (to do before and after the intervention for compare the results)
measure: Urine concentration
time frame: During the pregnancy (second and third trimester)
description: Assess if the program has an impact on the urinary endocrine disruptors's concentrations, this outcome will be determine with samples of urine (to do before and after the intervention for comparate the results)
measure: Milk concentration
time frame: After the birth of the child (first year)
description: Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program
measure: foetal growth
time frame: After the birth of the child (first year)
description: Study the relation between endocrine disruptors expositions and foetal growth by merging PREVED and EDDS (a previous trial) datas.
arm group label: Leaflet only
arm group type: No Intervention
description: Women will only receive a leaflet about endocrine disruptor at home.
arm group label: non immersive program
arm group type: Active Comparator
description: In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment
arm group label: immersive program
arm group type: Experimental
description: In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment
intervention type: Behavioral
intervention name: sensibilisation program "Ma maison, mon environnement santé"
description: The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.
arm group label: immersive program
arm group label: non immersive program
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor