<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/NCT03283189</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-350</org_study_id>
    <nct_id>NCT03283189</nct_id>
  </id_info>
  <brief_title>Cosmetics and Pregnancy</brief_title>
  <acronym>PERICOS</acronym>
  <official_title>Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence Régionale de Santé Rhône-Alpes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Observatoire Régional de Santé Auvergne-Rhône Alpes (ORS- ARA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The use of cosmetics is an important source of exposure to many chemicals including endocrine&#xD;
      disruptors. Recently, national and international scientific recommendations have been issued&#xD;
      to limit exposure to chemicals during pregnancy. However, the perception and the use of&#xD;
      cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are&#xD;
      to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant&#xD;
      women.&#xD;
&#xD;
      Understanding the risk perception, the knowledge, attitudes and expectations of women about&#xD;
      the use of cosmetics during pregnancy will help to set up effective strategies to improve&#xD;
      prevention of chemical exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A qualitative study of 60 pregnant women using six focus groups (9-11 pregnant women per&#xD;
      group) was implemented study in Auvergne Region, France. Six focus groups will be conducted&#xD;
      until data saturation.&#xD;
&#xD;
      The women will be recruited from the Clermont-Ferrand University Hospital (maternity type III&#xD;
      - 2 groups), the private clinic in Beaumont (maternity type II - 2 groups), the Saint-Flour&#xD;
      hospital center (maternity type I - 1 group), and from liberal health professionals (1&#xD;
      group).&#xD;
&#xD;
      If a women is found to be eligible, she will be invited to participate in the study. The&#xD;
      focus group discussions will be conducted in a private room in the maternity of the women.&#xD;
      They will last approximately 2 hours and will be led by an interviewer using an interview&#xD;
      grid.&#xD;
&#xD;
      All interviews will be audio-recorded, transcribed, coded and computerized for analysis with&#xD;
      the NVIVO v11 software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 28, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnant women's views on the risk related to the use of cosmetics</measure>
    <time_frame>at day 1 (during the interview)</time_frame>
    <description>the perception of the risks linked to the use of cosmetics in general, and creams for striae gravidarum in particular, were investigated during the focus groups interviews.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cosmetic's use during pregnancy</measure>
    <time_frame>at day 1 (during the interview)</time_frame>
    <description>How cosmetics (all cosmetics and creams for striae gravidarum) are used and modifications in the behavior of pregnant women (decrease of use, choice of other products, etc.). Investigated during the focus groups with a semi-structured interview. All information will be gathered at the time of the interview.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expectations of pregnant women in terms of information about the use of cosmetics</measure>
    <time_frame>at day 1 (during the interview)</time_frame>
    <description>needs and expectations of pregnant women in terms of information support and advice about the use of cosmetics were investigated during the focus groups with a semi-structured interview. All information will be gathered at the time of the interview</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <description>Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <description>Pregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6</arm_group_label>
    <description>Liberal follow-up of pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group discussions</intervention_name>
    <description>The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid. All interviews will be audio-recorded.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</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:&#xD;
&#xD;
          -  - Pregnant women between 22 (≥ 22 weeks) et ≤ 39 weeks of gestation;&#xD;
&#xD;
          -  Obstetric management in the Réseau de Santé en Périnatalité d'Auvergne (RSPA);&#xD;
&#xD;
          -  At least 18 years;&#xD;
&#xD;
          -  Understanding and speaking French;&#xD;
&#xD;
          -  And giving their signed agreement of participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate or to be registered during the collective interview;&#xD;
&#xD;
          -  Women with fetal death in utero or whose fetus or fetuses have a malformation;&#xD;
&#xD;
          -  Women with psychiatric disorders, mental confusion or language disorders making&#xD;
             impossible the interview;&#xD;
&#xD;
          -  Women with chronic dermatological pathology requiring dermatological care (eczema,&#xD;
             psoriasis, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cécile MARIE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Cécile MARIE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Françoise VENDITELLI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Pierre SAUVANT-ROCHAT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Reine FRADET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Paule CELSE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bonnie DELEPINE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Use of cosmetics</keyword>
  <keyword>Pregnant women</keyword>
  <keyword>Risk perception</keyword>
  <keyword>Preventive attitude</keyword>
  <keyword>Qualitative study</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/NCT03283189
org study id: CHU-350
nct id: NCT03283189
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The use of cosmetics is an important source of exposure to many chemicals including endocrine
      disruptors. Recently, national and international scientific recommendations have been issued
      to limit exposure to chemicals during pregnancy. However, the perception and the use of
      cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are
      to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant
      women.

      Understanding the risk perception, the knowledge, attitudes and expectations of women about
      the use of cosmetics during pregnancy will help to set up effective strategies to improve
      prevention of chemical exposure.
A qualitative study of 60 pregnant women using six focus groups (9-11 pregnant women per
      group) was implemented study in Auvergne Region, France. Six focus groups will be conducted
      until data saturation.

      The women will be recruited from the Clermont-Ferrand University Hospital (maternity type III
      - 2 groups), the private clinic in Beaumont (maternity type II - 2 groups), the Saint-Flour
      hospital center (maternity type I - 1 group), and from liberal health professionals (1
      group).

      If a women is found to be eligible, she will be invited to participate in the study. The
      focus group discussions will be conducted in a private room in the maternity of the women.
      They will last approximately 2 hours and will be led by an interviewer using an interview
      grid.

      All interviews will be audio-recorded, transcribed, coded and computerized for analysis with
      the NVIVO v11 software.
observational model: Other
time perspective: Cross-Sectional
measure: Pregnant women's views on the risk related to the use of cosmetics
time frame: at day 1 (during the interview)
description: the perception of the risks linked to the use of cosmetics in general, and creams for striae gravidarum in particular, were investigated during the focus groups interviews.
measure: Cosmetic's use during pregnancy
time frame: at day 1 (during the interview)
description: How cosmetics (all cosmetics and creams for striae gravidarum) are used and modifications in the behavior of pregnant women (decrease of use, choice of other products, etc.). Investigated during the focus groups with a semi-structured interview. All information will be gathered at the time of the interview.
measure: Expectations of pregnant women in terms of information about the use of cosmetics
time frame: at day 1 (during the interview)
description: needs and expectations of pregnant women in terms of information support and advice about the use of cosmetics were investigated during the focus groups with a semi-structured interview. All information will be gathered at the time of the interview
arm group label: Group 1
description: Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)
arm group label: Group 2
description: Pregnancy follow-up in the only maternity type III of the region (CHU) and in an urban area (around Clermont-Ferrand)
arm group label: Group 3
description: Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)
arm group label: Group 4
description: Pregnancy follow-up in the only private maternity (type II) of the region and in an urban area (around Clermont-Ferrand)
arm group label: Group 5
description: Pregnancy follow-up in a type I maternity and in a rural area (around Saint-Flour)
arm group label: Group 6
description: Liberal follow-up of pregnancy
intervention type: Other
intervention name: Group discussions
description: The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid. All interviews will be audio-recorded.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile MARIE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor