<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/NCT04494581</url>
  </required_header>
  <id_info>
    <org_study_id>GriCoVax - GERES</org_study_id>
    <secondary_id>2019-A00346-51</secondary_id>
    <nct_id>NCT04494581</nct_id>
  </id_info>
  <brief_title>GriCoVax Study in 4 Maternity Wards in the Ile-de-France Region</brief_title>
  <acronym>GriCoVax</acronym>
  <official_title>Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence Regionale de Sante d'Ile de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Agency of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implementation of organizational adjustments can enhance involvement of healthcare teams in&#xD;
      carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and&#xD;
      their families. Pertussis vaccination of pregnant women is envisaged by the French Health&#xD;
      Autority, considering that, given international experiences, vaccination during the second&#xD;
      trimester of pregnancy is safe, effective, and would aim to protect babies during the first&#xD;
      months of their life. Before considering such a recommendation in France, the acceptability&#xD;
      of this strategy by pregnant women and health professionals must be considered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicentre, descriptive study conducted in a declarative manner and supplemented by direct&#xD;
      observation by an investigator.&#xD;
&#xD;
      Main objectives:&#xD;
&#xD;
        -  Assess existing practices of the various actors involved in flu and pertussis&#xD;
           vaccination of pregnant or postpartum women medically followed in maternity wards.&#xD;
&#xD;
        -  Assess acceptability of pertussis and flu vaccination during pregnancy by women&#xD;
           medically followed in maternity wards, and by health professionals of theses facilities.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Assess flu and pertussis immunization coverage of pregnant and postpartum women and of&#xD;
           health professionals working in maternity wards.&#xD;
&#xD;
        -  Assess the links between immunization coverage of health professionals and their current&#xD;
           practices in promoting flu and pertussis vaccination of women in maternity wards.&#xD;
&#xD;
      Main outcome measures:&#xD;
&#xD;
        -  Identify in each maternity hospital facilitators of flu and pertussis vaccination.&#xD;
&#xD;
        -  Proportion of women willing to be vaccinated against pertussis and flu during pregnancy.&#xD;
&#xD;
        -  Proportion of health professionals agreeing to vaccinate pregnant women against flu and&#xD;
           pertussis.&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
        -  Flu and pertussis immunization coverage of pregnant and postpartum women.&#xD;
&#xD;
        -  Flu and pertussis immunization coverage of health professionals.&#xD;
&#xD;
        -  Proportion of patient records with vaccination trace.&#xD;
&#xD;
        -  Link between understanding of vaccines and vaccine-preventable diseases, and&#xD;
           immunization coverage of health professionals.&#xD;
&#xD;
        -  Link between attitudes and practices of health professionals, and immunization coverage&#xD;
           of patients.&#xD;
&#xD;
        -  Link between immunization coverage of patients and health professionals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify in each maternity hospital facilitators of flu and pertussis vaccination</measure>
    <time_frame>May 2019 - July 2019</time_frame>
    <description>Qualitative interviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of women willing to be vaccinated against pertussis and flu during pregnancy</measure>
    <time_frame>September 2019-December 2019</time_frame>
    <description>Questionnaire survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.</measure>
    <time_frame>October 2019-February 2020</time_frame>
    <description>Questionnaire survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Flu and pertussis immunization coverage of pregnant and postpartum women</measure>
    <time_frame>September 2019-December 2019</time_frame>
    <description>Questionnaire survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flu and pertussis immunization coverage of health professionals</measure>
    <time_frame>October 2019-February 2020</time_frame>
    <description>Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient records with vaccination trace</measure>
    <time_frame>October-December 2019</time_frame>
    <description>Review of sample of patient records</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">480</enrollment>
  <condition>Pertussis Vaccine</condition>
  <condition>Healthcare Worker Patient Transmission</condition>
  <condition>Pregnant Women</condition>
  <condition>Influenza Vaccination</condition>
  <arm_group>
    <arm_group_label>Pregnant and postpartum women</arm_group_label>
    <description>Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthcare workers</arm_group_label>
    <description>Health professionals over 18, working in maternity wards included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Questionnaire survey</description>
    <arm_group_label>Pregnant and postpartum women</arm_group_label>
    <arm_group_label>healthcare workers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Volunteer women and staff.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pregnant and postpartum women over 18 medically followed in maternity wards included.&#xD;
        Femmes enceintes ou en post-partum :&#xD;
&#xD;
        Health professionals over 18 working in maternity wards included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women under the protection of a conservator Temporary Health staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maternité Hôpital privé</name>
      <address>
        <city>Antony</city>
        <zip>92160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternité Hôpital Jean Verdier</name>
      <address>
        <city>Bondy</city>
        <zip>93143</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternité Notre Dame de Bon Secours - GH Paris St Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternité Port Royal</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</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>Whooping Cough</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04494581
org study id: GriCoVax - GERES
secondary id: 2019-A00346-51
nct id: NCT04494581
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Implementation of organizational adjustments can enhance involvement of healthcare teams in
      carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and
      their families. Pertussis vaccination of pregnant women is envisaged by the French Health
      Autority, considering that, given international experiences, vaccination during the second
      trimester of pregnancy is safe, effective, and would aim to protect babies during the first
      months of their life. Before considering such a recommendation in France, the acceptability
      of this strategy by pregnant women and health professionals must be considered.
Multicentre, descriptive study conducted in a declarative manner and supplemented by direct
      observation by an investigator.

      Main objectives:

        -  Assess existing practices of the various actors involved in flu and pertussis
           vaccination of pregnant or postpartum women medically followed in maternity wards.

        -  Assess acceptability of pertussis and flu vaccination during pregnancy by women
           medically followed in maternity wards, and by health professionals of theses facilities.

      Secondary objectives:

        -  Assess flu and pertussis immunization coverage of pregnant and postpartum women and of
           health professionals working in maternity wards.

        -  Assess the links between immunization coverage of health professionals and their current
           practices in promoting flu and pertussis vaccination of women in maternity wards.

      Main outcome measures:

        -  Identify in each maternity hospital facilitators of flu and pertussis vaccination.

        -  Proportion of women willing to be vaccinated against pertussis and flu during pregnancy.

        -  Proportion of health professionals agreeing to vaccinate pregnant women against flu and
           pertussis.

      Secondary endpoints:

        -  Flu and pertussis immunization coverage of pregnant and postpartum women.

        -  Flu and pertussis immunization coverage of health professionals.

        -  Proportion of patient records with vaccination trace.

        -  Link between understanding of vaccines and vaccine-preventable diseases, and
           immunization coverage of health professionals.

        -  Link between attitudes and practices of health professionals, and immunization coverage
           of patients.

        -  Link between immunization coverage of patients and health professionals.
observational model: Other
time perspective: Prospective
measure: Identify in each maternity hospital facilitators of flu and pertussis vaccination
time frame: May 2019 - July 2019
description: Qualitative interviews
measure: Proportion of women willing to be vaccinated against pertussis and flu during pregnancy
time frame: September 2019-December 2019
description: Questionnaire survey
measure: Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.
time frame: October 2019-February 2020
description: Questionnaire survey
measure: Flu and pertussis immunization coverage of pregnant and postpartum women
time frame: September 2019-December 2019
description: Questionnaire survey
measure: Flu and pertussis immunization coverage of health professionals
time frame: October 2019-February 2020
description: Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services
measure: Proportion of patient records with vaccination trace
time frame: October-December 2019
description: Review of sample of patient records
arm group label: Pregnant and postpartum women
description: Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria.
arm group label: healthcare workers
description: Health professionals over 18, working in maternity wards included.
intervention type: Other
intervention name: questionnaire
description: Questionnaire survey
arm group label: Pregnant and postpartum women
arm group label: healthcare workers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Whooping Cough
sharing ipd: No