<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/NCT04487171</url>
  </required_header>
  <id_info>
    <org_study_id>PI2020_843_0049</org_study_id>
    <nct_id>NCT04487171</nct_id>
  </id_info>
  <brief_title>Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic</brief_title>
  <acronym>COVIE-19/20</acronym>
  <official_title>Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier de Beauvais</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Hospital Saint Quentin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Compiègne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</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>
      Postpartum depression (PPD) represent around 15% of birth in developed countries. The context&#xD;
      of the COVID-19 epidemy represents a possible source of additional emotional distress. The&#xD;
      objective of this study is to determine the screening prevalence and risk factors of&#xD;
      postpartum depression, among women who deliver in fourth hospital in the North of France in&#xD;
      the context of the COVID epidemy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation of prevalence of clinically-significant post-partum depressive symptoms</measure>
    <time_frame>up to 35 days after delivery</time_frame>
    <description>Variation of prevalence of clinically-significant post-partum depressive symptoms</description>
  </primary_outcome>
  <enrollment type="Anticipated">248</enrollment>
  <condition>Postpartum Depression</condition>
  <condition>Covid19</condition>
  <condition>Prevalence</condition>
  <condition>Social Distance</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The mothers were administrated three questionnaires, (i) the Edinburgh Postnatal Depression Scale (EPDS), (ii) the State-Trait Anxiety Inventory (STAI-YA), and (iii) the Mother-to-Infant Bonding Scale (MIBS) in two stages, on days 2-3 after delivery and during a phone call between days 25-35.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single baby delivery&#xD;
&#xD;
          -  alive new born child without admission in neonatal intensive care unit&#xD;
&#xD;
          -  French-speaking mother&#xD;
&#xD;
          -  mother older than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuses the inclusion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women who deliver</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur FOULON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arthur FOULON, MD</last_name>
    <phone>(33)322087382</phone>
    <email>foulon.arthur@chu-amiens.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xavier BENAROUS, MD</last_name>
    <phone>(33)322087630</phone>
    <email>benarous.xavier@chu-amiens.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arthur Foulon, MD</last_name>
      <phone>(33)322087382</phone>
      <email>foulon.arthur@chu-amiens.fr</email>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postpartum Depression</keyword>
  <keyword>Covid19</keyword>
  <keyword>Prevalence</keyword>
  <keyword>Social Distance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT04487171
org study id: PI2020_843_0049
nct id: NCT04487171
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postpartum depression (PPD) represent around 15% of birth in developed countries. The context
      of the COVID-19 epidemy represents a possible source of additional emotional distress. The
      objective of this study is to determine the screening prevalence and risk factors of
      postpartum depression, among women who deliver in fourth hospital in the North of France in
      the context of the COVID epidemy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Variation of prevalence of clinically-significant post-partum depressive symptoms
time frame: up to 35 days after delivery
description: Variation of prevalence of clinically-significant post-partum depressive symptoms
intervention type: Other
intervention name: Questionnaire
description: The mothers were administrated three questionnaires, (i) the Edinburgh Postnatal Depression Scale (EPDS), (ii) the State-Trait Anxiety Inventory (STAI-YA), and (iii) the Mother-to-Infant Bonding Scale (MIBS) in two stages, on days 2-3 after delivery and during a phone call between days 25-35.
criteria: 
gender: Female
gender based: Yes
gender description: women who deliver
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arthur FOULON, MD
role: Principal Investigator
affiliation: CHU Amiens
last name: Arthur FOULON, MD
phone: (33)322087382
email: foulon.arthur@chu-amiens.fr
last name: Xavier BENAROUS, MD
phone: (33)322087630
email: benarous.xavier@chu-amiens.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No