<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/NCT04437342</url>
  </required_header>
  <id_info>
    <org_study_id>Covid-19 Postpartum depression</org_study_id>
    <nct_id>NCT04437342</nct_id>
  </id_info>
  <brief_title>Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia</brief_title>
  <official_title>Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General and Maternity Hospital of Athens Elena Venizelou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alexandra Hospital, Athens, Greece</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ioannina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>General and Maternity Hospital of Athens Elena Venizelou</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>
      The aim of this multicenter prospective study is to evaluate the association between the&#xD;
      Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic&#xD;
      and anaesthesiologic variables&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">October 27, 2020</completion_date>
  <primary_completion_date type="Actual">August 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>Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)</measure>
    <time_frame>40 days postpartum</time_frame>
    <description>Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)</measure>
    <time_frame>10 minutes postpartum</time_frame>
    <description>Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain</measure>
    <time_frame>2 minutes prior to discharge from the Postanaesthesia care unit</time_frame>
    <description>Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain</measure>
    <time_frame>2 minutes after admission to the Postanaesthesia care unit</time_frame>
    <description>Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">330</enrollment>
  <condition>Postpartum Depression</condition>
  <condition>Psychological Stress</condition>
  <condition>Maternal Distress</condition>
  <arm_group>
    <arm_group_label>Maternal Group</arm_group_label>
    <description>Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PHQ-9 (Patient Health Questionnaire) Depression Scale</intervention_name>
    <description>9 question questionnaire for assessment of depression</description>
    <arm_group_label>Maternal Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GAD-7 (General Anxiety Disorder) scale</intervention_name>
    <description>7 question questionnaire for assessment of General Anxiety Disorder</description>
    <arm_group_label>Maternal Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>38 questions questionnaire</intervention_name>
    <description>38 questions questionnaire</description>
    <arm_group_label>Maternal Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EPDS (Edinburgh Postnatal Depression Scale)</intervention_name>
    <description>10 questions scale for detection of postpartum depression</description>
    <arm_group_label>Maternal Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women admitted to the hospital for vaginal delivery or caesarean section&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pregnant women over the age of 18 that present for labour (vaginal delivery or&#xD;
             caesarean section)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not eligible in writing and reading in Greek&#xD;
&#xD;
          -  Drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Maternity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georgia Micha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elena Venizelou General and Maternity Hospital of Athens, Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>&quot;Elena Venizelou&quot; General and Maternity Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>11521</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aretaieio University Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandra Genaral Hospital Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ioannina Health Science</name>
      <address>
        <city>Ioannina</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ioannina, Medical School</name>
      <address>
        <city>Ioannina</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Thessaly Medical School</name>
      <address>
        <city>Larisa</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>General and Maternity Hospital of Athens Elena Venizelou</investigator_affiliation>
    <investigator_full_name>GEORGIA MICHA</investigator_full_name>
    <investigator_title>Anaesthesiologist, MD, MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>postpartum depression</keyword>
  <keyword>Covid-19 pandemic</keyword>
  <keyword>anaesthesia</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>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Research data, study protocol and statistical analysis plan will be available to the scientific community after publication. The corresponding author is responsible for reviewing these requests.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After publication of the article for indefinite time</ipd_time_frame>
  </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/NCT04437342
org study id: Covid-19 Postpartum depression
nct id: NCT04437342
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this multicenter prospective study is to evaluate the association between the
      Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic
      and anaesthesiologic variables
observational model: Other
time perspective: Prospective
measure: Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)
time frame: 40 days postpartum
description: Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)
measure: Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
time frame: 10 minutes postpartum
description: Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
time frame: 2 minutes prior to discharge from the Postanaesthesia care unit
description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)
measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
time frame: 2 minutes after admission to the Postanaesthesia care unit
description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)
arm group label: Maternal Group
description: Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.
intervention type: Other
intervention name: PHQ-9 (Patient Health Questionnaire) Depression Scale
description: 9 question questionnaire for assessment of depression
arm group label: Maternal Group
intervention type: Other
intervention name: GAD-7 (General Anxiety Disorder) scale
description: 7 question questionnaire for assessment of General Anxiety Disorder
arm group label: Maternal Group
intervention type: Other
intervention name: 38 questions questionnaire
description: 38 questions questionnaire
arm group label: Maternal Group
intervention type: Other
intervention name: EPDS (Edinburgh Postnatal Depression Scale)
description: 10 questions scale for detection of postpartum depression
arm group label: Maternal Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Maternity
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georgia Micha, PhD
role: Principal Investigator
affiliation: Elena Venizelou General and Maternity Hospital of Athens, Greece
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: General and Maternity Hospital of Athens Elena Venizelou
investigator full name: GEORGIA MICHA
investigator title: Anaesthesiologist, MD, MSc, PhD
mesh term: COVID-19
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Stress, Psychological
sharing ipd: Yes
ipd description: Research data, study protocol and statistical analysis plan will be available to the scientific community after publication. The corresponding author is responsible for reviewing these requests.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: After publication of the article for indefinite time