<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/NCT04432948</url>
  </required_header>
  <id_info>
    <org_study_id>Maternal Covid 19</org_study_id>
    <nct_id>NCT04432948</nct_id>
  </id_info>
  <brief_title>Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.</brief_title>
  <official_title>Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General and Maternity Hospital of Athens Elena Venizelou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 study is to assess the maternal psychological implication of the novel&#xD;
      coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an&#xD;
      impact of these implications on the anaesthetic practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">August 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>Association between Covid-19 pandemic and maternal psychological distress</measure>
    <time_frame>Pre-labour assessment</time_frame>
    <description>Association between Covid-19 pandemic and maternal psychological distress assessed by 2 scales and one questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice</measure>
    <time_frame>Pre-labour assessment</time_frame>
    <description>Association between Covid-19 pandemic and anaesthetic practice assessed by a 38 questions questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Covid-19</condition>
  <condition>Maternal Psychological Distress</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Maternal Group</arm_group_label>
    <description>Pregnant women administered into a maternity public hospital in labour (vaginal delivery, caesarean section)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PHQ-9 Depression Scale</intervention_name>
    <description>It involves a 9-question scale that detects 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>It involves a 7-question scale that detects 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>It involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice</description>
    <arm_group_label>Maternal Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women in labour that present into the maternity hospital from June-August 2020, during&#xD;
        the Covid-19 pandemic&#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 in labour (vaginal delivery or&#xD;
             caesarean section)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychiatric disorders&#xD;
&#xD;
          -  drug abuse&#xD;
&#xD;
          -  not eligible to read and write in Greek&#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, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elena Venizelou General and Maternity Hospital of Athens, Greece</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Georgia Micha, Dr</last_name>
    <phone>+306974828254</phone>
    <email>mgeo3@yahoo.gr</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Georgia Micha, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.</citation>
    <PMID>32374420</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</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>Anesthesiologist MD, MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Psychological Distress</keyword>
  <keyword>Maternal</keyword>
  <keyword>Anaesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04432948
org study id: Maternal Covid 19
nct id: NCT04432948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the maternal psychological implication of the novel
      coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an
      impact of these implications on the anaesthetic practice.
observational model: Other
time perspective: Prospective
measure: Association between Covid-19 pandemic and maternal psychological distress
time frame: Pre-labour assessment
description: Association between Covid-19 pandemic and maternal psychological distress assessed by 2 scales and one questionnaire
measure: Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice
time frame: Pre-labour assessment
description: Association between Covid-19 pandemic and anaesthetic practice assessed by a 38 questions questionnaire
arm group label: Maternal Group
description: Pregnant women administered into a maternity public hospital in labour (vaginal delivery, caesarean section)
intervention type: Other
intervention name: PHQ-9 Depression Scale
description: It involves a 9-question scale that detects depression
arm group label: Maternal Group
intervention type: Other
intervention name: GAD-7 General anxiety disorder scale
description: It involves a 7-question scale that detects general anxiety disorder
arm group label: Maternal Group
intervention type: Other
intervention name: 38-questions questionnaire
description: It involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice
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, Dr
role: Principal Investigator
affiliation: Elena Venizelou General and Maternity Hospital of Athens, Greece
last name: Georgia Micha, Dr
phone: +306974828254
email: mgeo3@yahoo.gr
facility: 
status: Recruiting
contact: 
country: Greece
citation: Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.
PMID: 32374420
responsible party type: Principal Investigator
investigator affiliation: General and Maternity Hospital of Athens Elena Venizelou
investigator full name: GEORGIA MICHA
investigator title: Anesthesiologist MD, MSc, PhD
mesh term: COVID-19
sharing ipd: Undecided