xml: <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/NCT05997953</url>
    </required_header>
    <id_info>
      <org_study_id>520235</org_study_id>
      <nct_id>NCT05997953</nct_id>
    </id_info>
    <brief_title>Screening of Postpartum Depression in Egyptian Women</brief_title>
    <official_title>Assessment of the Edinburgh Postnatal Depression Scale as Screening Tool for Postpartum Depression Among Women Delivering at Egyptian Tertiary Care System University Hospital: Prevalence and Risk Factors Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</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 goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale&#xD;
        as screening tool for Postpartum Depression among women delivering at Egyptian tertiary&#xD;
        health care system, University Hospital, regarding Prevalence and risk factors.&#xD;
  &#xD;
        participants of this study with fill the Edinburgh Postnatal Depression Scale and their&#xD;
        socio-demographic, obstetric and psychological data will be collected and analysed.&#xD;
  &#xD;
        prevalence of postpartum depression in Egyptian women will be assessed as well as the&#xD;
        associated risk factors&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</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>Number screening positive for possible postpartum depression by Arabic EPDS</measure>
      <time_frame>2 weeks postpartum</time_frame>
      <description>Number of participants screening positive for possible postpartum depression, defined as a score of 13 or higher on the validated Arabic version of the Edinburgh Postnatal Depression Scale (EPDS) Participants with a positive screen (EPDS score ≥13) will be referred for psychiatric consultation for diagnostic confirmation and treatment of postpartum depression</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sociodemographic, clinical, and psychosocial predictors of postpartum depression risk</measure>
      <time_frame>At 2 weeks postpartum</time_frame>
      <description>Identification of sociodemographic, clinical, and psychosocial risk factors associated with screening positive for possible postpartum depression, as determined by bivariate and multivariate regression analyses of factors correlated with an Arabic EPDS score ≥13.&#xD;
  Sociodemographic factors will include maternal age, education level, occupation, socioeconomic status, etc.&#xD;
  Clinical factors will include obstetric history, delivery method, neonatal health status, etc.&#xD;
  Psychosocial factors will include social support, stress levels, family dynamics, etc.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Postpartum Depression</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Edinburgh Postnatal Depression Scale</intervention_name>
      <description>Edinburgh Postnatal Depression Scale used as screening tool for postpartum depression</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          2000 patients who underwent either vaginal birth or cesarean section at El-Hussien&#xD;
          University Hospital and agreed for followup and participation in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All patients who underwent vaginal/cesarean delivery and reported for follow and willing to&#xD;
          participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who were unwilling to participate in the study.&#xD;
  &#xD;
            -  Patients who are having difficulties comprehending the questionnaire of the study.&#xD;
  &#xD;
            -  Women who were on psychiatric medication during pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Muhamed Alhagrasy, M.D.</last_name>
      <phone>01017313413</phone>
      <email>MuhamedAhmed.216@azhar.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty od Medicine, Department of Obstetrics and Gynecology.</name>
        <address>
          <city>Cairo</city>
          <state>Cairo.</state>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Muhamed Alhagrasy, M.D.</last_name>
        <phone>00201017313413</phone>
        <email>MuhamedAhmed.216@azhar.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy</investigator_full_name>
      <investigator_title>lecturer and consultant at Obstetrics and Gynecology Department.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
text: 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/NCT05997953
  org study id: 520235
  nct id: NCT05997953
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale
        as screening tool for Postpartum Depression among women delivering at Egyptian tertiary
        health care system, University Hospital, regarding Prevalence and risk factors.
  
        participants of this study with fill the Edinburgh Postnatal Depression Scale and their
        socio-demographic, obstetric and psychological data will be collected and analysed.
  
        prevalence of postpartum depression in Egyptian women will be assessed as well as the
        associated risk factors
  observational model: Other
  time perspective: Cross-Sectional
  measure: Number screening positive for possible postpartum depression by Arabic EPDS
  time frame: 2 weeks postpartum
  description: Number of participants screening positive for possible postpartum depression, defined as a score of 13 or higher on the validated Arabic version of the Edinburgh Postnatal Depression Scale (EPDS) Participants with a positive screen (EPDS score ≥13) will be referred for psychiatric consultation for diagnostic confirmation and treatment of postpartum depression
  measure: Sociodemographic, clinical, and psychosocial predictors of postpartum depression risk
  time frame: At 2 weeks postpartum
  description: Identification of sociodemographic, clinical, and psychosocial risk factors associated with screening positive for possible postpartum depression, as determined by bivariate and multivariate regression analyses of factors correlated with an Arabic EPDS score ≥13.
  Sociodemographic factors will include maternal age, education level, occupation, socioeconomic status, etc.
  Clinical factors will include obstetric history, delivery method, neonatal health status, etc.
  Psychosocial factors will include social support, stress levels, family dynamics, etc.
  intervention type: Other
  intervention name: Edinburgh Postnatal Depression Scale
  description: Edinburgh Postnatal Depression Scale used as screening tool for postpartum depression
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 45 Years
  last name: Muhamed Alhagrasy, M.D.
  phone: 01017313413
  email: MuhamedAhmed.216@azhar.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
  investigator title: lecturer and consultant at Obstetrics and Gynecology Department.
  mesh term: Depression, Postpartum
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No