<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/NCT04409249</url>
  </required_header>
  <id_info>
    <org_study_id>Mtalmacprognosis</org_study_id>
    <nct_id>NCT04409249</nct_id>
  </id_info>
  <brief_title>Prognosis in Pregnant With COVID-19</brief_title>
  <official_title>Prognostic Factors in Pregnant Women With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      COVID-19 is a disease whose development, prognosis mechanism and immune status are still&#xD;
      unknown. The aim of the study is to determine the relationship between clinical and&#xD;
      laboratory data and the severity of the disease by evaluating the hematological and&#xD;
      radiological features of the patients. The secondary aim is to determine the predictive&#xD;
      values of clinical and laboratory data for the severity of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">May 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the factors affecting prognosis in pregnant women diagnosed with COVID-19</measure>
    <time_frame>3 Months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">155</enrollment>
  <condition>COVID-19</condition>
  <condition>Prognostic Factors</condition>
  <condition>Pregnancy</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>imaging, blood tests</intervention_name>
    <description>PCR and CT results, hemogram, urea, creatinine, AST, ALT, LDH, D-Dimer, ferritin, lipase, amylase, CRP, procalcitonin, albumin, total protein, coagulation tests-PT, APTT, Fibrinogen-, Troponin T, CK , electrolytes, blood gas, bilirubins</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary center data&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being pregnant with a diagnosis of COVID-19 between the ages of 18-45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected COVID-19 diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Halkali</state>
        <zip>34307</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Merve Aldikactioglu Talmac, MD</investigator_full_name>
    <investigator_title>Specialist of Obstetrics and Gynecology, Principal Investigator</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04409249
org study id: Mtalmacprognosis
nct id: NCT04409249
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is a disease whose development, prognosis mechanism and immune status are still
      unknown. The aim of the study is to determine the relationship between clinical and
      laboratory data and the severity of the disease by evaluating the hematological and
      radiological features of the patients. The secondary aim is to determine the predictive
      values of clinical and laboratory data for the severity of COVID-19.
observational model: Other
time perspective: Retrospective
measure: the factors affecting prognosis in pregnant women diagnosed with COVID-19
time frame: 3 Months
intervention type: Diagnostic Test
intervention name: imaging, blood tests
description: PCR and CT results, hemogram, urea, creatinine, AST, ALT, LDH, D-Dimer, ferritin, lipase, amylase, CRP, procalcitonin, albumin, total protein, coagulation tests-PT, APTT, Fibrinogen-, Troponin T, CK , electrolytes, blood gas, bilirubins
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Merve Aldikactioglu Talmac, MD
investigator title: Specialist of Obstetrics and Gynecology, Principal Investigator
mesh term: COVID-19
sharing ipd: Yes
ipd info type: Study Protocol