<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/NCT04443140</url>
  </required_header>
  <id_info>
    <org_study_id>70/2020</org_study_id>
    <nct_id>NCT04443140</nct_id>
  </id_info>
  <brief_title>Preeclampsia-like Syndrome Induced by COVID-19: Is it a Real Public Health Issue in Pregnancy During the Pandemic?</brief_title>
  <official_title>Evaluation of COVID-19 Incidence in Patients With Preeclampsia During Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who&#xD;
      applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of&#xD;
      Covid-19 related preeclampsia-like syndrome in this patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR&#xD;
      test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution&#xD;
      during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients&#xD;
      presented to our hospital during the pandemic will be involved in our study. The primary&#xD;
      outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">July 10, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Months</target_duration>
  <primary_outcome>
    <measure>PCR positivity</measure>
    <time_frame>3 months</time_frame>
    <description>To detect Covid-19 PCR test positivity among preeclamptic pregnant women</description>
  </primary_outcome>
  <enrollment type="Actual">131</enrollment>
  <condition>Covid-19</condition>
  <condition>Preeclampsia</condition>
  <condition>Pregnancy Related</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PCR, lung ultrasound</intervention_name>
    <description>PCR for Covid-19</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19&#xD;
        pandemic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs&#xD;
             between March 15, 2020 and June 1, 2020.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The pregnancies with known diagnosis of preeclampsia before Covid-19 pandemic&#xD;
&#xD;
          -  Preeclamptic patient without a Covid-19 PCR test result&#xD;
&#xD;
          -  Pregnant women who does not want to participate in study or does not want their&#xD;
             personal informations to be shared&#xD;
&#xD;
          -  Pregnant women less than 18 years old and more than 40 years old are excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant females are studied.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Resul Karakus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zeynep Kamil Maternity and Childrens Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34660</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.</citation>
    <PMID>32479682</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>Resul Karakuş</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>covıd-19</keyword>
  <keyword>pregnancy</keyword>
  <keyword>preeclampsia</keyword>
  <keyword>preeclampsia-like syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>demographic data of the participants and diagnostic test results will be shared</ipd_description>
  </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/NCT04443140
org study id: 70/2020
nct id: NCT04443140
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who
      applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of
      Covid-19 related preeclampsia-like syndrome in this patient group.
The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR
      test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution
      during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients
      presented to our hospital during the pandemic will be involved in our study. The primary
      outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..
observational model: Cohort
time perspective: Prospective
measure: PCR positivity
time frame: 3 months
description: To detect Covid-19 PCR test positivity among preeclamptic pregnant women
intervention type: Diagnostic Test
intervention name: PCR, lung ultrasound
description: PCR for Covid-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant females are studied.
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Resul Karakus, MD
role: Principal Investigator
affiliation: Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital
facility: 
country: Turkey
citation: Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.
PMID: 32479682
responsible party type: Principal Investigator
investigator affiliation: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
investigator full name: Resul Karakuş
investigator title: Medical Doctor
mesh term: COVID-19
mesh term: Pre-Eclampsia
sharing ipd: Undecided
ipd description: demographic data of the participants and diagnostic test results will be shared