<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/NCT04410939</url>
  </required_header>
  <id_info>
    <org_study_id>Gpolat1</org_study_id>
    <nct_id>NCT04410939</nct_id>
  </id_info>
  <brief_title>COVID-19 PCR Test Results in Asymptomatic Pregnants</brief_title>
  <official_title>COVID-19 PCR Test Results in Asymptomatic Pregnants Admitted for Birth and Other Interventions in Our Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University 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>
      In order to prevent contamination from the pregnant women hospitalized in this clinic, the&#xD;
      RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before&#xD;
      hospitalization. In addition, the same test is done before each operation and before the&#xD;
      operation. The aim of the study is to scan these tests retrospectively and to determine the&#xD;
      rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine&#xD;
      the importance of the measures to be taken in the pregnant women who undergo intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Actual">May 21, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of positive COVID-19 cases in asymptomatic pregnant women</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <enrollment type="Actual">179</enrollment>
  <condition>COVID-19</condition>
  <condition>Asymptomatic Pregnant</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Reverse transcription polymerase chain reaction</intervention_name>
    <description>PCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant and undergoing pregnant women.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant patients who apply to Istanbul Medipol University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asymptomatic pregnant women who will give birth in this clinic, dilatation and&#xD;
             curettage due to missed abortion, cerclage due to cervical insufficiency, medical&#xD;
             evacuation due to fetal anomaly, and routine PCR test taken for service for some&#xD;
             treatments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath,&#xD;
             sore throat, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.</citation>
    <PMID>32283004</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04410939
org study id: Gpolat1
nct id: NCT04410939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In order to prevent contamination from the pregnant women hospitalized in this clinic, the
      RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before
      hospitalization. In addition, the same test is done before each operation and before the
      operation. The aim of the study is to scan these tests retrospectively and to determine the
      rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine
      the importance of the measures to be taken in the pregnant women who undergo intervention.
observational model: Case-Crossover
time perspective: Retrospective
measure: Rate of positive COVID-19 cases in asymptomatic pregnant women
time frame: 1 day
intervention type: Diagnostic Test
intervention name: Reverse transcription polymerase chain reaction
description: PCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant and undergoing pregnant women.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.
PMID: 32283004
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd info type: Study Protocol