<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/NCT04437940</url>
  </required_header>
  <id_info>
    <org_study_id>Acibadem Maslak Ob&amp;Gyn</org_study_id>
    <nct_id>NCT04437940</nct_id>
  </id_info>
  <brief_title>Evaluation of Vaginal Fluid for Covid-19 Positivity in Women With Positive Nasofarengeal Covid-19 Test</brief_title>
  <official_title>Evaluation of Vaginal Fluid for Covid-19 Positivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem 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>
      Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples&#xD;
      of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk&#xD;
      of transmission of Covid-19 by intercourse or vaginal delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical&#xD;
      findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive&#xD;
      vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral&#xD;
      clearance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 10, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Vaginal fluid Covid-19 PCR test result</measure>
    <time_frame>1 month</time_frame>
    <description>Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>becoming negative from positive</measure>
    <time_frame>2 month</time_frame>
    <description>The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Covid-19 positive women</arm_group_label>
    <description>Women with nasofarangeal Covid-19 PCR test is positive</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Vaginal fluid Covid-19 PCR test</intervention_name>
    <description>Vaginal fluid samples are tested for Covid-19</description>
    <arm_group_label>Covid-19 positive women</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Vaginal fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women who are older than18 years old, who are considered to be covid-19 clinically and&#xD;
        radiologically positive or nasofarengeal Covid-19 PCR test is positive will be included.&#xD;
&#xD;
        Patients previously treated for covid-19 will be excluded from the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are positive nasofarengeal Covid-19 PCR test result&#xD;
&#xD;
          -  Women who are 18 years or older&#xD;
&#xD;
          -  Women who had sexual intercourse before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who had medical treatment for Covid-19&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women who are older than 18 years old Women who had sexual intercourse before</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Acibadem Maslak Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34457</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, Jiang J, Liu J, Zhang C, Shan W, Wang S, Rong Y, Chang J, Miao X, Ma X, Wang S. Severe acute respiratory syndrome coronavirus 2 detection in the female lower genital tract. Am J Obstet Gynecol. 2020 Jul;223(1):131-134. doi: 10.1016/j.ajog.2020.04.038. Epub 2020 May 4. No abstract available.</citation>
    <PMID>32376320</PMID>
  </reference>
  <results_reference>
    <citation>Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, Morse A, Xie Y, Li T, Zhu L. SARS-CoV-2 Is Not Detectable in the Vaginal Fluid of Women With Severe COVID-19 Infection. Clin Infect Dis. 2020 Jul 28;71(15):813-817. doi: 10.1093/cid/ciaa375.</citation>
    <PMID>32241022</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem University</investigator_affiliation>
    <investigator_full_name>Ozguc Takmaz</investigator_full_name>
    <investigator_title>MD,Assistant Professor</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>Undecided</sharing_ipd>
    <ipd_description>Data of the patients will be shared without personel informations</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/NCT04437940
org study id: Acibadem Maslak Ob&Gyn
nct id: NCT04437940
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples
      of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk
      of transmission of Covid-19 by intercourse or vaginal delivery.
Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical
      findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive
      vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral
      clearance.
observational model: Cohort
time perspective: Prospective
measure: Vaginal fluid Covid-19 PCR test result
time frame: 1 month
description: Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive
measure: becoming negative from positive
time frame: 2 month
description: The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test
arm group label: Covid-19 positive women
description: Women with nasofarangeal Covid-19 PCR test is positive
intervention type: Diagnostic Test
intervention name: Vaginal fluid Covid-19 PCR test
description: Vaginal fluid samples are tested for Covid-19
arm group label: Covid-19 positive women
Vaginal fluid
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women who are older than 18 years old Women who had sexual intercourse before
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, Jiang J, Liu J, Zhang C, Shan W, Wang S, Rong Y, Chang J, Miao X, Ma X, Wang S. Severe acute respiratory syndrome coronavirus 2 detection in the female lower genital tract. Am J Obstet Gynecol. 2020 Jul;223(1):131-134. doi: 10.1016/j.ajog.2020.04.038. Epub 2020 May 4. No abstract available.
PMID: 32376320
citation: Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, Morse A, Xie Y, Li T, Zhu L. SARS-CoV-2 Is Not Detectable in the Vaginal Fluid of Women With Severe COVID-19 Infection. Clin Infect Dis. 2020 Jul 28;71(15):813-817. doi: 10.1093/cid/ciaa375.
PMID: 32241022
responsible party type: Principal Investigator
investigator affiliation: Acibadem University
investigator full name: Ozguc Takmaz
investigator title: MD,Assistant Professor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: Data of the patients will be shared without personel informations