<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/NCT03777371</url>
  </required_header>
  <id_info>
    <org_study_id>HIVinPregnancies</org_study_id>
    <nct_id>NCT03777371</nct_id>
  </id_info>
  <brief_title>Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation</brief_title>
  <official_title>Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation</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>
      HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the&#xD;
      estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%,&#xD;
      pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load,&#xD;
      breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false&#xD;
      positivity in prenatal screening in our country, one of the factors affecting this is the&#xD;
      number of pregnancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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 effect of the number of pregnancies on Anti HIV false positivity rate</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">128</enrollment>
  <condition>HIV Seropositivity</condition>
  <condition>Acquired Immunodeficiency Syndrome</condition>
  <condition>Pregnancy, High Risk</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anti HIV Seropositive Pregnant Women</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women between 8 and 40 weeks of gestation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anti HIV seropositive Pregnant Women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anti HIV seronegative Pregnant Women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</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>Pınar Yalcin bahat</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>HIV Seropositivity</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </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/NCT03777371
org study id: HIVinPregnancies
nct id: NCT03777371
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the
      estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%,
      pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load,
      breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false
      positivity in prenatal screening in our country, one of the factors affecting this is the
      number of pregnancies.
observational model: Other
time perspective: Retrospective
measure: The effect of the number of pregnancies on Anti HIV false positivity rate
time frame: 5 years
intervention type: Other
intervention name: Anti HIV Seropositive Pregnant Women
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Yalcin bahat
investigator title: Principal Investigator
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: HIV Seropositivity
mesh term: Immunologic Deficiency Syndromes
sharing ipd: Yes