<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/NCT04463940</url>
  </required_header>
  <id_info>
    <org_study_id>0024-19-BRZ</org_study_id>
    <nct_id>NCT04463940</nct_id>
  </id_info>
  <brief_title>Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women</brief_title>
  <official_title>The Origin of Xanthine Oxidase and Its Metabolite, Uric Acid, in Preeclamptic Pregnant Women - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barzilai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barzilai Medical Center</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>
      Findings regarding the presence of xanthine oxidase and uric acid in different blood&#xD;
      locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric&#xD;
      acid levels in both umbilical cord artery and vein as well as maternal blood (3 &quot;locations&quot;)&#xD;
      in pregnant women with and without diagnosis of preeclampsia. The study population will be&#xD;
      divided into groups matching the three &quot;locations&quot; in order to describe and compare outcome&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Significance - findings regarding the presence of xanthine oxidase and uric acid in different&#xD;
      blood locations may provide a scientific basis for understanding the source of them in&#xD;
      preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical&#xD;
      cord artery and vein as well as maternal blood (3 &quot;locations&quot;). Methods - samples will be&#xD;
      collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid&#xD;
      &gt; 6 mg/dL. Than the study population will be divided into groups matching the three&#xD;
      &quot;locations&quot;. The investigators will describe and compare outcome levels (including Xanthine&#xD;
      oxidase, uric acid).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Uric Acid</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>mg/dL</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Hyperuricemia</condition>
  <arm_group>
    <arm_group_label>Umbilical cord arterial blood</arm_group_label>
    <description>participant's umbilical cord arterial blood will be obtained</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Umbilical cord venus blood</arm_group_label>
    <description>participant's umbilical cord Venus blood will be obtained</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maternal blood</arm_group_label>
    <description>participant's blood will be obtained</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Maternal blood</arm_group_label>
    <arm_group_label>Umbilical cord arterial blood</arm_group_label>
    <arm_group_label>Umbilical cord venus blood</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with and without diagnosis of Pre-Eclampsia and serum Uric Acid greater than&#xD;
        6 mg/dL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preeclampsia and none-preeclampsia diagnosed pregnant women.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or reported kidney disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Simon Shenhav, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barzilai University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yaniv Ovadia, Dr</last_name>
    <phone>+ 972 (0) 8 6745220</phone>
    <email>yanivo@bmc.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>78306</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Shenhav</last_name>
      <phone>972-86745937</phone>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barzilai Medical Center</investigator_affiliation>
    <investigator_full_name>Simon Shanhav</investigator_full_name>
    <investigator_title>Dr Simon Shenhav, head of High Risk Pregnancy Unit</investigator_title>
  </responsible_party>
  <keyword>Xanthine oxidase</keyword>
  <keyword>Uric acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Hyperuricemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04463940
org study id: 0024-19-BRZ
nct id: NCT04463940
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Findings regarding the presence of xanthine oxidase and uric acid in different blood
      locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric
      acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations")
      in pregnant women with and without diagnosis of preeclampsia. The study population will be
      divided into groups matching the three "locations" in order to describe and compare outcome
      levels.
Significance - findings regarding the presence of xanthine oxidase and uric acid in different
      blood locations may provide a scientific basis for understanding the source of them in
      preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical
      cord artery and vein as well as maternal blood (3 "locations"). Methods - samples will be
      collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid
      > 6 mg/dL. Than the study population will be divided into groups matching the three
      "locations". The investigators will describe and compare outcome levels (including Xanthine
      oxidase, uric acid).
observational model: Case-Control
time perspective: Prospective
measure: Uric Acid
time frame: through study completion, an average of 1 year
description: mg/dL
arm group label: Umbilical cord arterial blood
description: participant's umbilical cord arterial blood will be obtained
arm group label: Umbilical cord venus blood
description: participant's umbilical cord Venus blood will be obtained
arm group label: Maternal blood
description: participant's blood will be obtained
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Maternal blood
arm group label: Umbilical cord arterial blood
arm group label: Umbilical cord venus blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 55 Years
last name: Simon Shenhav, Dr
role: Principal Investigator
affiliation: Barzilai University Medical Center
last name: Yaniv Ovadia, Dr
phone: + 972 (0) 8 6745220
email: yanivo@bmc.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Barzilai Medical Center
investigator full name: Simon Shanhav
investigator title: Dr Simon Shenhav, head of High Risk Pregnancy Unit
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Hyperuricemia
sharing ipd: Undecided