<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/NCT03299777</url>
  </required_header>
  <id_info>
    <org_study_id>0036-17-NHR</org_study_id>
    <nct_id>NCT03299777</nct_id>
  </id_info>
  <brief_title>Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan</brief_title>
  <official_title>Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</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>
      Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the&#xD;
      changes are reversible after labor.&#xD;
&#xD;
      Materials and Methods&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to compare the Fibroscan results of preeclamptic women to normal&#xD;
      controls and to find out if the changes are reversible after labor.&#xD;
&#xD;
      Materials and Methods This prospective observational case-control study will include 50 women&#xD;
      admitted to the fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe&#xD;
      preeclampsia. Preeclampsia is diagnosed as a new onset of hypertension over 140/90, at least&#xD;
      two measurements at least four hours apart, and proteinuria (≥+1 in dipstick or &gt;300 mg/24&#xD;
      hr) after 20 weeks of gestation in a previously normotensive woman.&#xD;
&#xD;
      A control group will consist 100 normotensive women with normal pregnancy outcomes who were&#xD;
      admitted to our fetal-maternal unit during the same period. Demographic, clinical, laboratory&#xD;
      and sonographic data for the women participating will be collected from their chart. All&#xD;
      patients diagnosed with preeclampsia will undergo the following workup: sign and symptoms&#xD;
      evaluation, blood pressure follow up, 24-hour protein excretion in grams per day, complete&#xD;
      blood count, hepatic function test: AST, ALT and coagulation study, HBA1C, coagulation&#xD;
      function test and fibrotest. The Fibroscan test will be performed by a trained hepatologist,&#xD;
      who was blind to the women diagnosis. The fibroscan test will be done during the admission&#xD;
      after the diagnosis of preeclampsia, after delivery and 6 weeks post-partum.&#xD;
&#xD;
      Commonly used cutoffs are &gt;7 kPa for significant fibrosis. Statistical analysis will be&#xD;
      performed with SPSS using Mann Whitney test. Continuous variables will be analyzed using the&#xD;
      student's T test and categorical variables were analyzed using 2. Statistical significance&#xD;
      was set at a P value of &lt; 0.05. The local institutional review board approved this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</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>Comparing the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. Fibrotic tissue differs from healthy tissue in the way it responds to excitation</measure>
    <time_frame>2 years</time_frame>
    <description>Transient elastography is performed using transducer-induced vibrations at low frequency (50 Hz) and amplitudes. The transmitted shear waves propagate through the liver parenchyma. Pulse-echo ultrasound acquisition is used to follow the propagation of the shear wave and to measure its average speed. Results are expressed in kPa and can range from 2.5 to 75 kPa. Commonly used cutoffs in clinical settings are &gt;7 kPa for significant fibrosis and &gt;11 to 14 kPa for cirrhosis and CAP&gt;270 db/m2 for significant steatosis.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>A control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preeclampsia group</arm_group_label>
    <description>All patients diagnosed with preeclampsia will undergo the fibroscan test.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Materials and Methods This prospective observational case-control study will include 50&#xD;
        women admitted to the fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with&#xD;
        mild/severe preeclampsia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe&#xD;
        preeclampsia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less then 18&#xD;
&#xD;
          -  Fetal-maternal less then 24 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maya Wolf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Galilee Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maya Wolf, MD</last_name>
    <phone>972-507887800</phone>
    <email>mayaf@gmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maya Wolf, MD</last_name>
    <phone>972-507887800</phone>
    <email>HOMESICKID@YAHOO.COM</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Galil Medical Center</name>
      <address>
        <city>Nahariya</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maya Wolf, MD</last_name>
      <phone>972-507887800</phone>
      <email>homesickid@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2017</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>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03299777
org study id: 0036-17-NHR
nct id: NCT03299777
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the
      changes are reversible after labor.

      Materials and Methods
The purpose of the study is to compare the Fibroscan results of preeclamptic women to normal
      controls and to find out if the changes are reversible after labor.

      Materials and Methods This prospective observational case-control study will include 50 women
      admitted to the fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe
      preeclampsia. Preeclampsia is diagnosed as a new onset of hypertension over 140/90, at least
      two measurements at least four hours apart, and proteinuria (≥+1 in dipstick or >300 mg/24
      hr) after 20 weeks of gestation in a previously normotensive woman.

      A control group will consist 100 normotensive women with normal pregnancy outcomes who were
      admitted to our fetal-maternal unit during the same period. Demographic, clinical, laboratory
      and sonographic data for the women participating will be collected from their chart. All
      patients diagnosed with preeclampsia will undergo the following workup: sign and symptoms
      evaluation, blood pressure follow up, 24-hour protein excretion in grams per day, complete
      blood count, hepatic function test: AST, ALT and coagulation study, HBA1C, coagulation
      function test and fibrotest. The Fibroscan test will be performed by a trained hepatologist,
      who was blind to the women diagnosis. The fibroscan test will be done during the admission
      after the diagnosis of preeclampsia, after delivery and 6 weeks post-partum.

      Commonly used cutoffs are >7 kPa for significant fibrosis. Statistical analysis will be
      performed with SPSS using Mann Whitney test. Continuous variables will be analyzed using the
      student's T test and categorical variables were analyzed using 2. Statistical significance
      was set at a P value of < 0.05. The local institutional review board approved this study.
observational model: Cohort
time perspective: Prospective
measure: Comparing the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. Fibrotic tissue differs from healthy tissue in the way it responds to excitation
time frame: 2 years
description: Transient elastography is performed using transducer-induced vibrations at low frequency (50 Hz) and amplitudes. The transmitted shear waves propagate through the liver parenchyma. Pulse-echo ultrasound acquisition is used to follow the propagation of the shear wave and to measure its average speed. Results are expressed in kPa and can range from 2.5 to 75 kPa. Commonly used cutoffs in clinical settings are >7 kPa for significant fibrosis and >11 to 14 kPa for cirrhosis and CAP>270 db/m2 for significant steatosis.
arm group label: Control group
description: A control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period
arm group label: Preeclampsia group
description: All patients diagnosed with preeclampsia will undergo the fibroscan test.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maya Wolf, MD
role: Principal Investigator
affiliation: Western Galilee Medical Center
last name: Maya Wolf, MD
phone: 972-507887800
email: mayaf@gmc.gov.il
last name: Maya Wolf, MD
phone: 972-507887800
email: HOMESICKID@YAHOO.COM
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Eclampsia