<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/NCT03246542</url>
  </required_header>
  <id_info>
    <org_study_id>AAMABDELKADER 4</org_study_id>
    <nct_id>NCT03246542</nct_id>
  </id_info>
  <brief_title>Promising Bimarker Prediction of Outcome of HELLP Syndrome.</brief_title>
  <official_title>Association Between the Quantitative Assessment of Schistocytes in Peripheral Blood Smear and Prognosis of Patient Initially Diagnosed as HELLP Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AYMAN ABDELKADER MOHAMED ABDELKADER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity 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>
      HELLP syndrome is a life-threatening obstetric complication usually considered to be a&#xD;
      variant or complication of pre-eclampsia. And may occasionally be confused with other&#xD;
      diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis,&#xD;
      hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare,&#xD;
      antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura,&#xD;
      and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic&#xD;
      purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and&#xD;
      prognostic reasons. However, the clinical and histological features are so similar that&#xD;
      establishing the correct diagnosis is often difficult; furthermore, these disorders may occur&#xD;
      concurrently.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When TTP/HUS does occur during pregnancy, they often are confused initially with obstetric&#xD;
      diagnoses such as severe preeclampsia; hemolysis, elevated liver enzymes and low platelets&#xD;
      (HELLP) syndrome; acute fatty liver of pregnancy; eclampsia, and antiphospholipid antibody&#xD;
      syndrome. This might be related to the fact that the disease entity is rare and often is&#xD;
      unexpected. Nevertheless, a delay in diagnosis of TTP/HUS may result in life-threatening&#xD;
      maternal and fetal consequences. Aim of the current study was to compare the quantitative&#xD;
      assessment of schistocytes in peripheral blood smear between women initially diagnosed as&#xD;
      HELLP syndrome who showed no spontaneous resolution within 48 hrs after delivery and those&#xD;
      who showed spontaneous resolution within 48 hrs after delivery which may help in decreasing&#xD;
      the maternal mortality rate .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>laboratory changes after 48 hours of delivery</measure>
    <time_frame>48 hours</time_frame>
    <description>full blood count, liver function tests( AST, ALT, Bilirubin), kidney function (serum creatinine level), coagulation profile (INR, PTT, PT)</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Pre-Eclampsia, Severe</condition>
  <condition>HELLP Syndrome</condition>
  <condition>Microangiopathy</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>shistocytes percentage</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 100 women with an initial diagnosis of HELLP syndrome were recruited in the&#xD;
        study.&#xD;
&#xD;
        Blood sample taken within 12hrs peripartum and patients followed up 48hrs after delivery&#xD;
        and subdivided in to 2 groups according to improvement or deterioration after 48hrs after&#xD;
        delivery .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age more than 20 weeks.&#xD;
&#xD;
          -  Age from18 to 40 years old.&#xD;
&#xD;
          -  Fulfilled criteria for the diagnosis of severe preeclampsia.&#xD;
&#xD;
          -  Fulfilled criteria for the diagnosis of HELLP syndrome.&#xD;
&#xD;
        Diagnostic criteria for severe preeclampsia(one of the following):&#xD;
&#xD;
          -  Blood pressure of 160 mm Hg systolic or higher or 110 mm Hg diastolic or higher on two&#xD;
             occasions at least 6 hours apart while the patient is on bed rest (unless&#xD;
             antihypertensive therapy is intiated befor this time).&#xD;
&#xD;
          -  New onest Cerebral or visual disturbances.&#xD;
&#xD;
          -  Pulmonary edema or cyanosis.&#xD;
&#xD;
          -  Sever persistant epigastric or right upper-quadrant pain unresponsive to medication&#xD;
             and not accounted for by alternative diagnosis, or both.&#xD;
&#xD;
          -  Impaired liver function as indicated by abnormally elevated blood concentration of&#xD;
             liver enzymes (to twic normal concentration).&#xD;
&#xD;
          -  Thrombocytopenia (platlet count less than 100, 000 per microliter.&#xD;
&#xD;
        Diagnostic criteria for HELLP syndrome:&#xD;
&#xD;
          -  Hemolysis documented by an increased LDH level and progressive anemia .&#xD;
&#xD;
          -  Hepatic dysfunction documented by an LDH level &gt;600 IU/L, elevated liver enzymes&#xD;
             documented by AST &gt;40 IU/L, ALT&gt;40 IU/L, or both .&#xD;
&#xD;
          -  Thrombocytopenia documented by a platelet nadir less than 150, 000 cells/mm³.&#xD;
             Thrombocytopenia is subclassified as class one HELLP syndrome: platelet nadir ≤50, 000&#xD;
             cells/mm³, class two HELLP syndrome: platelet nadir ≤100, 000 cells/mm³, or class&#xD;
             three HELLP syndrome: platelet nadir ≤150, 000 cells/mm³..&#xD;
&#xD;
        Anticepation of Microangiopathic Hemolytic Anemia:&#xD;
&#xD;
        Thrombotic thrombocytopenic purpura-hemolytic uremic syndrome should be considered in all&#xD;
        pregnant women with severe thrombocytopenia, severe anemia, and elevated lactate&#xD;
        dehydrogenase enzyme.&#xD;
&#xD;
        Exclusion Criteria: any non included criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>AYMAN ABDELKADER MOHAMED ABDELKADER</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <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>HELLP Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03246542/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03246542/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03246542
org study id: AAMABDELKADER 4
nct id: NCT03246542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
HELLP syndrome is a life-threatening obstetric complication usually considered to be a
      variant or complication of pre-eclampsia. And may occasionally be confused with other
      diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis,
      hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare,
      antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura,
      and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic
      purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and
      prognostic reasons. However, the clinical and histological features are so similar that
      establishing the correct diagnosis is often difficult; furthermore, these disorders may occur
      concurrently.
When TTP/HUS does occur during pregnancy, they often are confused initially with obstetric
      diagnoses such as severe preeclampsia; hemolysis, elevated liver enzymes and low platelets
      (HELLP) syndrome; acute fatty liver of pregnancy; eclampsia, and antiphospholipid antibody
      syndrome. This might be related to the fact that the disease entity is rare and often is
      unexpected. Nevertheless, a delay in diagnosis of TTP/HUS may result in life-threatening
      maternal and fetal consequences. Aim of the current study was to compare the quantitative
      assessment of schistocytes in peripheral blood smear between women initially diagnosed as
      HELLP syndrome who showed no spontaneous resolution within 48 hrs after delivery and those
      who showed spontaneous resolution within 48 hrs after delivery which may help in decreasing
      the maternal mortality rate .
observational model: Cohort
time perspective: Prospective
measure: laboratory changes after 48 hours of delivery
time frame: 48 hours
description: full blood count, liver function tests( AST, ALT, Bilirubin), kidney function (serum creatinine level), coagulation profile (INR, PTT, PT)
intervention type: Diagnostic Test
intervention name: shistocytes percentage
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: AYMAN ABDELKADER MOHAMED ABDELKADER
investigator title: doctor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: HELLP Syndrome
mesh term: Syndrome
sharing ipd: No
provided document: 
provided document: 