<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/NCT04421183</url>
  </required_header>
  <id_info>
    <org_study_id>MUC 3</org_study_id>
    <nct_id>NCT04421183</nct_id>
  </id_info>
  <brief_title>Investigation of the Serum Mucoprotein 3 (MUC3) Protein Levels in Gestational Hypertensive Disease</brief_title>
  <acronym>MUC3</acronym>
  <official_title>Investigation of the Serum MUC3 Protein Levels in Gestational Hypertensive Disease (Preeclampsia-Eclampsia, Pregnancy Induced Hypertension, and HELLP Syndrome) Compared With Normal Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karadeniz Technical 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>
      Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for&#xD;
      maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein&#xD;
      takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This&#xD;
      study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of&#xD;
      pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20&#xD;
      gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010-&#xD;
      January 2011.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for&#xD;
      maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein&#xD;
      takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This&#xD;
      study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of&#xD;
      pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20&#xD;
      gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010-&#xD;
      January 2011. This is the first study measuring levels of serum mucoprotein three in&#xD;
      gestational hypertensive disease. MUC3 levels showed a distinctive increase in hypertensive&#xD;
      diseases of pregnancy compared with the pregnant control group. As a result, it is found that&#xD;
      plasma mucoprotein 3 levels increase as the severity of hypertensive diseases of pregnancy&#xD;
      increases; and plasma mucoprotein 3 could be a precursor for the evaluation of the severity&#xD;
      of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2010</start_date>
  <completion_date type="Actual">January 2, 2011</completion_date>
  <primary_completion_date type="Actual">January 1, 2011</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>Collection of Blood Samples</measure>
    <time_frame>6 months</time_frame>
    <description>The blood samples required for the study were obtained from samples taken into a heparinized tube. Maternal blood samples were taken at the time of diagnosis in patients with preeclamptic - eclamptic, gestational hypertension and HELLP syndrome before starting any treatment when they apply for delivery in normal pregnant women. After the blood samples were centrifuged at Eppendorf Centrifuge-5084R at 3000 G for 10 minutes, the serum was separated. Some of the serum collected were placed in a 1.5 cc Eppendorf tube and stored at -80 ˚C in the medical cooler (Ariston) in the Department of Obstetrics and Gynecology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of Mucoprotein in Serum</measure>
    <time_frame>1 month</time_frame>
    <description>After collecting all serum samples (80 pieces), they were dissolved at room temperature and MUC3 (Human Mucin 3, MUC3 ELISA Kit) level was measured in serum samples with the help of commercial ELISA kits. The measurement technique principle is given below.Mucoprotein content in serum was determined in ng/ml with the help of a special ELISA kit system and elements for mucoprotein 3.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Muc3</condition>
  <condition>Pregnancy Induced Hypertension</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>preeclampsia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <description>normal pregnancy without complication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>hellp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>eclampsia</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>draw blood</intervention_name>
    <description>draw blood from the all of patients</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who were diagnosed with hypertensive disease among the patients who applied to the&#xD;
        pregnant clinic of Karadeniz Technical University Faculty of Medicine, Obstetrics and&#xD;
        Gynecology Department with the approval of the KTÜ Faculty of Medicine Research Ethics&#xD;
        Committee dated 27.05.2010 and 154 number ( 80 cases, including the study group and 20&#xD;
        normotensive pregnant control group) were included in the study between June 2010 and&#xD;
        January 2011.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To accept the consent to participate in the research and sign the form,&#xD;
&#xD;
          -  According to ACOG 2002, pregnancy meets the criteria of hypertensive diseases [1], The&#xD;
             diagnosis of HELLP syndrome was made according to the criteria described by Sibai.&#xD;
             These; abnormal peripheral smear, schistocyte in the peripheral smear, lactate&#xD;
             dehydrogenase &gt; 600 U / L, hemolysis, total bilirubin&gt; 1.2 mg / dl, AST&gt; 70 U / L,&#xD;
             platelet count &lt;100,000mm3.&#xD;
&#xD;
          -  When the demographic characteristics and CVs of all cases were questioned in the&#xD;
             initial evaluation, not having chronic inflammation or acute infection, not having any&#xD;
             systemic disease, recurrent pregnancy loss, thrombophilia, antiphospholipid antibody&#xD;
             syndrome,&#xD;
&#xD;
          -  Not smoking, No history of cancer, No multiple pregnancies&#xD;
&#xD;
          -  Not using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and&#xD;
             antiepileptic drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and&#xD;
             antiepileptic drugs&#xD;
&#xD;
          -  smoking,history of cancer, multiple pregnancies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnancy is female-specific. therefore, women were included in the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karadeniz Technique University</name>
      <address>
        <city>Trabzon</city>
        <state>Ortahisar</state>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Suleyman Guven</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Muc3</keyword>
  <keyword>Preeclampsia</keyword>
  <keyword>Eclampsia</keyword>
  <keyword>HELLP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04421183
org study id: MUC 3
nct id: NCT04421183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for
      maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein
      takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This
      study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of
      pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20
      gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010-
      January 2011.
Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for
      maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein
      takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This
      study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of
      pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20
      gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010-
      January 2011. This is the first study measuring levels of serum mucoprotein three in
      gestational hypertensive disease. MUC3 levels showed a distinctive increase in hypertensive
      diseases of pregnancy compared with the pregnant control group. As a result, it is found that
      plasma mucoprotein 3 levels increase as the severity of hypertensive diseases of pregnancy
      increases; and plasma mucoprotein 3 could be a precursor for the evaluation of the severity
      of the disease.
observational model: Cohort
time perspective: Prospective
measure: Collection of Blood Samples
time frame: 6 months
description: The blood samples required for the study were obtained from samples taken into a heparinized tube. Maternal blood samples were taken at the time of diagnosis in patients with preeclamptic - eclamptic, gestational hypertension and HELLP syndrome before starting any treatment when they apply for delivery in normal pregnant women. After the blood samples were centrifuged at Eppendorf Centrifuge-5084R at 3000 G for 10 minutes, the serum was separated. Some of the serum collected were placed in a 1.5 cc Eppendorf tube and stored at -80 ˚C in the medical cooler (Ariston) in the Department of Obstetrics and Gynecology.
measure: Measurement of Mucoprotein in Serum
time frame: 1 month
description: After collecting all serum samples (80 pieces), they were dissolved at room temperature and MUC3 (Human Mucin 3, MUC3 ELISA Kit) level was measured in serum samples with the help of commercial ELISA kits. The measurement technique principle is given below.Mucoprotein content in serum was determined in ng/ml with the help of a special ELISA kit system and elements for mucoprotein 3.
arm group label: 1
description: preeclampsia
arm group label: 4
description: normal pregnancy without complication
arm group label: 2
description: hellp
arm group label: 3
description: eclampsia
intervention type: Diagnostic Test
intervention name: draw blood
description: draw blood from the all of patients
arm group label: 1
arm group label: 2
arm group label: 3
arm group label: 4
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnancy is female-specific. therefore, women were included in the study.
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Suleyman Guven
investigator title: professor
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
sharing ipd: No