xml: <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/NCT05973435</url>
    </required_header>
    <id_info>
      <org_study_id>17/I-4</org_study_id>
      <nct_id>NCT05973435</nct_id>
    </id_info>
    <brief_title>Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section</brief_title>
    <official_title>Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Clinic Dr Dragisa Misovic-Dedinje</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Clinic Dr Dragisa Misovic-Dedinje</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>
        The goal of this observational study is to assess the level of oxidative stress during&#xD;
        cesarean section depending on the type of anesthesia applied and to determine the factors&#xD;
        that can affect the level of oxidative stress.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  is there any association between specific parameters of pregnancy, socio-demographic&#xD;
             characteristics and laboratory analyses with an increased level of oxidative stress&#xD;
  &#xD;
          -  is there any association between type of anesthesia for ceasarean section with an&#xD;
             increased level of oxidative stress&#xD;
  &#xD;
        Blood sample would be taken from the participants in the study for these analyses on three&#xD;
        occasions in 3 test tubes (before cesarean section, during cesarean section and after&#xD;
        cesarean section).&#xD;
  &#xD;
        Researchers will compare patients that received general anesthesia with patients under spinal&#xD;
        regional anesthesia to see if there is any difference in level of oxidative stress measured&#xD;
        by laboratory parameters.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2023</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>Elevated level of oxidative stress</measure>
      <time_frame>2 hours after C section</time_frame>
      <description>We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Obstetric Anesthesia Problems</condition>
    <arm_group>
      <arm_group_label>General Anesthesia</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Spinal anesthesia</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood sampling</intervention_name>
      <description>Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).</description>
      <arm_group_label>General Anesthesia</arm_group_label>
      <arm_group_label>Spinal anesthesia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy pregnant women&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA status I and II&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA status III and IV&#xD;
  &#xD;
            -  Emergency C section&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nemanja Dimic, MD</last_name>
      <phone>+381655995727</phone>
      <email>nemanjadimic1989@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Predrag Stevanovic</last_name>
      <phone>+381648368033</phone>
      <email>baticaster@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Clinical Hospital Center &quot;Dr. Dragisa Misovic, Dedinje&quot;</name>
        <address>
          <city>Belgrade</city>
          <zip>11000</zip>
          <country>Serbia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nemanja Dimić, MD</last_name>
        <phone>+381655995727</phone>
        <email>nemanjadimic1989@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Predrag Stevanovic, MD, PhD</last_name>
        <phone>0648368033</phone>
        <email>baticaster@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Nemanja D Dimic, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Serbia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Clinic Dr Dragisa Misovic-Dedinje</investigator_affiliation>
      <investigator_full_name>Marina Boboš</investigator_full_name>
      <investigator_title>Dr.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973435
  org study id: 17/I-4
  nct id: NCT05973435
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to assess the level of oxidative stress during
        cesarean section depending on the type of anesthesia applied and to determine the factors
        that can affect the level of oxidative stress.
  
        The main questions it aims to answer are:
  
          -  is there any association between specific parameters of pregnancy, socio-demographic
             characteristics and laboratory analyses with an increased level of oxidative stress
  
          -  is there any association between type of anesthesia for ceasarean section with an
             increased level of oxidative stress
  
        Blood sample would be taken from the participants in the study for these analyses on three
        occasions in 3 test tubes (before cesarean section, during cesarean section and after
        cesarean section).
  
        Researchers will compare patients that received general anesthesia with patients under spinal
        regional anesthesia to see if there is any difference in level of oxidative stress measured
        by laboratory parameters.
  observational model: Cohort
  time perspective: Prospective
  measure: Elevated level of oxidative stress
  time frame: 2 hours after C section
  description: We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section.
  arm group label: General Anesthesia
  arm group label: Spinal anesthesia
  intervention type: Other
  intervention name: Blood sampling
  description: Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).
  arm group label: General Anesthesia
  arm group label: Spinal anesthesia
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nemanja Dimic, MD
  phone: +381655995727
  email: nemanjadimic1989@gmail.com
  last name: Predrag Stevanovic
  phone: +381648368033
  email: baticaster@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Serbia
  responsible party type: Principal Investigator
  investigator affiliation: University Clinic Dr Dragisa Misovic-Dedinje
  investigator full name: Marina Boboš
  investigator title: Dr.
  sharing ipd: No