<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/NCT03247894</url>
  </required_header>
  <id_info>
    <org_study_id>KDAR FN Brno 2017</org_study_id>
    <nct_id>NCT03247894</nct_id>
  </id_info>
  <brief_title>Obstetric Anesthesia and Analgesia and Multiple Sclerosis</brief_title>
  <acronym>OBAANAMS</acronym>
  <official_title>Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masaryk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brno University Hospital</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>
      Aim of the retrospective study was to evaluate the influence of the labour on the clinical&#xD;
      course of the parturients with MS in selected 6 month follow-up interval and to evaluate to&#xD;
      possible influence of the different anesthesia/analgesia types on the course of MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few&#xD;
      foreign studies. The most frequently afflicted patients by MS are women of childbearing age&#xD;
      and influence of anesthesia or obstetric epidural analgesia has only not been investigated in&#xD;
      Czech Republic. The study aims to retrospectively compare the further course of the disease&#xD;
      of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by&#xD;
      caesarean section or vaginally with epidural analgesia , with patients who gave birth&#xD;
      spontaneously without anesthesia.The aim of the study was to evaluate the influence of the&#xD;
      labour on the clinical course of MS and further evaluate the possible influence of the type&#xD;
      of anesthesia/analgesia in the peripartal period on the MS progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Months</target_duration>
  <primary_outcome>
    <measure>Multiple sclerosis decompensation/progression at 3rd month</measure>
    <time_frame>3 months after labour</time_frame>
    <description>Relapse occurence from labour to 3 months, after delivery was recorded. A relapse was defined as the appearance or worsening of symptoms of neurologic dysfunction lasting more than 24 hours, new lesions on MRI or need of reinforcement in treatment. For disease state after delivery we used dichotomic approach: relapse (at least one) or no relapses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple sclerosis decompensation/progression</measure>
    <time_frame>3 months after labour</time_frame>
    <description>Relapse occurence from labour to 6 months after delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MS progression and the type of anesthetic method</measure>
    <time_frame>6 months after labour</time_frame>
    <description>MS progression comparison due to the type of anethesia</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>MS patients who after labour</arm_group_label>
    <description>Patients with multiple sclerosis after labour in tertiary center was screened for progression of MS in 10 months period after labour</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data search</intervention_name>
    <description>Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period</description>
    <arm_group_label>MS patients who after labour</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parturients with multiple sclerosis after labour in tertiary perinatology center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parturients with multiple sclerosis&#xD;
&#xD;
          -  Possible follow up - neurologic examination available after 10 month from delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  probable or no multiple sclerosis at time of labor&#xD;
&#xD;
          -  unknown neurology history&#xD;
&#xD;
          -  unknown data on neurology outcome 6 months after labour&#xD;
&#xD;
          -  Incomplete data&#xD;
&#xD;
          -  Follow-up not possible&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Parturients with multiple sclerosis</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Brno University Hospital</name>
      <address>
        <city>Brno, Czechia, 62500</city>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>May 25, 2019</last_update_submitted>
  <last_update_submitted_qc>May 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Petr Štourač, MD</investigator_full_name>
    <investigator_title>doc.MD. Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Multiple sclerosis, anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT03247894
org study id: KDAR FN Brno 2017
nct id: NCT03247894
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim of the retrospective study was to evaluate the influence of the labour on the clinical
      course of the parturients with MS in selected 6 month follow-up interval and to evaluate to
      possible influence of the different anesthesia/analgesia types on the course of MS.
The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few
      foreign studies. The most frequently afflicted patients by MS are women of childbearing age
      and influence of anesthesia or obstetric epidural analgesia has only not been investigated in
      Czech Republic. The study aims to retrospectively compare the further course of the disease
      of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by
      caesarean section or vaginally with epidural analgesia , with patients who gave birth
      spontaneously without anesthesia.The aim of the study was to evaluate the influence of the
      labour on the clinical course of MS and further evaluate the possible influence of the type
      of anesthesia/analgesia in the peripartal period on the MS progression.
observational model: Cohort
time perspective: Other
measure: Multiple sclerosis decompensation/progression at 3rd month
time frame: 3 months after labour
description: Relapse occurence from labour to 3 months, after delivery was recorded. A relapse was defined as the appearance or worsening of symptoms of neurologic dysfunction lasting more than 24 hours, new lesions on MRI or need of reinforcement in treatment. For disease state after delivery we used dichotomic approach: relapse (at least one) or no relapses.
measure: Multiple sclerosis decompensation/progression
time frame: 3 months after labour
description: Relapse occurence from labour to 6 months after delivery
measure: MS progression and the type of anesthetic method
time frame: 6 months after labour
description: MS progression comparison due to the type of anethesia
arm group label: MS patients who after labour
description: Patients with multiple sclerosis after labour in tertiary center was screened for progression of MS in 10 months period after labour
intervention type: Other
intervention name: Data search
description: Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period
arm group label: MS patients who after labour
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Parturients with multiple sclerosis
minimum age: 18 Years
maximum age: 70 Years
facility: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Petr Štourač, MD
investigator title: doc.MD. Ph.D.
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided