<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/NCT03013140</url>
  </required_header>
  <id_info>
    <org_study_id>201610025RIND</org_study_id>
    <nct_id>NCT03013140</nct_id>
  </id_info>
  <brief_title>Preloading to Prevent Hypotension During Cesarean Section</brief_title>
  <official_title>Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University 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>
      Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in&#xD;
      caesarean section can effectively reduce the incidence of hypotension and fetal&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal anesthesia in the cesarean section often causes significant peripheral vascular&#xD;
      dilatation, decreases blood pressure and cardiac output reduction which leads to maternal&#xD;
      nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of&#xD;
      vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can&#xD;
      not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In&#xD;
      the present study, perioperative goal directed fluid therapy is used. The non-invasive&#xD;
      continuous hemodynamic monitor is used in this study, and the parameters (blood pressure&#xD;
      (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to&#xD;
      determine the parameters of the blood transfusion in cesarean section as infusion guidelines.&#xD;
      The application of Clearsight system to the pre-infusion of target-guided crystalloid&#xD;
      solution is compared with the infusion of quantitative crystalline solution in the hope of&#xD;
      reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving&#xD;
      uteroplacental perfusion and reducing the incidence of fetal acidosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">June 9, 2019</completion_date>
  <primary_completion_date type="Actual">November 29, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of maternal hypotension</measure>
    <time_frame>delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage of vasopressor</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fluid volume</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Obstetric Anesthesia Problems</condition>
  <arm_group>
    <arm_group_label>Goal-directed preloading</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat &quot;Ringer's Injection&quot; 3ml/kg within 3 minutes with 1-min gap until change in SV (ΔSV) &lt;5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preloading</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml &quot;Ringer's injection&quot; with a pressurizer within 15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluid therapy</intervention_name>
    <description>Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat &quot;Ringer's Injection&quot; 3ml/kg within 3 minutes with 1-min gap until ΔSV&lt;5%</description>
    <arm_group_label>Goal-directed preloading</arm_group_label>
    <other_name>&quot;Ringer's Injection&quot;</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal anaesthesia</intervention_name>
    <description>Inject marcaine and fentanyl to CSF for anaesthesia</description>
    <arm_group_label>Goal-directed preloading</arm_group_label>
    <arm_group_label>Preloading</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. 20-45 y/o parturient&#xD;
&#xD;
          2. Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo&#xD;
             cesarean section&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Emergent C/S&#xD;
&#xD;
          2. BMI&gt;35kg/m2&#xD;
&#xD;
          3. Height &lt;150cm or &gt;175 cm&#xD;
&#xD;
          4. Patients with major cardiovascular disease, preeclampsia or eclampsia.&#xD;
&#xD;
          5. Gestational age &lt; 36wks&#xD;
&#xD;
          6. Multiple pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YiShiuan Lin</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NTUH</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anesthesia, Obstetric</keyword>
  <keyword>fluid therapy</keyword>
  <keyword>cesarean section</keyword>
  <keyword>spinal anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03013140
org study id: 201610025RIND
nct id: NCT03013140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in
      caesarean section can effectively reduce the incidence of hypotension and fetal
      complications.
Spinal anesthesia in the cesarean section often causes significant peripheral vascular
      dilatation, decreases blood pressure and cardiac output reduction which leads to maternal
      nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of
      vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can
      not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In
      the present study, perioperative goal directed fluid therapy is used. The non-invasive
      continuous hemodynamic monitor is used in this study, and the parameters (blood pressure
      (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to
      determine the parameters of the blood transfusion in cesarean section as infusion guidelines.
      The application of Clearsight system to the pre-infusion of target-guided crystalloid
      solution is compared with the infusion of quantitative crystalline solution in the hope of
      reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving
      uteroplacental perfusion and reducing the incidence of fetal acidosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Incidence of maternal hypotension
time frame: delivery
measure: Dosage of vasopressor
time frame: delivery
measure: Total fluid volume
time frame: delivery
arm group label: Goal-directed preloading
arm group type: Experimental
description: Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until change in SV (ΔSV) <5%
arm group label: Preloading
arm group type: Active Comparator
description: Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.
intervention type: Drug
intervention name: Fluid therapy
description: Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until ΔSV<5%
arm group label: Goal-directed preloading
other name: "Ringer's Injection"
intervention type: Procedure
intervention name: Spinal anaesthesia
description: Inject marcaine and fentanyl to CSF for anaesthesia
arm group label: Goal-directed preloading
arm group label: Preloading
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: YiShiuan Lin
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypotension
mesh term: Anesthetics
sharing ipd: No