<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/NCT04432675</url>
  </required_header>
  <id_info>
    <org_study_id>CINI-AD-20205-13</org_study_id>
    <nct_id>NCT04432675</nct_id>
  </id_info>
  <brief_title>Effects of Crystal Solution and Colloid Solution on Mother and Fetus</brief_title>
  <official_title>Comparison of the Effects of Crystal Solution (Lactic Acid Ringer's Solution) and Colloid Solution (Hydroxyethyl Starch) on Mother and Fetus After Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China International Neuroscience Institution</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China International Neuroscience Institution</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>
      Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid&#xD;
      solution (hydroxyethyl starch) on mother and fetus after cesarean section&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy&#xD;
      with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well&#xD;
      as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole&#xD;
      operation of elective cesarean section&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2022</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 2022</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hypotension</measure>
    <time_frame>during operation procedure</time_frame>
    <description>The incidence of maternal hypotension during the operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>umbilical vein blood gases</measure>
    <time_frame>24 hours</time_frame>
    <description>umbilical vein blood gases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>umbilical artery blood gases</measure>
    <time_frame>24 hours</time_frame>
    <description>umbilical artery blood gases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal vein blood gase</measure>
    <time_frame>24 hours</time_frame>
    <description>Maternal vein blood gase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidences of maternal complications</measure>
    <time_frame>24 hours</time_frame>
    <description>The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic data at time point</measure>
    <time_frame>24 hours</time_frame>
    <description>Hemodynamic data at time point</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Spinal Anesthesia</condition>
  <condition>Parturition</condition>
  <arm_group>
    <arm_group_label>hydroxyethl starch group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hydroxyethl starch</intervention_name>
    <description>10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch</description>
    <arm_group_label>hydroxyethl starch group</arm_group_label>
    <other_name>Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactated Ringer's solution</intervention_name>
    <description>10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution</description>
    <arm_group_label>The control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy singleton pregnancy scheduled for elective cesarean section under CSEA;&#xD;
             American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; Age ranging from 20&#xD;
             to 40 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of mental disorder or epilepsy; History of central nervous system (CNS)&#xD;
             disease; Preexisting or pregnancy-induced hypertension; History of lumber injury;&#xD;
             Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index&#xD;
             (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine&#xD;
             antidepressants.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanghai Cui</last_name>
    <role>Study Chair</role>
    <affiliation>China International Neuroscience Institution</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xuanwu hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04432675
org study id: CINI-AD-20205-13
nct id: NCT04432675
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid
      solution (hydroxyethyl starch) on mother and fetus after cesarean section
The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy
      with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well
      as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole
      operation of elective cesarean section
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: hypotension
time frame: during operation procedure
description: The incidence of maternal hypotension during the operation
measure: umbilical vein blood gases
time frame: 24 hours
description: umbilical vein blood gases
measure: umbilical artery blood gases
time frame: 24 hours
description: umbilical artery blood gases
measure: Maternal vein blood gase
time frame: 24 hours
description: Maternal vein blood gase
measure: The incidences of maternal complications
time frame: 24 hours
description: The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively.
measure: Hemodynamic data at time point
time frame: 24 hours
description: Hemodynamic data at time point
arm group label: hydroxyethl starch group
arm group type: Experimental
description: 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
arm group label: The control group
arm group type: Active Comparator
description: 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
intervention type: Drug
intervention name: hydroxyethl starch
description: 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
arm group label: hydroxyethl starch group
other name: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection
intervention type: Drug
intervention name: Lactated Ringer's solution
description: 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
arm group label: The control group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Yanghai Cui
role: Study Chair
affiliation: China International Neuroscience Institution
facility: 
country: China
responsible party type: Sponsor