<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/NCT01706341</url>
  </required_header>
  <id_info>
    <org_study_id>NCU-573</org_study_id>
    <nct_id>NCT01706341</nct_id>
  </id_info>
  <brief_title>The Effect of Administering a Small Dose of Glucose During Cesarean Section</brief_title>
  <official_title>The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nagoya City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nagoya City University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of administering a small dose of&#xD;
      glucose on the pregnant women and their neonates during cesarean section. We investigate the&#xD;
      safety and efficacy of use of a glucose-containing solution for the pregnant women and the&#xD;
      neonates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapid infusion of large amount of glucose is associated with fetal hyperglycemia,&#xD;
      hyperinsulinemia, and neonatal hypoglycemia. However, the effect of small dose of glucose is&#xD;
      unclear. We conducted a pilot study of small dose of glucose. We investigated the effect of a&#xD;
      glucose-containing fluid on the blood sugar of the umbilical artery. We found that in the&#xD;
      case of no-glucose-containing fluid, there were some cases in which umbilical arterial&#xD;
      concentration of glucose was less than 50 mg/dl, which might cause neonatal hypoglycemia. In&#xD;
      addition, in the case of 1%-glucose-containing fluid, mean umbilical arterial concentration&#xD;
      of glucose was 97 mg/dl.&#xD;
&#xD;
      The purpose of this study is to investigate the effect of administering a small dose of&#xD;
      glucose on the pregnant women and their neonates during cesarean section. We investigate the&#xD;
      safety and efficacy of use of a glucose-containing solution for the pregnant women and the&#xD;
      neonates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">October 2013</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The blood glucose concentration in the neonates at one hour of age</measure>
    <time_frame>One hour of age</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The blood glucose concentration in the neonates at two hour of age</measure>
    <time_frame>Two hour of age</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Evidence of clinical complications (especially, low glucose symptoms)</measure>
    <time_frame>Within the first 3 days after cesarean section</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>acetate Ringer's solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acetate Ringer's solution with 1% glucose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administering the acetate Ringer's solution that contains 1% glucose as an initial infusion A total infusion volume of the acetate Ringer's solution containing 1% glucose is 1500ml (containing 15g of glucose)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>administer acetate Ringer's solution</intervention_name>
    <description>During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.</description>
    <arm_group_label>acetate Ringer's solution</arm_group_label>
    <arm_group_label>acetate Ringer's solution with 1% glucose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetate Ringer's solution containing no glucose</intervention_name>
    <arm_group_label>acetate Ringer's solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetate Ringer's solution containing 1% glucose</intervention_name>
    <arm_group_label>acetate Ringer's solution with 1% glucose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cesarean section who met the criteria of the American Society of&#xD;
             Anesthesiologists physical status of 1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA physical status &gt;=3, Obesity (BMI&gt;35), Height&gt;=175cm, Weight&gt;=80Kg&#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>Yoshihito Fujita, MD. PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology, Nagoya City Universtiy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yoshihito Fujita, MD. PhD.</last_name>
    <phone>+81-52-851-5511</phone>
    <phone_ext>8281</phone_ext>
    <email>masui@med.nagoya-cu.ac.jp</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saya Yoshizawa, MD.</last_name>
    <phone>+52-851-5511</phone>
    <phone_ext>8281</phone_ext>
    <email>sayasaya2002@yahoo.co.jp</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Departiment of Anesthesiology, Nagoya City University Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>467-8601</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yoshihito Fujita, MD. PhD.</last_name>
      <phone>+81-52-851-5511</phone>
      <phone_ext>8281</phone_ext>
      <email>masui@med.nagoya-cu.ac.jp</email>
    </contact>
    <contact_backup>
      <last_name>Saya Yoshizawa, MD.</last_name>
      <phone>+52-851-5511</phone>
      <phone_ext>8281</phone_ext>
      <email>sayasaya2002@yahoo.co.jp</email>
    </contact_backup>
    <investigator>
      <last_name>Saya Yoshizawa, MD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nagoya City University</investigator_affiliation>
    <investigator_full_name>Yoshihito Fujita, MD</investigator_full_name>
    <investigator_title>Associate professor, the department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>cesarean section</keyword>
  <keyword>intravenous fluid</keyword>
  <keyword>a glucose-containing solution</keyword>
  <keyword>fetal hypoglycemia</keyword>
  <keyword>neonatal hypoglycemia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>July 11, 2018</submitted>
    <returned>October 4, 2018</returned>
  </pending_results>
  <!-- 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/NCT01706341
org study id: NCU-573
nct id: NCT01706341
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the effect of administering a small dose of
      glucose on the pregnant women and their neonates during cesarean section. We investigate the
      safety and efficacy of use of a glucose-containing solution for the pregnant women and the
      neonates.
Rapid infusion of large amount of glucose is associated with fetal hyperglycemia,
      hyperinsulinemia, and neonatal hypoglycemia. However, the effect of small dose of glucose is
      unclear. We conducted a pilot study of small dose of glucose. We investigated the effect of a
      glucose-containing fluid on the blood sugar of the umbilical artery. We found that in the
      case of no-glucose-containing fluid, there were some cases in which umbilical arterial
      concentration of glucose was less than 50 mg/dl, which might cause neonatal hypoglycemia. In
      addition, in the case of 1%-glucose-containing fluid, mean umbilical arterial concentration
      of glucose was 97 mg/dl.

      The purpose of this study is to investigate the effect of administering a small dose of
      glucose on the pregnant women and their neonates during cesarean section. We investigate the
      safety and efficacy of use of a glucose-containing solution for the pregnant women and the
      neonates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The blood glucose concentration in the neonates at one hour of age
time frame: One hour of age
measure: The blood glucose concentration in the neonates at two hour of age
time frame: Two hour of age
measure: Evidence of clinical complications (especially, low glucose symptoms)
time frame: Within the first 3 days after cesarean section
arm group label: acetate Ringer's solution
arm group type: Active Comparator
description: Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml
arm group label: acetate Ringer's solution with 1% glucose
arm group type: Active Comparator
description: Administering the acetate Ringer's solution that contains 1% glucose as an initial infusion A total infusion volume of the acetate Ringer's solution containing 1% glucose is 1500ml (containing 15g of glucose)
intervention type: Drug
intervention name: administer acetate Ringer's solution
description: During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.
arm group label: acetate Ringer's solution
arm group label: acetate Ringer's solution with 1% glucose
intervention type: Drug
intervention name: acetate Ringer's solution containing no glucose
arm group label: acetate Ringer's solution
intervention type: Drug
intervention name: acetate Ringer's solution containing 1% glucose
arm group label: acetate Ringer's solution with 1% glucose
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Yoshihito Fujita, MD. PhD.
role: Study Chair
affiliation: Department of Anesthesiology, Nagoya City Universtiy
last name: Yoshihito Fujita, MD. PhD.
phone: +81-52-851-5511
phone ext: 8281
email: masui@med.nagoya-cu.ac.jp
last name: Saya Yoshizawa, MD.
phone: +52-851-5511
phone ext: 8281
email: sayasaya2002@yahoo.co.jp
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Nagoya City University
investigator full name: Yoshihito Fujita, MD
investigator title: Associate professor, the department of Anesthesiology
mesh term: Pharmaceutical Solutions
submitted: July 11, 2018
returned: October 4, 2018