<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/NCT03280706</url>
  </required_header>
  <id_info>
    <org_study_id>tcc-anele-2017</org_study_id>
    <nct_id>NCT03280706</nct_id>
  </id_info>
  <brief_title>Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial</brief_title>
  <acronym>GEMCO</acronym>
  <official_title>Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brasilia University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brasilia 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>
      This study evaluates the gastric emptying of pregnant woman at term who received one of the&#xD;
      three solutions: maltodextrin, orange juice or coffee with milk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed&#xD;
      envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral&#xD;
      area in right lateral decubiti. All solutions will have the same volume and total of&#xD;
      calories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2017</start_date>
  <completion_date type="Actual">February 2, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator and outcomes assessor will not know to which group each woman was allocated</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Gastric antral area</measure>
    <time_frame>baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.</time_frame>
    <description>Change from Baseline Gastric antral area measured by ultrasound</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Gastric Emptying</condition>
  <condition>Pregnancy Vomits</condition>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange Juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of orange juice, 200kcal, 2,82g of protein, 0,67g of fat, 47,08g of carbohydrate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coffee with milk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of coffee with milk, 200kcal, 10,6g of protein, 10,73g of fat, 14,9g of carbohydrate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Maltodextrin 50g in water 500ml</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Orange Juice</intervention_name>
    <description>Orange juice 480ml + 20ml of water</description>
    <arm_group_label>Orange Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Coffee with milk</intervention_name>
    <description>Coffee with milk (330 ml of milk + 220 of water)</description>
    <arm_group_label>Coffee with milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy at term&#xD;
&#xD;
          -  Fasted with an emptying stomach (assessed by ultrasound)&#xD;
&#xD;
          -  During Labor&#xD;
&#xD;
          -  No diabetes, esophageal disease, obesity&#xD;
&#xD;
          -  Not emergency&#xD;
&#xD;
          -  High risk of need of general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vomiting before the end of the protocol&#xD;
&#xD;
          -  Did not drink the whole solutions&#xD;
&#xD;
          -  Ultrasound not performed for any reason&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel MN Guimaraes, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario de Brasilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Brasilia University</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>7000000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.anestesiologiaunb.com.br</url>
    <description>Our website</description>
  </link>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brasilia University Hospital</investigator_affiliation>
    <investigator_full_name>Gabriel Magalhaes Nunes Guimaraes</investigator_full_name>
    <investigator_title>Head of anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Gastric Emptying</keyword>
  <keyword>labor</keyword>
  <keyword>maltodextrin</keyword>
  <keyword>orange juice</keyword>
  <keyword>coffee</keyword>
  <keyword>ultrasound</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will make it available in our website</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>6 months after the end of the study</ipd_time_frame>
    <ipd_access_criteria>Open access</ipd_access_criteria>
    <ipd_url>http://www.anestesiologiaunb.com.br</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>February 26, 2020</submitted>
    <returned>March 10, 2020</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/NCT03280706
org study id: tcc-anele-2017
nct id: NCT03280706
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the gastric emptying of pregnant woman at term who received one of the
      three solutions: maltodextrin, orange juice or coffee with milk.
Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed
      envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral
      area in right lateral decubiti. All solutions will have the same volume and total of
      calories.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator and outcomes assessor will not know to which group each woman was allocated
measure: Change from Baseline Gastric antral area
time frame: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.
description: Change from Baseline Gastric antral area measured by ultrasound
arm group label: Maltodextrin
arm group type: Experimental
description: Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.
arm group label: Orange Juice
arm group type: Active Comparator
description: Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of orange juice, 200kcal, 2,82g of protein, 0,67g of fat, 47,08g of carbohydrate.
arm group label: Coffee with milk
arm group type: Active Comparator
description: Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of coffee with milk, 200kcal, 10,6g of protein, 10,73g of fat, 14,9g of carbohydrate.
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: Maltodextrin 50g in water 500ml
arm group label: Maltodextrin
intervention type: Dietary Supplement
intervention name: Orange Juice
description: Orange juice 480ml + 20ml of water
arm group label: Orange Juice
intervention type: Dietary Supplement
intervention name: Coffee with milk
description: Coffee with milk (330 ml of milk + 220 of water)
arm group label: Coffee with milk
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Gabriel MN Guimaraes, MsC
role: Study Chair
affiliation: Hospital Universitario de Brasilia
facility: 
country: Brazil
url: http://www.anestesiologiaunb.com.br
description: Our website
responsible party type: Principal Investigator
investigator affiliation: Brasilia University Hospital
investigator full name: Gabriel Magalhaes Nunes Guimaraes
investigator title: Head of anesthesiology
sharing ipd: Yes
ipd description: Will make it available in our website
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 6 months after the end of the study
ipd access criteria: Open access
ipd url: http://www.anestesiologiaunb.com.br
submitted: February 26, 2020
returned: March 10, 2020