<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/NCT03800251</url>
  </required_header>
  <id_info>
    <org_study_id>8-2018</org_study_id>
    <nct_id>NCT03800251</nct_id>
  </id_info>
  <brief_title>Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section</brief_title>
  <official_title>Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coombe Women and Infants University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coombe Women and Infants 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>
      The aim of the study is to use sequential ultrasound evaluation of the gastric volume to&#xD;
      determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for&#xD;
      elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia&#xD;
      preOp).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent research suggests that attention to nutrition before operation leads to a speedier&#xD;
      recovery through moderating the metabolic responses to surgery, improving well-being,&#xD;
      decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other&#xD;
      hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current&#xD;
      fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy&#xD;
      non-pregnant adults and consensus agreement.&#xD;
&#xD;
      The aim of the study is to use sequential ultrasound evaluation of the gastric volume to&#xD;
      determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for&#xD;
      elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia&#xD;
      preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides&#xD;
      0.5kcal/ml).&#xD;
&#xD;
      Patients who are fasting according to the current guidelines and agree to partake in the&#xD;
      study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least&#xD;
      2hours before their scheduled theatre time. Patients will then have their gastric volume&#xD;
      assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested&#xD;
      fluid to leave the stomach. The results of the study will give us more information regarding&#xD;
      gastric emptying in the investigator's patient population and may lead to reduced fasting&#xD;
      times, increasing patient comfort and improving the patient experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 6, 2018</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time interval required to return to the fasting grade.</measure>
    <time_frame>2 hours</time_frame>
    <description>The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section</measure>
    <time_frame>10 minutes</time_frame>
    <description>Initial &quot;fasting&quot; scan will be performed in all patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken for the antral cross sectional area (measured by ultrasound) to reach &lt;9.6 cm2 (suggested cut off value for ingested volumes &lt; 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink</measure>
    <time_frame>2 hours</time_frame>
    <description>Sequential ultrasound scans will be performed at 15 min intervals for 2 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antral cross sectional area at 2 hours</measure>
    <time_frame>2 hours</time_frame>
    <description>Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Gastric Emptying</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Fasting parturients at term</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml</intervention_name>
    <description>Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink</description>
    <arm_group_label>Fasting parturients at term</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective LSCS&#xD;
&#xD;
          -  18yrs&#xD;
&#xD;
          -  gestation &gt;38 gestation weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Previous upper GI surgery&#xD;
&#xD;
          -  Known disorder of gastric emptying&#xD;
&#xD;
          -  Hiatus Hernia&#xD;
&#xD;
          -  BMI &gt;40&#xD;
&#xD;
          -  Diabetes Mellitus, Gestational Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Petar Popivanov</last_name>
    <phone>+353 (01) 4085662</phone>
    <email>ppopivanov@coombe.ie</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michelle Walsh</last_name>
    <phone>+353 (01) 4085662</phone>
    <email>michowalsh@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Coombe Women and Infants University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>D08XW7X</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petar Popivanov, Dr</last_name>
      <phone>+353 (01) 408 5662</phone>
      <email>ppopivanov@coombe.ie</email>
    </contact>
    <investigator>
      <last_name>Michelle Walsh, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Coombe Women and Infants University Hospital</investigator_affiliation>
    <investigator_full_name>Petar Popivanov</investigator_full_name>
    <investigator_title>Consultant Anaesthetist</investigator_title>
  </responsible_party>
  <keyword>Gastric Emptying</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Elective Cesarean section</keyword>
  <keyword>Fasting</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>At the moment there is no plan whether or not to make the IPD available to other researchers.</ipd_description>
  </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/NCT03800251
org study id: 8-2018
nct id: NCT03800251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to use sequential ultrasound evaluation of the gastric volume to
      determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for
      elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia
      preOp).
Recent research suggests that attention to nutrition before operation leads to a speedier
      recovery through moderating the metabolic responses to surgery, improving well-being,
      decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other
      hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current
      fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy
      non-pregnant adults and consensus agreement.

      The aim of the study is to use sequential ultrasound evaluation of the gastric volume to
      determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for
      elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia
      preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides
      0.5kcal/ml).

      Patients who are fasting according to the current guidelines and agree to partake in the
      study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least
      2hours before their scheduled theatre time. Patients will then have their gastric volume
      assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested
      fluid to leave the stomach. The results of the study will give us more information regarding
      gastric emptying in the investigator's patient population and may lead to reduced fasting
      times, increasing patient comfort and improving the patient experience.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach.
primary purpose: Treatment
masking: None (Open Label)
measure: Time interval required to return to the fasting grade.
time frame: 2 hours
description: The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).
measure: Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section
time frame: 10 minutes
description: Initial "fasting" scan will be performed in all patients
measure: Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink
time frame: 2 hours
description: Sequential ultrasound scans will be performed at 15 min intervals for 2 hours.
measure: Antral cross sectional area at 2 hours
time frame: 2 hours
description: Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).
arm group label: Fasting parturients at term
arm group type: Other
description: Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study
intervention type: Dietary Supplement
intervention name: Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml
description: Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink
arm group label: Fasting parturients at term
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Petar Popivanov
phone: +353 (01) 4085662
email: ppopivanov@coombe.ie
last name: Michelle Walsh
phone: +353 (01) 4085662
email: michowalsh@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Coombe Women and Infants University Hospital
investigator full name: Petar Popivanov
investigator title: Consultant Anaesthetist
sharing ipd: Undecided
ipd description: At the moment there is no plan whether or not to make the IPD available to other researchers.