<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/NCT03776565</url>
  </required_header>
  <id_info>
    <org_study_id>2017029F</org_study_id>
    <nct_id>NCT03776565</nct_id>
  </id_info>
  <brief_title>Comparison of Antrum Surface Between Women With Operative Hysteroscopy or Planned Caesarean Section</brief_title>
  <acronym>ECHOCESAR</acronym>
  <official_title>Gastric Ultrasound Before Planned Caesarean Section or Operative Hysteroscopy : How Much Pregnancy Changes Surface of Antrum of the Stomach ? Comparative Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of&#xD;
      stomach and compare if divergence sizes can be observed between women with a operative&#xD;
      hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be&#xD;
      adapted to the population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">November 27, 2019</completion_date>
  <primary_completion_date type="Actual">November 27, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of antral surface</measure>
    <time_frame>Just before anesthesia and surgery</time_frame>
    <description>Measure of gastric antrum surface by Ultrasound on operative hysteroscopy women and planned caesarean section women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of Perlas score</measure>
    <time_frame>Before surgery</time_frame>
    <description>Perlas score (Grade 0, defined as an empty antrum in both the supine and the right lateral decubitus positions, indicates that the stomach is completely empty; grade 1, defined as visualisation of gastric fluid content in the right lateral position only, corresponds to low gastric fluid volume; grade 2, defined by visualisation of liquid contents in both supine and right lateral positions, suggests a high gastric fluid volume with increased risk for pulmonary aspiration) measure by Ultrasound on operative hysteroscopy women and planned caesarean section women.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of anxiety on gastric residue with a numeric scale</measure>
    <time_frame>Before surgery</time_frame>
    <description>Measure of anxiety with a numeric scale (0 = no anxiety, 10 = maximal anxiety)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of frequency of intraoperative inhalation</measure>
    <time_frame>During surgery</time_frame>
    <description>Comparison of proportion of inhalation between the two population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fasting on gastric residue between the two populations</measure>
    <time_frame>Before surgery</time_frame>
    <description>Comparison of antral surface with fasting as covariable</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">137</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Operative hysteroscopy</arm_group_label>
    <description>women with an operative hysteroscopy planned</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Planned caesarean section</arm_group_label>
    <description>Pregnant women with a planned caesarean section</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound of antrum of stomach</description>
    <arm_group_label>Operative hysteroscopy</arm_group_label>
    <arm_group_label>Planned caesarean section</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women comming to hospital/sites for a planned caesarean section or operative hysteroscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 40&#xD;
&#xD;
          -  Membership of a national insurance scheme&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
          -  Physical status score or American Society of Anesthesiologists (ASA) score = 1 or 2&#xD;
&#xD;
          -  Planned caesarean section or operative hysteroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to give her written consent (not speaking French), under legal protection&#xD;
&#xD;
          -  Insulin-dependant diabetes&#xD;
&#xD;
          -  Hiatus hernia&#xD;
&#xD;
          -  History of gastro-oesophageal surgery&#xD;
&#xD;
          -  Contraindication to right lateral decubitus&#xD;
&#xD;
          -  Treatments with anti-acids before ultrasounds.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Frederic Mercier, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hopital Beclere (APHP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Béclère (APHP)</name>
      <address>
        <city>Clamart</city>
        <zip>92141</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 31, 2019</last_update_submitted>
  <last_update_submitted_qc>December 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03776565
org study id: 2017029F
nct id: NCT03776565
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of
      stomach and compare if divergence sizes can be observed between women with a operative
      hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be
      adapted to the population.
observational model: Case-Control
time perspective: Prospective
measure: Measure of antral surface
time frame: Just before anesthesia and surgery
description: Measure of gastric antrum surface by Ultrasound on operative hysteroscopy women and planned caesarean section women.
measure: Measure of Perlas score
time frame: Before surgery
description: Perlas score (Grade 0, defined as an empty antrum in both the supine and the right lateral decubitus positions, indicates that the stomach is completely empty; grade 1, defined as visualisation of gastric fluid content in the right lateral position only, corresponds to low gastric fluid volume; grade 2, defined by visualisation of liquid contents in both supine and right lateral positions, suggests a high gastric fluid volume with increased risk for pulmonary aspiration) measure by Ultrasound on operative hysteroscopy women and planned caesarean section women.
measure: Assessment of anxiety on gastric residue with a numeric scale
time frame: Before surgery
description: Measure of anxiety with a numeric scale (0 = no anxiety, 10 = maximal anxiety)
measure: Assessment of frequency of intraoperative inhalation
time frame: During surgery
description: Comparison of proportion of inhalation between the two population
measure: Incidence of fasting on gastric residue between the two populations
time frame: Before surgery
description: Comparison of antral surface with fasting as covariable
arm group label: Operative hysteroscopy
description: women with an operative hysteroscopy planned
arm group label: Planned caesarean section
description: Pregnant women with a planned caesarean section
intervention type: Other
intervention name: Ultrasound
description: Ultrasound of antrum of stomach
arm group label: Operative hysteroscopy
arm group label: Planned caesarean section
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
last name: Frederic Mercier, MD PhD
role: Study Director
affiliation: Hopital Beclere (APHP)
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No