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ECHOmater: Ultrasound Assessment of Gastric Content in Fasted Pregnant Women

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04277013
Collaborator
(none)
1,200
Enrollment
1
Location
50
Anticipated Duration (Months)
24
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode.

The main objective is evaluating prevalency of "full stomach" in differents stages of pregnancy in fasted pregnant women.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Subjects will be recruited at Montpellier University Hospital, from fasted pregnant women before surgery or from ultrasound exam performed during pregnancy.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ultrasound Assessment of Gastric Content in Fasted Pregnant Women : a Prospective Study
    Actual Study Start Date :
    Mar 1, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Qualitative assessment of gastric content [1 day]

      Qualitative assessment of gastric content using "Perlas Grade

    Secondary Outcome Measures

    1. Quantitative assessment of gastric content [1 day]

      Quantitative assessment of gastric content by measuring antral area

    2. Feasibility evaluation of gastric ultrasound [pregnancy]

      Feasibility evaluation of gastric ultrasound during pregnancy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    Inclusion criteria

    An subject must fulfill all of the following criteria in order to be eligible for study enrollment:

    • Aged at least 18 years old

    • Pregnant women

    • Fasted ( at least 6h for solid , 2h for clear fluid )

    Exclusion criteria

    • Previous Bariatric surgery / upper gastro-intestinal surgery

    • Adult under protection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Christophe DADURE, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04277013
    Other Study ID Numbers:
    • RECHMPL19_0560
    First Posted:
    Feb 20, 2020
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Anaesthesia
    Obstetric
    Diagnostic imaging
    Stomach
    Ultrasonography

    Study Results

    No Results Posted as of Jan 31, 2022