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NCT04277013 Clinical Trial

Ultrasound Assessment of Gastric Content in Fasted Pregnant Women

Pregnant Women Clinical Trial

— ECHOmater  

Official title:
Ultrasound Assessment of Gastric Content in Fasted Pregnant Women : a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04277013
Other study ID # RECHMPL19_0560
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 1, 2024

Study information
Verified date January 2022
Source University Hospital, Montpellier
Contact Fanny Bauchy, MD
Phone 467338256
Email f-bauchy@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date May 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative assessment of gastric content Qualitative assessment of gastric content using "Perlas Grade 1 day
Secondary Quantitative assessment of gastric content Quantitative assessment of gastric content by measuring antral area 1 day
Secondary Feasibility evaluation of gastric ultrasound Feasibility evaluation of gastric ultrasound during pregnancy pregnancy
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