Ultrasound Assessment of Gastric Content in Fasted Pregnant Women (ECHOmater)

January 28, 2022 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The Investigator would like to perform an ultrasound assessment of gastric content to every fasted pregnant women before surgery or during ultrasound exam happening during standard pregnancy monitoring.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative assessment of gastric content
Time Frame: 1 day
Qualitative assessment of gastric content using "Perlas Grade
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative assessment of gastric content
Time Frame: 1 day
Quantitative assessment of gastric content by measuring antral area
1 day
Feasibility evaluation of gastric ultrasound
Time Frame: pregnancy
Feasibility evaluation of gastric ultrasound during pregnancy
pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

May 1, 2024

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL19_0560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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