NCT04277013

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

February 17, 2020

Last Update Submit

January 28, 2022

Conditions

Gastric UltrasoundPregnant WomenFasting ( 6H for Solid ; 2H for Clear Fluid )

Keywords

AnaesthesiaObstetricDiagnostic imagingStomachUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Qualitative assessment of gastric content

    Qualitative assessment of gastric content using "Perlas Grade

    1 day

Secondary Outcomes (2)

  • Quantitative assessment of gastric content

    1 day

  • Feasibility evaluation of gastric ultrasound

    pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 )

You may not qualify if:

  • Previous Bariatric surgery / upper gastro-intestinal surgery
  • Adult under protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Christophe DADURE, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Fanny Bauchy, MD

CONTACT

467338256f-bauchy@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 20, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

FR(1)