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Ultrasound Assessment of Gastric Volume in High-Risk Pregnant Women At Term

ULTRASOUND ASSESSMENT of GASTRIC CONTENT in FASTED PREGNANT WOMEN: PROSPECTIVE OBSERVATIONAL STUDY

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06803225
Enrollment
500
Registered
2025-01-31
Start date
2025-03-01
Completion date
2025-11-01
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Respiratory Aspiration of Gastric Content

Brief summary

The risk of pulmonary aspiration of gastric contents remains a significant risk during anesthesia, especially in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This prospective observational study aimed to (1) qualitatively and quantitatively describe the sonographic appearance of the gastric antrum in fasted high-risk pregnant women during the third trimester and (2) evaluate the relationship between demographic and clinical variables and the gastric antral cross-sectional area (CSA).

Detailed description

The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted high-risk pregnant women in the 3rd trimester. The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.

Interventions

DIAGNOSTIC_TESTTwo-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer

Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer

Sponsors

The Chaim Sheba Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Non-labouring pregnant women at 3rd trimester (≥ 28 weeks) 2. 18 years or older. 3. ASA physical status I-III 4. Hospitilized in High Risk Pregnancy Department 5. Ability to understand the rationale of the study assessments and provide signed informed consent. 6. Written informed consent

Exclusion criteria

1. Patients with American Society of Anesthesiology (ASA) physical status class IV. 2. Patient age \< 18 years 3. Pregnant patients with upper gastrointestinal (GI) disease and pathology. 4. History of upper GI tract surgical procedures. 5. History of medications that affect gastrointestinal motility. 6. Inability to understand the rationale of the study assessments and provide signed informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Qualitative assessment of the antrum of the stomach10 minPatients will be classified as follows; Grade 0: the antrum appears empty on both supine and right lateral decubitus positions; grade 1: gastric fluid is visible on the right lateral decubitus position only, suggesting a small fluid volume; and grade 2: gastric fluid is observed in the antrum in both supine and right lateral decubitus, suggesting a larger fluid volume.

Secondary

MeasureTime frameDescription
Quantitative assessment of the antrum of the stomach10 minThree consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).

Contacts

Primary ContactMaxim Glebov Dr Maxim Glebov, MD
hlebau@gmail.com+972585893324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026