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NCT Number: NCT06803225

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Qualitative assessment of the antrum of the stomach

    Time frame: 10 min

    Patients 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 outcomes

  1. Quantitative assessment of the antrum of the stomach

    Time frame: 10 min

    Three consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).

Study contacts

Contact information is provided by the study sponsor or research team.

Maxim Glebov Dr Maxim Glebov, MD

CONTACT

[email protected]

+972585893324

Sponsors and collaborators

Lead sponsor

The Chaim Sheba Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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