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PregnancyNCT06803225

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

An observational study of Pregnancy and Respiratory Aspiration of Gastric Content, run by The Chaim Sheba Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer
How many people
500 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 1 Nov 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Fasted (6h solids, 2h fluids) high-risk pregnant women at 3rd trimester

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Maxim Glebov Dr Maxim Glebov, MD contact

+972585893324

hlebau@gmail.com

About this study

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

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).

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Qualitative assessment of the antrum of the stomach

    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.

    Measured: 10 min

Secondary outcomes (1)

  1. Quantitative assessment of the antrum of the stomach

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

    Measured: 10 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803225
Sponsor's protocol ID
1346-24-SMC
Status last verified
Dec 2024
First submitted
27 Jan 2025
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to share individual participant data due to a specific request from our institution, which prioritises maintaining the confidentiality and privacy of patient information. The hospital's data-sharing policies and regulatory constraints are designed to safeguard sensitive health data and prevent potential risks of participant re-identification, even after anonymisation.

Publications

  • Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.

    PubMed 26580836

  • Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.

    PubMed 29230709

  • Roukhomovsky M, Zieleskiewicz L, Diaz A, Guibaud L, Chaumoitre K, Desgranges FP, Leone M, Chassard D, Bouvet L; AzuRea, CAR'Echo Collaborative Networks. Ultrasound examination of the antrum to predict gastric content volume in the third trimester of pregnancy as assessed by MRI: A prospective cohort study. Eur J Anaesthesiol. 2018 May;35(5):379-389. doi: 10.1097/EJA.0000000000000749.

    PubMed 29210844

  • Zieleskiewicz L, Bouvet L, Einav S, Duclos G, Leone M. Diagnostic point-of-care ultrasound: applications in obstetric anaesthetic management. Anaesthesia. 2018 Oct;73(10):1265-1279. doi: 10.1111/anae.14354. Epub 2018 Jul 26.

    PubMed 30047997

  • Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

    PubMed 29624530

  • Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

    PubMed 21712716

  • Dean G, Jacobs AR, Goldstein RC, Gevirtz CM, Paul ME. The safety of deep sedation without intubation for abortion in the outpatient setting. J Clin Anesth. 2011 Sep;23(6):437-42. doi: 10.1016/j.jclinane.2011.05.001. Epub 2011 Aug 9.

    PubMed 21831622

  • D'Angelo R, Smiley RM, Riley ET, Segal S. Serious complications related to obstetric anesthesia: the serious complication repository project of the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2014 Jun;120(6):1505-12. doi: 10.1097/ALN.0000000000000253.

    PubMed 24845921

  • Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.

    PubMed 16563326

  • MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.

    PubMed 20993766

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Respiratory Aspiration of Gastric Content, run by The Chaim Sheba Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maxim Glebov Dr Maxim Glebov, MD (+972585893324, hlebau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative assessment of the antrum of the stomach (time frame: 10 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803225, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.

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