An observational study in Pregnancy and Respiratory Aspiration of Gastric Content, sponsored by The Chaim Sheba Medical Center. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by The Chaim Sheba Medical Center · Observational
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).
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.
27 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 11 observational studies indexed under Respiratory Aspiration of Gastric Contents.
Browse Respiratory Aspiration of Gastric Contents studies →The Chaim Sheba Medical Center is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fasted (6h solids, 2h fluids) high-risk pregnant women at 3rd trimester
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer
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.
Time frame: 10 min
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).
Time frame: 10 min
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Mar 2025; primary completion for Aug 2025, 5 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Respiratory Aspiration of Gastric Contents →
The Chaim Sheba Medical Center