Gastric Ultrasound in Diabetic and Non-Diabetic Pregnant Women (NCT05959135) | Clinical Trial Compass
CompletedNot Applicable
Gastric Ultrasound in Diabetic and Non-Diabetic Pregnant Women
Turkey (Türkiye)80 participantsStarted 2023-07-26
Plain-language summary
Perioperative aspiration is particularly concerning in pregnant women due to anatomical changes. To mitigate this risk, pre-anesthetic fasting is recommended, with varying guidelines. Gastric ultrasound can non-invasively assess stomach contents, and mathematical models help estimate stomach volumes using the gastric antral cross-sectional area (CSA).
This study aims to compare CSA and estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for cesarean section, as diabetes may affect stomach fullness. Additionally, it will investigate the relation between demographic and clinical variables and CSA values.
This research can shed light on diabetes' influence on aspiration risk in pregnancy and evaluate fasting guidelines, underscoring the significance of gastric ultrasound.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients belonging to American Society of Anesthesiology (ASA) physical status class II-III.
* Aged between 18 and 40 years.
* Gestational age greater than 37 weeks.
* BMI\< 35 kg/m2
Exclusion Criteria:
* Patients belonging to American Society of Anesthesiology (ASA) physical status class III-IV.
* Patients under the age of 18.
* Patients taken to surgery on an emergency basis.
* Relatives of patients who do not provide consent.
* Pregnant patients with upper gastrointestinal (GI) diseases and pathologies.
* Body Mass Index (BMI) greater than 35 kg/m2.
* Patients with a history of using medications that affect gastrointestinal motility (e.g., opioids).
* Severe organ dysfunction.
* Pre-existing neurological deficits.
* Intellectual disabilities.
* Anatomical deformities.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Antral cross-sectional area (in square centimeters)
Timeframe: 2 months
2
Perlas equation for gastric volume (mL)
Timeframe: 2 months
3
Roukhomovsky equation for gastric volume (mL)
Timeframe: 2 month
Trial details
NCT IDNCT05959135
SponsorSisli Hamidiye Etfal Training and Research Hospital