RecruitingNot Applicable

Gastric Ultrasound After Clear Fluid Intake in Diabetic and Non-Diabetic Pregnant Women

Turkey (Türkiye)80 participantsStarted 2025-12-01

Plain-language summary

Pulmonary aspiration of gastric contents during anesthesia is a serious perioperative complication associated with significant morbidity and mortality. Pregnant patients are at increased risk of aspiration due to physiological changes such as delayed gastric emptying and increased intra-abdominal pressure. In addition, diabetes may impair gastric motility because of autonomic neuropathy, potentially leading to gastroparesis and increased gastric residual volume. Current fasting guidelines allow the intake of clear fluids up to two hours before anesthesia. However, the effect of preoperative oral clear fluid intake on gastric volume in diabetic pregnant patients remains unclear. This prospective observational study aims to compare gastric volume measured by gastric ultrasonography in diabetic and non-diabetic pregnant women undergoing elective cesarean delivery. All participants will receive 200 ml of water two hours before surgery. Gastric ultrasonography will be performed before fluid intake and two hours after intake to evaluate gastric volume and gastric content. The results of this study may help improve the assessment of aspiration risk and guide perioperative fasting recommendations in pregnant patients, particularly those with diabetes.

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: * Pregnant women aged 18-40 years * Scheduled for elective cesarean section under spinal anesthesia * Singleton pregnancy * ASA physical status II * Patients who provide written informed consent Exclusion Criteria: * Refusal to participate in the study * Contraindication to spinal anesthesia * Known allergy to study medications * Multiple pregnancy * Severe systemic disease (ASA III or higher) * Pre-existing neurological disease * Infection at the spinal puncture site

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

Gastric Volume Measured by Ultrasonography

Timeframe: Before oral clear fluid intake and two hours after fluid intake before anesthesia

Trial details

NCT IDNCT07482098

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

İrem Dinçer, MD

+905333641512 iremdincer97@gmail.com

View on ClinicalTrials.gov More Pregnancy trials