Gastric Ultrasound After Clear Fluid Intake in Diabetic and Non-Diabetic Pregnant Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorAnkara City Hospital Bilkent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women aged 18-40 years
Scheduled for elective cesarean section under spinal anesthesia
Singleton pregnancy
ASA physical status II
Disqualifiers
Refusal to participate in the study
Contraindication to spinal anesthesia
Known allergy to study medications
Multiple pregnancy
Trial population
Pregnant women aged 18-40 years undergoing elective cesarean section under spinal anesthesia at a tertiary care hospital. The study includes both diabetic and non-diabetic pregnant women who meet the eligibility criteria and provide informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Diabetic Pregnant Women
Group B: Non-Diabetic Pregnant Women
Trial outcomes
Primary outcomes
1
Gastric Volume Measured by Ultrasonography
Gastric antral cross-sectional area will be measured using gastric ultrasonography and gastric volume will be calculated using the Roukhomovsky formula. Gastric volume will be compared between diabetic and non-diabetic pregnant women undergoing elective cesarean delivery.
Time frame
Before oral clear fluid intake and two hours after fluid intake before anesthesiaSecondary outcomes
1
Qualitative Assessment of Gastric Contents
Gastric contents will be qualitatively assessed using the Perlas grading system (Grade 0-2) in both supine and right lateral decubitus positions.
Time frame
Before oral clear fluid intake and two hours after fluid intake2
Aspiration Risk Based on Gastric Volume
Aspiration risk will be assessed using the threshold of gastric volume greater than 1.5 ml/kg.
Time frame
Two hours after oral clear fluid intake before anesthesiaSponsors and contacts
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Source ClinicalTrials.gov