Gastric Ultrasound After Clear Fluid Intake in Diabetic and Non-Diabetic Pregnant Women
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 95 people enrolled
- Started
- 1 Dec 2025
- Ended
- 29 Jul 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Oral water intake
- Record updated
- 15 October 2026
Who can take part
- Age
- 18 years to 40 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Pregnant women aged 18-40 years
- Scheduled for elective cesarean delivery
- ASA physical status II or III
- Patients who provide written informed consent
- Singleton pregnancy
- No contraindication to regional anesthesia
- Compliance with standard preoperative fasting requirements
Who cannot take part
- Previously diagnosed diabetic gastroparesis
- Pregestational diabetes mellitus (type 1 or type 2)
- History of upper gastrointestinal disease or gastroesophageal reflux disease
- History of esophageal, gastric, or upper abdominal surgery
- Pre-existing neurological disease
- Infection at the spinal puncture site
- Active labor
- Refusal to participate in the study
- Contraindication to regional anesthesia
- Anatomical abnormalities of the upper gastrointestinal tract
- ASA physical status IV or higher
- Inability to adequately visualize the gastric antrum by ultrasonography
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Pulmonary aspiration of gastric contents during anesthesia is a serious perioperative complication associated with significant morbidity and mortality. Pregnant women are at increased risk of aspiration because of physiological changes such as delayed gastric emptying and increased intra-abdominal pressure. In addition, gestational diabetes mellitus (GDM) may affect gastric motility and gastric emptying.
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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 pregnant women with GDM remains unclear.
This prospective interventional study compares gastric volume measured by gastric ultrasonography in term pregnant women with and without gestational diabetes mellitus (GDM) undergoing elective cesarean delivery. Participants receive 200 mL of oral water after baseline gastric ultrasonography. Gastric ultrasonography is performed before water intake (T1), immediately after completion of water intake (T2), and two hours after water intake immediately before anesthesia (T3) to evaluate gastric volume and gastric content.
The study aims to improve the assessment of gastric volume and perioperative fasting in pregnant women, particularly those with gestational diabetes mellitus.
The 2 groups in the trial
- Gestational Diabetes Mellitus (GDM) GroupTreatment being tested
Term pregnant women with gestational diabetes mellitus managed with diet or insulin during pregnancy. Participants receive 200 mL of oral water after baseline gastric ultrasonography and undergo gastric ultrasonography at three predefined time points: before water intake (T1), immediately after water intake (T2), and 2 hours after water intake (T3).
Treatment: Oral water intake
- Control GroupTreatment being tested
Term pregnant women without gestational diabetes mellitus. Participants receive 200 mL of oral water after baseline gastric ultrasonography and undergo gastric ultrasonography at three predefined time points: before water intake (T1), immediately after water intake (T2), and 2 hours after water intake (T3).
Treatment: Oral water intake
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Preoperative Clear Fluid Intake on Gastric Volume in Diabetic and Non-Diabetic Pregnant Women Assessed by Gastric Ultrasonography
- Record updated
- 15 October 2026