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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Primary endpoint(s) modified Show 9 more changesShow less
    • Phase changed: not specified → not applicable
    • Trial completed
    • Final enrollment: 95 participants (planned 80)
    • Interventions modified
    • Primary and study completion dates changed from estimate of Jul 2026 to Jul 29, 2026
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 73 words
    • Site details revised
  3. Enrollment increased: 70 → 80 participantsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. 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.
Trial Details
NCT Number NCT07482098
Lead Sponsor Ankara City Hospital Bilkent
Conditions
(from sponsor)		 Pregnancy, Gestational Diabetes Mellitus (GDM)
Related terms Diabetes, Gestational
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov