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

NCT07482098 | Recruiting

• 1 other identifier: IDGASTRICUSG2025
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Diabetes in Pregnancy; Pulmonary Aspiration

Keywords

Gastric Ultrasound; Cesarean Delivery; Preoperative Fasting; Gastric Volume; Aspiration Risk; Pregnant Women

Outcome Measures

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.

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

Secondary Outcomes (2)

• Qualitative Assessment of Gastric Contents

  Before oral clear fluid intake and two hours after fluid intake

• Aspiration Risk Based on Gastric Volume

  Two hours after oral clear fluid intake before anesthesia

Study Arms (2)

Diabetic Pregnant Women

Pregnant women with diet-controlled diabetes undergoing elective cesarean delivery. Participants will receive 200 ml of water two hours before surgery and gastric ultrasonography will be performed before and after fluid intake.

Non-Diabetic Pregnant Women

Pregnant women without diabetes undergoing elective cesarean delivery. Participants will receive 200 ml of water two hours before surgery and gastric ultrasonography will be performed before and after fluid intake.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

İrem Dinçer, MD

CONTACT

+905333641512; iremdincer97@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor MD

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)