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NCT Number: NCT07482098

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

İrem Dinçer, MD

CONTACT

[email protected]

+905333641512

About this study

Pulmonary aspiration of gastric contents is one of the most feared complications of obstetric anesthesia and may lead to severe morbidity and mortality. Pregnancy is associated with physiological changes such as delayed gastric emptying, increased intra-abdominal pressure, and gastroesophageal reflux, all of which may increase the risk of aspiration during anesthesia. Diabetes mellitus may further affect gastric motility due to autonomic neuropathy, potentially leading to gastroparesis and increased gastric residual volume.

Preoperative fasting guidelines from major anesthesia societies recommend that patients may consume 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 controversial.

This single-center prospective observational study will be conducted in pregnant women scheduled for elective cesarean delivery. A total of 70 participants will be included and divided into two groups: diabetic pregnant women and non-diabetic pregnant women. All participants will receive 200 ml of water two hours before surgery according to standard fasting guidelines.

Gastric ultrasonography will be performed before fluid intake and two hours after fluid intake. The gastric antrum will be identified using anatomical landmarks including the left lobe of the liver, pancreas, aorta, and inferior vena cava. Measurements will be obtained in both the semi-recumbent and right lateral decubitus positions.

The gastric antral cross-sectional area will be calculated using the formula:

CSA = (D1 × D2 × π) / 4.

Gastric volume will be estimated using the Roukhomovsky equation. In addition to quantitative measurements, qualitative assessment of gastric contents will be performed using the Perlas grading system.

The primary objective of the study is to compare gastric volume between diabetic and non-diabetic pregnant women after preoperative clear fluid intake. Secondary objectives include qualitative evaluation of gastric contents and assessment of aspiration risk defined as gastric volume greater than 1.5 ml/kg.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gastric Volume Measured by Ultrasonography

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

    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.

Secondary outcomes

  1. Qualitative Assessment of Gastric Contents

    Time frame: Before oral clear fluid intake and two hours after fluid intake

    Gastric contents will be qualitatively assessed using the Perlas grading system (Grade 0-2) in both supine and right lateral decubitus positions.

  2. Aspiration Risk Based on Gastric Volume

    Time frame: Two hours after oral clear fluid intake before anesthesia

    Aspiration risk will be assessed using the threshold of gastric volume greater than 1.5 ml/kg.

Study contacts

Contact information is provided by the study sponsor or research team.

İrem Dinçer, MD

CONTACT

[email protected]

+905333641512

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effect of Preoperative Clear Fluid Intake on Gastric Volume in Diabetic and Non-Diabetic Pregnant Women Assessed by Gastric Ultrasonography

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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