Gastric Ultrasound in Term Pregnants

Not Applicable

Completed

• Conditions: Diabetes; Pregnancy
• Interventions: Procedure: Gastric ultrasound

• Registration Number: NCT06493110
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Detailed Description

Food residues in the stomach of patients scheduled for surgery are a major risk factor for pulmonary aspiration, leading to significant morbidity and mortality. This risk is particularly critical in pregnant women who may require surgery without proper fasting. National guidelines recommend fasting for 6 hours for solid foods, 4 hours for breast milk, and 2 hours for clear liquids. These guidelines apply equally to adults and children. Pregnant patients scheduled for elective surgery follow the same fasting rules as non-pregnant patients.

Gastroparesis, defined as delayed gastric emptying without mechanical obstruction, affects 30-50% of diabetic (DM) patients. Ultrasound measurement of the gastric antral area can help identify whether the stomach is full in symptomatic patients. Gastric ultrasound is a valuable tool for assessing aspiration risk in pregnant women, especially during emergency surgeries, and has shown promise in fasting non-pregnant patients scheduled for elective surgery.

In this study, the investigators aimed to evaluate the gastric antrum using ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in a standard fasting state before surgery. The primary goal was qualitative assessment, with secondary objectives including quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Study Timeline

• Study Start: 2024-03-12
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-09
• Primary Completion: 2024-07-12
• Study Completion: 2024-07-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Patients with good mental status
2. Pregnant patients aged ≥18 years
3. Patients in ASA II-III group
4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
5. Term pregnant women (gestational age ≥ 36 weeks)
6. 50-120kg weight
7. 150cm height or taller
8. Written informed consent

Exclusion Criteria

1. Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
2. Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
3. Pregnant women with term labor or obstetric emergency
4. Twin pregnancy -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetic term pregnant	Gastric ultrasound	1. Patients with good mental status 2. Pregnant patients aged ≥18 years 3. Patients in ASA II-III group 4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids) 5. Term pregnant women (gestational age ≥ 36 weeks) 6. 50-120kg weight 7. 150cm height or taller 8. Have written informed consent
non-diabetic term pregnant	Gastric ultrasound	1. Patients with good mental status 2. Pregnant patients aged ≥18 years 3. Patients in ASA II-III group 4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids) 5. Term pregnant women (gestational age ≥ 36 weeks) 6. 50-120kg weight 7. 150cm height or taller 8. Have written informed consent

Primary Outcome Measures

Name	Time	Method
Gastric Antrum Quality	12 months	Qualitative evaluation of the gastric antrum using ultrasound: For the qualitative evaluation of the gastric antrum, we used a grading scale where the gastric antrum is classified as Grade 0, 1, or 2. The grading criteria are as follows: Grade 0: The stomach appears empty in both supine and right lateral decubitus positions.; Grade 1: The stomach appears empty in the supine position but shows clear fluid in the right lateral decubitus position.; Grade 2: Clear fluid is seen in the stomach in both supine and right lateral decubitus positions.

Secondary Outcome Measures

Name	Time	Method
Aspiration Risk	12 months	Number of participants with a high aspiration risk based on gastric volume.
Preoperative Anxiety Effect	12 moths	Measurement of stomach content volume related to preoperative anxiety levels.
Gastric Volume	12 months	Quantitative measurement of gastric volume in milliliters.

Trial Locations

Locations (2)

KahramanmarasSIU; 🇹🇷 Kahramanmaraş, Turkey

Kahramanmaraş Sutcu Imam University; 🇹🇷 Kahramanmaraş, Turkey