Gastric Ultrasound in Term Pregnants

Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Pregnancy
• Intervention / Treatment: Procedure: Gastric ultrasound

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 Type: Observational
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaraş, Turkey, 46100
    • Kahramanmaras Sutcu Imam University
  • Kahramanmaraş, Turkey, 46100
    • KahramanmarasSIU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This cohort comprised 30 diabetic and 30 non-diabetic individuals. The included participants were mentally healthy, aged 18 and above, classified as ASA II-III according to the American Society of Anesthesiologists, and had a gestational age of 36 weeks or more.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diabetic term pregnant; Patients with good mental status; Pregnant patients aged ≥18 years; Patients in ASA II-III group; Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids); Term pregnant women (gestational age ≥ 36 weeks); 50-120kg weight; 150cm height or taller; Have written informed consent	Procedure: Gastric ultrasound; To compare gastric volumes in standard fasting state before surgery in diabetic and non-diabetic pregnant women by evaluating the gastric antrum with ultrasound.
non-diabetic term pregnant; Patients with good mental status; Pregnant patients aged ≥18 years; Patients in ASA II-III group; Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids); Term pregnant women (gestational age ≥ 36 weeks); 50-120kg weight; 150cm height or taller; Have written informed consent	Procedure: Gastric ultrasound; To compare gastric volumes in standard fasting state before surgery in diabetic and non-diabetic pregnant women by evaluating the gastric antrum with ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Antrum Quality	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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Gastric ultrasound; Preoperative fasting; Term pregnant
• Other Study ID Numbers: 2022/26-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No