Gastric Ultrasound in Term Pregnants
Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kahramanmaraş, Turkey, 46100
- Kahramanmaras Sutcu Imam University
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Kahramanmaraş, Turkey, 46100
- KahramanmarasSIU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- Written informed consent
Exclusion Criteria:
- Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
- Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
- Pregnant women with term labor or obstetric emergency
- Twin pregnancy -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
diabetic term pregnant
|
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
|
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
Time Frame: 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. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric Volume
Time Frame: 12 months
|
Quantitative measurement of gastric volume in milliliters.
|
12 months
|
|
Aspiration Risk
Time Frame: 12 months
|
Number of participants with a high aspiration risk based on gastric volume.
|
12 months
|
|
Preoperative Anxiety Effect
Time Frame: 12 moths
|
Measurement of stomach content volume related to preoperative anxiety levels.
|
12 moths
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/26-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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