- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513675
Gastric Volume and Fasting Duration in Pregnant Women (PREG-GAS)
Comparison of Gastric Volume Measured by Ultrasonography According to Preoperative Fasting Duration in Pregnant Women Undergoing Elective Cesarean Section and Evaluation of Influencing Factors
This prospective observational study aimed to evaluate the effect of preoperative fasting duration on gastric volume and antral visibility in pregnant women undergoing elective cesarean section. Patients were divided into two groups according to fasting duration (6-8 hours and 8-10 hours), and preoperative gastric ultrasonography was performed to assess antral cross-sectional area and gastric volume.
Additionally, the study investigated the relationship between gastric ultrasound findings and postoperative complications such as nausea and vomiting. The influence of demographic and clinical variables, including age, body mass index, ASA score, and fetal characteristics, on gastric volume was also evaluated.
Study Overview
Status
Detailed Description
This prospective observational study was conducted to evaluate the effect of preoperative fasting duration on gastric volume and antral visibility in pregnant women undergoing elective cesarean section. A total of 90 pregnant women were included in the study and divided into two groups based on fasting duration (6-8 hours and 8-10 hours).
Preoperative gastric ultrasonography was performed in all patients to measure antral cross-sectional area and estimate gastric volume. Gastric content was also assessed using antral grading. Demographic and clinical data including age, body mass index, ASA physical status, comorbidities, and fetal characteristics were recorded.
Postoperative outcomes such as nausea, vomiting, and aspiration were evaluated and their relationship with gastric ultrasound findings was analyzed. Additionally, factors affecting gastric volume were assessed using statistical models.
The results of this study may contribute to improved perioperative risk stratification and individualized assessment of aspiration risk in obstetric anesthesia, and may help optimize preoperative fasting protocols.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul
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Kartal, Istanbul, Turkey (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women aged 18-45 years Gestational age between 37-40 weeks Scheduled for elective cesarean section ASA physical status II-III Body mass index (BMI) < 35 kg/m² Undergoing spinal anesthesia
Exclusion Criteria:
- BMI ≥ 35 kg/m² Emergency cesarean section Known gastrointestinal disease (e.g., gastroesophageal reflux disease) Use of medications affecting gastric motility History of gastric surgery Presence of infiltrative diseases (e.g., scleroderma, amyloidosis) Use of antiemetic drugs within 24 hours before surgery Severe hypertension during pregnancy (systolic >160 mmHg or diastolic >110 mmHg) Multiple pregnancy Patients who refused to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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grup 1 label 6-8 Hours Fasting
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grup 1 label 6-8 Hours Fasting. grup 2 label8-10 Hours Fasting
Grup 1: Pregnant women undergoing elective cesarean section with a preoperative fasting duration of 6-8 hours. Grup 2: Pregnant women undergoing elective cesarean section with a preoperative fasting duration of 8-10 hours. |
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6-8 Hours Fasting
Pregnant women undergoing elective cesarean section with a preoperative fasting duration of 6-8 hours.
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8-10 Hours Fasting
Pregnant women undergoing elective cesarean section with a preoperative fasting duration of 8-10 hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric Volume Measured by Ultrasonography
Time Frame: Preoperative period (before anesthesia induction)
|
Preoperative gastric volume measured using gastric ultrasonography in pregnant women undergoing elective cesarean section, and comparison between different fasting duration groups (6-8 hours vs 8-10 hours).
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Preoperative period (before anesthesia induction)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antral Cross-Sectional Area
Time Frame: Preoperative period
|
Measurement of gastric antral cross-sectional area using ultrasonography and comparison between fasting duration groups.
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Preoperative period
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAD-FR-42-2024
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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