Gastric Volume and Fasting Duration in Pregnant Women (PREG-GAS)

March 31, 2026 updated by: Dr. Fırat Mavi, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Kartal, Istanbul, Turkey (Türkiye), 34865
        • Kartal Dr. Lütfi Kırdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women aged 18-45 years with term gestation (37-40 weeks), ASA physical status II-III, and body mass index below 35 kg/m² who were scheduled for elective cesarean section under spinal anesthesia at a tertiary care hospital were included in this study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
grup 1 label 6-8 Hours Fasting
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.
6-8 Hours Fasting
Pregnant women undergoing elective cesarean section with a preoperative fasting duration of 6-8 hours.
8-10 Hours Fasting
Pregnant women undergoing elective cesarean section with a preoperative fasting duration of 8-10 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
Preoperative period (before anesthesia induction)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Preoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAD-FR-42-2024

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

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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