Gastric Ultrasound Before Elective Cesarean Section

January 5, 2026 updated by: Ekin Deniz KUTLU

Bedside Gastric Ultrasound Before Elective Cesarean Section: Observational Study

Due to the physiologically delayed gastric emptying in pregnant women, the potential risk of aspiration before cesarean delivery constitutes an important source of perioperative complications, and when it occurs, it is associated with increased maternal morbidity and/or mortality. Systematic reviews and meta-analyses have demonstrated that, compared with non-pregnant women, gastric emptying is delayed particularly during the first trimester of pregnancy, and that gastric emptying does not occur in cases who have consumed solid food within the last 8 hours and in whom labor has begun.

This study aims to evaluate preoperative gastric volumes by ultrasonography in ASA II pregnant women (according to the American Society of Anesthesiologists classification, healthy parturients without complications) scheduled to undergo elective cesarean delivery under general or spinal anesthesia, based on different fasting durations for solid and liquid intake, with the type of liquid.

Although previous research in pregnant populations has predominantly focused on the importance of gastric ultrasonography in the presence of gestational diabetes mellitus, this thesis study aims to generate data from the general population. The findings are expected to enable individualized preventive measures to reduce aspiration-related complications during cesarean deliveries performed under general or spinal anesthesia, thereby contributing to patient safety.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

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

Study Contact

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Healthy term pregnant women aged 18-45 years, ASA II, scheduled for elective cesarean section

Description

Inclusion Criteria:

  • Aged 18-45 years
  • Term pregnant women classified as ASA II scheduled for elective cesarean section
  • Those who voluntarily agree to participate in the study

Exclusion Criteria:

  • Cases requiring emergency (Lucas classification based on the urgency of caesarean section, Category 1-2)
  • Multiple pregnancies

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
ASA II term pregnant women aged 18-45 years scheduled for elective cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstetric Ultrasonographic Assessment: Gastric volume
Time Frame: 60-90 minutes before surgery

1. Obstetric Ultrasonographic Assessment: Gastric Volume

Gastric volume will be calculated by ultrasonography (with two mathematical models from the literature) before elective cesarean delivery and recorded in milliliters.
60-90 minutes before surgery
Time of last solid food / liquid intake The time of the last solid food and liquid intake by the pregnant women will be recorded in hours. Liquid type will be also recorded.
Time Frame: 60-90 minutes before surgery
The time of the last solid food and liquid intake by the pregnant women will be recorded in hours. Liquid type will be also recorded.
60-90 minutes before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative data
Time Frame: 60-90 minutes before surgery
In the preoperative period; the patient's age, weight (kg), body mass index (BMI, kg/m²), and gestational age (weeks + days) will be recorded.
60-90 minutes before surgery

Collaborators and Investigators

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

Sponsor

Ekin Deniz KUTLU

Investigators

  • Principal Investigator: Ekin KUTLU, Gazi University 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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 218

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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