Gastric UltrasoundNCT07335172
Gastric Ultrasound Before Elective Cesarean Section
An observational study of Gastric Ultrasound and Elective Cesarean Section, run by Ekin Deniz KUTLU.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gastric Ultrasound, Elective Cesarean Section, Pregnant Women
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Apr 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Healthy term pregnant women aged 18-45 years, ASA II, scheduled for elective cesarean section
Who may be able to join
- 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
Who cannot join
- Cases requiring emergency (Lucas classification based on the urgency of caesarean section, Category 1-2)
- Multiple pregnancies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Keywords
- Gastric Ultrasound, elective cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASA II term pregnant women aged 18-45 years scheduled for elective cesarean delivery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Ultrasonographic Assessment: Gastric volume
- 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.
Measured: 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.
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.
Measured: 60-90 minutes before surgery
Secondary outcomes (1)
Preoperative data
In the preoperative period; the patient's age, weight (kg), body mass index (BMI, kg/m²), and gestational age (weeks + days) will be recorded.
Measured: 60-90 minutes before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ekin Deniz KUTLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ekin Deniz KUTLU, Gazi University
- Investigators
- Ekin KUTLU, Principal investigator, Gazi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335172
- Sponsor's protocol ID
- 218
- Status last verified
- Nov 2025
- First submitted
- 5 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Gastric Ultrasound Before Elective Cesarean Section: Observational Study
- ClinicalTrials.gov ID
- NCT07335172
- Acronym / sponsor ID
- 218
- Keywords
- Gastric Ultrasound, elective cesarean section
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ekin Deniz KUTLUUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASA II term pregnant women aged 18-45 years scheduled for elective cesarean delivery | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy term pregnant women aged 18-45 years, ASA II, scheduled for elective cesarean section
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cases requiring emergency (Lucas classification based on the urgency of caesarean section, Category 1-2)
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Preoperative data
Time frame: 60-90 minutes before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ekin KUTLU principal investigator
Gazi University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ultrasound and Elective Cesarean Section, run by Ekin Deniz KUTLU.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekin KUTLU (+905389501999, ekindenizkutlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Ultrasonographic Assessment: Gastric volume (time frame: 60-90 minutes before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.