PregnancyPREG-GASNCT07513675
Gastric Volume and Fasting Duration in Pregnant Women
An observational study of Pregnancy and Ceserean Section, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Ceserean Section, Gastric Volume
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital
Kartal, Istanbul, 34865
About this study
Official title: 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.
Read the 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.
- Keywords
- gastric ultrasound, fasting duration, gastric volume, antral cross-sectional area, aspiration risk, obstetric anesthesia, Cesarean section
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
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 |
|---|---|---|
| grup 1 label 6-8 Hours Fasting | Not described | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Gastric Volume Measured by Ultrasonography
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).
Measured: Preoperative period (before anesthesia induction)
Secondary outcomes (1)
Antral Cross-Sectional Area
Measurement of gastric antral cross-sectional area using ultrasonography and comparison between fasting duration groups.
Measured: Preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Fırat Mavi, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513675
- Sponsor's protocol ID
- KAD-FR-42-2024
- Acronym
- PREG-GAS
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Volume Measured by Ultrasonography According to Preoperative Fasting Duration in Pregnant Women Undergoing Elective Cesarean Section and Evaluation of Influencing Factors
- ClinicalTrials.gov ID
- NCT07513675
- Acronym / sponsor ID
- PREG-GAS / KAD-FR-42-2024
- Keywords
- gastric ultrasound, fasting duration, gastric volume, antral cross-sectional area, aspiration risk, obstetric anesthesia, Cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Apr 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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
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).
1 secondary outcome
Antral Cross-Sectional Area
Time frame: Preoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Ceserean Section, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Volume Measured by Ultrasonography (time frame: Preoperative period (before anesthesia induction)). 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 7 Apr 2026.