Gestational Diabetes Mellitus (GDM)GDMNCT07816705
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
An observational study of Gestational Diabetes Mellitus (GDM) and Obstetric Anesthesia, run by Gaziantep City Hospital.
Trial summary
The primary objective of this study is to compare gastric volume prior to elective cesarean section between pregnant women diagnosed with gestational diabetes mellitus (GDM) and those without GDM. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
- What is being tested?
- GASTRIC ULTRASONOGRAPHY
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 1 Oct 2027
- How long will I take part?
- 1 Day
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, GESTATIONAL AGE OF 36 WEEKS OR MORE.
Who may be able to join
- Pregnant women aged 18-65 years with a singleton pregnancy. Gestational age of 36 weeks or more. ASA physical status classification of II-III. Participants will be selected from patients scheduled for elective cesarean section who have been informed about the objectives and procedures of the study and who sign the informed consent form.
Who cannot join
- Emergency cesarean section cases. Multiple pregnancies. Patients with gastrointestinal diseases, including symptomatic or treatment-requiring gastroesophageal reflux disease, peptic ulcer disease, active symptomatic gastritis, a history of diabetic gastroparesis, inflammatory bowel diseases (Crohn's disease or ulcerative colitis), or a history of gastrointestinal surgery, particularly gastric or esophageal surgery.
- Patients with systemic diseases that may affect gastric motility, including type 1 or type 2 diabetes mellitus (excluding GDM), uncontrolled hypothyroidism or hyperthyroidism, neurological diseases (e.g., Parkinson's disease, multiple sclerosis, or autonomic neuropathy), or connective tissue diseases (e.g., scleroderma).
- Patients with severe systemic comorbidities, including ASA physical status classification IV or higher, advanced cardiac disease (e.g., NYHA class III-IV heart failure), advanced respiratory system disease (e.g., severe chronic obstructive pulmonary disease or restrictive lung disease), renal failure (stage 4-5 chronic kidney disease), or hepatic failure (Child-Pugh class B-C).
- Patients using medications that may affect gastric motility, including prokinetic agents, anticholinergic drugs, or opioids.
- Patients who refuse to participate in the study or do not sign the informed consent form.
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: Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section, With And Without Gestational Diabetes Mellitus
The primary objective of this study is to compare gastric volume prior to elective cesarean section between pregnant women diagnosed with gestational diabetes mellitus (GDM) and those without GDM.
The secondary objectives are to evaluate the effect of GDM on preoperative residual gastric volume and to obtain data that could contribute to clinical anesthesia practices regarding the risk of aspiration.
This study aims to obtain objective ultrasonographic data regarding the adequacy of standard fasting periods in pregnant women, particularly in the presence of GDM.
Read the detailed description
During pregnancy, gastric emptying can be affected and the risk of aspiration may increase due to physiological hormonal changes, elevated intra-abdominal pressure, and slowed gastrointestinal motility. Although cesarean sections are often performed under regional anesthesia, they remain clinically relevant in terms of aspiration risk due to the potential need for general anesthesia (1, 2).
Gestational diabetes mellitus (GDM) is a common metabolic disorder during pregnancy that may affect autonomic nervous system function and gastrointestinal motility. While diabetic gastroparesis is well characterized in patients with type 1 and type 2 diabetes mellitus, data regarding the effect of GDM on gastric emptying dynamics remain limited (2, 3).
In recent years, gastric ultrasonography has become an increasingly utilized method in anesthesia practice, enabling the non-invasive assessment of gastric contents and volume. This technique allows for the objective evaluation of gastric contents regardless of standard fasting intervals and facilitates an individualized assessment of aspiration risk (3).
The rationale for this study is to determine the effect of GDM on preoperative gastric volume by comparing gastric volumes measured via gastric ultrasound in pregnant women scheduled for elective cesarean sections, with and without a diagnosis of GDM, thereby contributing to perioperative anesthetic risk assessment.
This study has been designed as a prospective, observational, comparative, and parallel-group clinical trial.
Patient Selection: Pregnant women to be included in the study will be selected via a consecutive sampling method (based on the order of arrival) from among patients scheduled for elective cesarean section at Gaziantep City Hospital by the Department of Anesthesiology and Reanimation and the Department of Obstetrics and Gynecology, who meet the inclusion and exclusion criteria.
Patients will be grouped solely based on the presence or absence of gestational diabetes mellitus (GDM). No selective sampling will be performed regarding age, body mass index, obstetric characteristics, surgical team, or fetal characteristics.
Patients will be divided into two groups:
Group 1: Pregnant women diagnosed with gestational diabetes mellitus (GDM)
Group 2: Pregnant women without a diagnosis of gestational diabetes mellitus (GDM)
Data regarding the patients included in the study will be obtained from patient charts, Hospital Information Management System (HIMS) records, and ultrasonographic measurements performed by the researcher during the preoperative period. All data will be prospectively recorded on a standardized case report form.
Data to be Collected:
Demographic Data: Age, body mass index (BMI), gestational age
Clinical Data: Presence of gestational diabetes mellitus (GDM), ASA physical status classification, fasting durations (separately for solids and liquids, in hours), and comorbidities
Ultrasonographic Measurements: Anteroposterior (AP) diameter of the gastric antrum, craniocaudal (CC) diameter, antral cross-sectional area (CSA), and estimated gastric volume (mL)
During the preoperative period, the gastric antrum will be assessed using an ultrasound device by an experienced anesthesia resident or anesthesiologist. The patient will be examined in both the supine and right lateral decubitus positions. The anteroposterior and craniocaudal diameters of the gastric antrum will be measured, and the antral cross-sectional area will be calculated.
For patients enrolled in the study, transabdominal gastric ultrasound will be performed twice, in two different positions, during the preoperative period. No interventions will be made regarding the planned medical treatment or surgical procedure. Only non-invasive routine medical measurements will be performed to assess the patient's current clinical status.
- Being tested
- GASTRIC ULTRASONOGRAPHY
- Keywords
- Gastricusg, GDM, GestasyonelDiabetesMellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GASTRIC ULTRASONOGRAPHYDiagnostic test
Bedside gastric ultrasound performed with a curvilinear probe in the supine and right lateral decubitus positions. The antrum is imaged in a sagittal plane at the level of the aorta; antral cross-sectional area (CSA) is measured and gastric volume is estimated using the Perlas model. Qualitative antral grading (Grade 0-2) is also recorded.
| Study group | Role | What they receive |
|---|---|---|
| GDM Group | Pregnant women with a confirmed diagnosis of gestational diabetes mellitus (per IADPSG/Carpenter-Coustan criteria) at ≥24 weeks of gestation, undergoing bedside gastric ultrasonography. Receives: Diagnostic Test: GASTRIC ULTRASONOGRAPHY | |
| Non-GDM Group | Pregnant women without gestational diabetes, matched for gestational age and fasting duration, undergoing the same gastric ultrasonography protocol Receives: Diagnostic Test: GASTRIC ULTRASONOGRAPHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Objective Of This Study Is To Compare Gastric Volume Prior To Elective Cesarean Section Between Pregnant Women Diagnosed With Gestational Diabetes Mellitus (GDM) And Those Without GDM.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- 54 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Tunç, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816705
- Sponsor's protocol ID
- KAEK-110
- Acronym
- GDM
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Calisir F, Oksuz G. Comparison of gastric volumes using ultrasound in term pregnant women with and without gestational diabetes before elective cesarean delivery: an observational cohort study. J Matern Fetal Neonatal Med. 2025 Dec;38(1):2508267. doi: 10.1080/14767058.2025.2508267. Epub 2025 May 21.
PubMed 40399137Amaral CK, Benevides ML, Benevides MM, Sampaio DL, Fontes CJF. [Ultrasound assessment of gastric antrum in term pregnant women before elective cesarean section]. Braz J Anesthesiol. 2019 May-Jun;69(3):266-271. doi: 10.1016/j.bjan.2019.03.001. Epub 2019 Apr 19.
PubMed 31006483Garg H, Podder S, Bala I, Gulati A. Comparison of fasting gastric volume using ultrasound in diabetic and non-diabetic patients in elective surgery: An observational study. Indian J Anaesth. 2020 May;64(5):391-396. doi: 10.4103/ija.IJA_796_19. Epub 2020 May 1.
PubMed 32724247
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section, With And Without Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07816705
- Acronym / sponsor ID
- GDM / KAEK-110
- Keywords
- Gastricusg, GDM, GestasyonelDiabetesMellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 14 Sep 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.
The primary objective of this study is to compare gastric volume prior to elective cesarean section between pregnant women diagnosed with gestational diabetes mellitus (GDM) and those without GDM.
The secondary objectives are to evaluate the effect of GDM on preoperative residual gastric volume and to obtain data that could contribute to clinical anesthesia practices regarding the risk of aspiration.
This study aims to obtain objective ultrasonographic data regarding the adequacy of standard fasting periods in pregnant women, particularly in the presence of GDM.
Detailed description
During pregnancy, gastric emptying can be affected and the risk of aspiration may increase due to physiological hormonal changes, elevated intra-abdominal pressure, and slowed gastrointestinal motility. Although cesarean sections are often performed under regional anesthesia, they remain clinically relevant in terms of aspiration risk due to the potential need for general anesthesia (1, 2).
Gestational diabetes mellitus (GDM) is a common metabolic disorder during pregnancy that may affect autonomic nervous system function and gastrointestinal motility. While diabetic gastroparesis is well characterized in patients with type 1 and type 2 diabetes mellitus, data regarding the effect of GDM on gastric emptying dynamics remain limited (2, 3).
In recent years, gastric ultrasonography has become an increasingly utilized method in anesthesia practice, enabling the non-invasive assessment of gastric contents and volume. This technique allows for the objective evaluation of gastric contents regardless of standard fasting intervals and facilitates an individualized assessment of aspiration risk (3).
The rationale for this study is to determine the effect of GDM on preoperative gastric volume by comparing gastric volumes measured via gastric ultrasound in pregnant women scheduled for elective cesarean sections, with and without a diagnosis of GDM, thereby contributing to perioperative anesthetic risk assessment.
This study has been designed as a prospective, observational, comparative, and parallel-group clinical trial.
Patient Selection: Pregnant women to be included in the study will be selected via a consecutive sampling method (based on the order of arrival) from among patients scheduled for elective cesarean section at Gaziantep City Hospital by the Department of Anesthesiology and Reanimation and the Department of Obstetrics and Gynecology, who meet the inclusion and exclusion criteria.
Patients will be grouped solely based on the presence or absence of gestational diabetes mellitus (GDM). No selective sampling will be performed regarding age, body mass index, obstetric characteristics, surgical team, or fetal characteristics.
Patients will be divided into two groups:
Group 1: Pregnant women diagnosed with gestational diabetes mellitus (GDM)
Group 2: Pregnant women without a diagnosis of gestational diabetes mellitus (GDM)
Data regarding the patients included in the study will be obtained from patient charts, Hospital Information Management System (HIMS) records, and ultrasonographic measurements performed by the researcher during the preoperative period. All data will be prospectively recorded on a standardized case report form.
Data to be Collected:
Demographic Data: Age, body mass index (BMI), gestational age
Clinical Data: Presence of gestational diabetes mellitus (GDM), ASA physical status classification, fasting durations (separately for solids and liquids, in hours), and comorbidities
Ultrasonographic Measurements: Anteroposterior (AP) diameter of the gastric antrum, craniocaudal (CC) diameter, antral cross-sectional area (CSA), and estimated gastric volume (mL)
During the preoperative period, the gastric antrum will be assessed using an ultrasound device by an experienced anesthesia resident or anesthesiologist. The patient will be examined in both the supine and right lateral decubitus positions. The anteroposterior and craniocaudal diameters of the gastric antrum will be measured, and the antral cross-sectional area will be calculated.
For patients enrolled in the study, transabdominal gastric ultrasound will be performed twice, in two different positions, during the preoperative period. No interventions will be made regarding the planned medical treatment or surgical procedure. Only non-invasive routine medical measurements will be performed to assess the patient's current clinical status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM Group | – | Diagnostic Test: GASTRIC ULTRASONOGRAPHYPregnant women with a confirmed diagnosis of gestational diabetes mellitus (per IADPSG/Carpenter-Coustan criteria) at ≥24 weeks of gestation, undergoing bedside gastric ultrasonography. |
| Non-GDM Group | – | Diagnostic Test: GASTRIC ULTRASONOGRAPHYPregnant women without gestational diabetes, matched for gestational age and fasting duration, undergoing the same gastric ultrasonography protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, GESTATIONAL AGE OF 36 WEEKS OR MORE.
Key inclusion criteria (1 listed)
- Pregnant women aged 18-65 years with a singleton pregnancy. Gestational age of 36 weeks or more. ASA physical status classification of II-III. Participants will be selected from patients scheduled for elective cesarean section who have been informed about the objectives and procedures of the study and who sign the informed consent form.
Key exclusion criteria (5 listed)
- Emergency cesarean section cases. Multiple pregnancies. Patients with gastrointestinal diseases, including symptomatic or treatment-requiring gastroesophageal reflux disease, peptic ulcer disease, active symptomatic gastritis, a history of diabetic gastroparesis, inflammatory bowel diseases (Crohn's disease or ulcerative colitis), or a history of gastrointestinal surgery, particularly gastric or esophageal surgery.
- Patients with systemic diseases that may affect gastric motility, including type 1 or type 2 diabetes mellitus (excluding GDM), uncontrolled hypothyroidism or hyperthyroidism, neurological diseases (e.g., Parkinson's disease, multiple sclerosis, or autonomic neuropathy), or connective tissue diseases (e.g., scleroderma).
- Patients with severe systemic comorbidities, including ASA physical status classification IV or higher, advanced cardiac disease (e.g., NYHA class III-IV heart failure), advanced respiratory system disease (e.g., severe chronic obstructive pulmonary disease or restrictive lung disease), renal failure (stage 4-5 chronic kidney disease), or hepatic failure (Child-Pugh class B-C).
- Patients using medications that may affect gastric motility, including prokinetic agents, anticholinergic drugs, or opioids.
- Patients who refuse to participate in the study or do not sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GASTRIC ULTRASONOGRAPHYBedside gastric ultrasound performed with a curvilinear probe in the supine and right lateral decubitus positions. The antrum is imaged in a sagittal plane at the level of the aorta; antral cross-sectional area (CSA) is measured and gastric volume is estimated using the Perlas model. Qualitative antral grading (Grade 0-2) is also recorded. | Diagnostic test | GDM Group, Non-GDM Group |
Primary outcome
The Primary Objective Of This Study Is To Compare Gastric Volume Prior To Elective Cesarean Section Between Pregnant Women Diagnosed With Gestational Diabetes Mellitus (GDM) And Those Without GDM.
Time frame: 1 YEAR
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 6 Nov 2026.
- Results publication: PubMed 40399137Calisir F, Oksuz G. Comparison of gastric volumes using ultrasound in term pregnant women with and without gestational diabetes before elective cesarean delivery: an observational cohort study. J Matern Fetal Neonatal Med. 2025 Dec;38(1):2508267. doi: 10.1080/14767058.2025.2508267. Epub 2025 May 21.
- Results publication: PubMed 31006483Amaral CK, Benevides ML, Benevides MM, Sampaio DL, Fontes CJF. [Ultrasound assessment of gastric antrum in term pregnant women before elective cesarean section]. Braz J Anesthesiol. 2019 May-Jun;69(3):266-271. doi: 10.1016/j.bjan.2019.03.001. Epub 2019 Apr 19.
- Results publication: PubMed 32724247Garg H, Podder S, Bala I, Gulati A. Comparison of fasting gastric volume using ultrasound in diabetic and non-diabetic patients in elective surgery: An observational study. Indian J Anaesth. 2020 May;64(5):391-396. doi: 10.4103/ija.IJA_796_19. Epub 2020 May 1.
- Individual participant dataSharing planned: Yes
Related trials for Gestational Diabetes Mellitus (GDM)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus (GDM) and Obstetric Anesthesia, run by Gaziantep City Hospital.
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 5 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 6 Nov 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 Mehmet Tunç (+90 542 373 6350, otuncoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Objective Of This Study Is To Compare Gastric Volume Prior To Elective Cesarean Section Between Pregnant Women Diagnosed With Gestational Diabetes Mellitus (GDM) And Those Without GDM. (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07816705, which also lists 3 linked publications.
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 6 Nov 2026.