An observational study in Gestational Diabetes Mellitus (GDM) and Obstetric Anesthesia, sponsored by Gaziantep City Hospital. Not yet recruiting. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Gaziantep City Hospital · Observational
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.
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 54 is below the median of 180 across 289 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Gaziantep City Hospital is the lead sponsor of 21 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 6, 2026. See what changed
PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, GESTATIONAL AGE OF 36 WEEKS OR MORE.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women aged 18-65 years with a singleton pregnancy. Gestational age of 36 weeks or more. 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 form.
Exclusion Criteria:
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 classification IV or higher, advanced cardiac disease (e.g., class III-IV heart failure), advanced respiratory system disease (e.g., severe or restrictive lung disease), renal failure (stage 4-5 chronic kidney disease), or hepatic failure ( 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 form.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with a confirmed diagnosis of gestational diabetes mellitus (per IADPSG/Carpenter-Coustan criteria) at ≥24 weeks of gestation, undergoing bedside gastric ultrasonography.
Diagnostic Test: GASTRIC ULTRASONOGRAPHY
Pregnant women without gestational diabetes, matched for gestational age and fasting duration, undergoing the same gastric ultrasonography protocol
Diagnostic Test: GASTRIC ULTRASONOGRAPHY
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.
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
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Start is estimated for Nov 2026; primary completion for Sep 2027, 9 months later.
Of 142 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 70. This study's planned 9 months is below that.
Counting every sponsor, half of 144 studies reached it within 43 months; a quarter within 19 and three quarters within 73.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Gaziantep City Hospital