ULTRASOUND ASSESSMENT OF GASTRİC VOLUME IN PREGNANT WOMEN UNDERGOİNG ELECTİVE CESAREAN SECTİON, WITH AND WITHOUT GESTATİONAL DIABETES MELLITUS

NCT07816705 | Not Yet Recruiting DMC

• 1 other identifier: KAEK-110
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Gestational Diabetes Mellitus (GDM); Obstetric Anesthesia

Keywords

Gastricusg; GDM; GestasyonelDiabetesMellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  1 YEAR

Study Arms (2)

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.

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

Diagnostic Test: GASTRIC ULTRASONOGRAPHY

Interventions

GASTRIC ULTRASONOGRAPHY DIAGNOSTIC_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.

GDM Group; Non-GDM Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, GESTATIONAL AGE OF 36 WEEKS OR MORE.

You may qualify if:

• PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY,
• GESTATIONAL AGE OF 36 WEEKS OR MORE,
• ASA PHYSICAL STATUS CLASSIFICATION OF II-III WILL BE INCLUDED IN THE STUDY.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Related Publications (3)

• 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.

  PMID: 40399137 RESULT

• Amaral 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.

  PMID: 31006483 RESULT

• Garg 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.

  PMID: 32724247 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mehmet Tunç

CONTACT

+90 542 373 6350; otuncoo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL RESIDENT

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR