ULTRASOUND ASSESSMENT OF GASTRİC VOLUME IN PREGNANT WOMEN UNDERGOİNG ELECTİVE CESAREAN SECTİON, WITH AND WITHOUT GESTATİONAL DIABETES MELLITUS (GDM)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mehmet Tunç
- Phone Number: +90 542 373 6350
- Email: otuncoo@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
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 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
Non-GDM Group
Pregnant women without gestational diabetes, matched for gestational age and fasting duration, undergoing the same gastric ultrasonography protocol
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 YEAR
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK-110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.