About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, GESTATIONAL AGE OF 36 WEEKS OR MORE.
Trial design
Cohort
Prospective
Treatments tested in this trial
GASTRIC ULTRASONOGRAPHY
Diagnostic testBedside 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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