Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section

NCT06621706 | Recruiting

• 1 other identifier: FMBSUREC/01092024/Fakhry
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section.

Conditions

Pulmonary Aspiration; Gastric Content Aspiration

Keywords

Diabetic; Gastric ultrasonography; Pregnant

Outcome Measures

Primary Outcomes (1)

• mean antral cross-sectional area of stomach

  mean antral cross-sectional area of stomach after 8 h of fasting in term pregnant diabetic and non-diabetic women undergoing elective caesarean section.

  8 hours of fasting

Secondary Outcomes (2)

• the mean antral cross-sectional area of stomach

  6 hours of fasting

• gastric antral grade

  6 and 8 hours of fasting

Study Arms (2)

Diabetic term pregnant group

Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes

Device: Gastric ultrasonography

Non-diabetic term pregnant group

Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes

Device: Gastric ultrasonography

Interventions

Gastric ultrasonography DEVICE

Women will be requested to fast 2 hours for clear drinks, 6 hours for a light meal, and 8 hours for a meal high in fried or fatty content prior to their next antenatal clinic visit. On the day of assessment, fasting and dietary compliance will be confirmed individually with each woman and Gastric ultrasonography will be performed after sex and eight hours of fasting food. Women will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by a semi-recumbent (45 degrees head up) right lateral position (RLP). In both positions the gastric antrum will be identified in the sagittal plane with its internal anatomical landmarks identified, i.e. the left lobe of the liver anteriorly and the abdominal aorta posteriorly.

Diabetic term pregnant group; Non-diabetic term pregnant group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible 140 patients are aged from 18-40 years, with an American Society of Anaesthesiologists (ASA) physical status of II-III, and are scheduled to undergo elective caesarean section.

You may qualify if:

• pregnant women undergoing elective caesarean section
• aged between 18-40 years
• belonging to ASA II-III
• gestational age greater than 37 weeks
• BMI\< 35 kg/m2

You may not qualify if:

• patients who refuse to give consent
• patients taken to surgery on an emergency basis, -pregnant patients with upper gastrointestinal (GI) diseases and pathologies
• patients with a history of using medications that affect gastrointestinal motility (e.g., opioids), severe organ dysfunction
• pre-existing neurological deficits, intellectual disabilities and anatomical deformities.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University hospital

Banī Suwayf, Beni Suweif Governorate, 62814, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dina M Fakhry, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Fakhry, MD

CONTACT

+201289998680; dina_fakhry_91@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: September 25, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

EG (1)