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

NCT ID: NCT06621706

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2025-09-25

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.

Detailed Description

Fasting is a mandatory requirement prior to elective anesthesia and is intended to reduce gastric fluid volume and the risk of aspiration of gastric contents and subsequent organ injury. Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality and its severity depends upon the gastric volume and nature of the aspirate.

A high-risk stomach refers to a gastric volume associated with an increased risk of pulmonary aspiration and is defined in most published literature as the presence of any solid or liquid content >1.5 mL/kg Pregnant women have been considered to be at particular risk of aspiration syndromes as a consequence of physiological changes during pregnancy which lead to relaxation of lower oesophageal sphincter and mechanical upward displacement of the stomach by the enlarged uterus.

European Society of Anaesthesiology (ESA) recommends fasting for ≥2 hours after clear liquids and 6 hours after light meals before elective surgery, including in pregnant patients. In contrast, the American Society of Anesthesiology guidelines specifically exclude pregnant women and the Society for Obstetric Anesthesia and Perinatology taskforce recommended a fasting period of 6-8 hours, depending on the nature of food ingested.

Diabetic patients can present with diabetic gastropathy, an autonomic neuropathy associated with delayed gastric emptying in the absence of gastric outlet obstruction tend, predisposing them to increased risk of aspiration as compared to non-diabetic patients.

To date, standard fasting guidelines for people with diabetes are still up for debate.. European Society of Anaesthesiology (ESA) 2011 Fasting guidelines state that diabetic patients can follow the same guidelines as healthy adults, While American Society of Anesthesiologists (ASA) in 2017 fasting guidelines mentioned that the standard eight hours fasting may not apply or may need to be modified for patients with coexisting diseases or conditions that can affect gastric emptying or fluid volume.

With the advent of portable ultrasound machines, performing point-of-care ultrasound has become relatively easy and feasible. Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment. It can identify the nature and the volume of the gastric content, i.e., empty, clear fluid and solid and when clear fluid is present, its volume can be quantified.

In this study, we will analyse the stomach contents of Non-labouring term pregnant women after six and eight hours of fasting, using previously described qualitative and quantitative ultrasonographic assessments.

Conditions

Pulmonary Aspiration; Gastric Content Aspiration

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic term pregnant group

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

Gastric ultrasonography

Intervention Type: 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.

Non-diabetic term pregnant group

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

Gastric ultrasonography

Intervention Type: 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.

Interventions

Gastric ultrasonography

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Dina Mahmoud Fakhry

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina M Fakhry, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Beni-Suef University hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina M Fakhry, MD

Role: CONTACT

dina_fakhry_91@yahoo.com

+201289998680

Facility Contacts

Dina M Fakhry, MD

Role: primary

dina_fakhry_91@yahoo.com

+201289998680

Dina Fakhry, MD

Role: backup

dina_fakhry_91@yahoo.com

+201289998680

Other Identifiers

FMBSUREC/01092024/Fakhry

Identifier Type: -

Identifier Source: org_study_id