Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorBeni-Suef University
About this trial
The aim of the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pregnant women undergoing elective caesarean section
aged between 18-40 years
belonging to ASA II-III
gestational age greater than 37 weeks
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Gastric ultrasonography
DeviceWomen 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Diabetic term pregnant group1 intervention
Group B: Non-diabetic term pregnant group1 intervention
Trial outcomes
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.
Time frame
8 hours of fastingSecondary outcomes
1
the mean antral cross-sectional area of stomach
mean antral cross-sectional area of stomach after 6 h of fasting presence of solid food contents in the gastric antrum,
Time frame
6 hours of fasting2
gastric antral grade
The qualitative assessment of the gastric contents will be also done for presence of any clear fluid or solid food particles and a gastric antral grade, as described by Perlas et al. was designated based on the presence of fluid as follows: Grade 0 = absence of fluid in both supine and RLP; Grade 1 = fluid in RLP only; Grade 2 = fluid in both supine and RLPs
Time frame
6 and 8 hours of fastingSponsors and contacts
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Source ClinicalTrials.gov