Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After approval by the Institutional Review Board, the investigators will obtain consent from patients. The consent will be obtained by the authorized personnel as per protocol, in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. A gastric ultrasound with a low frequency (1-5 Hz) curvilinear array transducer using a Philips (CX-50) (Bothell, WA. USA) with image compounding technology, will be performed in each patient. The ultrasound procedure will be performed in the supine position and in a semi-recumbent right lateral position. The antrum will be identified in the sagittal plane between the liver, pancreas and aorta between peristaltic contractions. The ultrasound will be performed in each patient, in each position by three operators: two staff anesthesiologists and an anesthesia resident in presence of a medical student who will make sure that the standards for the procedure are uniform between operators (three images will be recorded by each operator per position in each patient). A qualitative assessment will be initially made, consisting of three grades: Grade 0, no fluid evidenced; Grade 2, clear fluid is evidenced only in right lateral decubitus position, and Grade 3, fluid is evidenced in both positions. Quantitative measurement of the cross-sectional area of the antrum (CSA) will be done by means of free tracing calipers. The full-thickness of the gastric wall will be included in the measurement and the average from the three images of each operator will be recorded. CSA will be calculated using the following formula:
CSA =(π x mean anteroposterior diameter x mean longitudinal diameter)/4
In addition to qualitative and quantitative ultrasound measures, the investigators will record demographic variables including age, BMI, weeks of gestation, gravity and parity.
The investigators plan to evaluate the existence of a relationship between cross-sectional area of the antrum (CSA) and BMI in term pregnant women using measurements of the CSA taken with free tracing calipers in ultrasound
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Augusta University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant patients >37 weeks of gestation
- Age older than 18 years
- NPO status >6 hours
Exclusion Criteria:
- Unwillingness to participate in the study
- Diagnosis of upper gastrointestinal disease
- Episode of vomiting within the last 6 hours
- Patients taking gastric pro-kinetic medications
- Diabetes mellitus
- Prior gastric, esophageal or upper abdominal surgery
- Allergy to US gel
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Scheduled cesarean section
Gastric ultrasound in term pregnant patients to correlate with NPO time in relation to body mass index
|
Gastric ultrasound to measure antrum cross sectional area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cross sectional area of gastric antrum
Time Frame: 10 minutes
|
Cross sectional area of gastric antrum
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: 10 minutes
|
Body mass index
|
10 minutes
|
|
Fasting time
Time Frame: 8 hours
|
NPO status
|
8 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 1184342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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