Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women

Pregnancy Related Clinical Trial

Official title:

Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555604
• Other study ID #: 1184342
• Status: Completed
• Start date: May 29, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study seeks to determine if a relationship exists between gastric antrum cross-sectional area measured using ultrasound and BMI in term pregnant women (>37 weeks gestation).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 15, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pregnant patients >37 weeks of gestation

2. Age older than 18 years

3. NPO status >6 hours

Exclusion Criteria:

1. Unwillingness to participate in the study

2. Diagnosis of upper gastrointestinal disease

3. Episode of vomiting within the last 6 hours

4. Patients taking gastric pro-kinetic medications

5. Diabetes mellitus

6. Prior gastric, esophageal or upper abdominal surgery

7. Allergy to US gel

Related Conditions & MeSH terms

• Airway Aspiration
• Aspiration
• Pregnancy Related

Intervention

Diagnostic Test:
• Gastric ultrasound
Gastric ultrasound to measure antrum cross sectional area

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area of gastric antrum	Cross sectional area of gastric antrum	10 minutes
Secondary	BMI	Body mass index	10 minutes
Secondary	Fasting time	NPO status	8 hours