Pregnancy RelatedNCT03555604
Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
An observational study of Pregnancy Related and Aspiration, run by Augusta University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Aspiration, Airway Aspiration
- What is being tested?
- Gastric ultrasound
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 15 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Term pregnant patients scheduled for cesarean section, who meet inclusion criteria
Who may be able to join
- Pregnant patients >37 weeks of gestation
- Age older than 18 years
- NPO status >6 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Conditions
- Pregnancy Related, Aspiration, Airway Aspiration
- Being tested
- Gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic test
Gastric ultrasound to measure antrum cross sectional area
| Study group | Role | What they receive |
|---|---|---|
| Scheduled cesarean section | Gastric ultrasound in term pregnant patients to correlate with NPO time in relation to body mass index Receives: Diagnostic Test: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area of gastric antrum
Cross sectional area of gastric antrum
Measured: 10 minutes
Secondary outcomes (2)
BMI
Body mass index
Measured: 10 minutes
Fasting time
NPO status
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start29 May 2018
- Primary completion31 May 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555604
- Sponsor's protocol ID
- 1184342
- Status last verified
- Jul 2019
- First submitted
- 1 Jun 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
- ClinicalTrials.gov ID
- NCT03555604
- Acronym / sponsor ID
- 1184342
- Conditions
- Pregnancy Related, Aspiration, Airway Aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scheduled cesarean section | – | Diagnostic Test: Gastric ultrasoundGastric ultrasound in term pregnant patients to correlate with NPO time in relation to body mass index |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Term pregnant patients scheduled for cesarean section, who meet inclusion criteria
Key inclusion criteria (3 listed)
- Pregnant patients >37 weeks of gestation
- Age older than 18 years
- NPO status >6 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasoundGastric ultrasound to measure antrum cross sectional area | Diagnostic test | Scheduled cesarean section |
Primary outcome
Cross sectional area of gastric antrum
Time frame: 10 minutes
Cross sectional area of gastric antrum
2 secondary outcomes
BMI
Time frame: 10 minutes
Fasting time
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Aspiration, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross sectional area of gastric antrum (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.