NCT03555604

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

June 1, 2018

Last Update Submit

July 1, 2019

Conditions

Pregnancy RelatedAspirationAirway Aspiration

Outcome Measures

Primary Outcomes (1)

  • Cross sectional area of gastric antrum

    Cross sectional area of gastric antrum

    10 minutes

Secondary Outcomes (2)

  • BMI

    10 minutes

  • Fasting time

    8 hours

Study Arms (1)

Scheduled cesarean section

Gastric ultrasound in term pregnant patients to correlate with NPO time in relation to body mass index

Diagnostic Test: Gastric ultrasound

Interventions

Gastric ultrasoundDIAGNOSTIC_TEST

Gastric ultrasound to measure antrum cross sectional area

Scheduled cesarean section

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTerm pregnant patients scheduled for cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Term pregnant patients scheduled for cesarean section, who meet inclusion criteria

You may qualify if:

  • Pregnant patients \>37 weeks of gestation
  • Age older than 18 years
  • NPO status \>6 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Anesthesiology and Perioperative Medicine

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 13, 2018

Study Start

May 29, 2018

Primary Completion

May 31, 2019

Study Completion

June 15, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)