Pregnancy Related
Conditions
Keywords
Pregnancy, Urine Testing, Medical Diagnostics
Brief summary
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.
Interventions
DIAGNOSTIC_TESTPregnancy test
Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy
Sponsors
Northwestern University
Voyant Diagnostics, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient age 18 years and older, upper age limit of 45 years * Female patient * Patients undergoing any procedures for pregnancy diagnosis and confirmation * English speaking The following special population will be included: * Pregnant women
Exclusion criteria
* Adults unable to consent * Individuals who are not yet adults (infants, children, and teenagers) * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy in determining pregnancy status | Time of collection - 1 month post collection | Compare qualitative pregnancy test results generated by Voyant's device with urine pregnancy test result(s) and, if applicable, serum pregnancy test results performed at Northwestern University. From this comparison, we will determine the accuracy of Voyant's device. We will be using the same urine sample used at Northwestern. |
Countries
United States
Contacts
Primary ContactMichael Tu, MS, BS
Backup ContactClaire Y Zhou, BA
Outcome results
None listed