Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy

Voyant Diagnostics

Status: Unknown

Conditions: Pregnancy Related

Treatments: Diagnostic Test: Pregnancy test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03575286

1

Details and patient eligibility

About

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.

Enrollment: 123 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

123 participants in 2 patient groups

Pregnant female

Description:

Patient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University.

Treatment:

Diagnostic Test: Pregnancy test

Non-pregnant female

Description:

Patient has been determined not pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University.

Treatment:

Diagnostic Test: Pregnancy test