MedTrace Logo

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

NCT03575286 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2018-07-10

No results posted yet for this study

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.

Conditions

  • Pregnancy Related

Interventions

DIAGNOSTIC_TEST

Pregnancy test

Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy

Sponsors & Collaborators

Principal Investigators

  • MaryEllen Pavone, MD, MSCI · Northwestern University, Department of Obstetrics and Gynecology

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2019-03-31
Completion
2019-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575286 on ClinicalTrials.gov