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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant female

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

Pregnancy test

Intervention Type DIAGNOSTIC_TEST

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

Non-pregnant female

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

Pregnancy test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Pregnancy test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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