Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.
NCT03134274 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2017-08-22
Summary
The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.
Conditions
- Pregnancy
Interventions
- DEVICE
-
Dip HBDA
Participant receive Dip HBDA semiquantitative urinalyiss kit to be used at home one day after routine prenatal consultation. Dip HBDA consists of a testing kit containing calibration color board, 10 parameter urine dipstick and a urine cup as well as a smartphone application. Application guides participant through the test flow. Dipstick is immersed in urine cup, placed on color board and scanned with smartphone.
Sponsors & Collaborators
- collaborator OTHER
-
Healthy.io Ltd.
lead INDUSTRY
Principal Investigators
-
Anne Burke, MD · Johns Hopkins Medical
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-07
- Primary Completion
- 2017-10-31
- Completion
- 2017-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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