Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
NCT00812890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2011-07-22
Summary
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
3. Assess user comprehension of the pregnancy test, especially assessment of the result.
Conditions
Interventions
- DEVICE
-
semi-quantitative pregnancy test
Sponsors & Collaborators
-
Gynuity Health Projects
collaborator OTHER - lead OTHER
Principal Investigators
-
Dr Paul D Blumenthal · Stanford University
-
Richard Fischer · Planned Parenthood Mar Monte
-
Steve Lichtenberg · Family Planning Associates Medical
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2009-09-30
- Completion
- 2009-09-30
Countries
- United States
Study Locations
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