Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision

Study Overview
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Brief Summary
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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: Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. Assess user comprehension of the pregnancy test, especially assessment of the result.

Detailed Description
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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: Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. Assess user comprehension of the pregnancy test, especially assessment of the result.

Official Title
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Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision

Conditions
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Infertility

Intervention / Treatment
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* Device: semi-quantitative pregnancy test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years or older, presenting for early abortion, pre-natal care, or fertility services. If pregnant, gestational age < 84 days by LMP, ultrasound or clinical assessment. Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up. Able to consent to study participation. Exclusion Criteria: Women less than 18 years of age. Women who are not pregnant, except if presenting for IVF services.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: semi-quantitative pregnancy test|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome |  | 15 minutes pregnancy test reading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess user comprehension of the test. |  | study duration |