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

Phase 1

Completed

• Conditions: Infertility

• Registration Number: NCT00812890
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-22
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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.

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Exclusion Criteria

• Women less than 18 years of age.
• Women who are not pregnant, except if presenting for IVF services.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess user comprehension of the test.	study duration

Trial Locations

Locations (3)

Planned Parenthood Mar Monte; 🇺🇸 Sacromento, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Family Planning Associates Medical; 🇺🇸 Chicago, Illinois, United States