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Completed

NCT Number: NCT00812890

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Planned Parenthood Mar Monte, Sacromento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semi-quantitative pregnancy test

Device

Primary outcomes

  1. 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

    Time frame: 15 minutes pregnancy test reading

Secondary outcomes

  1. To assess user comprehension of the test.

    Time frame: study duration

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Gynuity Health Projects

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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