Clinical trial NCT00812890: Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
Official title: Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Gynuity Health Projects
First posted: 2008-12-22
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 15 minutes pregnancy test reading
Secondary outcomes:
measure: To assess user comprehension of the test.
timeFrame: study duration
Other outcomes:
Locations:
city: Sacromento
country: United States
facility: Planned Parenthood Mar Monte
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Chicago
country: United States
facility: Family Planning Associates Medical
state: Illinois
Study officials:
affiliation: Stanford University
name: Dr Paul D Blumenthal
role: PRINCIPAL_INVESTIGATOR
affiliation: Planned Parenthood Mar Monte
name: Richard Fischer
role: SUB_INVESTIGATOR
affiliation: Family Planning Associates Medical
name: Steve Lichtenberg
role: SUB_INVESTIGATOR
References: