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

Stanford University

Status and phase: Completed; Phase 1

Conditions: Infertility

Treatments: Device: semi-quantitative pregnancy test

Study type: Interventional

Funder types: Other

Identifiers

NCT00812890

SU-11042008-1333

14922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)