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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812890
• Other study ID #: SU-11042008-1333
• Secondary ID: 14922
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2008
• Last updated: July 20, 2011
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• semi-quantitative pregnancy test

Locations

Country	Name	City	State
United States	Family Planning Associates Medical	Chicago	Illinois
United States	Planned Parenthood Mar Monte	Sacromento	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess user comprehension of the test.		study duration	No