Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
Completed · Phase 1
Conditions studied: Infertility
In brief
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.
Key facts
- Study ID
- NCT00812890
- Run by
- Stanford University
- People needed
- 400
- Starts
- 2008-11-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2011-07-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Women less than 18 years of age.
- Women who are not pregnant, except if presenting for IVF services.
Where it is running
- 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
Full record on ClinicalTrials.gov
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