Back to resultsExploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
semi-quantitative pregnancy test
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility
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.
Sites / Locations
- Planned Parenthood Mar Monte
- Stanford University School of Medicine
- Family Planning Associates Medical
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To assess user comprehension of the test.
Full Information
NCT ID
NCT00812890
First Posted
December 18, 2008
Last Updated
July 20, 2011
Sponsor
Stanford University
Collaborators
Gynuity Health Projects
1. Study Identification
Unique Protocol Identification Number
NCT00812890
Brief Title
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
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
Gynuity Health Projects
4. Oversight
5. Study Description
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:
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
semi-quantitative pregnancy test
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess user comprehension of the test.
Time Frame
study duration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Paul D Blumenthal
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Fischer
Organizational Affiliation
Planned Parenthood Mar Monte
Official's Role
Sub-Investigator
First Name & Middle Initial & Last Name & Degree
Steve Lichtenberg
Organizational Affiliation
Family Planning Associates Medical
Official's Role
Sub-Investigator
Facility Information:
Facility Name
Planned Parenthood Mar Monte
City
Sacromento
State/Province
California
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Family Planning Associates Medical
City
Chicago
State/Province
Illinois
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
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