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

This study has been completed.
Sponsor:
Collaborator:
Gynuity Health Projects
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00812890
First received: December 18, 2008
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.

Condition Intervention Phase
Infertility
Device: semi-quantitative pregnancy test
Device: Semi-Quantitative Pregnancy Test
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision

Resource links provided by NLM:


Further study details as provided by Stanford University:

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 [ Time Frame: 15 minutes pregnancy test reading ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess user comprehension of the test. [ Time Frame: study duration ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812890

Locations
United States, California
Planned Parenthood Mar Monte
Sacromento, California, United States
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
Family Planning Associates Medical
Chicago, Illinois, United States
Sponsors and Collaborators
Stanford University
Gynuity Health Projects
Investigators
Principal Investigator: Dr Paul D Blumenthal Stanford University
Sub-Investigator: Richard Fischer Planned Parenthood Mar Monte
Sub-Investigator: Steve Lichtenberg Family Planning Associates Medical
  More Information

No publications provided

Responsible Party: Dr Paul D Blumenthal, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00812890     History of Changes
Other Study ID Numbers: SU-11042008-1333, 14922
Study First Received: December 18, 2008
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 21, 2014