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

This study is currently recruiting participants.

Verified by Stanford University, December 2008

First Received: December 18, 2008 No Changes Posted

Sponsors and Collaborators:	Stanford University Gynuity Health Projects
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00812890

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:

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.

Condition	Intervention	Phase
Infertility	Device: semi-quanitative pregnancy test	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision

Resource links provided by NLM:

MedlinePlus related topics: Infertility Urine and Urination

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

1. 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 of the pregnancy test.

Secondary Outcome Measures:

3. To assess user comprehension of the test.

Estimated Enrollment:	400
Study Start Date:	November 2008

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

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

Contacts

Contact: Kelsey Lynd, MPH

(650) 721-1237

klynd@stanford.edu

Locations

United States, California
Planned Parenthood Mar Monte	Recruiting
Sacromento, California, United States
Contact: Jill MacAfee 408-287-7532 ext 174 Jill_Macafee@ppmarmonte.org
Sub-Investigator: Richard Fischer
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Kelsey Lynd, MPH 650-721-1237 klynd@stanford.edu
Principal Investigator: Dr Paul D Blumenthal
United States, Illinois
Family Planning Associates Medical	Recruiting
Chicago, Illinois, United States
Contact: Michelle Howe 312-707-8988 mhowe77@hotmail.com
Sub-Investigator: Steve Lichtenberg

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

Study ID Numbers:	SU-11042008-1333, 14922
Study First Received:	December 18, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00812890 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 28, 2009