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

NCT00812890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-07-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

semi-quantitative pregnancy test

Sponsors & Collaborators

Principal Investigators

  • Dr Paul D Blumenthal · Stanford University

  • Richard Fischer · Planned Parenthood Mar Monte

  • Steve Lichtenberg · Family Planning Associates Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812890 on ClinicalTrials.gov