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

July 20, 2011 updated by: Stanford University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacromento, California, United States
        • Planned Parenthood Mar Monte
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Illinois
      • Chicago, Illinois, United States
        • Family Planning Associates Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
15 minutes pregnancy test reading

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess user comprehension of the test.
Time Frame: study duration
study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-11042008-1333
  • 14922

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on semi-quantitative pregnancy test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe