NCT00812890

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:

  1. 1.Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
  2. 2.Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
  3. 3.Assess user comprehension of the pregnancy test, especially assessment of the result.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

10 months

First QC Date

December 18, 2008

Last Update Submit

July 20, 2011

Conditions

Infertility

Outcome Measures

Primary Outcomes (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

    15 minutes pregnancy test reading

Secondary Outcomes (1)

  • To assess user comprehension of the test.

    study duration

Interventions

semi-quantitative pregnancy testDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Women less than 18 years of age.
  • Women who are not pregnant, except if presenting for IVF services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Planned Parenthood Mar Monte

Sacromento, California, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Family Planning Associates Medical

Chicago, Illinois, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Dr Paul D Blumenthal

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Richard Fischer

    Planned Parenthood Mar Monte

    SUB INVESTIGATOR

  • Steve Lichtenberg

    Family Planning Associates Medical

    SUB INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

US(3)