Exploring Semi-Quantitative Pregnancy Tests and Their Imp... | NCT00812890

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

NCT00812890

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jul 22, 2011Estimated

Enrollment

400Actual

Phase

Phase 1

Conditions

Infertility

Interventions

semi-quantitative pregnancy test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
14922

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Dec 18, 2008

First Submission Date that Met QC Criteria

Dec 18, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2011

Last Update Posted Date

Jul 22, 2011Estimated

Name	Class
Gynuity Health Projects	OTHER

Description Module

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:

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Name	Type	Description	Arm Group Labels	Other Names
semi-quantitative pregnancy test	Device

Outcomes Module

Primary Outcomes

Measure	Description	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		15 minutes pregnancy test reading

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Paul D Blumenthal	Stanford University	Principal Investigator
Richard Fischer	Planned Parenthood Mar Monte	Sub-Investigator
Steve Lichtenberg	Family Planning Associates Medical	Sub-Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood Mar Monte		Sacromento	California		United States
Stanford University School of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided