Performance Evaluation Study for Clearblue Pregnancy Test | NCT01077583

Studies
Performance Evaluation Study for Clearblue Pregnancy Test

NCT01077583

Sponsor

SPD Development Company Limited

Status

Completed

Last Update Posted

Sep 28, 2011Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Not provided

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

Status Module

Record Verification Date

Jan 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

Jan 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Feb 26, 2010

First Submission Date that Met QC Criteria

Feb 26, 2010

First Posted Date

Mar 1, 2010Estimated

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

Sep 27, 2011

Last Update Posted Date

Sep 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.

Detailed Description

Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.

Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent to participate in the study and agree to comply with study procedures.
Has menstrual bleeds.
Seeking to become pregnant.
Intend to seek medical care during pregnancy.

Exclusion Criteria:

Has positive pregnancy test on screening.
Has received medical treatment for infertility or is participating in an assisted fertility program.
Known condition to contra-indicate pregnancy.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Eligibility:

Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy Volunteers Yes.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Phyllis Marx, MD	Radiant Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiant Research Inc		Atlanta	Georgia	30342-1524	United States
Radiant Research, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24079475	Derived	Larsen J, Buchanan P, Johnson S, Godbert S, Zinaman M. Human chorionic gonadotropin as a measure of pregnancy duration. Int J Gynaecol Obstet. 2013 Dec;123(3):189-95. doi: 10.1016/j.ijgo.2013.05.028. Epub 2013 Sep 3.