MedDataX Logo

Performance Evaluation Study for Clearblue Pregnancy Test

NCT ID: NCT01077583

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SPD Development Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Phyllis Marx, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Radiant Research Inc

Atlanta, Georgia, United States

Site Status

Radiant Research, Inc.

Chicago, Illinois, United States

Site Status

Radiant Research Inc

Edina, Minnesota, United States

Site Status

Radiant Research Inc

Dallas, Texas, United States

Site Status

Radiant Research Inc

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24079475 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROTOCOL-0148

Identifier Type: -

Identifier Source: org_study_id