Clearblue Pregnancy Test Lay User Usage Study

NCT04746014 | Completed FDA Device

• 1 other identifier: PROTOCOL-1133
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

The Clearblue home pregnancy test (HPT) is an over the counter urine hCG (human chorionic gonadotrophin) visual pregnancy test which is intended for the detection of pregnancy. This study will assess the performance of the HPT in the hands of the lay user by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

Conditions

Pregnancy

Keywords

Lay User

Outcome Measures

Primary Outcomes (1)

• Accuracy of Clearblue Pregnancy Test

  Number of pregnancy tests in agreement with pregnancy status

  3 days

Secondary Outcomes (3)

• Co-ordinator Agreement

  1 day

• Comprehension of Instructions for Use

  1 day

• Device Usability

  1 day

Interventions

Clearblue Pregnancy Test DIAGNOSTIC_TEST

Urine Pregnancy Test

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant or not pregnant volunteers requiring or wishing to conduct a pregnancy test to determine or confirm pregnancy status.

You may qualify if:

• Female
• Aged 18 and over
• Interested in conducting a personal pregnancy test to determine or confirm their pregnancy status
• Willing to reveal their pregnancy status
• Willing to provide a blood sample
• Willing to give informed consent

You may not qualify if:

• Significant affiliation with SPD
• Used the investigational pregnancy test previously
• Qualified or trainee healthcare professional (HCP)
• Has professional experience (in current or previous job) of using dipstick type tests or lateral flow devices
• Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
• Has a medical condition that means that it is not appropriate to give a blood sample

Sponsors & Collaborators

• SPD Development Company Limited: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and serum samples

Study Officials

• Sarah Johnson, PhD

  SPD Development Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: February 9, 2021
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

US (1)