NCT04043169

Brief Summary

The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

July 30, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 20, 2020

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

August 1, 2019

Last Update Submit

February 19, 2020

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Clearblue pregnancy test

    Number of pregnancy test results in agreement with clinical pregnancy status

    3 days

Secondary Outcomes (3)

  • Sample method agreement

    1 day

  • Coordinator agreement

    1 day

  • Device usability

    1 day

Interventions

Clearblue pregnancy testDIAGNOSTIC_TEST

Urine pregnancy test

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant, or not pregnant volunteers requiring or wishing to conduct a pregnancy test.

You may qualify if:

  • Female
  • Aged 18 to 45
  • Willing to conduct a 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
  • Has professional experience of using lateral flow-based devices
  • Beyond the first trimester of pregnancy
  • Taken a hormonal preparation containing hCG in the last month.
  • Has a medical condition that means that it is not appropriate to give a blood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample Serum sample

Study Officials

  • Sarah Johnson

    SPD Development company Ltd.

    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

August 1, 2019

First Posted

August 2, 2019

Study Start

July 30, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

February 20, 2020

Record last verified: 2019-07

Locations

US(1)