NCT02636166

Brief Summary

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site. Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
943

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable pregnancy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
Last Updated

December 21, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

October 20, 2015

Last Update Submit

December 16, 2015

Conditions

Pregnancy

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status

    The accuracy of the investigational HPT in volunteer hands compared to pregnancy status

    3 months

Secondary Outcomes (5)

  • Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT.

    3 months

  • Number of participants recording a false positive or false negative pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status.

    3 months

  • Calculation of the level of certainty a user can have if the device gives a pregnant (positive predictive value (PPV)) or not pregnant result (Negative predictive value(NPV)).

    3 months

  • Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet.

    3 months

  • Participants opinion on using the product.

    3 months

Study Arms (1)

Pregnancy test

OTHER

Clearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test

Other: Clearblue Investigational Pregnancy testOther: Professional pregnancy testOther: Clearblue Marketed Pregnancy test

Interventions

Clearblue Investigational Pregnancy testOTHER

Clearblue Investigational Pregnancy test

Pregnancy test
Professional pregnancy testOTHER

Alere Professional use pregnancy test

Pregnancy test
Clearblue Marketed Pregnancy testOTHER

Clearblue Marketed Pregnancy test

Pregnancy test

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Aged 18 or over
  • Willing to conduct a personal pregnancy test and reveal their pregnancy status
  • Willing to give informed consent

You may not qualify if:

  • Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P\&G), or affiliates.
  • Has an immediate relative\* currently or previously employed by SPD, Alere, Unipath or P\&G or affiliates
  • Previously used the investigational HPT within the last six months
  • Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
  • Confirmed to be pregnant by a healthcare professional and beyond the first trimester
  • Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illingworth Research Ltd

Macclesfield, Chester, SK11 7QJ, United Kingdom

Location

Study Officials

  • Juliet Hulse

    Illingworth Research Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

December 21, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

December 21, 2015

Record last verified: 2015-10

Locations

GB(1)