Home Pregnancy Test Evaluation Study
1 other identifier
interventional
250
1 country
1
Brief Summary
This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests. The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 6, 2018
CompletedStudy Start
First participant enrolled
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2018
CompletedNovember 9, 2018
July 1, 2018
2 months
June 6, 2018
November 8, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
1. Demonstration of volunteer preference for a HPTs.
• The cumulative scores on a 7-point likert scale for ease of use questions on the device usability at home questionnaire, where 1 equals very good and 7 equals very poor for each attribute.
1 week
2. Demonstration of volunteer readability of HPTs
• The cumulative scores on a 7-point likert scale for readability questions on the device readability at SPD questionnaire, where 1 equals very easy and 7 equals very difficult for each attribute.
1 week
3. Demonstration of consumer preference for a HPT
• The ranking of each Home Pregnancy Test in order of preference
1 week
Secondary Outcomes (2)
1. Accuracy of reading
1 week
Agreement of reading
1 week
Study Arms (1)
pregnancy test
OTHERpregnancy tests
Interventions
Each participant will use 4 different home pregnancy tests
Eligibility Criteria
You may qualify if:
- Female
- Aged 18-45 years
- Willing to give informed consent
- Willing to conduct a personal home pregnancy test and reveal their pregnancy status
You may not qualify if:
- Currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott, or affiliates
- Has an immediate relative\* currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott or affiliates
- Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl®
- Recently miscarried and yet to have 2 complete menstrual cycles before study start
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPD Development Company Ltd.
Bedford, Bedfordshire, MK44 3UP, United Kingdom
Related Publications (1)
Boxer J, Weddell S, Broomhead D, Hogg C, Johnson S. Home pregnancy tests in the hands of the intended user. J Immunoassay Immunochem. 2019;40(6):642-652. doi: 10.1080/15321819.2019.1671861. Epub 2019 Sep 26.
PMID: 31556778DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
July 18, 2018
Study Start
June 6, 2018
Primary Completion
August 13, 2018
Study Completion
August 13, 2018
Last Updated
November 9, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share