Home Pregnancy Test Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- 2. Demonstration of volunteer readability of HPTs
研究概览
简要总结
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.
详细描述
The study will be conducted in two parts:
Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used.
Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product.
Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs).
At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18-45 years
- •Willing to give informed consent
- •Willing to conduct a personal home pregnancy test and reveal their pregnancy status
排除标准
- •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
研究组 & 干预措施
pregnancy test
pregnancy tests
干预措施: home pregnancy test (Diagnostic Test)
结局指标
主要结局
2. Demonstration of volunteer readability of HPTs
时间窗: 1 week
• 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. Demonstration of volunteer preference for a HPTs.
时间窗: 1 week
• 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.
3. Demonstration of consumer preference for a HPT
时间窗: 1 week
• The ranking of each Home Pregnancy Test in order of preference
次要结局
- Agreement of reading(1 week)
- 1. Accuracy of reading(1 week)