Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cognitive evaluation via survey and calculating the consistency
研究概览
简要总结
The Mira Pregnancy Test is an over-the-counter urine hCG test intended for early detection of pregnancy. The test is indicated for use four days before the expected period. Throughout this study, volunteers with non-medical backgrounds were recruited to test hCG with urine samples using the Mira Pregnancy Test during the not pregnancy cycle or pregnancy cycle. To perform the study, a total number of more than 200 volunteers will be recruited to participate in the study.
详细描述
The studies include two parts, which are a lay user study and a urine samples test during the trying to conceive cycle.
Part 1: Lay user study Part 2: Detection of hCG in Early Pregnancy Clinical Samples
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 and over
- •Willing to give informed consent
- •Willing to conduct a personal home pregnancy test and reveal their pregnancy status
- •Have a working smartphone
排除标准
- •Have a medical background or have been in a related industry/occupation
- •Volunteers who are unfit to participate in the research by the researcher
- •Used the investigational pregnancy test previously
- •Has a medical condition
- •Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
结局指标
主要结局
Cognitive evaluation via survey and calculating the consistency
时间窗: From July 2022 to August 2022
The consistency between the lay-user test results and the actual test results
The accuracy of data was expressed as per the Pregnancy Detection Rate
时间窗: From July 2022 to August 2022
The number of positive results on different days obtained by the user of the Mira pregnancy test is divided by the total number of women who confirmed pregnancy.
次要结局
未报告次要终点