Performance Evaluation Study for Clearblue Pregnancy Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.
研究概览
简要总结
The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.
详细描述
Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.
Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Provide written informed consent to participate in the study and agree to comply with study procedures.
- •Has menstrual bleeds.
- •Seeking to become pregnant.
- •Intend to seek medical care during pregnancy.
排除标准
- •Has positive pregnancy test on screening.
- •Has received medical treatment for infertility or is participating in an assisted fertility program.
- •Known condition to contra-indicate pregnancy.
结局指标
主要结局
The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.
时间窗: 1 year
次要结局
未报告次要终点