Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Accuracy in determining pregnancy status
研究概览
简要总结
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Patient age 18 years and older, upper age limit of 45 years
- •Female patient
- •Patients undergoing any procedures for pregnancy diagnosis and confirmation
- •English speaking
- •The following special population will be included:
- •Pregnant women
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, and teenagers)
- •Prisoners
结局指标
主要结局
Accuracy in determining pregnancy status
时间窗: Time of collection - 1 month post collection
Compare qualitative pregnancy test results generated by Voyant's device with urine pregnancy test result(s) and, if applicable, serum pregnancy test results performed at Northwestern University. From this comparison, we will determine the accuracy of Voyant's device. We will be using the same urine sample used at Northwestern.
次要结局
未报告次要终点