NCT06228131已完成不适用
Detection of hCG in Early Pregnancy Clinical Samples
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.
研究概览
简要总结
To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-55 years of age；
- •In a state of preparing for pregnancy;
- •Voluntary and sign informed consent form.
排除标准
- •Within 8 weeks of childbirth or abortion；
- •The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
结局指标
主要结局
To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.
时间窗: 10day
Percentage Pregnancy Results (%) for early pregnancy urine samples on different days from day -8 to day +1 relative to the expected period. Percentage Pregnancy Results (%): 79% (day -5 relative to the expected period)
次要结局
未报告次要终点
研究者
研究点 (2)
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