Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome
研究概览
简要总结
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
详细描述
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:
- Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
- Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
- Assess user comprehension of the pregnancy test, especially assessment of the result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18 years or older, presenting for early abortion, pre-natal care, or fertility services.
- •If pregnant, gestational age < 84 days by LMP, ultrasound or clinical assessment.
- •Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- •Able to consent to study participation.
排除标准
- •Women less than 18 years of age.
- •Women who are not pregnant, except if presenting for IVF services.
结局指标
主要结局
To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome
时间窗: 15 minutes pregnancy test reading
次要结局
- To assess user comprehension of the test.(study duration)