A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting
研究概览
简要总结
A prospective observational study to test the feasibility of smartphone enabled uChek urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess attitudes of clinicians towards uChek as a new technology for urinalysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.
排除标准
- •Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.
结局指标
主要结局
Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting
时间窗: 6 months
1. Test the feasibility of using the uChek urinalysis device to detect biomarkers of preeclampsia/eclampsia at over 22 weeks of gestation as compared to using the sites' current urinalysis method. A correlation analysis of the rate of detection of protein in urine between the uChek and the standard visual dipstick test using the quantitative results from the visual dipstick test and uChek results collected at each of three ANC visits.
次要结局
- Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC(6 months)