Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Hematocrit
研究概览
简要总结
Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture.
详细描述
This will be a prospective cohort study. The investigators will recruit 41 pregnant women admitted for delivery. Following delivery, a sample of vaginal blood will be collected and the Hemi device will be used to obtain hematocrit. These results will be masked to the clinical team until the time of data collection. A CBC will also be collected via venipuncture at this time. This study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between the ages of 18-50
- •Admission for vaginal delivery
- •Singleton pregnancy
- •Term gestation (>=37 weeks)
排除标准
- •Pregnant women < 18 years or > 50 years
- •Incarcerated patients
- •Patient unwilling or unable to provide consent
- •Enrolled in another trial that may affect outcome
结局指标
主要结局
Hematocrit
时间窗: During delivery
Comparison of hematocrit from vaginal blood sample versus systemic sample
次要结局
- Time to obtain results(During delivery)