Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Hemoglobin (g /dL) Accuracy of Masimo RAD 67
研究概览
简要总结
Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. This screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment.
MasimoTM has developed a non-invasive device that can detect anemia without a blood draw. This device has not been extensively studied in pregnant patients. The aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.
详细描述
This is a prospective observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. The device is FDA approved for use in adults, children, and neonates. The current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. The purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture) when patients receive routine hemoglobin measurement during the course of their prenatal care.
The research team will approach pregnant patients who are presenting for prenatal care at Beth Israel Deaconess Medical Center, including the Labor and Delivery Triage Unit. The research team also will approach patients during an antepartum or postpartum admission.
The research team will use the Masimo Rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. Study personnel will receive training on proper device use and cleaning by the local Masimo support team.
At the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. The devices requires 1-3 minutes for an accurate measurement.
After the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone using a validated skin tone scale.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant or postpartum;
- •Age ≥18 years old;
- •Undergoing phlebotomy for clinical purpose
排除标准
- 未提供
结局指标
主要结局
Hemoglobin (g /dL) Accuracy of Masimo RAD 67
时间窗: At time of phlebotomy
Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time.
次要结局
- Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone(At time of phlebotomy)
- Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age(At time of phlebotomy)
研究者
Ethan Litman
Clinical Fellow in Obstetrics, Gynecology and Reproductive Biology
Beth Israel Deaconess Medical Center