Correlation of Non-invasive Hemoglobin Measurement With Bleeding During Cesarean Delivery: The PPHgb Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Determine the critical threshold of SpHb drop during cesarean delivery
研究概览
简要总结
This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. Participants in the study will be undergoing a cesarean delivery at the George Washington University Hospital and during delivery the patient will wear the device on their fingertip so that hemoglobin measurements can be continuously recorded. No changes from routine medical management will occur during the study.
详细描述
This project is a prospective, observational study aimed to predict bleeding using hemoglobin trends measured non-invasively in patients undergoing elective cesarean delivery at the George Washington University Hospital.
The primary outcome is trend in hemoglobin measurement, at which additional interventions are required to control hemorrhage. The overall goal is to be able to determine a threshold point in which a drop in the hemoglobin level indicates severe bleeding in anticipation of postpartum hemorrhage. Through the observation of the continuous monitoring of hemoglobin across all participants and correlating those with severe hemorrhage to the magnitude of drop or time of drop, this could potentially optimize the hemorrhage protocol and might limit the need for blood transfusion and decrease maternal mortality and morbidity.
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
- 是
入选标准
- •Pregnant women age 18 - 50 years old
- •Patients scheduled for cesarean delivery at >34 weeks gestation
- •Patients who failed trial of labor and require cesarean delivery
排除标准
- •Patients with spontaneous or operative vaginal delivery
- •Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
- •Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
- •Patients with hyperbilirubinemia
结局指标
主要结局
Determine the critical threshold of SpHb drop during cesarean delivery
时间窗: At the time of surgery
Correlation of the time a SpHb drop occurs with the time of hemorrhagic intervention decision
时间窗: At the time of surgery
Hemorrhagic interventions include: uterotonic drugs, surgical suturing, uterine tamponade devices, blood transfusion, etc.
次要结局
- Correlation of the change in SpHb from pre-delivery to post-delivery values and the reported estimated blood loss or change in laboratory blood hemoglobin values.(Within 72 hours before surgery and 24 hours after surgery)
研究者
Jaclyn Phillips
Principal Investigator
George Washington University