NCT03409822已完成不适用
The Effectiveness of Intraoperative Non-invasive Hemoglobin Monitoring in Parturients With Placenta Previa Undergoing Cesarean Section: Prospective Observational Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- The change of total hemoglobin
研究概览
简要总结
Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean section with placenta previa and this will be compared with actual laboratory findings.
The investigators will investigate whether noninvasive hemoglobin monitoring can adequately reflect the massive bleeding that occurs within a short period of time and find out if it matches the actual laboratory findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman
- •Elective Cesarean section
- •Placenta previa
排除标准
- •Decline of consent
- •Peripheral vascular disease
- •Cyanosis due to congenital heart disease
- •Refusal of transfusion
- •Mental retardation
研究组 & 干预措施
Placenta previa
Other
干预措施: Masimo SpHb™ monitor (Device)
结局指标
主要结局
The change of total hemoglobin
时间窗: 10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
次要结局
- The change of oxygen content(10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure)
- The change of pleth variability index(10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure)
- The change of perfusion index(10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure)
- The change of methemoglobin(10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure)
- The change of carboxyhemoglobin(10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure)
研究者
Hyo-Seok Na
Principle investigator
Seoul National University Bundang Hospital
研究点 (2)
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