NCT04753671已完成不适用
Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Description of the QUANTRA® parameters range intervals before and after vaginal delivery
研究概览
简要总结
Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)
- •Delivering vaginally without postpartum hemorrhage for 60 patients
- •Delivering through a programmed C-section for 20 patients
- •Having given a non-opposition agreement to participate in the study.
- •Major patient with social insurance
排除标准
- •Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.
结局指标
主要结局
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
时间窗: At 30 minutes +/- 10 minutes after delivery
次要结局
- Description of the QUANTRA® parameters range intervals before and after vaginal delivery(At 30 up to 60 minutes after birth and placental removal.)
- Comparison between end of pregnancy and immediate postpartum reference values (both vaginal and caesarean deliveries)(At 30 up to 60 minutes after birth)
研究者
研究点 (1)
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