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临床试验/NCT02149472
NCT02149472已完成不适用

Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage

Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research1 个研究点 分布在 1 个国家目标入组 1,649 人开始时间: 2015年2月4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
1,649
试验地点
1
主要终点
Early haemostatic predictors of major obstetric haemorrhage

研究概览

简要总结

Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken.

In this study the investigators aim to identify haemostatic parameters that during the course of haemorrhage are responsible for the on-going towards major bleeding. By doing this, cut-off points can be defined for future interventions aiming to stop this bleeding process in an early stage. Traditional coagulation parameters are currently not useful for clinical decision making, because of long turn around times. Therefore the added value of available coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric haemorrhage.

A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From all women a bleeding score will be obtained during their pregnancy by means of a validated questionnaire. The predictive value of this bleeding score for the occurrence of major obstetric haemorrhage will be evaluated.

If postpartum haemorrhage develops (blood loss) > 1000 cc, blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding and major bleeding will be elucidated. Interchangeability and comparability of conventional haemostatic parameters and ROTEM profiles will also be evaluated.

The overall goal of the investigators is becoming more able to predict major obstetric haemorrhage in an early stage of postpartum haemorrhage and define thresholds for goal-directed hemostatic therapies.

详细描述

See 'brief summary'

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

入选标准

  • Pregnancy, gestation age > 24 weeks

排除标准

  • Age < 18
  • Adults incapable of giving informed consent
  • Gestational age < 24 weeks

结局指标

主要结局

Early haemostatic predictors of major obstetric haemorrhage

时间窗: Postpartum haemorrhage within the 24 hrs hours after childbirth

During early postpartum haemorrhage changes in hemostatic parameters leading to major obstetric haemorrhage will be identified. Conventional hemostatic parameters and ROTEM profiles will be studied.

次要结局

  • Predictive value bleeding score in pregnancy for MOH(Third trimester of pregnancy - 24 hours postpartum)
  • Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters(Postpartum haemorrhage within first 24 hrs after childbirth)
  • Incidence of underlying bleeding disorders in patients with MOH(3 months postpartum)

研究者

发起方
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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