Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)
研究概览
简要总结
This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery
- •Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)
排除标准
- •There are no exclusion criteria
研究组 & 干预措施
NovoSeven
Women with severe postpartum haemorrhage treated with NovoSeven
干预措施: Eptacog alfa (activated) (Drug)
Standard of care
Women with severe postpartum haemorrhage treated with standard of care
干预措施: Standard of care (Other)
结局指标
主要结局
Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)
时间窗: 20 min-24 hours following time 0
Count of participants (yes/no) Time 0 definition for all endpoints: Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.
次要结局
- Amount of blood products transfused(From delivery to 24 hours after time 0)
- Occurrence of hysterectomy (yes/no)(20 min-24 hours following time 0)
- Occurrence of thromboembolic events (yes/no)(From time 0 until 5 days after time 0)
- Estimated blood loss(From delivery to 24 hours after time 0)