The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- D-dimer
研究概览
简要总结
This study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth.
详细描述
Postpartum Hemorrhage (PPH) is a potentially life-threatening complication of labour and a leading cause of maternal mortality and morbidity. It is defined as a blood loss of 500ml or more in the first 24 hours after birth and it is estimated that about 2% of all parturients are affected. Postpartum hemorrhage is responsible for 8% of maternal deaths in in industrialized nations. The prophylactic use of an uterotonic agent is suggested to reduce the risk of postpartum bleeding.
Tranexamic acid has become another candidate for the prevention of postpartum hemorrhage over the past ten years. It has an antifibrinolytic effect and inhibits hyperfibrinolysis, its clinical effects have been demonstrated in several contexts. In clinical trials outside of obstetrics, tranexamic acid has been found to reduce the need for transfusions during elective procedures and to reduce mortality in patients with extra- or intracranial trauma. In recent studies it is suggested to administer Tranexamic acid already prophylactically during cesarean delivery to reduce blood loss and avoid hyperfibrinolysis and PPH.
What is not known, is how often patients are affected by hyperfibrinolysis during cesarean section and vaginal birth without it manifesting as PPH. In trauma patients, for example, hyperfibrinolysis was found in 5% and moderate hyperfibrinolysis in 57%.
It is unusual to establish a prophylactic treatment without any data on the incidence of the condition, which is aimed to be treated. Therefore, the aim of the study is to provide a data basis for the incidence of hyperfibrinolysis after vaginal delivery and cesarean section.
Primary Aim:
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
- 是
入选标准
- •Women aged 18 years and older with a singleton or multiple pregnancy who volunteer for the present study and give one blood sample of 6ml
排除标准
- •Age < 18 years
- •Emergency cesarean section
- •History of thrombocytopathy or coagulation disorders
- •Therapy with drugs that influence thrombocyte function and coagulation (ASS less than 5 days ago, clopidogrel, prasugrel, ticagrelor or similar)
- •Lack of consent
结局指标
主要结局
D-dimer
时间窗: immediate after birth
D-dimer level
Incidence of Hyperfibrinolysis
时间窗: immediate after birth
Ly30-Index is used as marker for Hyperfibrinolysis
次要结局
未报告次要终点
