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临床试验/NCT05975112
NCT05975112招募中不适用

The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2023年6月1日最近更新:
适应症

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

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

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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