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临床试验/NCT05127642
NCT05127642已完成不适用

Hemostatic Assessment of Postpartum Hemorrhage Cases Using Sonoclot Signature

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.

研究概览

简要总结

Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis.

Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery.

There are many causes of postpartum hemorrhage. Most cases develop from uterine atony, which accounts for 75% of cases. Even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency.

Coagulation plays an important role in postpartum hemostasis. Primary and especially secondary coagulation disorders are risk factors for Postpartum hemorrhage.

When bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. Recent studies show that fibrinogen concentration during the initial management of Postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage.

Various methods are used to record coagulation profile. One of them is estimation by sonoclot.

Viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count.

Identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of Postpartum hemorrhage and preventing severe maternal outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • patients in childbearing period.
  • Patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage).
  • Patients with causes of Postpartum hemorrhage like uterine atony, preeclampsia, blood diseases as inherited and prepartum acquired coagulopathies, and others e.g., acute fatty liver of pregnancy, amniotic fluid embolism, etc.

排除标准

  • Patients with bleeding after 24 hours from delivery (secondary postpartum hemorrhage).
  • Patients with miscarriages (bleeding before 22 weeks of gestation) or Antepartum hemorrhage.
  • Traumatic causes of postpartum hemorrhage e.g., rupture uterus, abruptio placenta, Lacerations, hematomas, Uterine inversion, and iatrogenic trauma.

研究组 & 干预措施

Postpartum hemorrhage patients

Controls (non postpartum hemorrhage patients)

结局指标

主要结局

Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Abdelnasser Mohammed Omran

resident doctor, clinical Pathology department.

Assiut University

研究点 (1)

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