NCT07275476招募中不适用
Fibrin Clot Properties and Thrombin Generation in Pregnancy Women With and Without Obstetric Complications.
Jagiellonian University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fibrin clot phenotype
研究概览
简要总结
- The structure of fibrin clot and thrombin generation may vary between trimesters of pregnancy.
- Unfavorably altered fibrin clot properties along with enhanced thrombin generation may lead to the development of complications during pregnancy such as TE and hypertensive disorders.
- The application of machine learning techniques may help to identify previously undetected phenotypes with increased risk of TE and hypertensive disorders during pregnancy.
详细描述
Taken together, the integration of both fibrin clot properties and thrombin generation markers in pregnant women using modern science techniques may reveal new mechanisms explaining the relationship between altered fibrin clot properties and certain pregnancy complications. Moreover, it may help to identify new clot phenotypes of potential clinical significance, indicating prothrombotic risk or elevated chance of development of hypertensive disorders during pregnancy.
Specific working hypotheses:
- The structure of fibrin clot and thrombin generation may vary between trimesters of pregnancy.
- Unfavorably altered fibrin clot properties along with enhanced thrombin generation may lead to the development of complications during pregnancy such as TE and hypertensive disorders.
- The application of machine learning techniques may help to identify previously undetected phenotypes with increased risk of TE and hypertensive disorders during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •I. age 18-40 years; II. natural conception (without assisted reproductive techniques).
排除标准
- •I. use of hormonal therapy (i.e., oral contraceptives, progestogens) within 3 months before or during pregnancy; II. use of anticoagulants oral/subcutaneous within 3 months before or during pregnancy; III. increased risk factors of VTE (i.e., obesity - body mass index >30 kg/m2; smoking) or history of VTE; IV. Concomitant diseases, i.e: severe hypertension, diabetes mellitus, autoimmune diseases (i.e., systemic lupus erythematosus, antiphospholipid syndrome); V. congenital or acquired thrombophilia (i.e., mutation factor V Leiden, prothrombin mutation).
结局指标
主要结局
Fibrin clot phenotype
时间窗: 12 months
Fibrin clot phenotype
次要结局
未报告次要终点
研究者
Magdalena Piróg, MD
Principal Investigator
Jagiellonian University
研究点 (1)
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