跳至主要内容
临床试验/NCT03920332
NCT03920332已完成不适用

Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

University Hospital, Geneva3 个研究点 分布在 3 个国家目标入组 149 人开始时间: 2019年9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
149
试验地点
3
主要终点
Prevalence of normal issue pregnancy

研究概览

简要总结

The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

详细描述

Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
  • At lest one past pregnancy

排除标准

  • No past pregnancy
  • Not confirmed fibrinogen disorder

结局指标

主要结局

Prevalence of normal issue pregnancy

时间窗: At inclusion

All pregnancy not resulting in miscarriage, stillbirth or abortion

次要结局

  • Prevalence of pregnancy without complications(At inclusion)
  • Post-partum complications(At inclusion)
  • Modalities of delivery(At inclusion)
  • Fibrinogen variations(At inclusion)

研究者

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

Casini Alessandro

MD, Principal Investigator

University Hospital, Geneva

研究点 (3)

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