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临床试验/NCT04253535
NCT04253535已完成不适用

A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2020年2月14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
91
试验地点
1
主要终点
Recurrence of CAD during pregnancy, childbirth or puerperium

研究概览

简要总结

Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.

详细描述

In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the University Hospital of Nantes.

To determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Extracranial carotid or vertebral dissection
  • Symptomatic dissection (with symptom onset within the last four weeks)
  • Spontaneous dissection
  • Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.

排除标准

  • Minors or adults under guardianship
  • Intracranial artery dissection
  • Traumatic or iatrogenic dissection
  • Patient refusal to participate

结局指标

主要结局

Recurrence of CAD during pregnancy, childbirth or puerperium

时间窗: Day 0

This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.

次要结局

  • To determine the absolute risk of recurrence of CAD in this population.(Day 0)
  • To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.(Day 0)
  • To study the reasons of absence of pregnancy after a history of CAD(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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