A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 36
- 主要终点
- Occurrence of obstetrical complications among patients with rare vascular anomalies.
研究概览
简要总结
There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome or related, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby.
The purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death.
In this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years and ≤45 years at the time of inclusion
- •Pregnant and/or having given birth less than 1 month (≤ 30 days)
- •Clinically and/or radiological and/or molecular biology diagnosis of a rare vascular disease before or during pregnancy or one month after delivery.
- •Having been informed of all pertinent aspects of the study and provided oral non-opposition.
排除标准
- •Any person not fulfilling the inclusion criteria or refusing to take part in the study.
- •Major under legal protection
结局指标
主要结局
Occurrence of obstetrical complications among patients with rare vascular anomalies.
时间窗: Every 3 months up to 21 months
The primary outcome measure is the occurrence of specific and serious obstetrical complications during the pregnancy period and and after 12 months among patients with rare vascular anomalies, obtained via phone questionnaire.
次要结局
未报告次要终点