Diagnostic Exclusion Value of a Negative Single Distal and Proximal Lower Limb Veins Compression Ultrasonography in Pregnant and Post-partum Women With a Clinically Suspected Deep Vein Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Objectively confirmed thromboembolic events
研究概览
简要总结
The objective of the EDVIGE study is to determine whether a negative single distal and proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein thrombosis in pregnant and post-partum women with clinical suspicion of DVT.
详细描述
A single distal and proximal leg veins compression ultrasonography has been shown to safely rule out the diagnosis of DVT when negative. The safety of this strategy has never been verified in pregnant or postpartum women. It could however be limited in that clinical setting, because of modified hemodynamics, hampered observation conditions, lack of respiratory modulation, higher proportion of isolated iliac deep vein thromboses. The objective of the EDVIGE study is to assess the safety of this diagnostic strategy during pregnancy and post-partum.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with an ongoing pregnancy or within three-months post-partum and a clinically suspected deep vein thrombosis
排除标准
- •suspicion of pulmonary embolism
- •age less than 18 years
- •impossible follow-up
结局指标
主要结局
Objectively confirmed thromboembolic events
时间窗: 3 months
次要结局
未报告次要终点