NCT00695942已完成不适用
Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- sFlt1/plGF ratio
研究概览
简要总结
Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.
详细描述
Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of PVP and VTE.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •previous history of one or more PVC episodes (preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR<10th percentile, recurrence miscarriage >2, unexplained IUFD or IUFD after abruption placentae, eclampsia.
- •Previous history of personal VTE
- •Diabete (treated with diet or insulin)
- •chronic hypertension
- •chronic renal pathology
- •Antihopholipids syndrome
- •early and late pregnancy (<18 years, >38 years)
- •family history of cardiovascular disease of VTE
- •known biological thrombophilia without any personal past history of PVC or VTE
排除标准
- •Multiple pregnancy
- •past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection
- •previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly
结局指标
主要结局
sFlt1/plGF ratio
时间窗: 20, 24, 28, 32, 36 weeks
次要结局
- SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE(20, 24, 28, 32, 36 SA)
- thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE(20, 24, 28, 32 and 36 weeks)
- echographic data as potential predictive factors of VTE and or PVP(22 and 32 weeks)
- sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE(20, 24, 28, 32 and 36 weeks)
研究者
研究点 (3)
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