NCT01357941Unknown不适用
Prospective Study Assessing the Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Symptomatic venous thromboembolism
研究概览
简要总结
Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with prior VTE are based primarily on expert opinion and the optimal clinical management strategy remains unclear.
This multicentre, prospective cohort study aims to test the following hypotheses:
- Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort)
- Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)
All study patients will receive 6 weeks of postpartum prophylaxis.
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
- •Confirmed pregnancy (positive serum or urine)
- •At least 18 years of age
- •History of one prior episode of VTE consisting of DVT (diagnosed by compression ultrasonography [CUS] or venography) and/or PE (diagnosed by ventilation-perfusion [V/Q] lung scintigraphy, computed tomographic pulmonary angiography [CTPA], or traditional pulmonary angiography)
排除标准
- •Ongoing need for therapeutic anticoagulation for prevention or treatment of cardioembolic stroke
- •Known high-risk thrombophilia (specifically antithrombin deficiency, protein S deficiency, protein C deficiency, homozygosity for the factor V Leiden or prothrombin G20210A mutations, antiphospholipid antibody or compound abnormalities)
- •VTE within 3 months of the current pregnancy
- •Clinical risk factor for initial episode of VTE, if present, not resolved (excluding pregnancy)
- •Known contraindication to anticoagulation (including active, uncontrolled bleeding or major bleed within the previous 4 weeks)
- •For patients with prior unprovoked VTE, contraindication to LMWH (including allergy, HIT, impaired renal function, osteoporosis)
- •Geographic or social factors precluding follow-up
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
Symptomatic venous thromboembolism
时间窗: antepartum period (expected average 7 months)
Symptomatic objectively confirmed recurrent VTE, including proximal DVT, non-fatal PE, and fatal PE during antepartum period
次要结局
- Symptomatic recurrent venous thromboembolism(antepartum period (expected average 7 months) and first 3 months postpartum)
- Symptomatic recurrent pulmonary embolism(antepartum period (expected average 7 months) and first 3 months postpartum)
- Thrombocytopenia or heparin-induced thrombocytopenia (HIT)(antepartum period (expected average 7 months))
- Symptomatic osteoporosis(antepartum period (expected average 7 months) and first 3 months postpartum)
- Other complications(antepartum (expected average 7 months) and within first 3 months postpartum)
- Pregnancy complications and outcomes(antepartum period (expected average 7 months))
- Fetal anomalies(antepartum (expected average 7 months) and during first 3 months postpartum)
- Major and minor bleeding(antepartum (expected average 7 months))
研究者
研究点 (2)
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