NCT07140211招募中3 期
Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study
Marc Blondon8 个研究点 分布在 1 个国家目标入组 9,200 人开始时间: 2025年10月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9,200
- 试验地点
- 8
- 主要终点
- Venous thrombotic outcomes
研究概览
简要总结
The goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). The main questions it aims to answer are:
- compared to no treatment, does short-term postpartum LMWH modify the risk of venous thromboembolism within 90 days of delivery?
- compared to no treatment, does short-term postpartum LMWH modify the risks of bleeding and wound complications? Participants will take low-dose LMWH for 7-10 days or no treatment, and will be followed for 90 days post-delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •postpartum women after delivery AND ≥1 major risk factor / ≥2 minor risk factors:
- •Major risk factors: Emergency cesarean section ; Pre-pregnancy BMI ≥35kg/m2 ; Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) ; Pre-eclampsia ; Pre-term delivery ; Peripartum systemic infection ; Intra-uterine growth restriction ; Pregnancy loss
- •Minor risk factors: Age ≥35 years ; Pre-pregnancy BMI 30.0-34.9kg/m2 ; Current smoking ; Elective cesarean section ; Postpartum hemorrhage ; Antenatal immobility
排除标准
- •≥2 doses of postpartum LMWH
- •Any indication for therapeutic anticoagulation
- •A high-risk of postpartum VTE
- •An increased bleeding risk
- •A contra-indication to heparin
研究组 & 干预措施
No treatment
No Intervention
Low-molecular-weight heparin
Experimental
干预措施: Low-dose low-molecular-weight heparin (Drug)
结局指标
主要结局
Venous thrombotic outcomes
时间窗: Within 90 days post-randomization
Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism)
次要结局
- Heparin-induced thrombocytopenia(Within 90 days post-randomization)
- Bleeding(Within 90 days post-randomization)
- All-cause mortality(Within 90 days post-randomization)
- Maternity clot risk(Within 90 days post-randomization)
- VTE surveillance (imaging)(Within 90 days post-randomization)
- Duration of hospital stay(Within 90 days post-randomization)
- Serious adverse events(Within 90 days post-randomization)
- Surgical site / perineal complications, and endometritis(Within 90 days post-randomization)
- Septic pelvic thrombosis(Within 90 days post-randomization)
- Superficial vein thrombosis(Within 90 days post-randomization)
- Stroke and cerebral vein thrombosis(Within 90 days post-randomization)
- Persistent lochia(At 42 day post-randomization)
- Maternal quality of life(At 14 days post-randomization)
研究者
Marc Blondon
Principal Investigator
University Hospital, Geneva
研究点 (8)
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