NCT05878899已完成3 期
Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Recruitement rate
研究概览
简要总结
In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals
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
- None
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
- •adult women within 48h of delivery, with:
- •≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility
- •and/or ≥1 of the following 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 (<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight <5th percentile)
排除标准
- •any indication for therapeutic anticoagulation
- •a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
- •an increased bleeding risk
- •a contra-indication to the use of heparin
研究组 & 干预措施
Enoxaparin
Experimental
Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Recruitement rate
时间窗: 6 months
Number of study inclusion per month
Study participation
时间窗: Within 48 hours after delivery
Proportion of eligible women who are presented the study and who accept to participate
次要结局
- Venous thromboembolism(Within 90 day after delivery)
- Satisfaction with study intervention(After completion of the 10 days of study drug)
- Bleeding(Within 90 day after delivery)
- Surgical site complication(Within 90 day of delivery)
- Heparin-induced thrombocytopenia(Within 90 day of delivery)
- Septic pelvic thrombophlebitis(Within 90 day of delivery)
- All-cause mortality(Within 90 day of delivery)
研究者
Marc Blondon
Principal Investigator
University Hospital, Geneva
研究点 (1)
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