Low Molecular Weight hEparin vs. Aspirin Post-partum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
This is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.
详细描述
A single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks for women at moderate to high risk of developing VTE to determine feasibility of conducting a large non inferiority trial using the same regimens.
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
- •Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or
- •Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or
- •Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and
- •> 18 years of age.
排除标准
- •Pre-existing indication for therapeutic LMWH
- •Contraindication to ASA:
- •Known ASA allergy
- •Documented history of gastrointestinal ulcer
- •Known platelet count < 50x10^9/L at any time during the current pregnancy or postpartum
- •Contraindication to LMWH, e.g. known allergy
- •Active bleeding at any site, excluding physiological vaginal bleeding
- •Patients with bleeding disorders
- •Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum
研究组 & 干预措施
Prophylactic Low Molecular Weight Heparin (LMWH)
Prophylactic LMWH for 6 weeks postpartum
干预措施: Prophylactic low molecular weight heparin (Drug)
Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin
Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.
干预措施: Low molecular weight heparin and low-dose aspirin (Drug)
结局指标
主要结局
Enrollment Rate
时间窗: 1 year
Withdrawal of consent rate
时间窗: 1 year
Rates of contamination
时间窗: 6 weeks
List of the concurrent medication will be gathered on 3 week follow up, 6 week follow up and early discontinuation (before 6 weeks).
Consent Rate
时间窗: 1 year
Adherence to Prescription
时间窗: 6 weeks
Utilization of co-interventions for both: control group (6 week of Low Molecular Weight Heparin) or Treatment group (3 week of low molecular weight Heparin and 3 week of low dose aspirin).
次要结局
- VTE event rate(3 months)
- Bleeding assessment six weeks following delivery(6 weeks)
- Anticoagulation Satisfaction Assessment using the PACT Scale(6 weeks)