A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 825
- 试验地点
- 14
- 主要终点
- Incidence of MB and CRNMB
研究概览
简要总结
The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.
详细描述
The goal of this study is to provide quality data using standardized outcome definitions on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experience outcomes and health care utilization for intrapartum and postpartum anticoagulation management among pregnant individuals on low-molecular-weight heparin (LMWH) for prevention of treatment of 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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:
- •Objectively confirmed VTE (DVT, superficial vein thrombosis [SVT], PE or unusual site thrombosis) diagnosed during the current pregnancy;
- •Objectively confirmed VTE diagnosed in a prior pregnancy;
- •Objectively confirmed VTE diagnosed when not pregnant;
- •Inherited or acquired thrombophilia requiring anticoagulation.
- •Receiving any dose or type of LMWH during the antepartum period
排除标准
- •Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrial fibrillation, prevention of placenta-mediated pregnancy complications, or prevention of recurrent pregnancy loss (participants can be included with a diagnosis of antiphospholipid syndrome (APS) with or without thrombotic events)
- •Unable to provide or declined consent.
- •Home or birthing centre planned delivery.
结局指标
主要结局
Incidence of MB and CRNMB
时间窗: Delivery up to 6 weeks postpartum
To estimate the combined incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) for the six most common antepartum strategies.
次要结局
- Practice Patterns(Prior to delivery and following delivery)
- MB and CRNMB incidence in the immediate and 6 W postpartum period(Within 24 hours of delivery and up to 6 weeks postpartum)
- Incidence of VTE(Delivery to 6 weeks postpartum)
- Anti-Xa levels(Delivery)
- Patient Experience(Delivery)
- Healthcare Utilization(Before and after delivery)
- MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption(6 weeks postpartum)
- Wound Hematoma(Delivery to 6 weeks postpartum)
- Hemoglobin Levels around Delivery(Before and after delivery)