A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures
研究概览
简要总结
The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.
详细描述
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.
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
- 是
入选标准
- •Cesarean delivery at the University of Utah Health
排除标准
- •Contraindication to anticoagulation
- •Plan for therapeutic anticoagulation
- •Known renal dysfunction (creatinine clearance <30mL/minute)
- •History of venous thromboembolism
- •High risk thrombophilia
- •Receipt of antepartum anticoagulation for >2 weeks
研究组 & 干预措施
Enoxaparin
Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures
时间窗: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks
Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures
次要结局
- Rate of Venous Thromboembolism(6 Weeks)
- Rate of Wound Hematoma or Infection(6 Weeks)
- Rate of Bleeding Complications(6 Weeks)
研究者
Ann Bruno
Assistant Professor Obstetrics And Gynecology
University of Utah