Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Prophylactic peak anti-Xa level
研究概览
简要总结
The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery women. Half of participants will receive a fixed dose of LMWH, while the other half will receive a weight-based dose. The hypothesis is that the use of a weight-based dose will result in more women reaching prophylactic levels.
详细描述
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The immediate postpartum period is a high risk time for VTE, and cesarean delivery is an additional risk factor. In the United States, use of postpartum VTE prophylaxis with low-molecular weight heparin (LMWH) is commonly used but without a standard protocol or dose across all hospitals. A fixed-dose of LMWH is frequently used based on data from non-obstetric studies. However, there are concerns that in the postpartum population this fixed dose may not be adequate for prophylaxis.
This study aims to evaluate the efficacy of fixed dose versus weight-based LMWH to reach prophylactic anti-Xa levels in post-cesarean delivery women. This will be a randomized controlled trial (RCT) with half of participants receiving a fixed dose of LMWH and half of participants receiving a weight-based dose of LMWH. The hypothesis is that the use of a weight-based LMWH compared to a fixed dose will result in more women achieving prophylactic anti-Xa levels.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cesarean delivery
- •Meet facility guidelines for postpartum venous thromboembolism (VTE) prophylaxis: Presence of 1 major, or 2 or more moderate, risk factors.
- •Major risk factors: history of venous thromboembolism, high risk thrombophilia, BMI ≥40, high risk medical comorbidities (heart disease, sickle cell disease, systemic lupus erythematosus, inflammatory bowel disease), cesarean hysterectomy, nephrotic range proteinuria, or cesarean intrapartum/during labor
- •Moderate risk factors: BMI > 30, multifetal pregnancy, postpartum hemorrhage (>1L blood loss), tobacco use, non-laboring or elective cesarean, preeclampsia, infection, preterm delivery (< 37 weeks gestational age), age > 35 years, low risk thrombophilia, family history of venous thromboembolism, stillbirth, varicose veins, prolonged labor (> 24 hours)
排除标准
- •Contraindication to anticoagulation
- •Plan for therapeutic anticoagulation (antepartum or postpartum)
- •Known renal dysfunction (Creatinine clearance < 30 mL/minute)
研究组 & 干预措施
Weight-based LMWH
Participants will receive a weight-based dose of prophylactic enoxaparin.
- For all BMI groups: 0.5mg/kg rounded to the nearest 10mg will be injected subcutaneously every 12 hours
干预措施: Enoxaparin (Drug)
Fixed LMWH
Participants will receive a fixed dose of prophylactic enoxaparin.
- For BMI <40: 40mg injected subcutaneously every 24 hours
- For BMI > or = to 40: 40mg injected subcutaneously every 12 hours
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Prophylactic peak anti-Xa level
时间窗: Postoperative day #3 at peak (4-6 hours post-dose)
Anti-Xa level in prophylactic range (0.2 to 0.6 IU/mL)
次要结局
- Wound Complications(From delivery through 6 weeks postpartum)
- Venous thromboembolism(From delivery through 6 weeks postpartum)
研究者
Torri Metz
Principal Investigator
University of Utah