Apixaban Versus Enoxaparin for Thromboprophylaxis After Delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
研究概览
简要总结
The purpose of this study is to compare the use of oral apixaban to subcutaneous enoxaparin for venous thromboembolism (VTE) prophylaxis in postpartum women at high risk for VTE. The primary goal is to evaluate medication adherence rates and patient satisfaction with the treatment.
详细描述
Venous thromboembolism (VTE) is a leading cause of pregnancy-related morbidity and mortality. Current guidelines recommend pharmacologic thromboprophylaxis with low-molecular-weight heparin (LMWH), such as enoxaparin, for postpartum women with increased risk factors. However, common patient complaints related to enoxaparin include injection site reaction, pain, bruising, bleeding, nausea, vomiting, and cost. Oral anticoagulation therapy, such as apixaban (an oral factor Xa inhibitor), could obviate many of these negative effects.This single-center, prospective, open-blinded randomized controlled trial aims to investigate the use of apixaban versus enoxaparin for VTE prophylaxis in the postpartum period. Eligible postpartum women (after vaginal or cesarean delivery) with high risk for VTE will be randomized in a 1:1 ratio.
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
- •Age ≥ 18 years.
- •After Vaginal or C/S delivery.
- •Need prophylactic treatment in a preventive dose.
- •Presence of one or more high risk factors: Active infection, IBD, Heart disease, Type 1 diabetes with nephropathy, IV drug user, Surgical operation in Postpartum period, Emergency cesarean section.
- •OR presence of 2 low risk factors: Age > 35, post-partum hemorrhage > 1000 ml, Cesarean section, Hysterectomy, BMI > 30, Multiparity- Third birth or more, Active Smoking, Obstetric complications in current pregnancy (including preeclampsia, preterm birth before 37 weeks, active infection including chorioamnionitis, prolonged labor over 24 hours), Twin birth, Immobility, Large varicose veins, Stillbirth
排除标准
- •Breast feeding.
- •Predispose to hypercoagulability
- •Familial history of VTE.
- •Antiphospholipid syndrome (APS).
- •Prior VTE.
- •Anticoagulant treatment before or during pregnancy.
- •BMI > 40
- •History of severe renal or hepatic disease.
- •Use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
- •Known diagnosis of bleeding dyscrasia (eg, von Willebrand disease).
- •Spinal/epidural hematoma or spinal puncture.
- •Active pathological bleeding or high risk of bleeding.
- •Hemoglobin > 9 mg/dl before the delivery.
结局指标
主要结局
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
时间窗: up to 6 weeks postpartum
Patient-reported treatment convenience assessed using a study-specific questionnaire. The primary measurement is an 11-point general convenience Visual Analog Scale (VAS) where patients rate the overall convenience of their assigned post-partum anticoagulant treatment (oral vs. subcutaneous) from 0 ("Not convenient at all") to 10 ("Very convenient"). Higher scores indicate a higher level of treatment convenience. The outcome also incorporates a categorical question evaluating whether the treatment was easy to take/receive (categorized as: Agree, Neutral, Disagree).
Medication Adherence Rate Assessed by Patient Self-Report
时间窗: Up to 6 weeks postpartum
Adherence to the prescribed thromboprophylaxis regimen, assessed via patient self-report within the study questionnaire. Adherence is evaluated through targeted categorical questions regarding compliance: (1) whether the patient faced difficulties remembering to take the medication, and (2) whether any dose was missed during the hospitalization period. Responses are categorized as "Agree," "Neutral," or "Disagree." The outcome will be reported as the percentage of patients who demonstrated adherence (i.e., no missed doses and no memory difficulties) versus non-adherent patients
Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS)
时间窗: Up to 6 weeks postpartum
Intensity of pain specifically associated with the administration of the assigned anticoagulant therapy. This is evaluated using an 11-point Visual Analog Scale (VAS) embedded in the questionnaire. Patients who report experiencing treatment-related pain rate its intensity on a scale ranging from 0 ("No pain at all") to 10 ("Unbearable pain"). Lower scores indicate lower pain levels and better treatment tolerance.
Patient Treatment Preference and Recommendation Assessed by Self-Report
时间窗: Up to 6 weeks postpartum
Patient preference for future short-term preventative treatment options based on their experience during the clinical trial. Patients select their preferred route of administration from three options: Oral tablets, Subcutaneous injections, or No preference. Additionally, the assessment includes a categorical question on whether the patient would recommend their assigned treatment to another person (Categorized as: Agree, Disagree, Do not know). Results will be presented as the proportion (%) of patients in each preference and recommendation category.
次要结局
- Incidence of Venous Thromboembolism (VTE)(up to 6 weeks postpartum)
- Incidence of major bleeding and bleeding events(up to 6 weeks postpartum)
- Decrease in hemoglobin values(From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days))
- Incidence of adverse events(up to 6 weeks postpartum)
- ACTS Burden Score(Up to 6 weeks postpartum)
- ACTS Benefit Score(Up to 6 weeks postpartum)
- Treatment Convenience Score(Up to 6 weeks postpartum)
研究者
Ron Beloosesky MD
Head of the Gynecology and Obstetric Ultrasonography Unit.
Rambam Health Care Campus