The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Incidence of Diagnosis of Preeclampsia
研究概览
简要总结
Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.
详细描述
Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI at enrollment >/= 30
- •plan for ASA for preeclampsia prevention
排除标准
- •BMI < 30
- •already on ASA
研究组 & 干预措施
162mg daily aspirin dose
obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA
干预措施: 162mg aspirin dose (Drug)
结局指标
主要结局
Incidence of Diagnosis of Preeclampsia
时间窗: Through study completion, an average for 10 months
by acog definitions
次要结局
- Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2(Through study completion, an average for 10 months)
研究者
Kara M Rood, MD
Prinicple Investigator
Ohio State University