NCT04645004已完成1 期
Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PFA-100
研究概览
简要总结
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy
详细描述
This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •<16 weeks' gestational age
- •Singleton pregnancy
- •Plan to take 81mg aspirin due to high risk history (below), but not yet initiated
- •≥1 risk factor:
- •Chronic hypertension
- •Type I or II diabetes
- •Previous preeclampsia
- •Renal disease
- •Autoimmune disease (SLE) OR
- •≥2 risk factor:
- •Nulliparity
- •IVF pregnancy
- •Black race or socioeconomic disadvantaged
- •Prior adverse pregnancy outcome
排除标准
- •Contraindication to aspirin
- •Current or planned use of any other anticoagulation
- •Current need for dialysis
- •Use of aspirin therapy prior to enrollment in the current pregnancy
- •Thrombocytopenia (<150)
- •Other known platelet disorder/thrombophilia at enrollment
研究组 & 干预措施
Aspirin
Other
81mg aspirin daily
干预措施: Aspirin 81Mg Non-enteric coated Tab (Drug)
结局指标
主要结局
PFA-100
时间窗: 4 week post initiation
PFA-100 epi closure time (Siemens)
serum thromboxane
时间窗: 4 week post initiation
ELISA based quantification of serum thromboxane B2
salicylic acid level
时间窗: 24 hour
time/concentration profile
次要结局
- Urinary thromboxane(4 week post initiation)
研究者
研究点 (1)
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