Treatment With Aspirin After Preeclampsia: TAP Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent of participants eligible, enrolled and retained (feasibility)
研究概览
简要总结
The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
详细描述
This is a pilot randomized, single-center, double-blind placebo-control study of low dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or identical appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, Investigators and outcomes assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum individuals ≥18 years old
- •Preeclampsia diagnosis
排除标准
- •Fetal anomaly
- •Multiple gestation
- •Pre-pregnancy hypertension
- •Allergy or contraindication to low-dose aspirin
- •Pre-pregnancy diabetes
研究组 & 干预措施
Placebo Group
Similar appearing placebo pill daily for 6 months will be given to subjects.
干预措施: Placebo (Drug)
Intervention Group
Low-dose [81 mg] aspirin pill daily for 6 months will be given to subjects
干预措施: Low-dose aspirin (Drug)
结局指标
主要结局
Percent of participants eligible, enrolled and retained (feasibility)
时间窗: Baseline to approximately 6 months postpartum
To determine the feasibility of conducting a single-site randomized controlled trial of 6 months of postpartum low-dose aspirin vs. placebo in women with preeclampsia.
次要结局
- Study visit diastolic BP(6 months postpartum)
- Study visit systolic BP(6 months postpartum)
- Endothelial function EC50%(6 months postpartum)
- Change in diastolic blood pressure(2 to 6 months postpartum)
- Change in mean arterial pressure(2 to 6 months postpartum)
- Anti-hypertensive medication use(6 months postpartum)
- Therapeutic intensity score(6 months postpartum)
- Mean home diastolic blood pressure(delivery through 6 months postpartum)
- Mean home mean arterial pressure(delivery through 6 months postpartum)
- Study visit mean arterial pressure(6 months postpartum)
- Mean nocturnal systolic blood pressure(6 months postpartum)
- Mean daytime diastolic blood pressure(6 months postpartum)
- Classification of hypertension(6 months postpartum)
- Mean home systolic blood pressure(delivery through 6 months postpartum)
- Mean overall mean arterial pressure(6 months postpartum)
- Mean daytime systolic blood pressure(6 months postpartum)
- Mean nocturnal diastolic blood pressure(6 months postpartum)
- Mean nocturnal mean arterial pressure(6 months postpartum)
- Mean daytime mean arterial pressure(6 months postpartum)
- Mean overall systolic blood pressure(6 months postpartum)
- Mean overall diastolic blood pressure(6 months postpartum)
- Endothelial function Emax(6 months postpartum)
- Endothelial function change in EC50%(2 to 6 months postpartum)
- Change in systolic blood pressure(2 to 6 months postpartum)
- Endothelial function change in Emax(2 to 6 months postpartum)
- Study visit systolic BP(2 months postpartum)
- Study visit diastolic BP(2 months postpartum)
- Study visit mean arterial pressure(2 months postpartum)
- Anti-hypertensive medication use(2 months postpartum)
- Therapeutic intensity score(2 months postpartum)
- Classification of hypertension(2 months postpartum)
- Endothelial function EC50%(2 months postpartum)
- Endothelial function Emax(2 months postpartum)
研究者
Malamo Countouris
Assistant Professor
University of Pittsburgh