Low Dose Aspirin for Preeclampsia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how low-dose aspirin reduces blood vessel issues in women who experienced preeclampsia, a pregnancy-related disorder. Researchers will examine aspirin's effects on small blood vessels in the skin and analyze blood samples for signs of inflammation. Eligible participants include women who are 12 weeks to 5 years postpartum and have had either preeclampsia or a normal pregnancy, regardless of aspirin use during pregnancy. As an Early Phase 1 trial, this research focuses on understanding aspirin's effects in people, offering participants a chance to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
The trial requires that you stop taking daily aspirin, statins, cholesterol-lowering medications, and antihypertensive medications to participate.
Is there any evidence suggesting that low dose aspirin is likely to be safe for humans?
Research has shown that low-dose aspirin is generally safe during pregnancy. Specifically, doses between 75 and 150 mg per day have been used to help prevent preeclampsia, a condition affecting some pregnant women. Studies suggest starting low-dose aspirin between 12 and 28 weeks of pregnancy for those at high risk of developing this condition.
Although safety data for doses up to 150 mg per day is limited, experts agree that low-dose aspirin is usually well-tolerated. Higher doses of aspirin are generally not recommended during pregnancy due to potential risks. Overall, low-dose aspirin is widely accepted and used for preventing preeclampsia, with few side effects reported in studies.12345Why do researchers think this study treatment might be promising for preeclampsia?
Researchers are excited about the use of low-dose aspirin for preeclampsia because it offers a potentially safer and more accessible option compared to current treatments, which often involve more intensive interventions like antihypertensive medications or early delivery. Aspirin is unique in its ability to improve microvascular function by influencing blood flow and reducing inflammation, which are crucial factors in managing preeclampsia. This approach could lead to better outcomes for both mothers and babies, making it a promising area of study.
What evidence suggests that low dose aspirin might be an effective treatment for preeclampsia?
Research has shown that taking low-dose aspirin can lower the risk of preeclampsia, a condition that can occur during pregnancy. Studies have found that aspirin can reduce the chance of developing preeclampsia by 34% when taken correctly. The best results come from taking 75-150 mg daily. Evidence also suggests that starting aspirin before 20 weeks of pregnancy is most effective. Although the exact mechanism of aspirin is not fully understood, it is believed to reduce inflammation and improve blood flow. Overall, low-dose aspirin is considered a reliable option for women at high risk of preeclampsia.16789
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older who are 12 weeks to 5 years postpartum. It's suitable for those with a history of normal pregnancy or preeclampsia, regardless of low dose aspirin use during pregnancy. Women currently on daily aspirin, with skin diseases, tobacco use, certain chronic diseases like reduced kidney function, using cholesterol medications or antihypertensives, prior hypertension or gestational diabetes, current pregnancy, underweight BMI (<18.5), or allergies to study materials and drugs cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo assessment of microvascular function using intradermal microdialysis and blood draws to isolate inflammatory cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aspirin
Aspirin is already approved in European Union, United States, Canada, China for the following indications:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
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Who Is Running the Clinical Trial?
Anna Stanhewicz, PhD
Lead Sponsor