Low Dose Aspirin for Preeclampsia
Trial Summary
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.
What data supports the effectiveness of the drug low-dose aspirin for preventing preeclampsia?
Is low-dose aspirin safe for pregnant women and their babies?
How does low-dose aspirin differ from other drugs for preeclampsia?
Low-dose aspirin is unique in its ability to selectively inhibit thromboxane, a substance that increases blood pressure and reduces blood flow to the placenta, without significantly affecting prostacyclin, which promotes blood flow and reduces blood pressure. This makes it particularly effective in preventing preeclampsia in high-risk pregnancies, and it is considered safe for both the mother and fetus.13489
What is the purpose of this trial?
Preeclampsia is a pregnancy disorder affecting \~5-10% of pregnancies in the United States. Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. Low dose aspirin (LDA; 75-150mg/daily) is currently the most effective and clinically accepted therapy for reducing preeclampsia prevalence in women at high risk for developing the syndrome. The purpose of this study is to interrogate the mechanisms by which LDA therapy mitigates persistent vascular dysfunction in postpartum women who have had preeclampsia.In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had a history of preeclampsia. As a compliment to these measurements, they also draw blood from the subjects and isolate the inflammatory cells.
Eligibility Criteria
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
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
Treatment Details
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anna Stanhewicz, PhD
Lead Sponsor