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Nonsteroidal Anti-inflammatory Drug
Low Dose Aspirin for Preeclampsia
Phase < 1
Recruiting
Research Sponsored by Anna Stanhewicz, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the study visit, an average of 4 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to determine whether taking low dose aspirin (LDA) can reduce long-term risk of cardiovascular disease in women who had preeclampsia during pregnancy.
Who is the study for?
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.
What is being tested?
The study investigates how low dose aspirin therapy affects blood vessel function after childbirth in women who had preeclampsia. Researchers will examine the microvascular function in the skin using intradermal microdialysis to deliver Acetylcholine and Endothelin-1 locally and analyze inflammatory cells from drawn blood.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects associated with similar procedures may include minor pain at injection sites, potential bruising or bleeding where blood is drawn; allergic reactions could occur if sensitivity to applied substances exists.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the study visit, an average of 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the study visit, an average of 4 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
microvascular endothelial function
microvascular endothelin-1-mediated constriction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: assessment of microvascular functionExperimental Treatment2 Interventions
The investigators use intradermal microdialysis to deliver acetylcholine, acetylcholine + L-NAME, endothelin-1, endothelin-1 + BQ-788, and endothelin-1 + BQ-123 to the cutaneous microvasculature.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcholine
2013
Completed Phase 2
~220
Endothelin-1
2008
N/A
~20
Find a Location
Who is running the clinical trial?
Anna Stanhewicz, PhDLead Sponsor
10 Previous Clinical Trials
362 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I used low-dose aspirin during a normal pregnancy.I have a liver, metabolic condition, or kidney disease with reduced kidney function.I take aspirin every day.I have a skin condition.I am taking medication to lower my cholesterol.I had preeclampsia and did not take low-dose aspirin during my pregnancy.I am currently taking medication for high blood pressure.I am 18 years old or older.I had preeclampsia and took low-dose aspirin during my pregnancy.I had a normal pregnancy without taking low dose aspirin.
Research Study Groups:
This trial has the following groups:- Group 1: assessment of microvascular function
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.