Actively Recruiting
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Led by Ohio State University · Updated on 2026-05-04
10742
Participants Needed
16
Research Sites
276 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.
CONDITIONS
Official Title
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Live intrauterine pregnancy at 16 weeks and 6 days gestational age or less based on best clinical obstetric estimate
- Age 14 years or older and able to provide informed consent
- At least one high-risk criterion: prior preeclampsia, chronic hypertension diagnosed before randomization, pre-gestational diabetes, twin gestation (including reduced higher order pregnancy to twins before 14 weeks), chronic kidney disease, or autoimmune disease
- Or two or more moderate-risk criteria: nulliparity, obesity (BMI 30 or higher), age 35 years or older, Black race, low income, personal risk factors (previous low birth weight or small for gestational age infant, unexplained stillbirth, placental abruption, pregnancy interval over 10 years), family history of preeclampsia, or in vitro fertilization
- Not currently on aspirin or on aspirin for obstetrical reasons with randomization before 13 weeks gestation or started aspirin within 2 weeks prior to randomization if after 13 weeks
You will not qualify if you...
- Allergy or hypersensitivity to aspirin or any condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal polyps, NSAID-induced asthma, active gastrointestinal bleeding, G6PD deficiency, severe liver dysfunction, bleeding disorders, history of bariatric surgery)
- Current or planned aspirin use in pregnancy for non-obstetrical reasons (e.g., previous stroke or heart attack)
- Age under 14 years
- Involuntary confinement or detention
- Reduced decision-making capacity
- Obstetrical ultrasound showing major congenital abnormality, suspected fetal aneuploidy, fetal demise, or planned pregnancy termination
- Participation in another trial affecting the primary outcome without prior approval
- Plan to deliver at a non-participating site without accessible medical records
- Monoamniotic twin pregnancy
- Participation in this trial in a prior pregnancy
- Triplet or higher order pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University of Mississippi
Jackson, Mississippi, United States, 39216
Actively Recruiting
6
University of New Mexico
Albuquerque, New Mexico, United States, 27710
Actively Recruiting
7
Columbia University
New York, New York, United States, 10032
Actively Recruiting
8
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
9
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
10
University of Pittsburg Magee
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
11
Brown University
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
University of Texas, Houston
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
14
Inova HealthSystem
Falls Church, Virginia, United States, 22042
Actively Recruiting
15
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, United States, 23501
Actively Recruiting
16
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Maged Costantine, MD, MBA
CONTACT
K
Kara Rood, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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