Actively Recruiting
Comparative 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
56 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
Researchers are studying the prevention of hypertensive disorders of pregnancy (HDP), such as preeclampsia and gestational hypertension, which affect about 15% of pregnant individuals and disproportionately impact certain populations. The study aims to compare the effectiveness of two aspirin doses, 162 mg/day versus 81 mg/day, in preventing these conditions. It also seeks to understand factors influencing adherence to aspirin therapy to improve its implementation and benefits at the population level. Participants will be randomly assigned to take either 81 mg or 162 mg of aspirin daily during pregnancy. The study is designed as a large, pragmatic, comparative effectiveness trial with a quadruple masking approach to maintain objectivity. Researchers will monitor outcomes related to hypertensive disorders, maternal and neonatal health, and safety, as well as patient-reported experiences. The study will follow participants from early pregnancy through delivery and postpartum periods. During the trial, participants will be closely monitored for the development of hypertensive disorders from more than 20 weeks of gestation until hospital discharge after delivery, with follow-up extending up to six weeks postpartum. Researchers will collect data on preterm birth, maternal and neonatal complications, and adherence to aspirin therapy. Patient questionnaires on maternal health and bonding with the infant will also be included. The trial is sponsored by Ohio State University and is expected to continue until 2030, with participants involved from early pregnancy through the postpartum period.
CONDITIONS
Brief 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 or before 16 weeks and 6 days gestational age
- Age 14 years or older and able to provide informed consent
- At least one high-risk factor: prior preeclampsia, chronic hypertension before randomization, pre-gestational diabetes, twin gestation, chronic kidney disease, or autoimmune disease
- Or two or more moderate-risk factors: no prior delivery after 20 weeks, obesity (BMI 30 or higher), age 35 or older at due date, Black race, low income, personal risk factors like previous low birth weight infant, family history of preeclampsia, or in vitro fertilization
- Not currently on aspirin or started aspirin for pregnancy-related reasons within specified timing prior to randomization
You will not qualify if you...
- Allergy or contraindication to aspirin (e.g., active peptic ulcer, nasal polyps, asthma from NSAIDs, bleeding disorders, severe liver problems)
- Aspirin use for non-pregnancy reasons
- Age under 14 years
- Involuntary confinement or diminished decision-making capacity
- Major fetal abnormalities, fetal demise, suspected aneuploidy, or planned pregnancy termination
- Participation in another trial affecting the main outcome without approval
- Planning to deliver at a non-participating site without medical record access
- Monoamniotic twin pregnancy
- Prior participation in this trial during a previous pregnancy
- Triplets or higher order pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery, up to about 22 weeks
Participants take either 81 mg or 162 mg of aspirin daily to prevent hypertensive disorders of pregnancy.
Regular visits as part of routine prenatal care
Duration - Up to 6 weeks after delivery
Participants are monitored postpartum for up to 6 weeks to assess maternal and neonatal outcomes.
Approximately 1 to 2 postpartum visits
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
K
Kara Rood, MD
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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