Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
NCT ID: NCT06468202
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
10742 participants
INTERVENTIONAL
2024-10-18
2030-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 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. The trial will achieve the following specific aims:
Specific Aim 1: To compare the frequency of HDP (primary outcome), as well as other important secondary outcomes (gHTN, PE, preterm PE, PE-related adverse outcomes, aspirin-related safety outcomes, and patient-reported outcomes related to maternal health, pregnancy, and childbirth experiences) between the two aspirin treatment arms.
Specific Aim 2: To compare the gestational age at birth and the frequency of adverse perinatal outcomes (preterm birth, perinatal death, small-for-gestational-age birth, neonatal intensive care unit admission, and complications of prematurity), as well as patient-reported outcomes related to maternal-infant bonding between the two aspirin treatment arms.
Specific Aim 3: To use quantitative and qualitative analyses to elucidate facilitators and barriers associated with adherence to aspirin therapy in at-risk individuals during pregnancy in order to facilitate future implementation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
81 mg Aspirin
Treatment A consisting of 81mg of aspirin (1 pill of 81mg \& 1 matching placebo) daily
Aspirin 81 mg
Participants will be assigned to 81mg Aspirin
162 mg Aspirin
Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily
Aspirin 162 mg
Participants will be assigned to 162mg Aspirin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aspirin 81 mg
Participants will be assigned to 81mg Aspirin
Aspirin 162 mg
Participants will be assigned to 162mg Aspirin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. age 14 years or older and able to provide informed consent,
3. at least one of the following high-risk criteria: i) any prior pregnancy complicated by preeclampsia ii) current pregnancy complicated by chronic hypertension diagnosed before randomization (ACOG) iii) pre-gestational diabetes (on medication for diabetes prior to pregnancy, or diabetes is diagnosed prior to randomization with hemoglobin A1C of 6.5% or greater or abnormal 3-hour glucose tolerance test) iv) twin gestation (including higher order pregnancy reduced to twins prior to 14 weeks) v) chronic kidney disease vi) autoimmune disease (e.g., antiphospholipid syndrome, systemic lupus erythematous)
4. or two or more moderate-risk criteria for HDP (per USPSTF), i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of randomization) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) low income vi) personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome \[unexplained stillbirth\], placental abruption, interval \>10 years between pregnancies) vii) Family history of preeclampsia (i.e., mother or sister) viii) In vitro fertilization
5. patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- randomized before 130/7 weeks gestation, or ii- randomized on or after 13 0/7 weeks gestation and started aspirin within 2 weeks prior to randomization (e.g., aspirin started for HDP prevention at 12 0/7 weeks and patient randomized at 13 2/7 weeks).
Exclusion Criteria
2. current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction),
3. age \< 14 years,
4. involuntarily confined or detained,
5. considered as having a diminished decision-making capacity,
6. obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination,
7. participation in another trial that affects the primary outcome, without prior approval of the PI,
8. plan to deliver at an outside participating site with inability to obtain medical records,
9. monoamniotic twin gestation because of the risk of fetal demise and preterm delivery,
10. participation in this trial in prior pregnancy,
11. triplet or higher order pregnancy.
14 Years
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Patient-Centered Outcomes Research Institute
OTHER
Northwestern University
OTHER
Preeclampsia Foundation
OTHER
Ohio State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maged Costantine
MD, MBA, Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maged Costantine, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Denise Sholtens, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University Data Analysis and Coordinating Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
University of Mississippi
Jackson, Mississippi, United States
University of New Mexico
Albuquerque, New Mexico, United States
Columbia University
New York, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
University of Pittsburg Magee
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
University of Texas, Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Inova HealthSystem
Falls Church, Virginia, United States
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Akila Subramaniam, MD, MPH
Role: primary
Donna Campbell, PhD
Role: backup
Kimberly Gregory, MD, MPH
Role: primary
Samia Saeb
Role: backup
Mary Norton, MD
Role: primary
Nuriye Sahin-Hodoglugil, DrPH
Role: backup
Michelle Kominiarek, MD
Role: primary
Catherine Arguelles
Role: backup
Rachel Morris, MD
Role: primary
Laura Coats
Role: backup
Christina Yarrington, MD
Role: primary
Karen S Taylor
Role: backup
Uma Reddy, MD
Role: primary
Cassandra Almonte
Role: backup
Kim Boggess, MD
Role: primary
Kelly Clark
Role: backup
Maged Costantine, MD, MBA
Role: primary
Kara Rood, MD
Role: backup
Hyagriv Simhan, MD
Role: primary
Jeanette Boyce
Role: backup
William Grobman, MD, MBA
Role: primary
Angelica Demartino
Role: backup
Baha Sibai, MD
Role: primary
Sunbola Ashimi, PhD
Role: backup
Torri Metz, MD
Role: primary
Amber Sowles, BSN, RN
Role: backup
Antonio Saad, MD
Role: primary
Michelle Cassidy, PhD, RN
Role: backup
George Saade, MD
Role: primary
Kristin Ayers
Role: backup
Anna Palatnik, MD
Role: primary
Alyssa Hernandez, DO
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00079100
Identifier Type: -
Identifier Source: org_study_id