Hypertensive Disorders of PregnancyPhase 4ASPIRINNCT06468202
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
A Phase 4 study testing Aspirin 81 mg and Aspirin 162 mg in people with Hypertensive Disorders of Pregnancy and Preeclampsia, run by Ohio State University at 16 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 35 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension
- What is being tested?
- Aspirin 81 mg and Aspirin 162 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,742 participants
- Where
- 16 sitesUnited States
- Study dates
- 18 Oct 2024to 1 Feb 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- live intrauterine gestation ≤16 6/7 weeks gestational age based on best clinical obstetric estimate,
- age 14 years or older and able to provide informed consent,
- 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)
- 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
- 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).
Who cannot join
- known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal polyps, NSAID-induced asthma, active gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, history of bariatric surgery),
- current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction),
- age < 14 years,
- involuntarily confined or detained,
- considered as having a diminished decision-making capacity,
- obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination,
Show all 11Show fewer
- participation in another trial that affects the primary outcome, without prior approval of the PI,
- plan to deliver at an outside participating site with inability to obtain medical records,
- monoamniotic twin gestation because of the risk of fetal demise and preterm delivery,
- participation in this trial in prior pregnancy,
- triplet or higher order pregnancy.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 27710
Christina Yarrington, MD, CYarrington@salud.unm.edu
Karen S Taylor, kataylor@salud.unm.edu
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Akila Subramaniam, MD, MPH, asubramaniam@uabmc.edu
Donna Campbell, PhD, 205-996-6268, dcampbell@uabmc.edu
- Recruiting
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
Kim Boggess, MD, kim_boggess@med.unc.edu
Kelly Clark, Kelly_Clark@med.unc.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Michelle Kominiarek, MD, Michelle.Kominiarek@nm.org
Catherine Arguelles, catherine.marek@nm.org
- Recruiting
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
Maged Costantine, MD, MBA, 614-293-2222, Maged.Costantine@osumc.edu
Kara Rood, MD, 614-293-8045, Kara.Rood@osumc.edu
- Recruiting
Inova HealthSystem
Falls Church, Virginia, 22042
Antonio Saad, MD, Antonio.Saad@inova.org
Michelle Cassidy, PhD, RN, 703-776-4600, Michelle.Cassidy@inova.org
- Recruiting
University of Texas, Houston
Houston, Texas, 77030
Baha Sibai, MD, Baha.M.Sibai@uth.tmc.edu
Sunbola Ashimi, PhD, Sunbola.S.Ashimi@uth.tmc.edu
- Recruiting
University of Mississippi
Jackson, Mississippi, 39216
Rachel Morris, MD, morris@umc.edu
Laura Coats, Lcoats@umc.edu
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Kimberly Gregory, MD, MPH
Samia Saeb, Samia.Saeb@cshs.org
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Anna Palatnik, MD, apalatnik@mcw.edu
Alyssa Hernandez, DO, 414-955-2781, alyhernandez@mcw.edu
- Recruiting
Columbia University
New York, New York, 10032
Matthew Hoffman, MD, (646) 284-5360, mh4795@cumc.columbia.edu
Cassandra Almonte, ca2344@cumc.columbia.edu
- Recruiting
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, 23501
George Saade, MD, SaadeGR@EVMS.edu
Kristin Ayers, ayerskl@evms.edu
- Recruiting
University of Pittsburg Magee
Pittsburgh, Pennsylvania, 15213
Hyagriv Simhan, MD, simhhn@upmc.edu
Jeanette Boyce, tessje@upmc.edu
- Recruiting
Brown University
Providence, Rhode Island, 02905
William Grobman, MD, MBA, WGrobman@KentRI.org
Angelica Demartino, (401) 274-1122 ext. 48521, AMDemartino@CareNE.org
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Torri Metz, MD, Torri.Metz@hsc.utah.edu
Amber Sowles, BSN, RN, 801-585-5499, Amber.Sowles@hsc.utah.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Mary Norton, MD, (415) 476-4080, Mary.Norton@ucsf.edu
Nuriye Sahin-Hodoglugil, DrPH, nuriye.sahin-hodoglugil@ucsf.edu
About this study
Official title: Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
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.
Read the detailed description
Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) and gestational hypertension (gHTN), occur in ~15% of pregnant individuals, disproportionately affect self-identified non-Hispanic Black individuals (with the understanding that race is a socially defined construct and the inequity is related to social determinants of health), are increasing in frequency, and are associated with short- and long-term maternal and neonatal morbidities and mortality. There are currently no available therapeutics to treat individuals with HDP; thus, developing interventions for the prevention of HDP is of substantial public health significance. The U.S. Preventive Services Task Force (USPSTF) and other professional societies recommend or endorse the use of aspirin for prevention of HDP in individuals at high or moderate risk. However, there is great uncertainty regarding optimal dosing, whether there is heterogeneity of effectiveness of aspirin in reducing the risk of HDP among different populations, and what factors are associated with adherence.
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.
- Being tested
- Aspirin 81 mg, Aspirin 162 mg
- Keywords
- Hypertensive disorders of pregnancy, Aspirin treatment, Pregnancy, Preeclampsia
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81 mgDrug
Participants will be assigned to 81mg Aspirin
Aspirin 162 mgDrug
Participants will be assigned to 162mg Aspirin
| Study group | Role | What they receive |
|---|---|---|
| 81 mg Aspirin | Experimental | Treatment A consisting of 81mg of aspirin (1 pill of 81mg \& 1 matching placebo) daily Receives: Drug: Aspirin 81 mg |
| 162 mg Aspirin | Experimental | Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily Receives: Drug: Aspirin 162 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertensive Disorder of Pregnancy (HDP)
HDP defined as preeclampsia or antepartum gHTN based on ACOG criteria
Measured: From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks
Secondary outcomes (15)
Preeclampsia
preeclampsia based on ACOG criteria
Measured: From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks
Preterm preeclampsia
Preeclampsia per ACOG criteria with delivery < 37 weeks'
Measured: From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks
Postpartum preeclampsia
Postpartum preeclampsia per ACOG criteria
Measured: From delivery weeks till 6 weeks postpartum; 6 weeks
Gestational hypertension
Gestational hypertension per ACOG criteria
Measured: From >20 weeks until onset of labor, up to 22 weeks
Severe maternal morbidity
Need for intensive care, maternal admission to a hospital within the first 42 days postpartum for obstetric complications, or blood product transfusion
Measured: From randomization up to 6 weeks postpartum, up to 48 weeks
Core preeclampsia outcomes
Composite and individual maternal outcomes (Mortality, Eclampsia, Stroke, Cortical blindness, Retinal detachment, Pulmonary edema, Acute kidney injury, Liver capsule hematoma, Placental abruption, Postpartum hemorrhage, Elevated liver enzymes, Thrombocytopenia, ICU admission, Mechanical ventilation)
Measured: From randomization up to 6 weeks postpartum, up to 48 weeks
Bleeding complications (maternal)
Antepartum bleeding and Placental abruption
Measured: From randomization till delivery up to 36 weeks, up to 36 weeks
Bleeding complications (maternal)
Postpartum hemorrhage
Measured: From delivery till hospital discharge, up to 1 week
Adherence to aspirin
pill count
Measured: From randomization until last day of medication intake, up to 42 weeks
Preterm birth
Delivery <37 weeks
Measured: At time of delivery
Gestational age at birth
Gestational age in weeks at time of delivery
Measured: At time of delivery
Core offspring/neonatal outcomes
Composite and individual neonatal outcomes (Stillbirth, SGA, Neonatal mortality, Neonatal seizures, Admission to NICU, Respiratory support)
Measured: up to 6 weeks post-delivery
Rate of SGA
Rate of birthweight <10th percentile
Measured: At time of birth
Bleeding complications (neonatal)
Any neonatal intraventricular or intracranial hemorrhage
Measured: Up to 6 weeks post-delivery
Complications of prematurity and neonatal safety outcomes
Composite of RDS, Grade III-IV IVH, PVL, Stage 2/3 NEC, BPD, Stage III or higher ROP, or early onset sepsis
Measured: Up to 6 weeks post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start18 Oct 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double-blind, multicenter, comparative effectiveness trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10,742 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Northwestern University, Preeclampsia Foundation
- Responsible party
- Principal investigator, Maged Costantine, Ohio State University
- Investigators
- Maged Costantine, MD, MBA, Principal investigator, Ohio State UniversityDenise Sholtens, PhD, Principal investigator, Northwestern University Data Analysis and Coordinating Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468202
- Sponsor's protocol ID
- Pro00079100
- Acronym
- ASPIRIN
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No