Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Key facts
- Where
- Albuquerque, Austin, Birmingham, Chapel Hill, Chicago, Columbus, Falls Church, Greenville, Houston, Jackson, Los Angeles, Milwaukee, New Orleans, New York, Norfolk, Pittsburgh, Providence, Salt Lake City, and San Francisco, United StatesSee the 20 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 35 years old?
Source: NCT06468202, who can take part
Where in United States
- University of New MexicoAlbuquerque, United StatesTaking people
- Austin Maternal Fetal MedicineAustin, United StatesNot yet recruiting
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- University of North Carolina, Chapel HillChapel Hill, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbus, United StatesTaking people
- Inova HealthSystemFalls Church, United StatesTaking people
- University of South Carolina GreenvilleGreenville, United StatesNot yet recruiting
- Baylor College of MedicineHouston, United StatesNot yet recruiting
- University of Texas HoustonHouston, United StatesTaking people
- University of MississippiJackson, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Ochsner Baptist Medical CenterNew Orleans, United StatesNot yet recruiting
- Columbia UniversityNew York, United StatesTaking people
- Eastern Virginia Medical School - Old Dominion UniversityNorfolk, United StatesTaking people
- University of Pittsburg MageePittsburgh, United StatesTaking people
- Brown UniversityProvidence, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ohio State University
- Trial code
- NCT06468202
- Record updated
- 27 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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).
Exclusion: current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction),; participation in another trial that affects the primary outcome, without prior approval of the PI,; participation in this trial in prior pregnancy,; 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),; 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,; 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,; triplet or higher order pregnancy.