Comparing two doses of aspirin to prevent pregnancy-related high blood pressure issues

Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

This study is testing if a higher dose of aspirin can better prevent high blood pressure problems during pregnancy for women at risk.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10742 (estimated)
• Ages: 14 Years to 35 Years
• Sex: Female
• Sponsor: Ohio State University (Academic / other)
• Locations: 16 sites (Birmingham, Alabama and 15 other locations)
• Trial ID: NCT06468202 on ClinicalTrials.gov

What this trial studies

This trial aims to determine whether a higher dose of aspirin (162 mg/day) is more effective than a standard dose (81 mg/day) in preventing hypertensive disorders of pregnancy (HDP), such as preeclampsia and gestational hypertension, among at-risk individuals. The study will also explore factors influencing adherence to aspirin therapy to enhance the implementation of findings for broader public health benefits. Conducted as a pragmatic, comparative effectiveness trial, it will involve participants with specific high-risk criteria and will assess the impact of aspirin on maternal and neonatal health outcomes.

Who should consider this trial

Good fit: Ideal candidates include pregnant individuals under 17 weeks gestation with a history of preeclampsia or other specified high-risk conditions.

Not a fit: Patients who do not meet the high or moderate-risk criteria for hypertensive disorders of pregnancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prevention strategies for hypertensive disorders during pregnancy, potentially reducing maternal and neonatal complications.

How similar studies have performed: Previous studies have indicated the potential benefits of aspirin in preventing hypertensive disorders in pregnancy, but this specific comparative effectiveness approach is novel.

Eligibility criteria

Inclusion Criteria:

1. live intrauterine gestation ≤16 6/7 weeks gestational age based on best clinical obstetric estimate,
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:

1. 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),
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.

Where this trial is running

Birmingham, Alabama and 15 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• University of California, San Francisco — San Francisco, California, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)
• University of Mississippi — Jackson, Mississippi, United States (Recruiting)
• University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
• Columbia University — New York, New York, United States (Recruiting)
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (Recruiting)
• University of Pittsburg Magee — Pittsburgh, Pennsylvania, United States (Recruiting)
• Brown University — Providence, Rhode Island, United States (Recruiting)
• University of Texas, Houston — Houston, Texas, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)
• Inova HealthSystem — Falls Church, Virginia, United States (Recruiting)
• Eastern Virginia Medical School - Old Dominion University — Norfolk, Virginia, United States (Recruiting)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Maged Costantine, MD, MBA — Ohio State University
• Study coordinator: Maged Costantine, MD, MBA

Conditions Hypertensive Disorders of Pregnancy; Preeclampsia; Gestational Hypertension; Hypertensive disorders of pregnancy; Aspirin treatment; Pregnancy