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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 New Mexico
  Albuquerque, New Mexico, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Maged Costantine, MD, MBA — Ohio State University
• Study coordinator: Maged Costantine, MD, MBA
• Email: Maged.Costantine@osumc.edu
• Phone: 614-293-2222

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Aspirin with or without low‑molecular‑weight heparin to prevent preeclampsia in high‑risk pregnancy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.