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Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)

RecruitingPhase 1, Phase 2Ages 16 Years - 55 YearsFemaleThomas Jefferson University
NCT06826859 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin resp

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📋 Eligibility rules (as published)
Inclusion Criteria * Singleton gestation gestational age \<16 0/7 weeks, dating confirmed with ultrasound * ≥1 high risk factor for preeclampsia or ≥2 moderate risk factors as per United States Preventative Services Task Force (2021) * Recommendation for 162mg aspirin daily in pregnancy * Age 16-55 years old Exclusion criteria * Contraindication to aspirin * Current or planned use of any other anticoagulation * Thrombocytopenia, other known platelet or bleeding disorder * Abnormally elevated baseline PFA-100 epinephrine closure time prior to aspirin initiation
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What it tests

  • Daily aspirin (ASA)
  • Split dose aspirin (ASA)
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Where

1 site
Thomas Jefferson University
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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