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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT06826859
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Preeclampsia
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Daily aspirin (ASA) — DRUG
    162mg aspirin taken daily
  • Split dose aspirin (ASA) — DRUG
    81mg aspirin q12hours

Study Details

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 response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.

Key Dates

Start date
Jun 26, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Daily aspirin
    162mg aspirin daily
  • Experimental: Split dose aspirin
    81mg aspirin q12 hours

Primary Outcome Measure

Aspirin Response PFA-100 epinephrine closure time (seconds) [ Time Frame: 2-4 weeks after aspirin initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19060
Rupsa C Boelig, MD
[email protected]
215-955-5000
Brandy Firman
[email protected]
Rupsa C Boelig, MD (PRINCIPAL_INVESTIGATOR)

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