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NCT06826859RecruitingPhase 1/2

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

Dose Based Aspirin Pharmacokinetics and Pharmacodynamics in Pregnancy and Association With Pregnancy Outcomes

Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
400 (estimated)
First submitted
28 Jan 2025
Start date
26 Jun 2025
Primary completion date
1 Jul 2029
Lead sponsor
Thomas Jefferson University
NCT number
NCT06826859

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 400
  • From 26 Jun 2025 to the primary completion date, 1 Jul 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Abnormally elevated baseline PFA-100 epinephrine closure time prior to aspirin initiation

Lab values

  • Thrombocytopenia, other known platelet or bleeding disorder

Other

  • Contraindication to aspirin
  • Current or planned use of any other anticoagulation

Who the study is looking for

  • 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

Age in the registry: 16 years to 55 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Thomas Jefferson University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.