RightFit
RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two aspirin schedules: 162 mg once a day or 81 mg twice a day. It is for pregnant people at higher risk of preeclampsia, a pregnancy problem that causes high blood pressure. Researchers will study how the body responds to each schedule and how that response may relate to pregnancy outcomes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 16 to 55 years old.
  • Are pregnant with one baby and less than 16 weeks along, with pregnancy dates checked by ultrasound.
  • Have at least 1 high-risk factor or 2 moderate-risk factors for preeclampsia under the 2021 U.S. Preventive Services Task Force guidelines.
  • Have been advised to take 162 mg of aspirin each day during pregnancy.

Who can't join

  • Have a medical reason that makes aspirin unsafe for you.
  • Take or plan to take another blood-thinning medicine.
  • Have low platelets, another known platelet problem, or a bleeding disorder. Platelets are blood cells that help stop bleeding.
  • Before starting aspirin, have an abnormally long clotting time on a blood test called the PFA-100 epinephrine closure time test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

PA