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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Daily aspirin (ASA)

162mg aspirin taken daily

DRUG

Split dose aspirin (ASA)

81mg aspirin q12hours

Locations (1)

Thomas Jefferson University
Philadelphia, Pennsylvania, United States