Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)
Recruiting · NCT06826859 · Interventional (participants receive a specific treatment) · Lead sponsor: Thomas Jefferson University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
1 location listed across 1 US state.
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States