Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daily aspirin (ASA), Split dose aspirin (ASA).
- Who it may be relevant to
- Registry conditions: Preterm Birth, Preeclampsia. Basic parameters: 16 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dose Based Aspirin Pharmacokinetics and Pharmacodynamics in Pregnancy and Association With Pregnancy Outcomes
Overview
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.
Detailed description
This is an unblinded randomized controlled Phase I/II trial comparing high risk singleton pregnancies randomized to 162mg daily (daily dose) vs 81mg q12hours (split dose). Participants will be enrolled prior to 16 weeks gestation. The primary outcome is platelet inhibition as assessed by PFA-100 epinephrine closure time, assessed 2-4 weeks after initiation and again at 28-32 weeks gestation. A subset of participants will be enrolled in a pharmacokinetic study to evaluate pharmacokinetics of aspirin in pregnancy at the two dosing intervals. Secondary outcomes include urine thromboxane at each visit, platelet associated microRNAs. Individual factors associated with aspirin pharmacokinetics and pharmacodynamics in pregnancy will be assessed. Finally, the relationship between these pharmacodynamic markers and pregnancy outcome will be evaluated.
Interventions
- Drug Daily aspirin (ASA)
162mg aspirin taken daily - Drug Split dose aspirin (ASA)
81mg aspirin q12hours
Primary outcome measures
- Aspirin Response PFA-100 epinephrine closure time (seconds) [Time frame: 2-4 weeks after aspirin initiation]
Secondary outcome measures (12)
- Aspirin response (PFA-100 epinephrine closure time) [Time frame: 28-32 weeks gestation]
- Urinary thromboxane concentration [Time frame: 2-4 weeks after aspirin initiation]
- Urinary Thromboxane concentration [Time frame: 28-32 weeks gestation]
- Inadequate aspirin response [Time frame: 2-4 weeks after aspirin initiation]
- Inadequate aspirin response [Time frame: 28-32 weeks gestation]
- Preterm birth [Time frame: Delivery]
- Indicated preterm birth [Time frame: delivery]
- Spontaneous preterm birth [Time frame: delivery]
- MicroRNAs [Time frame: 2-4 weeks after aspirin initiation]
- MicroRNAs [Time frame: 28-32 weeks gestation]
- Placental histopathology [Time frame: Delivery]
- Birthweight [Time frame: Delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Thomas Jefferson University — Philadelphia
Identifiers
NCT: NCT06826859 · IRISID-2024-1554 · 1R01HD112076