NCT06826859 Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)
| NCT ID | NCT06826859 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Thomas Jefferson University |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-06-26 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 400 participants in total. It began in 2025-06-26 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06826859 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 55 Years, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06826859 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06826859 currently recruiting?
Yes, NCT06826859 is actively recruiting participants. Contact the research team at rupsa.boelig@jefferson.edu for enrollment information.
Where is the NCT06826859 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06826859 clinical trial?
NCT06826859 is sponsored by Thomas Jefferson University. The trial plans to enroll 400 participants.