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

NCT ID: NCT06826859

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-26
• Study Completion Date: 2029-12-31

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.

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.

Conditions

Preterm Birth; Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Daily aspirin

162mg aspirin daily

Group Type: ACTIVE_COMPARATOR

Daily aspirin (ASA)

Intervention Type: DRUG

162mg aspirin taken daily

Split dose aspirin

81mg aspirin q12 hours

Group Type: EXPERIMENTAL

Split dose aspirin (ASA)

Intervention Type: DRUG

81mg aspirin q12hours

Interventions

Daily aspirin (ASA)

162mg aspirin taken daily

Intervention Type: DRUG

Split dose aspirin (ASA)

81mg aspirin q12hours

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rupsa C Boelig, MD

Role: CONTACT

rupsa.boelig@jefferson.edu

215-955-5000

Facility Contacts

Rupsa C Boelig, MD

Role: primary

rupsa.boelig@jefferson.edu

215-955-5000

Brandy Firman

Role: backup

brandy.firman@jeffereson.edu

Other Identifiers

1R01HD112076

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRISID-2024-1554

Identifier Type: -

Identifier Source: org_study_id