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

NCT06826859 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRISID-2024-15541R01HD112076
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Preeclampsia

Keywords

Aspirin; Preeclampsia; Preterm birth; Pregnancy; Pharmacokinetics; Pharmacodynamics; Phase I/II; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Aspirin Response PFA-100 epinephrine closure time (seconds)

  Difference in PFA-100 epinephrine closure time (seconds)

  2-4 weeks after aspirin initiation

Secondary Outcomes (25)

• Aspirin response (PFA-100 epinephrine closure time)

  28-32 weeks gestation

• Urinary thromboxane concentration

  2-4 weeks after aspirin initiation

• Urinary Thromboxane concentration

  28-32 weeks gestation

• Inadequate aspirin response

  2-4 weeks after aspirin initiation

• Inadequate aspirin response

  28-32 weeks gestation

Study Arms (2)

Daily aspirin

ACTIVE COMPARATOR

162mg aspirin daily

Drug: Daily aspirin (ASA)

Split dose aspirin

EXPERIMENTAL

81mg aspirin q12 hours

Drug: Split dose aspirin (ASA)

Interventions

Daily aspirin (ASA) DRUG

162mg aspirin taken daily

Daily aspirin

Split dose aspirin (ASA) DRUG

81mg aspirin q12hours

Split dose aspirin

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19060, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Central Study Contacts

Rupsa C Boelig, MD

CONTACT

215-955-5000; rupsa.boelig@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biostatistical analysis, all laboratory assessments will be conducted by personnel blinded to study groupl
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 14, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after study completion
• Access Criteria: Data will be submitted to NICHD DASH and may be requested through DASH

Locations

US (1)