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Search / Trial NCT06826859

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

Launched by THOMAS JEFFERSON UNIVERSITY · Feb 12, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Aspirin Preeclampsia Preterm Birth Pregnancy Pharmacokinetics Pharmacodynamics Phase I/Ii Randomized Clinical Trial

ClinConnect Summary

The DASH trial is studying how different ways of taking aspirin might help pregnant women at high risk for complications like preeclampsia and preterm birth. Preeclampsia is a serious condition that can affect both the mother and baby, and aspirin is often recommended to lower these risks. In this study, women who are recommended to take aspirin will be divided into two groups: one group will take a higher dose of 162 mg once a day, while the other group will take a lower dose of 81 mg twice a day. Researchers want to see how these different doses affect how well aspirin works and whether they can improve outcomes for mothers and their babies.

To participate in this trial, women must be between 16 and 55 years old and in early pregnancy (less than 16 weeks). They should have at least one high-risk factor for preeclampsia or two moderate risk factors, based on guidelines from health experts. However, women with certain health issues, like a bleeding disorder or those taking other blood-thinning medications, cannot join the study. Participants will be monitored throughout the trial to understand how each dosing method impacts their health and pregnancy outcomes. This research aims to find the best way to use aspirin safely and effectively in pregnancy, ultimately helping to improve health for both mothers and their babies.

Gender

FEMALE

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

About Thomas Jefferson University

Thomas Jefferson University is a distinguished academic institution located in Philadelphia, Pennsylvania, renowned for its commitment to advancing healthcare through research and education. As a clinical trial sponsor, the university leverages its extensive resources and interdisciplinary expertise to conduct innovative research aimed at improving patient outcomes. With a focus on translational medicine, Thomas Jefferson University collaborates with various stakeholders, including healthcare professionals, industry partners, and regulatory agencies, to ensure the highest standards of scientific rigor and ethical conduct in its clinical trials. The institution is dedicated to fostering a culture of excellence in research, ultimately contributing to the advancement of medical knowledge and the development of novel therapeutic interventions.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported