Clinical Trial

Low Dose Aspirin for Preterm Preeclampsia Preventionmg/day Dose in High-risk Patients

Active, Not Recruiting Phase 4

Summary

This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2022-08-23; most recent amendment 2025-12-12.

Status change: Active, Not Recruiting → Completed 2025-12-12

Status change: Not Yet Recruiting → Active, Not Recruiting 2025-01-13

Trial Details

NCT Number	NCT05514847
Lead Sponsor	University of Virginia
Conditions	Preeclampsia, Pregnancy Related
Enrollment	150 participants
Start Date	2022-10-01
Primary Completion	2023-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-15