drugset / Trial / NCT05514847

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

NCT05514847 ↗

Phase 4 Active not recruiting 150 enrolled University of Virginia
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2022-10-01
Primary completion
2023-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 81 mg —
Subject Aspirin Small molecule 162 mg —

Indications