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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Not applicable to Phase 4v2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jul 2023 to Dec 31, 2023
    • Study completion date: Dec 2023 to Dec 31, 2025
    • Start date changed from estimate of Aug 31, 2022 to Oct 1, 2022
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05514847
Lead Sponsor University of Virginia
Conditions
(from sponsor)		 Preeclampsia, Pregnancy Related
Related terms Pre-Eclampsia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov