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APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Study acronym: APPLE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 11 wordsv8 See this version in full on ClinicalTrials.gov ↗
  2. 3 versions Re-verified since Jan 23, 2025, no change to tracked fieldsv5-v7
  3. Eligibility criteria expanded, about 3 wordsv4 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2024 to Jun 12, 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2024 to Jun 12, 2024
    • Site details revised
  5. Primary and study completion dates: May 2029 to Jun 2029 Start date: May 2024 to Jun 2024v2 Show 1 more changeShow less
    • Start date: May 2024 to Jun 2024
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are: Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.
Trial Details
NCT Number NCT06408181
Lead Sponsor University of Pennsylvania
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Pre-Eclampsia, Pregnancy Loss
Enrollment 1,150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov