Clinical Trial

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Study acronym: APPLE
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-05-07; most recent amendment 2026-01-16.
Status change: Not Yet Recruiting → Recruiting 2024-06-13
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 2024-06-12
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-20