NCT06408181

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-Eclampsia
• Pregnancy Loss

Interventions

Type	Name	Description
DRUG	Aspirin 162 mg	Aspirin is a nonsteroidal anti-inflammatory drug.
DRUG	Aspirin 81mg	Aspirin is a nonsteroidal anti-inflammatory drug.

Timeline

• Start date: 2024-06-12
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2024-05-10
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study