RecruitingPhase 3NCT06408181

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Sponsor

University of Pennsylvania

Enrollment

1,150 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Pre-Eclampsia Pregnancy Loss

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

The APPLE trial tests whether taking low-dose aspirin early in pregnancy can help prevent pregnancy loss and preeclampsia (a dangerous blood pressure condition during pregnancy) in women who have one or more risk factors for these complications. **You may be eligible if...** - You are 18 to 45 years old and pregnant (6 weeks and 6 days pregnant or less) - You have at least one risk factor such as: previous preeclampsia, gestational diabetes, obesity, kidney disease, or carrying multiples - You are willing and able to take aspirin daily **You may NOT be eligible if...** - You are beyond 6 weeks and 6 days of pregnancy - You have a known allergy or intolerance to aspirin - You have conditions that make aspirin unsafe during pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin 162 mg

Aspirin is a nonsteroidal anti-inflammatory drug.

DRUGAspirin 81mg

Aspirin is a nonsteroidal anti-inflammatory drug.

Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06408181

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