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Antiplatelet Agent

Aspirin for Miscarriage and Preeclampsia (APPLE Trial)

Phase 3

Recruiting

Led By Kurt Barnhart, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia

Clinical indication for chronic use of NSAIDS during pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of delivery

Awards & highlights

Pivotal Trial

Summary

This trial aims to study the impact of starting low-dose aspirin early in pregnant women. It wants to find out if this early and specific dosing regimen can lower the chances of developing pre-e

Who is the study for?

The APPLE trial is for pregnant women who can start treatment no later than 6 weeks and 6 days into their pregnancy. It's designed to see if early aspirin use can prevent complications like pre-eclampsia or pregnancy loss. Women with certain health conditions or on conflicting medications may not be eligible.

What is being tested?

This study tests whether taking a double low-dose of aspirin (162mg) daily from very early in pregnancy, compared to a standard dose (81mg after the first trimester), reduces the risk of developing pre-eclampsia or experiencing pregnancy loss.

What are the potential side effects?

Aspirin may cause side effects such as gastrointestinal issues like heartburn, nausea, and stomach pain. There might also be an increased risk of bleeding. Pregnant women should discuss potential risks with their healthcare provider.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need blood thinners due to a clotting disorder or previous clots.

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I need to take NSAIDs regularly during my pregnancy.

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I cannot take aspirin due to asthma, nasal polyps, bleeding disorders, or past stomach ulcers.

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I have severe pelvic pain or heavy bleeding needing urgent care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Preeclampsia with or without severe features

Pregnancy Loss

Secondary study objectives

Biochemical pregnancy loss

Clinical pregnancy loss

Composite outcome of hypertensive disorders of pregnancy or pregnancy loss

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Double low-dose aspirinActive Control1 Intervention

Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery.

Group II: Standard of CarePlacebo Group1 Intervention

Participants will take 2 placebo pills from entrance into the study until 12 weeks gestational age, they will then take 1 placebo pill and 1 81mg aspirin until delivery.

0 / 4Eligibility criteria met