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Antiplatelet Agent

Aspirin for Miscarriage and Preeclampsia (APPLE Trial)

Phase 3
Recruiting
Led By Enrique Schisterman, PhD
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 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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,071 Previous Clinical Trials
42,712,772 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,043 Previous Clinical Trials
2,729,139 Total Patients Enrolled
Enrique Schisterman, PhDPrincipal InvestigatorUniversity of Pennsylvania
~767 spots leftby Jun 2029
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