Aspirin to Prevent Pregnancy Loss and Preeclampsia (APPLE) Study

This study, called APPLE, is looking at whether taking a specific dose of aspirin early in pregnancy can help prevent pre-eclampsia (a serious blood pressure condition during pregnancy) and pregnancy loss. Researchers want to see if starting 162 mg of aspirin very early in pregnancy (before 6 weeks and 6 days) or a placebo followed by 81 mg of aspirin later, is more effective than standard recommendations. You might be able to join if you are a woman between 18 and 45 years old, are less than 6 weeks and 6 days pregnant, and are willing to take oral medication. The study will measure if pre-eclampsia occurs between 20 weeks of pregnancy and delivery, and if pregnancy loss occurs from enrollment up to 24 weeks of gestation. The study aims to enroll 1150 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 1150 women. Participants will receive either 162 mg of aspirin or a placebo followed by 81 mg of aspirin.
What's involved
You would need to take oral medication (aspirin or placebo) daily from early pregnancy until delivery. You would also need to comply with all study procedures.
Compensation
Not stated in the trial record.
Follow-up
The study will track pre-eclampsia from 20 weeks of pregnancy until delivery, and pregnancy loss from enrollment up to 24 weeks of gestation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06408181

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Recruiting
PHASE3Ages 18–45InterventionalPrevention
University of Pennsylvania
~1,150 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:Aspirin 162 mgAspirin 81mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Preeclampsia with or without severe features
Measured over from 20 weeks pregnancy to delivery, approximately 20 weeks
+1 more outcome measured
Pre-Eclampsia
Pregnancy Loss
1 sites across 1 states
Pennsylvania1
  • Enrique Schisterman, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Kurt Barnhart, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

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  • Preeclampsia with or without severe featuresfrom 20 weeks pregnancy to delivery, approximately 20 weeks

    defined as two blood pressures (BPs) ≥ 140/90 mmHg at least 4 hours apart with proteinuria

  • Pregnancy Lossfrom enrollment to time of pregnancy loss, up to 24 weeks gestation

    Pregnancy loss prior to 24 weeks gestation