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APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia | Clinical Trials | Clareo Health

RECRUITINGPHASE3

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

NCT06408181•University of Pennsylvania

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

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated informed consent form.
•2. Stated willingness to comply with all study procedures and availability for the duration of the study.
•3. Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
•4. Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
•5. Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:
•1. preeclampsia in a previous pregnancy,
•2. gestational diabetes in a previous pregnancy,
•3. any documentation of fetal growth restriction or low birth weight in a prior pregnancy,
•4. preterm birth in a previous pregnancy,
•5. known multifetal gestation at enrollment,
+14 more criteria

Exclusion Criteria

•1. Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
•2. Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
•3. Clinical indication for chronic use of NSAIDS during pregnancy;
•4. Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
•5. Patients with pelvic pain or bleeding who require urgent care (i.e., active vaginal bleeding greater than or equal to expected menses, open cervical os suggesting active miscarriage or severe pain requiring evaluation for ectopic pregnancy)

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 12, 2024

Primary Completion Date

June 1, 2029

Completion Date

June 1, 2029

Last Updated

January 20, 2026

Enrollment

1,150

ESTIMATED participants

Conditions

Pre-EclampsiaPregnancy Loss

Interventions

Aspirin 162 mg

DRUG

Aspirin 81mg

DRUG

Contacts

Kurt T Barnhart, MD

CONTACT

215-662-2974 kbarnhart@pennmedicine.upenn.edu

Enrique Schisterman, PhD

CONTACT

enrique.schisterman@pennmedicine.upenn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Inclusion Criteria

Exclusion Criteria

Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

Vascular Biomarkers Predictive of the Progression From Hypertensive Disorders in Pregnancy to Preeclampsia in Pregnant Women

Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.

Bioimpedence and Arterial Function Monitoring at Birth and in Infants

Tender Loving Care for Recurrent Pregnancy Loss

Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines