Actively Recruiting
APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
Led by University of Pennsylvania · Updated on 2026-01-20
1150
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to follow all study procedures and be available for the study duration.
- Ability and willingness to take oral medication as prescribed.
- Pregnancy less than or equal to 6 weeks and 6 days gestation.
- Age between 18 and 45 years.
- Having one or more risk factors for preeclampsia or pregnancy loss, including prior preeclampsia, gestational diabetes, fetal growth restriction, preterm birth, multifetal pregnancy, chronic hypertension, pregestational diabetes, kidney disease, systemic lupus erythematosus, nulliparity, BMI over 30, family history of preeclampsia, Black race (social reasons), maternal age 35 or older, lower income, conception with fertility treatment, history of pregnancy loss before 20 weeks, history of stillbirth, or more than 10 years since last pregnancy.
You will not qualify if you...
- Known allergy to aspirin or non-steroidal anti-inflammatory drugs.
- Need for anticoagulant therapy due to thrombosis, antiphospholipid syndrome, or major thrombophilia.
- Need for chronic use of NSAIDs during pregnancy.
- Medical reasons against aspirin use such as untreated uncontrolled asthma, symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcers.
- Pelvic pain or bleeding requiring urgent care, including active vaginal bleeding equal to or more than a normal period, open cervical os suggesting miscarriage, or severe pain needing evaluation for ectopic pregnancy.
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Kurt T Barnhart, MD
CONTACT
E
Enrique Schisterman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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