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
N/A
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
Researchers are studying the effects of early use of low-dose aspirin in pregnant women who have risk factors for preeclampsia or pregnancy loss. The study aims to find out if starting aspirin at a specific dose and time during pregnancy can lower the chances of developing preeclampsia or experiencing pregnancy loss compared to the usual recommendations. This is a Phase 3 clinical trial led by the University of Pennsylvania. Participants will be randomly assigned to one of two groups. One group will take two 81mg aspirin tablets daily from the start of the trial until delivery. The other group will take placebo pills until 12 weeks of pregnancy and then switch to one placebo and one 81mg aspirin tablet daily until delivery. The treatment starts no later than 6 weeks and 6 days of pregnancy and continues through delivery. During the study, participants will be monitored from enrollment through delivery, with researchers tracking outcomes such as preeclampsia, pregnancy loss, and other pregnancy complications. The main results measured include the occurrence of preeclampsia from 20 weeks of pregnancy to delivery and pregnancy loss up to 24 weeks gestation. Additional outcomes involve various pregnancy-related conditions and birth outcomes. The study includes safety monitoring and lasts through the entire pregnancy period, with careful follow-up until delivery.
CONDITIONS
Brief 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 provided
- 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, 6 days gestational age
- Female participants aged 18 to 45 with one or more risk factors for preeclampsia or pregnancy loss, including previous preeclampsia, gestational diabetes, fetal growth restriction, preterm birth, multifetal gestation, chronic hypertension, pregestational diabetes, kidney disease, lupus, nulliparity, BMI over 30, family history of preeclampsia, maternal age 35 or older, low income, fertility treatment conception, prior pregnancy loss before 20 weeks, prior stillbirth, or over 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 NSAID use during pregnancy
- Medical reasons preventing aspirin use, such as uncontrolled asthma, symptomatic nasal polyps, bleeding disorders, or gastrointestinal ulcers
- Presence of pelvic pain or bleeding needing urgent care, including active vaginal bleeding equal to or above menstrual levels, open cervical os suggesting miscarriage, or severe pain requiring ectopic pregnancy evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery (up to approximately 38 weeks)
Participants take aspirin or placebo pills daily from enrollment until delivery to prevent pregnancy loss and preeclampsia.
Regular visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Kurt T Barnhart, MD
E
Enrique Schisterman, PhD
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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