NCT06408181 · University of Pennsylvania
APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
(APPLE)
What this study is about
The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
- Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
- Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:
- preeclampsia in a previous pregnancy,
- gestational diabetes in a previous pregnancy,
- any documentation of fetal growth restriction or low birth weight in a prior pregnancy,
- preterm birth in a previous pregnancy,
- known multifetal gestation at enrollment,
- chronic hypertension,
- pregestational diabetes,
- kidney disease,
- systemic lupus erythematosus,
- nulliparity,
- pre-pregnancy body mass index \>30,
- family history of preeclampsia (i.e., mother or sister),
- Black persons (due to social, not biological reasons),
- Maternal age 35 years or older,
- lower income (will be determined by qualification of public health insurance),
- conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination),
- history of one or more prior pregnancy losses \<20 weeks gestation,
- history of stillbirth in a prior pregnancy,
- An interval of greater than 10 years since the last pregnancy.
Exclusion criteria
- Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
- 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;
- Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
- 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)
Where
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations