Could a simple aspirin pill save pregnancies? major trial launches
NCT ID NCT06408181
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests whether starting a higher dose of aspirin very early in pregnancy (before 7 weeks) can lower the risk of preeclampsia and pregnancy loss in women with risk factors. About 1,150 pregnant women will take either 162 mg of aspirin daily or a placebo followed by standard 81 mg aspirin. The goal is to see if this approach is more effective than current recommendations.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, 6. chronic hypertension, 7. pregestational diabetes, 8. kidney disease, 9. systemic lupus erythematosus, 10. nulliparity, 11. pre-pregnancy body mass index \>30, 12. family history of preeclampsia (i.e., mother or sister), 13. Black persons (due to social, not biological reasons), 14. Maternal age 35 years or older, 15. lower income (will be determined by qualification of public health insurance), 16. conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination), 17. history of one or more prior pregnancy losses \<20 weeks gestation, 18. history of stillbirth in a prior pregnancy, 19. An interval of greater than 10 years since the last pregnancy. Exclusion Criteria 1. Known allergies to aspirin. Exclusion to allergies to other non-steroidal anti-inflammatory agents (NSAID) will be determined on a case-by-case basis; 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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