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RecruitingPhase 3

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether starting 162 mg of aspirin early in pregnancy lowers the risk of pregnancy loss and preeclampsia, a pregnancy condition involving high blood pressure. It compares this with a pill with no active drug until 12 weeks, then 81 mg of aspirin; aspirin continues until delivery. It is for pregnant people ages 18–45 who are no more than 6 weeks and 6 days pregnant and have at least one listed risk factor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a consent form, agree to follow study steps, and be available for the whole study.
  • Be able to take medicine by mouth and agree to follow the aspirin schedule.
  • Be ages 18–45 and no more than 6 weeks and 6 days pregnant, based on your last period or fertility treatment date.
  • Have at least one risk factor listed in this or the following bullets: past preeclampsia, diabetes during a past pregnancy, a baby who grew too slowly or had low birth weight, or birth too early.
  • Other risk factors: pregnancy with more than one baby, long-term high blood pressure, diabetes before pregnancy, kidney disease, or lupus, a disease in which the immune system attacks the body.
  • Other risk factors: never having given birth, a body mass index (BMI, a measure of weight compared with height) over 30 before pregnancy, a mother or sister with preeclampsia, or age 35 or older.
  • Other risk factors: being Black, for social rather than biological reasons; lower income, based on qualifying for public health insurance; or pregnancy through fertility treatment.
  • Other risk factors: at least one past pregnancy loss before 20 weeks, a past stillbirth, or more than 10 years since your last pregnancy.

Who can't join

  • An aspirin allergy. Allergies to other NSAIDs, medicines used for pain and swelling, are reviewed case by case.
  • A medical need for blood-thinning treatment, including past or current blood clots, antiphospholipid syndrome, or another known major condition that raises the risk of blood clots.
  • A medical need to use NSAIDs regularly during pregnancy.
  • A medical reason you cannot take aspirin, including untreated, uncontrolled asthma; untreated growths inside the nose that cause symptoms; a bleeding disorder; or a past stomach or gut ulcer.
  • Pelvic pain or bleeding that needs urgent care, such as vaginal bleeding at least as heavy as a period, an open cervix suggesting a miscarriage, or severe pain needing checks for a pregnancy outside the womb.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

PA