Using aspirin to prevent pregnancy loss and preeclampsia

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

This study is testing if starting low-dose aspirin early in pregnancy can help women at risk for pregnancy loss and preeclampsia have healthier pregnancies.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1150 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Pennsylvania (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06408181 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of early initiation of double low-dose aspirin in pregnant women at risk for preeclampsia and pregnancy loss. Participants will start taking either 162 mg of aspirin or a placebo by 6 weeks and 6 days of gestation, followed by a reduced dose of 81 mg until delivery. The study aims to determine if this specific dosage and timing can effectively reduce the risks associated with these conditions compared to standard recommendations.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18-45 with one or more risk factors for preeclampsia or pregnancy loss, who are less than or equal to 6 weeks and 6 days gestational age.

Not a fit: Patients who do not have any risk factors for preeclampsia or pregnancy loss may not receive benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the incidence of preeclampsia and pregnancy loss in at-risk pregnant women.

How similar studies have performed: Other studies have shown promising results with aspirin in similar contexts, suggesting potential effectiveness of this approach.

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 or non-steroidal anti-inflammatory agents (NSAID);
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)

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Enrique Schisterman, PhD — University of Pennsylvania
• Study coordinator: Kurt T Barnhart, MD

Conditions: Pre-Eclampsia, Pregnancy Loss