APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
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.
• 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.