APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Kurt T Barnhart, MD
kbarnhart@pennmedicine.upenn.edu
215-662-2974
Backup
Enrique Schisterman, PhD
enrique.schisterman@pennmedicine.upenn.edu
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2029-06
Participants
Target number of participants: 1150
Treatments
Active_comparator: Double low-dose aspirin
Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery.
Placebo_comparator: Standard of Care
Participants will take 2 placebo pills from entrance into the study until 12 weeks gestational age, they will then take 1 placebo pill and 1 81mg aspirin until delivery.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov