APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Pennsylvania
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
Clinical indication for chronic use of NSAIDS during pregnancy;
Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
Trial design
Treatments tested in this trial
- Aspirin 162 mg
- Aspirin 81mg
Treatment groups
1,150 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov