APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06408181
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pre-Eclampsia
  • Pregnancy Loss

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Aspirin 162 mg — DRUG
    Aspirin is a nonsteroidal anti-inflammatory drug.
  • Aspirin 81mg — DRUG
    Aspirin is a nonsteroidal anti-inflammatory drug.

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
1,150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Preeclampsia with or without severe features [ Time Frame: from 20 weeks pregnancy to delivery, approximately 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Theresa Delahanty
[email protected]
Andrea Morley
[email protected]

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By research site
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