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Recruiting NCT06408181

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Phase III Interventional Pre-Eclampsia Pregnancy Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin 162 mg, Aspirin 81mg.
Who it may be relevant to
Registry conditions: Pre-Eclampsia, Pregnancy Loss. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Preeclampsia with or without severe features [Time frame: from 20 weeks pregnancy to delivery, approximately 20 weeks]
  • Pregnancy Loss [Time frame: from enrollment to time of pregnancy loss, up to 24 weeks gestation]
Secondary outcome measures (10)
  • Composite outcome of hypertensive disorders of pregnancy or pregnancy loss [Time frame: From enrollment to end of pregnancy, up to 38 weeks]
  • Preterm preeclampsia [Time frame: From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy]
  • Term preeclampsia [Time frame: From 37 weeks until delivery, up to 3 weeks]
  • Gestational Hypertension [Time frame: From 20 weeks of pregnancy to delivery, approximately 20 weeks]
  • Preeclampsia with severe features [Time frame: From 20 weeks of pregnancy to delivery, up to 20 weeks]
  • Preeclampsia without severe features [Time frame: From 20 weeks of pregnancy to delivery, up to 20 weeks]
  • Biochemical pregnancy loss [Time frame: From enrollment to time of pregnancy loss, up to approximately 20 weeks]
  • Clinical pregnancy loss [Time frame: From time of first ultrasound to 20 weeks pregnancy]
  • Preterm birth [Time frame: From enrollment to 36 weeks 6 days of pregnancy, up to delivery]
  • Small for gestational age [Time frame: At time of delivery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06408181 · 854886 · 1R01HD112308-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗