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APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

ConditionsPre-EclampsiaPregnancy Loss
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

This trial does not accept healthy volunteers

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. Exclusion to allergies to other non-steroidal anti-inflammatory agents (NSAID) will be determined on a case-by-case basis;

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin 162 mg

    Drug

    Aspirin is a nonsteroidal anti-inflammatory drug.

  • Aspirin 81mg

    Drug

    Aspirin is a nonsteroidal anti-inflammatory drug.

Treatment groups

1,150 Participants
are divided into 2 treatment groups
Group A: Double low-dose aspirinActive comparator 1 intervention
Group B: Standard of CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Preeclampsia with or without severe features

defined as two blood pressures (BPs) ≥ 140/90 mmHg at least 4 hours apart with proteinuria

Time frame
from 20 weeks pregnancy to delivery, approximately 20 weeks
2

Pregnancy Loss

Pregnancy loss prior to 24 weeks gestation

Time frame
from enrollment to time of pregnancy loss, up to 24 weeks gestation

Secondary outcomes

1

Composite outcome of hypertensive disorders of pregnancy or pregnancy loss

This composite outcome will include the diagnosis of any of the following: preterm preeclampsia, term preeclampsia, gestational hypertension, preeclampsia with severe features, preeclampsia without severe features, biochemical pregnancy loss, clinical pregnancy loss

Time frame
From enrollment to end of pregnancy, up to 38 weeks
2

Preterm preeclampsia

Diagnosis of preterm preeclampsia, occurring prior to 37 weeks in pregnancy

Time frame
From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy
3

Term preeclampsia

Diagnosis of term preeclampsia, occurring at 37 weeks or later in pregnancy

Time frame
From 37 weeks until delivery, up to 3 weeks
4

Gestational Hypertension

Defined as two BPs ≥ 140/90 mmHg at least 4 hours apart without proteinuria

Time frame
From 20 weeks of pregnancy to delivery, approximately 20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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