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APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

NCT06408181 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1150

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Pre-Eclampsia
  • Pregnancy Loss

Interventions

DRUG

Aspirin 162 mg

Aspirin is a nonsteroidal anti-inflammatory drug.

DRUG

Aspirin 81mg

Aspirin is a nonsteroidal anti-inflammatory drug.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Enrique Schisterman, PhD · University of Pennsylvania

  • Kurt Barnhart, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06408181 on ClinicalTrials.gov