MedTrace Logo

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

NCT06980025 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2026-04-09

No results posted yet for this study

Summary

This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.

Conditions

  • Preterm Delivery
  • Obstetrical Complications

Interventions

DRUG

162mg Aspirin

Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).

DRUG

81mg Aspirin

One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

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

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Rebecca G Clifton, PhD · The George Washington University Biostatistics Center

  • Matthew K Hoffman, MD, MPH · ChristianaCare Center for Women & Children's Health Research

  • Uma M Reddy, MD, MPH · Columbia University

  • Cande Ananth, PhD, MPH · Robert Wood Johnson Medical School - Rutgers Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-12-31
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06980025 on ClinicalTrials.gov