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RECRUITING Phase 3

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

NCT06980025 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG 162mg Aspirin
  • DRUG 81mg Aspirin

Study Locations (14)

North Carolina

  • University of North Carolina - Chapel Hill — Chapel Hill
  • Duke University — Durham

Ohio

  • Case Western Reserve University — Cleveland
  • Ohio State University — Columbus

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia
  • Magee Women's Hospital of UPMC — Pittsburgh

Texas

  • Baylor College of Medicine — Houston
  • University of Texas - Houston — Houston

Alabama

  • University of Alabama - Birmingham — Birmingham

California

  • Regents of the University of California San Francisco — San Francisco

Illinois

  • Northwestern University — Chicago

New York

  • Columbia University — New York

Trial Details

FieldValue
Enrollment Target 1,800 participants
Start Date 2025-07-01
Est. Completion 2029-02-28
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06980025

The ClinicalTrials.gov registry entry for NCT06980025 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Preterm Delivery appearing as the primary indexed condition, and to 2 interventions — of which 162mg Aspirin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06980025 reports 14 study locations spanning 10 distinct geographic areas — top geographies include North Carolina, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06980025 about?

NCT06980025 is a clinical study titled "Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial". 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 an...

What is the current status of trial NCT06980025?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,800 participants. The study started on 2025-07-01. Estimated completion is 2029-02-28.

What conditions does trial NCT06980025 study?

This clinical trial studies the following conditions: Preterm Delivery, Obstetrical Complications. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06980025?

The interventions under investigation include: 162mg Aspirin (DRUG), 81mg Aspirin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06980025?

This trial is sponsored by The George Washington University Biostatistics Center, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06980025 being conducted?

This trial has 14 study locations across Alabama, California, Illinois, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial