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NCT06980025 · ClinicalTrials.gov registry record · Phase 3

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

A Phase 3 study of Preterm Delivery and Obstetrical Complications, sponsored by The George Washington University Biostatistics Center.

Recruiting
Registry status
Phase 3
Development phase
1,800
Enrollment target
14
Study locations

NCT06980025 is a Phase 3 study of Preterm Delivery and Obstetrical Complications that is actively recruiting participants, run by The George Washington University Biostatistics Center. The registered enrollment target is 1,800 participants, above the 186-participant average among 3 other Preterm Delivery trials with a reported enrollment target (868% higher). The trial reports 14 study locations across 10 states.

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The verdict

NCT06980025, a Phase 3 study of Preterm Delivery and Obstetrical Complications, is actively recruiting participants, sponsored by The George Washington University Biostatistics Center.

RECRUITING
Registry status
Phase 3
Development phase
1,800 participants
Enrollment target
14
Study locations

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

What the Registry Record Tells You About NCT06980025

The ClinicalTrials.gov registry entry for NCT06980025 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 186-participant average among 3 other Preterm Delivery trials with a reported enrollment target (868% higher). The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.

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.

NCT06980025 reports 14 study locations spanning 10 distinct geographic areas - top geographies include North Carolina, Ohio, Pennsylvania.

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.

What interventions are being tested in trial NCT06980025?

The interventions under investigation include: 162mg Aspirin (DRUG), 81mg Aspirin (DRUG).

Who is sponsoring clinical trial NCT06980025?

This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.

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.

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

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