Clinical trialNCT06980025RecruitingPhase 3Interventional

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

SponsorThe George Washington University Biostatistics CenterEnrollment1,800Obstetrical ComplicationsPreterm Delivery

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Cande Ananth, PhD, MPH
Robert Wood Johnson Medical School - Rutgers Health
Principal Investigator
clinicaltrials.gov ↗
Matthew K Hoffman, MD, MPH
ChristianaCare Center for Women & Children's Health Research
Principal Investigator
clinicaltrials.gov ↗
Rebecca G Clifton, PhD
The George Washington University Biostatistics Center
Principal Investigator
clinicaltrials.gov ↗
Uma M Reddy, MD, MPH
Columbia University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama - Birmingham
Birmingham, Alabama, United States
Alan TN Tita, MD
Recruiting
Regents of the University of California San Francisco
San Francisco, California, United States
Mary Norton, MD
Recruiting
Northwestern University
Chicago, Illinois, United States
Lynn Yee, MD
Recruiting
Columbia University
New York, New York, United States
Uma Reddy, MD
Recruiting
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
John M Thorp, Jr., MD
Recruiting
Duke University
Durham, North Carolina, United States
Brenna Hughes, MD
Recruiting
Case Western Reserve University
Cleveland, Ohio, United States
Kelly Gibson, MD
Recruiting
Ohio State University
Columbus, Ohio, United States
Maged Costantine, MD
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Samuel Parry, MD
Recruiting
Magee Women'S Hospital of Upmc
Pittsburgh, Pennsylvania, United States
Hyagriv Simhan, MD
Recruiting
Brown University
Providence, Rhode Island, United States
Dwight J Rouse, MD
Recruiting
Baylor College of Medicine
Houston, Texas, United States
Catherine Eppes, MD, MPH
Recruiting
University of Texas - Houston
Houston, Texas, United States
Hector Mendez-Figueroa, MD
Recruiting
University of Utah Medical Center
Salt Lake City, Utah, United States
Torri Metz, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

162mg Aspirin81mg Aspirin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jul 2025
Primary completion: 31 Dec 2028
Completion: 28 Feb 2029
Last update posted: 9 Apr 2026
Registered enrollment: 1,800
Registry id: NCT06980025

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.