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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: Recruiting Phase 3 study of Preterm Delivery and Obstetrical Complications, sponsored by The George Washington University Biostatistics Center.
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 146-participant average among 4 other Preterm Delivery trials with a reported enrollment target (1133% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number and rate of participants who experience a recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2029-02-28 |
| Phase | Phase 3 |
What NCT06980025 shows while recruiting
NCT06980025 is an interventional study that assigns participants to a tested intervention. Its 1,800 participants enrollment target places it among the larger protocols in the corpus, above the 146-participant average among 4 other Preterm Delivery trials with a reported enrollment target (1133% higher).
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 lists 14 locations in 10 states (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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