Actively Recruiting
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Led by The George Washington University Biostatistics Center · Updated on 2026-04-09
1800
Participants Needed
14
Research Sites
191 weeks
Total Duration
On this page
Sponsors
T
The George Washington University Biostatistics Center
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 14 years or older
- Singleton pregnancy (twins reduced to singleton before 13 weeks 6 days gestation allowed)
- Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days
- Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following: spontaneous preterm birth, ischemic placental disease (including preeclampsia, small for gestational age, fetal growth restriction, placental abruption), or stillbirth excluding known genetic disorders or major congenital anomalies
You will not qualify if you...
- Allergy or hypersensitivity to aspirin or medical conditions contraindicating aspirin use (e.g., peptic ulcer disease, nasal polyps, NSAID-induced asthma, gastrointestinal bleeding, G6PD deficiency, severe liver dysfunction, bleeding disorders, heavy alcohol consumption)
- Use of other anticoagulants such as Heparin or Low-Molecular weight Heparin
- Platelet count below 100,000 microliters (thrombocytopenia)
- History of gastric bypass surgery
- Use of aspirin over 81 mg daily during current pregnancy without willingness or ability for a 2-week washout before randomization
- Known major Mullerian uterine anomalies (bicornuate, unicornuate, unresected uterine septum)
- Known fetal genetic disease or major malformations
- Fetal demise or planned pregnancy termination (selective reduction before 13 weeks 6 days from twins to singleton allowed)
- Conditions requiring invasive in-utero assessment or treatment (e.g., red cell antigen sensitization, neonatal alloimmune thrombocytopenia)
- Certain maternal medical conditions including treated hypertension requiring multiple agents, chronic kidney disease with serum creatinine ≥1.5 mg/dL, chronic oral glucocorticoid therapy, uncontrolled thyroid disease, NYHA stage II or greater cardiac disease
- Planned delivery before 37 weeks
- Participation in another interventional study affecting gestational age at delivery
- Previous participation in this trial during another pregnancy
- Delivery planned at a site not participating in this trial
AI-Screening
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Trial Site Locations
Total: 14 locations
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Columbia University
New York, New York, United States, 10032
Actively Recruiting
5
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
7
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
11
Brown University
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Texas - Houston
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
R
Rebecca G Clifton, PhD
CONTACT
T
Trisha Boekhoudt, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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