Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth
The George Washington University Biostatistics Center
1,800 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06980025