Clinical Trial

Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm Labour

Not Yet Recruiting
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Summary
Preterm birth-defined as delivery before 37 weeks of gestation-is a leading cause of neonatal morbidity and mortality worldwide, particularly in resource-limited settings. Women with a history of spontaneous preterm birth face a significantly higher risk of experiencing premature labor in subsequent pregnancies. Impaired uteroplacental blood flow, inflammation, and abnormal clot formation are key contributing factors to spontaneous preterm delivery. Low-dose aspirin is an affordable, widely available medication that exerts anti-inflammatory and antithrombotic effects by inhibiting platelet aggregation and prostaglandin synthesis. This study aims to evaluate whether low-dose aspirin (75 mg daily), initiated between 8 and 16 weeks of gestation, can effectively reduce the incidence of recurrent spontaneous preterm labor in pregnant women with a prior history of premature delivery compared to a placebo. Participants will be monitored throughout their pregnancy up to 36 weeks or delivery to evaluate gestational age at birth and labor outcomes.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-08-13
notable Enrollment increased: 80 -> 162 participants 2026-08-13
Trial Details
NCT Number NCT07745595
Lead Sponsor University of Health Sciences Lahore
Conditions Preterm Labor, Premature Birth
Enrollment 162 participants
Start Date 2026-08-20
Primary Completion 2027-02-15 (estimated)
Study Completion 2027-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-12