About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years.
Singleton alive pregnancy.
History of spontaneous preterm birth (22 to 37 weeks of gestation).
Hemoglobin (Hb) > 10 g/dL.
Disqualifiers
Primigravida.
Multiple pregnancy.
Maternal age > 40 years.
Known history of allergy or hypersensitivity to aspirin.
Trial design
Parallel
Treatments tested in this trial
Low-dose Aspirin
DrugParticipants take low-dose aspirin 75 mg orally once daily starting from 8-16 weeks of gestation until 36 weeks of gestation or delivery (whichever comes first), alongside routine clinical care (progesterone and cervical cerclage if indicated).
Placebo
Other interventionParticipants take a daily matching oral placebo tablet starting from 8-16 weeks of gestation until 36 weeks of gestation or delivery, alongside routine clinical care (per-rectal progesterone and cervical cerclage if indicated).
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Recurrent Spontaneous Preterm Labor
Proportion of participants who experience spontaneous onset of labor and delivery prior to completing 37 weeks (259 days) of gestation.
Locations
Sponsors and contacts
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