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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from University of Health Sciences Lahore

Record History

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  1. Primary endpoint(s) modified
    • Enrollment increased: 80 → 162 participants
    • Interventions: Manual Vacuum Aspiration (MVA) Cannula (Device), Pipelle Endometrial Suction Curette (Device) to Low-dose Aspirin (Drug), Placebo (Other)
    • Eligibility criteria expanded, about 5 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07745595
Lead Sponsor University of Health Sciences Lahore
Conditions
(from sponsor)		 Preterm Labor, Premature Birth
Related terms Obstetric Labor, Premature, Premature Birth
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov