Clinical Trial

Efficacy and Safety of Aspirin and Lansoprazole for Prevention of Preterm Birth in High-Risk Pregnant Women: A Biomarker-Enriched Trial

Not Yet Recruiting Phase 2/3
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Summary
This protocol describes a seamless Phase II/III, randomized, double-blind clinical trial evaluating the efficacy and safety of daily low-dose aspirin (81 mg) plus lansoprazole (30 mg) in pregnant individuals at high risk for preterm birth when compared to existing standard of care, identified through biomarker-enriched screening. Participants will be enrolled between 12-16+6 weeks' gestation and followed through delivery and postpartum. The primary objective is to determine whether the investigational combination reduces the incidence of preterm birth before 37 weeks of gestation compared with placebo.
Trial Details
NCT Number NCT07337655
Lead Sponsor Stanford University
Conditions Pre-term Birth
Enrollment 670 participants
Start Date 2026-10-01
Primary Completion 2030-09-30 (estimated)
Study Completion 2032-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-13