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

NCT07337655 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Pre-term Birth

Interventions

DRUG

Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg

1. Low-Dose Aspirin Dose: 81 mg Route: Oral Frequency: Once daily Timing: Preferably in the evening; may be taken with food Duration: From randomization (12+0 to 16+6 weeks' gestation) until delivery Rationale: Low-dose aspirin has anti-inflammatory, antiplatelet, and placental perfusion-enhancing properties and is widely used in pregnancy for prevention of hypertensive disorders. 2. Lansoprazole Dose: 30 mg Route: Oral Frequency: Once daily Timing: Preferably in the evening; may be taken with food Duration: From randomization (12+0 to 16+6 weeks' gestation) until delivery Rationale: Lansoprazole is a proton pump inhibitor with an established maternal-fetal safety profile. In addition to gastroprotection during aspirin therapy, it has immunomodulatory and anti-inflammatory effects that may act synergistically with aspirin to reduce pathways implicated in spontaneous preterm birth.

OTHER

Standard of Care

Standard of Care

Sponsors & Collaborators

Principal Investigators

  • Brice Gaudillière, MD, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-09-30
Completion
2032-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07337655 on ClinicalTrials.gov