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

Conditions

• Pre-term Birth

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg — DRUG
  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.
• Standard of Care — OTHER
  Standard of Care

Study Details

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.

Key Dates

Start date

Oct 1, 2026

Status verified

Jan 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2032

Study Design

Enrollment

670 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Combination Therapy (Aspirin & Lansoprazole)
  Aspirin \& Lansoprazole is taken once daily in the evening, preferably 30-60 minutes after dinner.
• Other: Standard of Care
  Standard of Care

Primary Outcome Measure

Number of Participants with a diagnosis of Preterm Birth before 37+0 weeks of gestation [ Time Frame: At or after 20+0 and before 37+0 weeks of gestation ]

Central Contacts

• Brice Gaudillière, MD, PhD
  (650) 723-6412
  [email protected]
• Grant Wells, MS
  650-714-4344
  [email protected]

Locations (1)

Find similar trials in Palo Alto, CA

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