Aspirin + Lansoprazole for Premature Birth

Overseen By Grant Wells, MS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Stanford University

Must not be taking: Anticoagulants, PPIs, H₂ blockers, others

Disqualifiers: Hypersensitivity, Bleeding disorders, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Approximately 21-25 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Brice Gaudillière, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for pregnant women at high risk of having their baby too early, who are between 12 and a little over 16 weeks pregnant. They should be identified as high-risk through special tests (biomarkers). Women can't join if they have health conditions or take medications that could interfere with the study or pose risks.

Inclusion Criteria

General Health: In otherwise stable health, with medical conditions related to pregnancy risk permitted if well controlled

Informed Consent: Ability and willingness to provide written informed consent and comply with study procedures

At increased risk for spontaneous preterm birth, defined by at least one of the following: Prior spontaneous preterm birth (<37 weeks), History of second-trimester pregnancy loss related to cervical insufficiency, Short cervical length (≤25 mm) identified per site standard prior to randomization, Other clinically significant risk factors for spontaneous preterm birth as determined by the investigator

Exclusion Criteria

History of aspirin-exacerbated respiratory disease (AERD), including asthma, nasal polyps, or bronchospasm triggered by aspirin or other NSAIDs

History of anaphylaxis or severe hypersensitivity to any component of the study drugs

Known hypersensitivity, allergy, or intolerance to aspirin, other salicylates, lansoprazole, or other proton pump inhibitors (PPIs)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily low-dose aspirin and lansoprazole from enrollment until delivery

Approximately 21-25 weeks

Regular prenatal visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after delivery

6 weeks postpartum

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Lansoprazole

Trial Overview

The trial is testing whether taking low-dose aspirin (81 mg) along with lansoprazole (30 mg) daily can prevent babies from being born too early, compared to the usual care given during pregnancy. It's a blind test where neither doctors nor patients know who gets the real medicine or placebo.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 1 Intervention

Standard of Care

Group II: Combination Therapy (Aspirin & Lansoprazole) Experimental Treatment 1 Intervention

Aspirin \& Lansoprazole is taken once daily in the evening, preferably 30-60 minutes after dinner.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+