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 trial tests whether a combination of low-dose aspirin and lansoprazole (a medication that reduces stomach acid) can lower the risk of preterm birth in pregnant individuals. The aim is to determine if this new treatment is more effective than the current standard care. Participants at higher risk of early delivery, such as those with a history of preterm birth or certain pregnancy complications, might be suitable candidates. The trial requires taking these medications daily in the evening and includes monitoring throughout pregnancy and after delivery. As a Phase 2, Phase 3 trial, it measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in maternal health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, like high-dose aspirin, other antiplatelet or NSAID therapies, and certain stomach acid reducers (PPIs or H₂ blockers), unless they can be adjusted or safely discontinued. If you're on medications that interact strongly with the trial drugs, you may need to stop or adjust those as well.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking low-dose aspirin with lansoprazole is generally safe for preventing preterm birth. In past studies, low-dose aspirin significantly reduced the number of preterm births and was considered safe for most pregnant people. For instance, one study found that 3.8% of those taking aspirin experienced preterm births, compared to 9.7% in the group not taking it, indicating aspirin's likely safety in this context.

Lansoprazole, which reduces stomach acid, is also known to be safe for many people. Both medications have FDA approval for other uses, adding to their safety assurance. Participants in earlier studies did not report any major side effects directly linked to these medications.

This trial is in its advanced stages, suggesting existing evidence supports the treatment's safety for humans. While discussing concerns with healthcare providers is always important, current data suggests that the combination of aspirin and lansoprazole is likely safe for those at high risk of preterm birth. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using aspirin and lansoprazole to potentially prevent premature births because this combination might offer a new approach compared to typical treatments. Aspirin is known to help with blood flow and inflammation, while lansoprazole is a proton pump inhibitor typically used for reducing stomach acid. Together, they might address underlying issues that contribute to early labor, such as inflammation and other physiological changes, in a way that current treatments, like progesterone supplements or lifestyle modifications, do not. This combination therapy could provide a dual-action approach, offering a novel and potentially more effective way to delay premature births.

What evidence suggests that this trial's treatments could be effective for preventing preterm birth?

Research has shown that low-dose aspirin can reduce the risk of preterm birth. One study found that women taking low-dose aspirin experienced fewer early births compared to those taking a placebo, a pill with no active medicine. Specifically, the study revealed a 55% lower risk of preterm birth for those on aspirin. In this trial, participants will receive either a combination therapy of aspirin and lansoprazole or the standard of care. Lansoprazole often prevents stomach irritation from aspirin. While researchers continue to study the effects of aspirin with lansoprazole on preterm birth, aspirin alone has shown promising results in reducing early births. ^{1 2 3 4 5}

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07337655

Efficacy and Safety of Aspirin and Lansoprazole for ...

Key secondary endpoints include preterm birth before 34 weeks, gestational age at delivery, hypertensive disorders of pregnancy, fetal growth ...

2.

withpower.com

withpower.com/trial/phase-2-and-3-pre-term-birth-9-2026-f4724

Aspirin + Lansoprazole for Premature Birth

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, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6152923/

Low-Dose Aspirin and Preterm Birth: A Randomized ...

Among women without a history of preterm birth (n=1005) the occurrence of preterm birth was 3.4% (17/500) and 4.8% (24/505) in the low-dose aspirin and placebo ...

4.

rep.bioscientifica.com

rep.bioscientifica.com/view/journals/rep/165/1/REP-22-0226.xml

Repurposing existing drugs as a therapeutic approach for the ...

Specifically, the ASPIRIN trial showed a reduction in the incidence of preterm birth and a decrease in perinatal mortality with aspirin as a ...

5.

physiciansweekly.com

physiciansweekly.com/post/effect-of-low-dose-aspirin-on-preterm-birth-prevention

Effect of Low-Dose Aspirin on Preterm Birth Prevention

Patients taking 100 mg daily before 16 weeks had a significantly lower risk of preterm birth at less than 37 weeks (RR 0.45, 95% CI 0.35–0.59), ...