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

Starting soon · Phase 2/Phase 3

Conditions studied: Pre-term Birth

In brief

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 facts

Study ID

NCT07337655

Run by

Stanford University

People needed

670

Starts

2026-10-01

Expected to finish

2032-09-30

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 to 45 years at the time of informed consent.
• Pregnancy: Singleton intrauterine pregnancy confirmed by ultrasound.
• Gestational Age: Between 12+0 and 16+6 weeks' gestation at randomization, based on first- or early second-trimester ultrasound dating.
• Risk Status: 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.
• Biomarker Enrichment: Positive preterm birth risk classification based on serum protein signature and/or digital-twin immunologic profile, as defined in the protocol.
• 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.
• Access to Care: Willingness to receive routine obstetric care at a participating study site and comply with follow-up through delivery and postpartum.

You may not qualify if…

• Hypersensitivity / Contraindications
• Known hypersensitivity, allergy, or intolerance to aspirin, other salicylates, lansoprazole, or other proton pump inhibitors (PPIs).
• 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.
• Hematologic / Bleeding Risk
• History of major gastrointestinal bleeding, peptic ulcer hemorrhage, intracranial hemorrhage, or other serious bleeding disorder.
• Known coagulopathy (e.g., hemophilia, von Willebrand disease) or platelet disorder relevant to aspirin use.
• Platelet count <100,000/µL at screening.
• Hemoglobin <8.0 g/dL at screening.
• Current or anticipated need for full-dose anticoagulation (e.g., therapeutic low-molecular-weight heparin) or dual antiplatelet therapy during pregnancy.
• Gastrointestinal / Hepatic / Renal
• Active peptic ulcer disease, erosive esophagitis, or known upper GI lesion at significant risk for bleeding, not adequately treated.
• History of recurrent peptic ulcer bleeding or perforation.
• Documented cirrhosis or clinically significant chronic liver disease (e.g., Child-Pugh B or C).
• Renal impairment, defined as Creatinine greater than 1.0 mg/dL, or currently on dialysis.
• Known inflammatory bowel disease with recent moderate-severe flare (e.g., requiring steroids or hospitalization in the last 3 months).
• Cardiovascular / Blood Pressure
• Persistent severe hypertension at screening (e.g., ≥160/110 mmHg on repeated measurements) not adequately controlled on therapy.
• Known significant structural heart disease or cardiomyopathy that, in the investigator's opinion, would increase risk with trial participation.
• Pregnancy-Related / Obstetric
• Multiple gestation (twins or higher-order).
• Known major fetal structural anomaly or chromosomal abnormality at screening (if results already available).
• Active preterm labor, preterm premature rupture of membranes (PPROM), or cervical dilation requiring emergent intervention at time of screening.
• Placenta previa with active bleeding or high risk of bleeding where aspirin is contraindicated.
• Planned elective termination of pregnancy.

Where it is running

• Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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