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

NCT07337655 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 84662
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with a diagnosis of Preterm Birth before 37+0 weeks of gestation

  The primary endpoint is the incidence of preterm birth before 37+0 weeks of gestation, defined as delivery occurring at or after 20+0 and before 37+0 weeks of gestation, in biomarker-identified high-risk pregnant participants randomized to aspirin + lansoprazole versus standard of care.

  At or after 20+0 and before 37+0 weeks of gestation

Secondary Outcomes (4)

• Incidence of preterm birth before 34+0 weeks of gestation.

  Before 34+0 weeks of gestation.

• Gestational age at delivery

  At delivery

• Incidence of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.

  At or after 20+0 and before 37+0 weeks of gestation

• Incidence of fetal growth restriction

  At delivery.

Study Arms (2)

Combination Therapy (Aspirin & Lansoprazole)

EXPERIMENTAL

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

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

Standard of Care

OTHER

Standard of Care

Other: Standard of Care

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.

Combination Therapy (Aspirin & Lansoprazole)

Standard of Care OTHER

Standard of Care

Standard of Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility to participate in this study is limited to pregnant individuals, regardless of gender identity. Participants must be able to become pregnant and be currently pregnant at the time of enrollment. Gender identity itself is not a criterion for inclusion or exclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Brice Gaudillière, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brice Gaudillière, MD, PhD

CONTACT

(650) 723-6412; gbrice@stanford.edu

Grant Wells, MS

CONTACT

650-714-4344; gwells2@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2032
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD Availability (Start Date): 6 months after publication of the primary results IPD Availability (End Date): 5 years after publication of the primary results
• Access Criteria: Who can access: Qualified researchers (e.g., academic investigators or industry scientists) with a methodologically sound proposal and appropriate expertise, following review and approval by the study sponsor/investigator team. What they can access: De-identified, participant-level individual participant data (IPD) underlying the primary and secondary outcome results, along with supporting documentation such as the study protocol, statistical analysis plan, data dictionary/codebook, and analytic code as available. How access will be provided: Access will be granted upon submission of a written request and research proposal, completion of a data use agreement (DUA), and confirmation of IRB/ethics approval or exemption as applicable. Approved users will receive access via a secure data-sharing platform or encrypted file transfer, with use limited to the approved analyses and no attempts at re-identification permitted.

Locations

US (1)