A Phase II/III Clinical Trial Evaluating the Efficacy and Safety of Aspirin and Lansoprazole in High-Risk Pregnant Women for the Prevention of Preterm Birth: A Biomarker-Enriched Design
Stanford University
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.
Description
This study is a seamless Phase II/III, randomized, double-blind, biomarker-enriched clinical trial designed to evaluate the efficacy and safety of low-dose aspirin (81 mg daily) combined with lansoprazole (30 mg daily) for the prevention of preterm birth in pregnant individuals at high risk for spontaneous preterm delivery. Participants are enrolled early in pregnancy, between 12+0 and 16+6 weeks' gestation, and followed through delivery and a 6-week postpartum period. Preterm birth remains a leading cause of neonatal morbidity and mortality, yet effective pharmacologic prevention strategies…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 randomizati…
Interventions
- DrugLow-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg
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.
- OtherStandard of Care
Standard of Care
Location
- Stanford UniversityPalo Alto, California