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.
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.
Prior spontaneous preterm birth (<37 weeks),
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.
Parallel
Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg
Drug1. 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.
Standard of Care
Other interventionStandard of Care
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.
Incidence of preterm birth before 34+0 weeks of gestation.
Incidence of preterm birth before 34+0 weeks of gestation.
Gestational age at delivery
Gestational age at delivery, analyzed as a continuous outcome (weeks).
Incidence of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.
Incidence of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.
Incidence of fetal growth restriction
Incidence of fetal growth restriction, including: * Small-for-gestational-age (SGA; birthweight \<10th percentile), * Low birthweight (\<2500 g), and * Very low birthweight (\<1500 g).
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