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NCT07337655 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Aspirin and Lansoprazole for Prevention of Preterm Birth in High-Risk Pregnant Women: A Biomarker-Enriched Trial
A Phase 2 study, sponsored by Stanford University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 670
- Enrollment target
NCT07337655: Clinical Trial Phase 2 study, sponsored by Stanford University.
NCT07337655 is a Phase 2 study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 670 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (404% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07337655, a Phase 2 study, has not yet begun recruiting, sponsored by Stanford University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 670 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Standard of Care
- DRUG Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 670 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 2 |
What is known before NCT07337655 opens enrollment
NCT07337655 is an interventional study that assigns participants to a tested intervention. The registered 670 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (404% higher).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT07337655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07337655 about?
NCT07337655 is a clinical study titled "Efficacy and Safety of Aspirin and Lansoprazole for Prevention of Preterm Birth in High-Risk Pregnant Women: A Biomarker-Enriched Trial". 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 throug...
What is the current status of trial NCT07337655?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 670 participants. The study started on 2026-10-01. Estimated completion is 2032-09-30.
What interventions are being tested in trial NCT07337655?
The interventions under investigation include: Standard of Care (OTHER), Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg (DRUG).
Who is sponsoring clinical trial NCT07337655?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07337655's enrollment target sits among peer trials
670 48th of 2000 higher than 1,953 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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