Clinical Trial

Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients

Recruiting
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Summary
The goal of the study is to determine the clinical performance of the PremaSure kit, more precisely to assess whether the PremaSure kit can be used as a self-test to assess the risk of premature delivery in patients showing symptoms of premature delivery. The sensitivity and specificity of the test will be determined using as an outcome the delivery of the patient in the 7/14 days following the test. The simplified procedure is the following: 1. Patients are recruited and screened for eligibility criteria 2. A healthcare professional collects a vaginal swab from the patient 3. The collected sample is tested on the PremaSure kit 4. Pregnancy outcome is compared to the PremaSure kit's result
Trial Details
NCT Number NCT07307365
Lead Sponsor Rea Diagnostics SA
Collaborators: Centre Hospitalier Universitaire Vaudois
Conditions Preterm Delivery
Enrollment 800 participants
Start Date 2025-12-05
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-29