Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
Rea Diagnostics SA
800 participants
Dec 5, 2025
OBSERVATIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07307365