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Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
Sponsor: Rea Diagnostics SA
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
800
Start Date
2025-12-05
Completion Date
2027-03
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Locations (1)
Centre Hospitalier Universtaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland