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
Informed Consent signed by the subject
Female patients above 18 years
Gestational week from 22w+0 days to 35w+6 days
Symptoms of prematurity.
Subject lacking capacity to provide informed consent
Enrolment of the project leader, their family members, employees and other dependent persons
Patients with ruptured amniotic membranes or blood in their vaginal discharge
Patients with vaginal examination in the last 24 hours
Rea Diagnostics SA
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Collaborator