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
Pregnant patients with symptoms of premature delivery.
Cohort
Prospective
Not listed
Evaluation of the clinical performance of the PremaSure kit
On the population of patients who have fully completed the study without experiencing a non-spontaneous delivery up to 14 days after the sample collection, we will determine the sensitivity, specificity, accuracy, positive and negative predictive values (PPV and NPV respectively) of the PremaSure test for the identification of pregnant women at risk of pre-term delivery at 7 and 14 days, respectively
Estimation of the clinical performance of the PremaSure kit on sub-group population
Estimation of sensitivity and specificity, PPV, NPV and prevalence for the risk of pre-term delivery of sub-groups, defined as any combination of the categories derived from the pregnancy information collected in the context of the present study. The statistical study power may not be attained for each subgroup. The aforementioned values will be determined considering as an outcome a delivery at 7 days, 14 days, or at any duration following the test.
Estimation of correlation coefficients between the participant pregnancy information and the outcome of the pregnancy
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Rea Diagnostics SA
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Collaborator
