Actively Recruiting
Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
Led by Rea Diagnostics SA · Updated on 2025-12-29
800
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
Sponsors
R
Rea Diagnostics SA
Lead Sponsor
C
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Female patients aged 18 years or older
- Pregnancy between 22 weeks and 35 weeks and 6 days gestation
- Showing symptoms of premature labor
You will not qualify if you...
- Unable to provide informed consent
- Project leader, their family members, employees, or dependents
- Ruptured amniotic membranes or blood in vaginal discharge
- Vaginal examination within the last 24 hours
- Previously enrolled in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universtaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1001
Actively Recruiting
Research Team
P
Pierre-Emmanuel Thiriet, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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