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
N/A
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
Researchers are evaluating the clinical performance of the PremaSure kit to determine if it can be used as a self-test for assessing the risk of premature delivery in pregnant women who show symptoms of early labor. The study aims to measure how accurately the kit predicts delivery within 7 to 14 days after testing, addressing the urgent need to identify women at risk of preterm birth, which is a leading cause of death in infants under five years old. The study involves recruiting eligible female patients between 22 weeks and 35 weeks plus 6 days of pregnancy who show symptoms of prematurity. A healthcare professional collects a vaginal swab sample, which is then tested using the PremaSure kit by a study nurse. The test results will be compared to the actual pregnancy outcome to assess the kit’s predictive performance. The test device is investigational and labeled for research use only. Participants will be closely monitored with data collected in electronic case report forms. Researchers will track pregnancy outcomes and correlate them with test results. The study includes informed consent, regular monitoring visits, and allows participants to withdraw at any time without affecting their clinical care. The main outcome is the performance of the PremaSure kit from enrollment until delivery, with additional analysis on subgroups and pregnancy information correlation.
CONDITIONS
Brief 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 above 18 years old
- Pregnancy between 22 weeks and 35 weeks plus 6 days gestation
- Showing symptoms of premature labor
You will not qualify if you...
- Unable to provide informed consent
- Project leader, family members, employees, or dependents enrolled
- Ruptured amniotic membranes or blood in vaginal discharge
- Vaginal examination within the last 24 hours
- Previous participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery
Participants undergo a vaginal swab performed by a healthcare professional and the PremaSure test is administered by a study nurse to assess premature delivery risk.
1 visit (in-person)
Duration - From enrollment until delivery
Participants are monitored until delivery to collect pregnancy and delivery information to evaluate the predictive performance of the PremaSure kit.
Follow-up visits as part of routine pregnancy care; exact number may vary
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
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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