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Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients

NCT07307365 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-12-29

No results posted yet for this study

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

Conditions

  • Preterm Delivery

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Rea Diagnostics SA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307365 on ClinicalTrials.gov