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

Recruiting now

Conditions studied: Preterm Delivery

In brief

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

Key facts

Study ID

NCT07307365

Run by

Rea Diagnostics SA

People needed

800

Starts

2025-12-05

Expected to finish

2027-03-01

Last updated by the study team

2025-12-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Informed Consent signed by the subject
• Female patients above 18 years
• Gestational week from 22w+0 days to 35w+6 days
• Symptoms of prematurity.

You may not qualify if…

• 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
• Previous enrolment in the current study

Where it is running

• Centre Hospitalier Universtaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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