PremaSure: a self-test to check the risk of preterm delivery in symptomatic pregnant patients.
Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
This will test whether the PremaSure self-test can tell symptomatic pregnant patients if they are likely to deliver within 7 or 14 days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rea Diagnostics SA Industry-sponsored |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT07307365 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls pregnant patients between 22+0 and 35+6 weeks who present with symptoms of preterm labor. A healthcare professional collects a vaginal swab and a study nurse performs the PremaSure test according to the instructions for use. Investigators then compare the test result with whether the patient delivers within 7 and 14 days to calculate sensitivity and specificity. Participants can withdraw at any time and delivery outcomes are collected after birth to evaluate predictive performance.
Who should consider this trial
Good fit: Pregnant patients aged 18 or older between 22+0 and 35+6 weeks gestation who are showing symptoms of prematurity and can provide informed consent are ideal candidates.
Not a fit: Patients with ruptured membranes, blood in vaginal discharge, a vaginal exam within 24 hours, or those unable to consent are excluded and unlikely to benefit from this study's testing approach.
Why it matters
Potential benefit: If accurate, the PremaSure self-test could give symptomatic pregnant patients quick information about short-term delivery risk to help guide care decisions.
How similar studies have performed: Similar point-of-care or biomarker-based tests for short-term preterm delivery risk have shown mixed results, so this study aims to establish the PremaSure kit's real-world diagnostic performance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent signed by the subject * Female patients above 18 years * Gestational week from 22w+0 days to 35w+6 days * Symptoms of prematurity. Exclusion Criteria: * 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 this trial is running
Lausanne, Canton of Vaud
- Centre Hospitalier Universtaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Study coordinator: Pierre-Emmanuel Thiriet, PhD
- Email: pierre-emmanuel.thiriet@readiagnostics.com
- Phone: +41216931345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.