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

NCT07307365 | Recruiting

• 1 other identifier: REA-2024-02260
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 1.Patients are recruited and screened for eligibility criteria
2. 2.A healthcare professional collects a vaginal swab from the patient
3. 3.The collected sample is tested on the PremaSure kit
4. 4.Pregnancy outcome is compared to the PremaSure kit's result

Conditions

Preterm Delivery

Keywords

Preterm Delivery; Self-test

Outcome Measures

Primary Outcomes (1)

• Evaluation of the clinical performance of the PremaSure kit

  On the population of patients who have fully completed the study without experiencing a non-spontaneous delivery up to 14 days after the sample collection, we will determine the sensitivity, specificity, accuracy, positive and negative predictive values (PPV and NPV respectively) of the PremaSure test for the identification of pregnant women at risk of pre-term delivery at 7 and 14 days, respectively

  From enrollment to the delivery of the patient

Secondary Outcomes (2)

• Estimation of the clinical performance of the PremaSure kit on sub-group population

  From enrollment until the delivery of the patient

• Estimation of correlation coefficients between the participant pregnancy information and the outcome of the pregnancy

  From enrollment until delivery of the patient.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biological female can be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with symptoms of premature delivery.

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

Sponsors & Collaborators

• Rea Diagnostics SA: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

Centre Hospitalier Universtaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1001, Switzerland

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Pierre-Emmanuel Thiriet, PhD

CONTACT

+41216931345; pierre-emmanuel.thiriet@readiagnostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CH (1)