PremaSure: a self-test to check the risk of preterm delivery in symptomatic pregnant patients.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Higher-dose versus standard-dose aspirin to prevent another early preterm birth

  This trial tests whether taking 162 mg daily aspirin instead of 81 mg, starting at 10–15 weeks of pregnancy, helps people with a prior early preterm birth avoid another preterm delivery or fetal death before 35 weeks.

  Recruiting at 14 sites Phase 3 The George Washington University Biostatistics Center · Birmingham, Alabama and 13 other locations · NCT06980025

• Predictive test for preterm birth in threatened preterm labor

  A test called Premaquick is being tried to see if it can better predict preterm delivery in pregnant people with threatened preterm labor.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT04374916

• Using synbiotics to reduce the risk of preterm birth

  This study is testing if taking synbiotics can help women at high risk for preterm birth have healthier pregnancies by improving their vaginal microbiome.

  Recruiting at 9 sites Ziekenhuis Oost-Limburg · Edegem, Antwerpen and 8 other locations · NCT05966649

• Caffeine in pregnancy: how the mother and baby handle it during delivery

  This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT07570121

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.