Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
Recruiting
Observational Study
Preterm Delivery
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 800 (estimated)
- Sponsor
- Rea Diagnostics SA · Industry
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About This Trial
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 te…
Trial Locations
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Eligibility 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 memb…
Contacts