U.S., Dec. 30 -- ClinicalTrials.gov registry received information related to the study (NCT07307365) titled 'Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients' on Dec. 15.
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. Patients are recruited and screen...