Using the MyCMV Tool to Improve Early Diagnosis of Cytomegalovirus Infection in Pregnant Women Evaluation of Software for Interpreting CMV Serology Results to Help Health Professionals

What this Trial Is About

Congenital cytomegalovirus CMV infection is the most common congenital infection in Europe, affecting about 0.4% of births. It is a leading cause of sensorineural hearing loss and neurodevelopmental disabilities when transmitted from mother to fetus, especially if the mother has a primary infection during pregnancy. Diagnosing CMV infection can be complex and may delay treatment that could help prevent transmission to the fetus. This research aims to evaluate whether a new decision-making software, called the MyCMV tool, helps health professionals interpret test results more quickly and accurately to detect primary CMV infection early in pregnancy. The study involves reviewing the CMV serology results of pregnant women who have been tested for CMV antibodies at certain hospitals. These results will be reinterpreted using the MyCMV tool, which analyzes laboratory data and pregnancy timing to assist in diagnosis. This reinterpretation is done for research purposes only and will not affect the clinical care of the patients. The study compares the detection rate of CMV infection using the MyCMV tool with the current expert-based method. Participants in the study are pregnant women with positive or borderline CMV IgM antibody results and known pregnancy start dates. Their medical information will be used to evaluate how well the MyCMV tool estimates the timing of infection and suggests additional tests. The main outcome measured is the detection rate of primary CMV infection in the first trimester. The study does not involve any new treatments or interventions for participants and focuses on analyzing existing test data.

Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals