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Clinical Trial Summary

The aim of this study is to evaluate a universal cCMV screening programme in the first trimester of pregnancy in primary care in Catalonia (Spain).


Clinical Trial Description

This is the pilot study of implementation of the CMV universal screening program in the first trimester of pregnancy Barcelona and its metropolitan area. General objective The aim of this study is to evaluate a universal CMV screening programme in the first trimester of pregnancy in primary care. Specific aims of this pilot study: 1. Estimate the percentage of acceptance of CMV screening in the population 2. To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy 3. To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester 4. To identify and describe the rate of fetal sequelae (due to the primary CMV infection in the first trimester), obtained by imaging techniques (ultrasound and MRI) 5. To identify and describe the rate of neonatal infection (congenital CMV) 6. To identify and describe the rate of sequelae for congenital CMV at one year of the child's age 7. To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV 8. To identify and describe the rate of legal of TOP following the diagnosis of fetal infection 9. To identify and describe the rate of TOP following the diagnosis of fetal anomalies 10. To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05699421
Study type Observational
Source Jordi Gol i Gurina Foundation
Contact Roser Gol
Phone +(34)935510174
Email rgol.bnm.ics@gencat.cat
Status Recruiting
Phase
Start date April 21, 2022
Completion date March 2025

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