NCT05699421

Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy (CITEMB Study)

Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy: A Multicentre Pilot Study in the Area of Barcelona (CITEMB Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,357 (actual)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Screening

Interventions

Type	Name	Description
OTHER	screening programme	CMV screening during the first trimester of pregnancy and neonatal

Timeline

• Start date: 2022-04-21
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2023-01-26
• Last updated: 2025-09-10

Locations

1 site across 1 country: Spain