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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Screening

Treatments: Other: screening programme

Study type: Observational

Funder types: Other

Identifiers

NCT05699421

22/097-P

Details and patient eligibility

About

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).

Full 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).

Enrollment: 3,357 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• maternal age 16 years or older, and
• gestational age less than 14 weeks.

Exclusion criteria

• language barrier preventing informed consent,
• gestational age at blood sampling above 14 weeks, and
• consent withdrawal

Trial design

3,357 participants in 1 patient group

CITEMB project participants

Description:

This is a single cohort, observational prospective multicenter study. The participating centers of the Barcelona Northern Metropolitan Area are primary attention centers - ASSIR Muntanya, ASSIR Esquerra, ASSIR Santa Coloma de Gramenet, ASSIR Badalona-Sant Adrià and hospitals - Vall d'Hebron University Hospital in Barcelona, BCNatal, Hospital Clínic /Hospital Sant Joan de Déu University of Barcelona and Trias i Pujol University Hospital.

Treatment:

Other: screening programme