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

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

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).

Study Overview

• Status: Completed
• Conditions: Screening
• Intervention / Treatment: Other: screening programme

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).

• Study Type: Observational
• Enrollment (Actual): 3357

Contacts and Locations

Study Locations

• Spain
  • Badalona, Spain
    • ASSIR Metropolitana Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

women > 16 years old (reproductive age), during first trimester of pregnancy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CITEMB project participants; 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.

Other: screening programme; CMV screening during the first trimester of pregnancy and neonatal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMV seroprevalence in first trimester of pregnancy	Nº IgG positive with negative IgM + IgG positive with positive IgM and high avidity) / Nº of serologies performed.	18-19 months
Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period	Nº IgG positive with IgM positive and low or intermediate avidity / Nº serologies performed.	18-19 months
Fetal infection rate at 2nd trimester amniocentesis	Nº positive PCR-CMV in amniotic fluid/total amniocentesis.	3-24 months
Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection	ultrasound or MRI abnormalities attributable to CMV/total primary infections (IgG positive with IgM positive and low or intermediate avidity).	3-24 months
Neonatal infection rate (congenital CMV)	no. PCR-CMV in neonatal urine/total primary infections (IgG positive with IgM positive and low or intermediate avidity).	6-27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Congenital CMV sequelae rate at one year of life	no. symptomatic cases at one year of life/total primary infections (IgG positive with IgM positive and low or intermediate avidity).	18-36 months
Rate of TOP after diagnosis of primary infections:	no. TOP before amniocentesis among cases of primary infection/total primary infection (IgG positive with IgM positive and low or intermediate avidity).	2-19 months
Rate of legal termination of pregnancy after diagnosis of fetal infection	no. TOP after positive PCR-CMV in amniotic fluid and no fetal involvement/total primoinfections (IgG positive with IgM positive and low or intermediate avidity).	3-19 months
Rate of TOP after diagnosis of fetal anomalies	no. TOP after PCR-CMV in positive amniotic fluid and with fetal involvement/total primoinfections (IgG positive with IgM positive and low or intermediate avidity).	3-19 months
no. TOP after PCR-CMV in positive amniotic fluid and with fetal involvement/total primoinfections (IgG positive with IgM positive and low or intermediate avidity).	total number of serologies performed in the 4 centers / number of first visits <14 weeks in the four centers	2-18 months
Annual cost of CMV screening in the first trimester		month 19-24

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Germans Trias i Pujol Hospital; Hospital Clínic Sede Maternitat; Vall d'Hebron Barcelona Hospital Campus; ASSIRs Barcelona; ASSIRs Metropolitana Nord

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; cytomegalovirus; vertical transmission; universal screening; child health prevention
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: 22/097-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No