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

NCT05699421 | Completed DMC

• 1 other identifier: 22/097-P
• Study Type: observational
• Target: 3,357
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Screening

Keywords

universal screening; pregnancy; cytomegalovirus; vertical transmission; child health prevention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Congenital CMV sequelae rate at one year of life

  18-36 months

• Rate of TOP after diagnosis of primary infections:

  2-19 months

• Rate of legal termination of pregnancy after diagnosis of fetal infection

  3-19 months

• Rate of TOP after diagnosis of fetal anomalies

  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).

  2-18 months

Study Arms (1)

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

Interventions

screening programme OTHER

CMV screening during the first trimester of pregnancy and neonatal

CITEMB project participants

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

ASSIR Metropolitana Nord

Badalona, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 26, 2023
• Study Start: April 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

ES (1)