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Completed

NCT Number: NCT05699421

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

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Key information

Conditions

Screening

Age range

16 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

ASSIR Metropolitana Nord

Badalona, Spain

About this study

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:

  • Estimate the percentage of acceptance of CMV screening in the population
  • To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy
  • To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester
  • 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)
  • To identify and describe the rate of neonatal infection (congenital CMV)
  • To identify and describe the rate of sequelae for congenital CMV at one year of the child's age
  • To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV
  • To identify and describe the rate of legal of TOP following the diagnosis of fetal infection
  • To identify and describe the rate of TOP following the diagnosis of fetal anomalies
  • To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

screening programme

Other

CMV screening during the first trimester of pregnancy and neonatal

Primary outcomes

  1. CMV seroprevalence in first trimester of pregnancy

    Time frame: 18-19 months

    Nº IgG positive with negative IgM + IgG positive with positive IgM and high avidity) / Nº of serologies performed.

  2. Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period

    Time frame: 18-19 months

    Nº IgG positive with IgM positive and low or intermediate avidity / Nº serologies performed.

  3. Fetal infection rate at 2nd trimester amniocentesis

    Time frame: 3-24 months

    Nº positive PCR-CMV in amniotic fluid/total amniocentesis.

  4. Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection

    Time frame: 3-24 months

    ultrasound or MRI abnormalities attributable to CMV/total primary infections (IgG positive with IgM positive and low or intermediate avidity).

  5. Neonatal infection rate (congenital CMV)

    Time frame: 6-27 months

    no. PCR-CMV in neonatal urine/total primary infections (IgG positive with IgM positive and low or intermediate avidity).

Secondary outcomes

  1. Congenital CMV sequelae rate at one year of life

    Time frame: 18-36 months

    no. symptomatic cases at one year of life/total primary infections (IgG positive with IgM positive and low or intermediate avidity).

  2. Rate of TOP after diagnosis of primary infections:

    Time frame: 2-19 months

    no. TOP before amniocentesis among cases of primary infection/total primary infection (IgG positive with IgM positive and low or intermediate avidity).

  3. Rate of legal termination of pregnancy after diagnosis of fetal infection

    Time frame: 3-19 months

    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).

  4. Rate of TOP after diagnosis of fetal anomalies

    Time frame: 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).

  5. 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).

    Time frame: 2-18 months

    total number of serologies performed in the 4 centers / number of first visits <14 weeks in the four centers

  6. Annual cost of CMV screening in the first trimester

    Time frame: month 19-24

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • ASSIRs Barcelona
  • ASSIRs Metropolitana Nord
  • Germans Trias i Pujol Hospital
  • Hospital Clínic Sede Maternitat
  • Vall d'Hebron Barcelona Hospital Campus

Registry information

Official study title

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

Acronym: CITEMB

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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