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

Last updated: September 3, 2025
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Overall Status: Completed

Phase

N/A

Condition

Cytomegalovirus Infections

Treatment

screening programme

Clinical Study ID

NCT05699421
22/097-P
  • Ages 16-45
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • maternal age 16 years or older, and

  • gestational age less than 14 weeks.

Exclusion

Exclusion Criteria:

  • language barrier preventing informed consent,

  • gestational age at blood sampling above 14 weeks, and

  • consent withdrawal

Study Design

Total Participants: 3357
Treatment Group(s): 1
Primary Treatment: screening programme
Phase:
Study Start date:
April 21, 2022
Estimated Completion Date:
March 31, 2025

Study 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).

Connect with a study center

  • ASSIR Metropolitana Nord

    Badalona,
    Spain

    Site Not Available

  • ASSIR Metropolitana Nord

    Badalona 3129028,
    Spain

    Site Not Available

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