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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina3,357 enrolled

Overview

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).

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

3,357

Conditions

Screening

Interventions

screening programmeOTHER

CMV screening during the first trimester of pregnancy and neonatal

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ASSIR Metropolitana Nord

Badalona, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 18-19 months

Fetal infection rate at 2nd trimester amniocentesis

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

Time frame: 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).

Time frame: 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).

Time frame: 6-27 months

Secondary Outcomes

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).

Time frame: 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).

Data from ClinicalTrials.gov

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