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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Screening

Intervention / Treatment
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* Other: screening programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CITEMB project participants<br>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<br>* CMV screening during the first trimester of pregnancy and neonatal<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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universal screening, pregnancy, cytomegalovirus, vertical transmission, child health prevention