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| Name | Class |
|---|---|
| Vall d'Hebron Barcelona Hospital Campus | UNKNOWN |
| Hospital ClÃnic Sede Maternitat | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| ASSIRs Barcelona |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 ClÃnic /Hospital Sant Joan de Déu University of Barcelona and Trias i Pujol University Hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| screening programme | Other | CMV screening during the first trimester of pregnancy and neonatal |
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| 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 |
| 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: |
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Inclusion Criteria:
Exclusion Criteria:
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women > 16 years old (reproductive age), during first trimester of pregnancy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASSIR Metropolitana Nord | Badalona | Spain |
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| UNKNOWN |
| ASSIRs Metropolitana Nord | UNKNOWN |
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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 |