Screening
Conditions
Keywords
universal screening, pregnancy, cytomegalovirus, vertical transmission, child health prevention
Brief 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).
Detailed 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).
Interventions
OTHERscreening programme
CMV screening during the first trimester of pregnancy and neonatal
Sponsors
Vall d'Hebron Barcelona Hospital Campus
Hospital Clínic Sede Maternitat
Germans Trias i Pujol Hospital
ASSIRs Barcelona
ASSIRs Metropolitana Nord
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMV seroprevalence in first trimester of pregnancy | 18-19 months | Nº IgG positive with negative IgM + IgG positive with positive IgM and high avidity) / Nº of serologies performed. |
| Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period | 18-19 months | Nº IgG positive with IgM positive and low or intermediate avidity / Nº serologies performed. |
| Fetal infection rate at 2nd trimester amniocentesis | 3-24 months | Nº positive PCR-CMV in amniotic fluid/total amniocentesis. |
| Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection | 3-24 months | ultrasound or MRI abnormalities attributable to CMV/total primary infections (IgG positive with IgM positive and low or intermediate avidity). |
| Neonatal infection rate (congenital CMV) | 6-27 months | no. PCR-CMV in neonatal urine/total primary infections (IgG positive with IgM positive and low or intermediate avidity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Congenital CMV sequelae rate at one year of life | 18-36 months | no. symptomatic cases at one year of life/total primary infections (IgG positive with IgM positive and low or intermediate avidity). |
| Annual cost of CMV screening in the first trimester | month 19-24 | — |
| Rate of TOP after diagnosis of primary infections: | 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). |
| Rate of legal termination of pregnancy after diagnosis of fetal infection | 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). |
| Rate of TOP after diagnosis of fetal anomalies | 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). |
| 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). | 2-18 months | total number of serologies performed in the 4 centers / number of first visits \<14 weeks in the four centers |
Countries
Spain
Outcome results
None listed