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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05699421
Other study ID # 22/097-P
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 21, 2022
Est. completion date March 2025

Study information

Verified date March 2024
Source Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Contact Roser Gol
Phone +(34)935510174
Email rgol.bnm.ics@gencat.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date March 2025
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
screening programme
CMV screening during the first trimester of pregnancy and neonatal

Locations

Country Name City State
Spain ASSIR Metropolitana Nord Badalona

Sponsors (6)

Lead Sponsor Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ASSIRs Barcelona, ASSIRs Metropolitana Nord, Germans Trias i Pujol Hospital, Hospital Clínic Sede Maternitat, Vall d'Hebron Barcelona Hospital Campus

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Fetal infection rate at 2nd trimester amniocentesis Nº positive PCR-CMV in amniotic fluid/total amniocentesis. 3-24 months
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Annual cost of CMV screening in the first trimester month 19-24
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