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

Screening Clinical Trial

— CITEMB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699421
• Other study ID #: 22/097-P
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Screening

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