Clinical trial NCT05699421: Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy (CITEMB Study)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Screening
Keywords: universal screening
pregnancy
cytomegalovirus
vertical transmission
child health prevention
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Vall d'Hebron Barcelona Hospital Campus
name: Hospital Clínic Sede Maternitat
name: Germans Trias i Pujol Hospital
name: ASSIRs Barcelona
name: ASSIRs Metropolitana Nord
First posted: 2023-01-26
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women \> 16 years old (reproductive age), during first trimester of pregnancy

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).

Eligibility criteria: 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

Primary outcomes:
measure: CMV seroprevalence in first trimester of pregnancy
timeFrame: 18-19 months
measure: Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period
timeFrame: 18-19 months
measure: Fetal infection rate at 2nd trimester amniocentesis
timeFrame: 3-24 months
measure: Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection
timeFrame: 3-24 months
measure: Neonatal infection rate (congenital CMV)
timeFrame: 6-27 months
Secondary outcomes:
measure: Congenital CMV sequelae rate at one year of life
timeFrame: 18-36 months
measure: Rate of TOP after diagnosis of primary infections:
timeFrame: 2-19 months
measure: Rate of legal termination of pregnancy after diagnosis of fetal infection
timeFrame: 3-19 months
measure: Rate of TOP after diagnosis of fetal anomalies
timeFrame: 3-19 months
measure: 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).
timeFrame: 2-18 months
measure: Annual cost of CMV screening in the first trimester
timeFrame: month 19-24
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: ASSIR Metropolitana Nord
Study officials:
References: