ScreeningCITEMBNCT05699421
Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy (CITEMB Study)
An observational study of Screening, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Screening
- What is being tested?
- screening programme
- How many people
- 3,357 participants
- Where
- 1 siteSpain
- Study dates
- 21 Apr 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: women > 16 years old (reproductive age), during first trimester of pregnancy
Who may be able to join
- maternal age 16 years or older, and
- gestational age less than 14 weeks.
Who cannot join
- language barrier preventing informed consent,
- gestational age at blood sampling above 14 weeks, and
- consent withdrawal
Trial locations and contacts
1 site in 1 country.
About this 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)
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).
Read the 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:
- Estimate the percentage of acceptance of CMV screening in the population
- To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy
- To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester
- 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)
- To identify and describe the rate of neonatal infection (congenital CMV)
- To identify and describe the rate of sequelae for congenital CMV at one year of the child's age
- To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV
- To identify and describe the rate of legal of TOP following the diagnosis of fetal infection
- To identify and describe the rate of TOP following the diagnosis of fetal anomalies
- To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain).
- Conditions
- Screening
- Being tested
- screening programme
- Keywords
- universal screening, pregnancy, cytomegalovirus, vertical transmission, child health prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening programmeOther
CMV screening during the first trimester of pregnancy and neonatal
| Study group | Role | What they receive |
|---|---|---|
| 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 Clínic /Hospital Sant Joan de Déu University of Barcelona and Trias i Pujol University Hospital. Receives: Other: screening programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18-19 months
Fetal infection rate at 2nd trimester amniocentesis
Nº positive PCR-CMV in amniotic fluid/total amniocentesis.
Measured: 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).
Measured: 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).
Measured: 6-27 months
Secondary outcomes (6)
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).
Measured: 18-36 months
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 2-18 months
Annual cost of CMV screening in the first trimester
Measured: month 19-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start21 Apr 2022
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Vall d'Hebron Barcelona Hospital Campus, Hospital Clínic Sede Maternitat, Germans Trias i Pujol Hospital, ASSIRs Barcelona, ASSIRs Metropolitana Nord
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699421
- Sponsor's protocol ID
- 22/097-P
- Acronym
- CITEMB
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05699421
- Acronym / sponsor ID
- CITEMB / 22/097-P
- Conditions
- Screening
- Keywords
- universal screening, pregnancy, cytomegalovirus, vertical transmission, child health prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,357 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Vall d'Hebron Barcelona Hospital Campus, Hospital Clínic Sede Maternitat, Germans Trias i Pujol Hospital, ASSIRs Barcelona, ASSIRs Metropolitana Nord
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Estimate the percentage of acceptance of CMV screening in the population
- To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy
- To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester
- 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)
- To identify and describe the rate of neonatal infection (congenital CMV)
- To identify and describe the rate of sequelae for congenital CMV at one year of the child's age
- To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV
- To identify and describe the rate of legal of TOP following the diagnosis of fetal infection
- To identify and describe the rate of TOP following the diagnosis of fetal anomalies
- To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CITEMB project participants | – | Other: screening programmeThis 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 Clínic /Hospital Sant Joan de Déu University of Barcelona and Trias i Pujol University Hospital. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- women > 16 years old (reproductive age), during first trimester of pregnancy
Key inclusion criteria (2 listed)
- maternal age 16 years or older, and
- gestational age less than 14 weeks.
Key exclusion criteria (3 listed)
- language barrier preventing informed consent,
- gestational age at blood sampling above 14 weeks, and
- consent withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening programmeCMV screening during the first trimester of pregnancy and neonatal | Other | CITEMB project participants |
Primary outcome
CMV seroprevalence in first trimester of pregnancy
Time frame: 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
Time frame: 18-19 months
Nº IgG positive with IgM positive and low or intermediate avidity / Nº serologies performed.
Fetal infection rate at 2nd trimester amniocentesis
Time frame: 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
Time frame: 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)
Time frame: 6-27 months
no. PCR-CMV in neonatal urine/total primary infections (IgG positive with IgM positive and low or intermediate avidity).
6 secondary outcomes
Congenital CMV sequelae rate at one year of life
Time frame: 18-36 months
Rate of TOP after diagnosis of primary infections:
Time frame: 2-19 months
Rate of legal termination of pregnancy after diagnosis of fetal infection
Time frame: 3-19 months
Rate of TOP after diagnosis of fetal anomalies
Time frame: 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).
Time frame: 2-18 months
Annual cost of CMV screening in the first trimester
Time frame: month 19-24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screening, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV seroprevalence in first trimester of pregnancy (time frame: 18-19 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.