Universal screening for cytomegalovirus infection in early pregnancy
Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy: A Multicentre Pilot Study in the Area of Barcelona (CITEMB Study)
This study is testing a new screening program for cytomegalovirus in pregnant women during their first trimester to see how well it works and if it can help prevent problems for babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | Female |
| Sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Academic / other |
| Locations | 1 site (Badalona) |
| Trial ID | NCT05699421 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates a universal cytomegalovirus (CMV) screening program for pregnant women in their first trimester in Catalonia, Spain. The study aims to assess the acceptance rate of CMV screening, the incidence of primary CMV infections, and the rates of vertical transmission and associated fetal sequelae. Additionally, it will analyze the economic implications of implementing such a screening program in primary care settings. The findings will help inform future public health strategies regarding CMV in pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 16 years or older with a gestational age of less than 14 weeks.
Not a fit: Patients who are unable to provide informed consent due to language barriers or those with a gestational age above 14 weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of congenital CMV infections and improve child health outcomes.
How similar studies have performed: Other studies have shown promising results with universal CMV screening approaches, indicating potential for success in this pilot program.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Badalona
- ASSIR Metropolitana Nord — Badalona, Spain (Recruiting)
Study contacts
- Study coordinator: Roser Gol
- Email: rgol.bnm.ics@gencat.cat
- Phone: +(34)935510174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.