Immune and viral markers that predict HCMV passing to the baby during pregnancy
Official title: Immunological and Virological Prognostic Markers of Human Cytomegalovirus (HCMV) Congenital Infection in Pregnant Women With Primary HCMV Infection.
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07477925 · Data updated 2026-11-12
This project will see if immune and viral markers in pregnant women with recent primary HCMV infection can predict whether the virus will be passed to the fetus.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | October 3, 2018 |
| Main results expected | October 3, 2026 |
| Study ends | October 3, 2026 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07477925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women over 18 with confirmed primary HCMV infection occurring within the first 26 weeks of gestation and with infection onset within three months before enrollment.
✕Probably not a fit
Women with known immunodeficiency, active HBV/HCV/HIV infection, autoimmune disease, inability to comply with protocol visits, or those unable to attend the Pavia site are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study that follows pregnant women with recent primary HCMV infection to measure maternal immune (T and B cell) responses and virological markers over time. Blood samples and virologic testing will be collected during pregnancy and newborns will be tested for congenital infection at birth. Researchers will correlate timing and quality of the maternal immune response and viral load with whether the fetus becomes infected and with newborn outcomes. Women with concurrent HBV, HCV, or HIV infection or known immunodeficiency are excluded and all visits occur at the Pavia site.
Why it matters
Potential benefit: If successful, the findings could help identify pregnancies at higher risk for congenital HCMV so those pregnancies can receive closer monitoring or earlier intervention.
How similar studies have gone: Previous observational studies have linked delayed maternal T- and B-cell responses to higher risk of fetal transmission, but clear, widely accepted predictive markers have not yet been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women \>18 years. * HCMV primary infection occurring within 26 weeks of gestation. * HCMV primary infection onset within 3 months before enrollment. * HCMV pre-conception (non-primary) infection and congenitally infected newborn Exclusion Criteria: * HBV, HCV, HIV infection. * Known immunodeficiency, immunosuppression or autoimmune disease. * Inability to comply with the requirements of the protocol.
Where it's running
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Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.