Immune and viral markers that predict HCMV passing to the baby during pregnancy
Immunological and Virological Prognostic Markers of Human Cytomegalovirus (HCMV) Congenital Infection in Pregnant Women With Primary HCMV Infection.
Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07477925
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia (other) |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07477925 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (RECRUITING)
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.
Conditions: Human Cytomegalovirus