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Comparative Study of Immunoglobulins and Valaciclovir for Cytomegalovirus Infection in Pregnancy – A Monocentric Analysis

Comparative Study of Immunoglobulins and Valaciclovir for Cytomegalovirus Infection in Pregnancy – A Monocentric Analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038307
Enrollment
40
Registered
2025-11-17
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women with confirmed CMV infection B25

Interventions

Group 1: Immunoglobulin Therapy for Congenital CMV Infection Group 2: Valaciclovir Therapy for Congenital CMV Infection

Sponsors

Klinik für Frauenheilkunde und Geburtshilfe Universitätsklinikum Essen
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: • Pregnant women with confirmed CMV infection • Treatment with Valaciclovir and/or Hyperimmunoglobulin in CMV-infected pregnant women treated at the Department of Obstetrics and Gynecology, University Hospital Essen.

Exclusion criteria

Exclusion criteria: • Missing documentation regarding CMV infection or the administered therapy (Valaciclovir or HIG). • Patients who did not receive either of the two mentioned treatment options. • Patients unable to provide informed consent, if additional contact is required to obtain missing information. • Patients who explicitly object to prospective contact or do not consent to supplementary data collection. • Patients without sufficient knowledge of German or English, if qualified linguistic counseling cannot be ensured.

Design outcomes

Primary

MeasureTime frame
-Incidence of congenital CMV infections: depending on the timing of infection during pregnancy and the therapy applied. -Severity of CMV infection (e.g., symptomatic vs. asymptomatic). -Incidence of severe perinatal complications (e.g., intrauterine fetal death).

Secondary

MeasureTime frame
-Time to onset of CMV infections. -Incidence of CMV-associated neurological deficits (e.g., microcephaly, hearing loss). -Impact on fetal development (e.g., growth restrictions, birth weight).

Countries

Germany

Contacts

Public ContactAntonella Iannaccone

Klinik für Frauenheilkunde und Geburtshilfe Universitätsklinikum Essen

Antonella.Iannaccone@uk-essen.de+49 201 723 3574

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026