Clinical Trials Logo

Clinical Trial Summary

Human cytomegalovirus (HCMV) is the leading infectious agent causing congenital disabilities such as mental retardation, psychomotor delay, hearing loss, speech and language disabilities, behavioural disorders and visual impairment. About 0.6% newborns are HCMV-congenitally infected and, among these, about 20% are symptomatic at birth or will develop long-term sequelae. The public health impact of congenital HCMV is substantial although greatly unrecognized. In Italy, estimated direct costs per affected child exceed €100.000 for a total of €60-70M. HCMV is also a significant cause of infection/disease in the immunocompromised host.

Epidemiological studies and population-based models have preliminarily documented that most of the burden associated to congenital HCMV would be due to non-primary maternal infection. Presently, reinfections are believed to be responsible for the great majority of infected fetuses born to immune mothers.

This study addresses incidence, outcome and prevention of congenital HCMV infection in seropositive pregnant women.The study includes 2 parts: part 1 in which the incidence and outcome of congenital HCMV is investigated in a large population of HCMV seropositive pregnant women and HCMV shedding and immune response is closely monitored in a subset of participants (nested study); part 2 in which the efficacy of an hygiene intervention is assessed.


Clinical Trial Description

Part 1. Epidemiologic study. To investigate incidence and outcome of congenital infection in immune mothers, clinical records of pregnant women are reviewed for HCMV serostatus at ≤ 13 weeks' gestation. Women with HCMV serology compatible with a remote infection are asked to participate in the study. Consenting women are given a pre-stamped, pre-addressed envelope containing a swab to collect newborn's saliva. Envelopes are sent by courier to a centralized diagnostic facility for HCMV testing.

Women can also be enrolled at delivery, provided that the woman has records of presence of virus-specific IgG and absence of IgM early during gestation(or in a previous pregnancy) or, in case of unknown serostatus, a sample of serum/plasma stored at ≤ 13 weeks' gestation is available for retrospective antibody testing (retrospective part of the epidemiology study).

Part 1. Nested study. A subset of IgG pos IgM neg women selected among those enrolled at ≤13 weeks' gestation in the epidemiology study are included in a nested study. These women are monitored at enrolment, 20, 30 weeks of gestation and at delivery by prospective determination of HCMV DNA excretion in different bodily fluids. In DNA-positive specimens selected HCMV genes will be sequenced.

Part 2. Prevention study. To assess the effectiveness of hygiene measures for prevention of congenital infection HCMV seropositive pregnant women are enrolled at ≤ 13 weeks' gestation. Part 2 starts when enrolment of Part 1 is completed. In practice, part 2 is a continuation of part 1 with the only addition of delivering hygiene information at enrolment.

Part 2 will not be performed in case congenital infection rate in Part 1 is <0.4% and clear maternal risk factor for intrauterine transmission cannot be identified at interim analysis (i.e. after examination of 5000 newborns).

In case HCMV DNA is detected in newborn's saliva, a urine sample is obtained for confirmation of congenital infection. Infants with documented congenital infection are clinically assessed at the time of diagnosis (for Part 1 and 2) and at one year of age (Part 1 only). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03973359
Study type Interventional
Source Foundation IRCCS San Matteo Hospital
Contact Daniele Lilleri, MD
Phone +39 0382 501501
Email d.lilleri@smatteo.pv.it
Status Recruiting
Phase N/A
Start date September 4, 2017
Completion date December 2020

See also
  Status Clinical Trial Phase
Completed NCT01923636 - Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero N/A
Completed NCT02005822 - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Phase 3
Completed NCT02139423 - Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening N/A
Completed NCT02351102 - Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy Phase 2/Phase 3
Withdrawn NCT02594566 - Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine Phase 1
Active, not recruiting NCT05170269 - Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) Phase 3
Not yet recruiting NCT06118515 - A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus Phase 1
Completed NCT02782988 - Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
Completed NCT02645396 - A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China
Terminated NCT01655212 - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial Phase 3
Completed NCT02710864 - A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
Completed NCT05754879 - Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
Terminated NCT03301415 - Asymptomatic Congenital CMV Treatment Phase 2
Completed NCT01376778 - A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) Phase 3