Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

Hanoi Obstetrics and Gynecology Hospital

Status: Enrolling

Conditions: Congenital Infection; Neonatal Disease; Prenatal Infection

Study type: Observational

Funder types: Other

Identifiers

NCT04822142

PSHN.0003.2021

Details and patient eligibility

About

To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population

Full description

Congenital cytomegalovirus infection (cCMV) is the main non-genetic cause of sensorineural hearing loss (SNHL), and a major cause of neuro-disability. High maternal CMV prevalence seems to be consistently associated with high prevalence of cCMV infection but the associated morbidity might be different from one population to another.

There exists no serologic marker useful to differentiate non-primary infection from primary infection. Since the morbidity of cCMV is similar between both primary and non-primary maternal infection, and to be infected in the first trimester is the major risk factor for long-term sequelae in neonates. Hence, it is needed to focus on finding markers that predict cCMV after maternal infection in the first trimester of pregnancy.

To date, the epidemiology of cCMV, the morbidity related to cCMV in Vietnamese population and the predictive value of Cytomegalovirus Polymerase Chain Reaction (CMV PCR) in maternal blood and urine in the first trimester remain unknown. Therefore, it is necessary to conduct this study.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth.
• Informed consent

Exclusion criteria

• Women under 18 years old.
• Miscarriages
• Stillbirths
• Premature delivery before 34th gestational week
• Loss to follow-up maternal monitoring.
• Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality.