Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

Congenital Cytomegalovirus Infection in Vietnam: Prevalence, Morbidity and Risk Factors

Sponsors

Lead Sponsor: Hanoi Obstetrics and Gynecology Hospital

Collaborator: Hôpital Necker-Enfants Malades

Source Hanoi Obstetrics and Gynecology Hospital
Brief Summary

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

Detailed 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.

Overall Status Not yet recruiting
Start Date May 1, 2021
Completion Date May 1, 2025
Primary Completion Date October 31, 2022
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Proportion of congenital CMV infection in Vietnamese neonates Within 7 days from birth
Secondary Outcome
Measure Time Frame
Estimating CMV seroprevalence in pregnant Vietnamese women Up to 24 months from recruitment
Evaluating the value of a positive CMV PCR in whole blood in the first trimester to predict infection in the neonate Up to 24 months from recruitment
Evaluating the value of a positive CMV PCR in maternal whole blood at delivery to predict a symptomatic infection in the neonate Up to 24 months from recruitment
Evaluating the value of a positive CMV PCR in urine in the first trimester to predict infection in the neonate Up to 24 months from recruitment
Evaluating the value of a positive CMV PCR in maternal urine at delivery to predict infection in the neonate Up to 24 months from recruitment
Estimating the prevalence of symptomatic cCMV in Vietnam Up to 48 months from birth
Estimating the prevalence of CMV related hearing loss in Vietnam Up to 48 months from birth
Estimating the prevalence of neurological sequelae at 2 years of age Up to 48 months from recruitment
Estimating the prevalence of at least one related CMV sequelae at 2 years of age Up to 48 months from recruitment
Evaluating the value of a positive CMV PCR in whole blood in the first trimester to predict a symptomatic infection in the neonate and the presence of any long-term sequelae at the age of 2 years Up to 48 months from recruitment
Evaluating the value of a positive CMV PCR in maternal whole blood at delivery to predict a symptomatic infection in the neonate Up to 48 months from recruitment
Evaluating the value of a positive CMV PCR in urine in the first trimester to predict a symptomatic infection in the neonate Up to 48 months from recruitment
Evaluating the value of a positive CMV PCR in maternal urine at delivery to predict a symptomatic infection in the neonate Up to 48 months from recruitment
Evaluating risk factors for cCMV in Vietnamese women Up to 24 months from recruitment
Evaluating the correlation between CMV PCR viral load in maternal whole blood and urine at first trimester and at delivery in mothers with infected neonates Up to 24 months from recruitment
Evaluating the correlation between CMV PCR viral load in maternal whole blood and urine at first trimester and at delivery in mothers without infected neonates Up to 24 months from recruitment
Comparing the sensitivity of CMV PCR on dry blood spot and saliva in screening congenital CMV infection Up to 24 months from recruitment
Enrollment 5000
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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 follow-up maternal monitoring. - Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Ha Nguyen Thi Thu, MD.PhD

Phone: 0084989661093

Email: [email protected]

Verification Date

March 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym CYMEVIE
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov

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