临床试验/NCT04822142

NCT04822142招募中不适用

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

Hanoi Obstetrics and Gynecology Hospital1 个研究点分布在 1 个国家目标入组 5,000 人开始时间: 2022年4月1日最近更新: 2024年3月1日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Hanoi Obstetrics and Gynecology Hospital
入组人数: 5,000
试验地点: 1
主要终点: Proportion of congenital CMV infection in Vietnamese neonates

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

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

排除标准

•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.

结局指标

主要结局

Proportion of congenital CMV infection in Vietnamese neonates

时间窗: Within 7 days from birth

Number of CMV positive neonates among all tested neonates

次要结局

To estimate the prevalence of cCMV related neurological sequelae in neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict infection in the neonates(Up to 25 months from recruitment)
To estimate the prevalence of symptomatic cCMV in neonates(Up to 25 months from recruitment)
To estimate CMV seroprevalence in pregnant Vietnamese women(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict a cCMV symptomatic infection in neonates(Up to 25 months from recruitment)
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with uninfected neonates in control group(Up to 25 months from recruitment)
To evaluate risks factors for cCMV in Vietnamese women(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the cCMV long-term sequelae at the age of 2 years(Up to 48 months from recruitment)
To estimate the prevalence of cCMV related hearing loss in neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in whole blood in the first trimester to predict the presence of symptomatic cCMV infection in neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict a cCMV symptomatic infection in neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the presence of symptomatic cCMV infection in neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the presence of symptomatic cCMV infection in neonates(Up to 25 months from recruitment)
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with uninfected neonates in control group(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict the cCMV long-term sequelae at the age of 2 years(Up to 48 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict infection in the neonates(Up to 25 months from recruitment)
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates(Up to 25 months from recruitment)
To calculate the false positive rate of CMV PCR on neonatal saliva versus on dry blood spot in screening congenital CMV infection(Up to 25 months from recruitment)
To calculate the false positive rate of CMV PCR on neonatal saliva versus on urine in screening congenital CMV infection(Up to 25 months from recruitment)
To estimate the prevalence of symptomatic cCMV at 2 years of age(Up to 48 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict infection in the neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict cCMV infection in the neonates(Up to 25 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict infection in the neonates(Up to 25 months from recruitment)
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates(Up to 25 months from recruitment)
To estimate the prevalence of cCMV related neurological sequelae at 2 years of age(Up to 48 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict the cCMV long-term sequelae at the age of 2 years(Up to 48 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the cCMV long-term sequelae at the age of 2 years(Up to 48 months from recruitment)
To estimate the prevalence of cCMV related hearing loss at 2 years of age(Up to 48 months from recruitment)
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict the cCMV long-term sequelae at the age of 2 years(Up to 48 months from recruitment)

研究者

发起方

Hanoi Obstetrics and Gynecology Hospital

申办方类型

Other

责任方

Sponsor

研究点 (1)

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