A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China

The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women.

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Key information

Conditions

Congenital Cytomegalovirus Infection Cytomegalovirus Infection Reactivation Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maternity and Child care of Huli District, Xiamen, Fujian, China

About this study

This study will be conducted at several Maternal and Child Health Hospitals (MCHHs) in China and the research activities will be integrated with routine medical services during pregnancy at the study sites.The investigators will build a perspective cohort study enrolling ~8000 pregnant women elder than 18 and following up their newborns at specific MCHHs.As a first step, The investigators will work with these hospitals to recruit the subjects. After being informed, the participants' remaining blood and urine samples (after their medical examinations) at their early, medium and late stages of pregnancy will be collected , and their newborns' urine and saliva samples will be collected after delivery. The aim of this study is to enroll 5000 series mother-newborns.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Females aged 18 and older
Pregnancy confirmed by ultrasound
Come to MCHHs for "Pregnancy Registry" within 24 weeks of pregnancy

Exclusion criteria

Not capable of complying with study procedures, or having a psychosis, two-stage affective psychosis, or have a tendency to suicide
Having any autoimmune diseases (include systemic lupus erythematosus, rheumatoid arthritis), immunodeficiency (e.g. AIDS), chronic disease history such as cancers

Treatment and study plan

Primary outcomes

Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.

Time frame: up to 45 months

Secondary outcomes

Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.

Time frame: up to 45 months

Sponsors and collaborators

Lead sponsor

Jun Zhang

Other

Collaborators

Merck Sharp & Dohme LLC
National Natural Science Foundation of China

Registry information

Official study title

A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Neonates in China

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Jan 1, 2016
Registry last updated: Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed