A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Neonates in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Cytomegalovirus Infection
- Sponsor
- Jun Zhang
- Enrollment
- 8855
- Locations
- 2
- Primary Endpoint
- Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women.
Detailed Description
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.
Investigators
Jun Zhang
Vice dean of School of Public Health,Xiamen University
Xiamen University
Eligibility Criteria
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
Outcomes
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.(up to 45 months)