NCT02645396

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,855 (actual)
• Sponsor: Jun Zhang · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infection Reactivation

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2016-01-01
• Last updated: 2019-04-23

Locations

2 sites across 1 country: China