Last updated on April 2017

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


Brief description of study

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

Detailed Study 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 pragmatically a cohort of ~8000 pregnant women aged 18 and above till the investigators successfully enroll 5000 live newborns at MCHHs and collect babies' saliva and urine samples.As a first step, The investigators will work with these hospitals to obtain the remaining blood/urine samples from ~8000 pregnant women at participants first visit to hospitals (for first trimester pregnancy services), and follow up participants till they deliver their babies and donate babies' urine and saliva samples. The arm of this study is to enroll 5000 pairs of newborns and their mothers. Only these newborns' mothers will remain in the final cohort and retrospectively their samples collected during pregnancy will be tested for data analysis. Other women whose newborns cannot be captured will be considered loss to follow-up and their samples will not be tested.

Clinical Study Identifier: NCT02645396

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Shulian Li, MD

Maternity and Child care of Huli District
Xiamen, China
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Fengxian Zheng

Maternity and Child care of Xinmi City
Zhengzhou, China
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