Clinical Trial: A Cohort Study of Cytomegalovirus（CMV） Infection Among Pregnant Women and Their Newborns in China

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Cohort Study of Cytomegalovirus（CMV） Infection Among Pregnant Women and Their Newborns in China

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

Detailed Summary: 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.
Sponsor: Jun Zhang

Current Primary Outcome: Number of cCMV infection in newborns born to CMV seropositive pregnant women. [ Time Frame: up to 45 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of cCMV infection in newborns to pregnant women at different baseline maternal PP150-IgG titers. [ Time Frame: up to 45 months ]

Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: July 31, 2015
Date Started: June 2015
Date Completion: December 2018
Last Updated: April 11, 2017
Last Verified: April 2017