NCT02645396|Completed
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Sponsor study identifier
observational
8,855
1 country
2
Study Start
June 2015
Actual (reported)Primary Completion
June 2018
Actual (reported)Study Completion
December 2018
Actual (reported)The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2015
Actual (reported)July 31, 2015
Actual (reported)January 1, 2016
Actual (reported)June 2018
Actual (reported)December 2018
Actual (reported)Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
up to 45 months
Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.
up to 45 months
This study will enroll \~8000 pregnant women aged 18 years and above at MCHHs. Pregnant women who meet the inclusion/exclusion criteria will be enrolled. All inclusion and exclusion criteria will be reviewed by investigators or qualified designees to ensure that each subject is qualified for the study. In general, those whose newborns (including early birth, any congenital anomaly) are successfully followed up remain in the study population. However, those with adverse pregnancy outcomes captured in the MCHHs, such as abortion and still birth, etc., will also be the investigators' subjects even though we cannot have newborns' urine/saliva samples.
Maternity and Child care of Huli District
Xiamen, Fujian, 361000, China
Maternity and Child care of Xinmi City
Zhengzhou, Henan, 450000, China
Huang Y, Li T, Yu H, Tang J, Song Q, Guo X, Wang H, Li C, Wang J, Liang C, Yao X, Qiu L, Zhuang C, Bi Z, Su Y, Wu T, Ge S, Zhang J. Maternal CMV seroprevalence rate in early gestation and congenital cytomegalovirus infection in a Chinese population. Emerg Microbes Infect. 2021 Dec;10(1):1824-1831. doi: 10.1080/22221751.2021.1969290.
blood/urine samples of the pregnant women; saliva /urine samples of the newborns
Jun Zhang, Professor
Xiamen University
8,855 participants (actual enrollment reported by the registry).
First Submitted
July 31, 2015
First Posted
January 1, 2016
Study Start
June 2015
Actual (reported)Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine
Contact the study team to confirm eligibility.
Primary Completion
June 2018
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
April 23, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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