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

NCT02645396 | Completed

• 1 other identifier: CMV-EPI-001
• Study Type: observational
• Target: 8,855
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Congenital Cytomegalovirus Infection; Cytomegalovirus Infection Reactivation

Keywords

Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

• Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.

  up to 45 months

Secondary Outcomes (1)

• Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.

  up to 45 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Females aged 18 and older
• Pregnancy confirmed by ultrasound
• Come to MCHHs for "Pregnancy Registry" within 24 weeks of pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Jun Zhang: lead
• Merck Sharp & Dohme LLC: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (2)

Maternity and Child care of Huli District

Xiamen, Fujian, 361000, China

Location

Maternity and Child care of Xinmi City

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• 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.

  PMID: 34392819 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood/urine samples of the pregnant women; saliva /urine samples of the newborns

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jun Zhang, Professor

  Xiamen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice dean of School of Public Health,Xiamen University

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: January 1, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

CN (2)