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

Completed

• Conditions: Congenital Cytomegalovirus Infection; Cytomegalovirus Infection Reactivation

• Registration Number: NCT02645396
• Lead Sponsor: Jun Zhang

Brief 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-01
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-20
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8855

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.	up to 45 months

Secondary Outcome Measures

Name	Time	Method
Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.	up to 45 months

Trial Locations

Locations (2)

Maternity and Child care of Xinmi City; 🇨🇳 Zhengzhou, Henan, China

Maternity and Child care of Huli District; 🇨🇳 Xiamen, Fujian, China