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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02645396

Enrollment

8855

Registered

2016-01-01

Start date

2015-06-30

Completion date

2018-12-31

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cytomegalovirus Infection, Cytomegalovirus Infection Reactivation

Keywords

Cytomegalovirus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results