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

Congenital Cytomegalovirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645396
• Other study ID #: CMV-EPI-001
• Status: Completed
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8855
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infection Reactivation
• Cytomegalovirus Infections
• Infection

Locations

Country	Name	City	State
China	Maternity and Child care of Huli District	Xiamen	Fujian
China	Maternity and Child care of Xinmi City	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Jun Zhang	Merck Sharp & Dohme Corp., National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.		up to 45 months
Secondary	Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.		up to 45 months