- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645396
A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China
April 20, 2019 updated by: Jun Zhang
A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Neonates in China
The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
8855
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fujian
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Xiamen, Fujian, China, 361000
- Maternity and Child care of Huli District
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Henan
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Zhengzhou, Henan, China, 450000
- Maternity and Child care of Xinmi City
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
Time Frame: up to 45 months
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up to 45 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.
Time Frame: up to 45 months
|
up to 45 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jun Zhang, Professor, Xiamen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
July 31, 2015
First Submitted That Met QC Criteria
December 31, 2015
First Posted (Estimate)
January 1, 2016
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 20, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMV-EPI-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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