Congenital Cytomegalovirus InfectionNCT02645396
A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China
An observational study of Congenital Cytomegalovirus Infection and Cytomegalovirus Infection Reactivation, run by Jun Zhang at 2 sites in China.
Trial summary
The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Cytomegalovirus Infection, Cytomegalovirus Infection Reactivation
- How many people
- 8,855 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Females aged 18 and older
- Pregnancy confirmed by ultrasound
- Come to MCHHs for "Pregnancy Registry" within 24 weeks of pregnancy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Maternity and Child care of Huli District
Xiamen, Fujian, 361000
Maternity and Child care of Xinmi City
Zhengzhou, Henan, 450000
About this study
Official title: 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.
Read the 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.
- Keywords
- Cytomegalovirus
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
Measured: 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.
Measured: up to 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Jun Zhang, Xiamen University
- Investigators
- Jun Zhang, Professor, Principal investigator, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645396
- Sponsor's protocol ID
- CMV-EPI-001
- Status last verified
- Apr 2019
- First submitted
- 31 Jul 2015
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34392819
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Neonates in China
- ClinicalTrials.gov ID
- NCT02645396
- Acronym / sponsor ID
- CMV-EPI-001
- Keywords
- Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,855 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Natural Science Foundation of China
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Females aged 18 and older
- Pregnancy confirmed by ultrasound
- Come to MCHHs for "Pregnancy Registry" within 24 weeks of pregnancy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
Time frame: up to 45 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Derived from this study: PubMed 34392819Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, Professor principal investigator
Xiamen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cytomegalovirus Infection and Cytomegalovirus Infection Reactivation, run by Jun Zhang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cCMV infection in newborns born to CMV seropositive pregnant women. (time frame: up to 45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.