Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE) (CYMEVIE)

February 28, 2024 updated by: Hanoi Obstetrics and Gynecology Hospital

Congenital Cytomegalovirus Infection in Vietnam: Prevalence, Morbidity and Risk Factors

To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Congenital cytomegalovirus infection (cCMV) is the main non-genetic cause of sensorineural hearing loss (SNHL), and a major cause of neuro-disability. High maternal CMV prevalence seems to be consistently associated with high prevalence of cCMV infection but the associated morbidity might be different from one population to another.

There exists no serologic marker useful to differentiate non-primary infection from primary infection. Since the morbidity of cCMV is similar between both primary and non-primary maternal infection, and to be infected in the first trimester is the major risk factor for long-term sequelae in neonates. Hence, it is needed to focus on finding markers that predict cCMV after maternal infection in the first trimester of pregnancy.

To date, the epidemiology of cCMV, the morbidity related to cCMV in Vietnamese population and the predictive value of Cytomegalovirus Polymerase Chain Reaction (CMV PCR) in maternal blood and urine in the first trimester remain unknown. Therefore, it is necessary to conduct this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Hanoi Obstetrics and Gynecology Hospital
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

5,000 mother/neonate pairs

Description

Inclusion Criteria:

  • Vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth.
  • Informed consent

Exclusion Criteria:

  • Women under 18 years old.
  • Miscarriages
  • Stillbirths
  • Premature delivery before 34th gestational week
  • Loss to follow-up maternal monitoring.
  • Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of congenital CMV infection in Vietnamese neonates
Time Frame: Within 7 days from birth
Number of CMV positive neonates among all tested neonates
Within 7 days from birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To estimate the prevalence of symptomatic cCMV in neonates
Time Frame: Up to 25 months from recruitment
Proportion of neonates presenting with at least one symptom related to cCMV in all cCMV neonates
Up to 25 months from recruitment
To estimate the prevalence of cCMV related hearing loss in neonates
Time Frame: Up to 25 months from recruitment
Proportion of cCMV related hearing loss in neonates in all cCMV neonates
Up to 25 months from recruitment
To estimate the prevalence of cCMV related neurological sequelae in neonates
Time Frame: Up to 25 months from recruitment
Proportion of cCMV related neurological sequelae in neonates in all cCMV neonates
Up to 25 months from recruitment
To estimate CMV seroprevalence in pregnant Vietnamese women
Time Frame: Up to 25 months from recruitment
Proportion of seropositive women in all tested pregnant women, including mother of CMV positive neonates and control group
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict infection in the neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal whole blood in the first trimester between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict infection in the neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal urine in the first trimester between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict cCMV infection in the neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal saliva in the first trimester between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict infection in the neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal whole blood at delivery between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict infection in the neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal urine at delivery between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in whole blood in the first trimester to predict the presence of symptomatic cCMV infection in neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal whole blood in the first trimester between symptomatic infected neonates and asymptomatic infected neonates
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict a cCMV symptomatic infection in neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal urine in the first trimester between symptomatic infected neonates and asymptomatic infected neonates
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the presence of symptomatic cCMV infection in neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal saliva in the first trimester between symptomatic infected neonates and asymptomatic infected neonates
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the presence of symptomatic cCMV infection in neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal whole blood at delivery between symptomatic infected neonates and asymptomatic infected neonates
Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict a cCMV symptomatic infection in neonates
Time Frame: Up to 25 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal urine at delivery between symptomatic infected neonates and asymptomatic infected neonates
Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates
Time Frame: Up to 25 months from recruitment
Evaluation the change of CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates
Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates
Time Frame: Up to 25 months from recruitment
Evaluation the change of CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates
Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with uninfected neonates in control group
Time Frame: Up to 25 months from recruitment
Evaluation the change of CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with uninfected neonates in control group
Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with uninfected neonates in control group
Time Frame: Up to 25 months from recruitment
Evaluation the change of CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with uninfected neonates in control group
Up to 25 months from recruitment
To calculate the false positive rate of CMV PCR on neonatal saliva versus on dry blood spot in screening congenital CMV infection
Time Frame: Up to 25 months from recruitment
Calculation of the rate of positive CMV PCR on neonatal saliva with a negative result on CMV PCR on neonatal dry blood spot in all CMV positive on neonatal saliva
Up to 25 months from recruitment
To calculate the false positive rate of CMV PCR on neonatal saliva versus on urine in screening congenital CMV infection
Time Frame: Up to 25 months from recruitment
Calculation of the rate of positive CMV PCR on neonatal saliva with a negative result on CMV PCR on neonatal urine in all CMV positive on neonatal saliva
Up to 25 months from recruitment
To evaluate risks factors for cCMV in Vietnamese women
Time Frame: Up to 25 months from recruitment
Factors that may differ between mothers of uninfected neonates and mothers of infected ones regarding maternal age, parity, gestity, twin pregnancy, known health conditions including hypertension, diabetes, HIV, auto immune diseases and living conditions will be analyzed
Up to 25 months from recruitment
To estimate the prevalence of symptomatic cCMV at 2 years of age
Time Frame: Up to 48 months from recruitment
Proportion of infants presenting with at least one symptom related to cCMV at 2 years of age in all cCMV infants
Up to 48 months from recruitment
To estimate the prevalence of cCMV related hearing loss at 2 years of age
Time Frame: Up to 48 months from recruitment
Proportion of infants with cCMV related hearing loss at 2 years of age in all cCMV infants
Up to 48 months from recruitment
To estimate the prevalence of cCMV related neurological sequelae at 2 years of age
Time Frame: Up to 48 months from recruitment
Proportion of infants with cCMV related neurological sequelae at 2 years of age in all cCMV infants
Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Time Frame: Up to 48 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal whole blood in the first trimester between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Time Frame: Up to 48 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal urine in the first trimester between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Time Frame: Up to 48 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal saliva in the first trimester between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the cCMV long-term sequelae at the age of 2 years
Time Frame: Up to 48 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal whole blood at delivery between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict the cCMV long-term sequelae at the age of 2 years
Time Frame: Up to 48 months from recruitment
Comparison of the proportion of a positive CMV PCR in maternal urine at delivery between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Up to 48 months from recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanoi Obstetrics and Gynecology Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hôpital Necker-Enfants Malades

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yves Ville, MD.PhD, Hôpital Necker-Enfants Malades
  • Study Director: Marianne Leruez-Ville, MD.PhD, Hôpital Necker-Enfants Malades
  • Study Director: Anh Nguyen Duy, MD.PhD, Hanoi Obstetrics and Gynecology Hospital
  • Principal Investigator: Ha Nguyen Thi Thu, MD.PhD, Hanoi Obstetrics and Gynecology Hospital
  • Principal Investigator: Linh Dinh Thuy, MD.PhD, Hanoi Obstetrics and Gynecology Hospital

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSHN.0003.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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