Estimating congenital cytomegalovirus infection prevalence in Vietnamese neonates
Congenital Cytomegalovirus Infection in Vietnam: Prevalence, Morbidity and Risk Factors
This study is trying to find out how common congenital cytomegalovirus infection is in newborns in Vietnam and what health problems it might cause over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hanoi Obstetrics and Gynecology Hospital Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT04822142 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the prevalence of congenital cytomegalovirus (cCMV) infection among Vietnamese neonates and assess the related morbidity over a two-year follow-up period. It will evaluate the predictive value of CMV replication levels in maternal blood and urine during the first trimester in a population with high maternal CMV seropositivity. The study seeks to understand the epidemiology of cCMV and its associated health impacts in this specific population, addressing a significant gap in current knowledge.
Who should consider this trial
Good fit: Ideal candidates for this study are Vietnamese pregnant women in their first trimester and their live neonates at birth.
Not a fit: Patients who may not benefit from this study include women under 18 years old, those experiencing miscarriages or stillbirths, and those who deliver prematurely before the 34th gestational week.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for congenital CMV infection, ultimately reducing morbidity in affected neonates.
How similar studies have performed: While this study addresses a specific population, similar studies in other regions have shown success in identifying the prevalence and morbidity associated with congenital CMV infections.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hanoi
- Hanoi Obstetrics and Gynecology Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Ha Nguyen Thi Thu, MD.PhD — Hanoi Obstetrics and Gynecology Hospital
- Study coordinator: Ha Nguyen Thi Thu, MD.PhD
- Email: thuha.ivf@gmail.com
- Phone: 0084989661093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.