Eliminating mother-to-child transmission of hepatitis B in China
A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China
This study is testing a plan to see if we can stop mothers with hepatitis B from passing the virus to their babies in China by 2030.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Sex | Female |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 15 sites (Guangzhou, Guangdong and 14 other locations) |
| Trial ID | NCT05172453 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the feasibility of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in China by 2030. It involves a multicenter, prospective cohort of pregnant women with chronic HBV infection, who are followed until their infants undergo post-vaccination serologic testing at 7-12 months of age. Data is collected through a mobile health application called 'SHIELD', which facilitates communication between mothers and healthcare providers and tracks various health metrics and outcomes. The study aims to implement a comprehensive management algorithm to prevent MTCT of HBV.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with chronic hepatitis B infection.
Not a fit: Patients who are co-infected with HIV or hepatitis C, or those with significant co-morbidities that affect compliance, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of hepatitis B in newborns, improving long-term health outcomes for affected families.
How similar studies have performed: Other studies have shown success in similar approaches to preventing mother-to-child transmission of viral infections, indicating potential for positive outcomes in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * pregnant women with chronic HBV infection. Exclusion Criteria: * positive serologic test for human immunodeficiency virus or hepatitis C virus; * any co-morbidity that might reduce compliance; * unable or unwilling to use the mobile health application-Shield APP
Where this trial is running
Guangzhou, Guangdong and 14 other locations
- Jinlin Hou — Guangzhou, Guangdong, China (Recruiting)
- 302 military hospital of China — Beijing, China (Recruiting)
- Beijing YouAn Hospital, Capital Medical University — Beijing, China (Recruiting)
- The First Affiliated Hospital of Jilin University — Chang chun, China (Recruiting)
- The First People's Hospital of Foshan — Foshan, China (Recruiting)
- Fifth Affiliated Hospital of Southern Medical University — Guangzhou, China (Recruiting)
- Guangdong Maternal and Child Care Hospital — Guangzhou, China (Recruiting)
- Guangzhou No. 8 People's Hospital — Guangzhou, China (Recruiting)
- Zhujiang Hospital, Southern Medical University — Guangzhou, China (Recruiting)
- Xixi Hospital of Hangzhou — Hangzhou, China (Recruiting)
- Third Hospital of Jiujiang — Jiujiang, China (Recruiting)
- Second Hospital of Nanjing — Nanjing, China (Recruiting)
- Shanghai Public Health Clinical Center — Shanghai, China (Recruiting)
- Shenzhen Baoan Maternal and Child Care Hospital — Shenzhen, China (Recruiting)
- The Third People's Hospital of Shenzhen — Shenzhen, China (Recruiting)
Study contacts
- Principal investigator: Jinlin Hou — Nanfang Hospital, Southern Medical University
- Study coordinator: Jinlin Hou
- Email: jlhousmu@163.com
- Phone: +86 13802727354
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.