Hepatitis B, ChronicNCT05172453
Mother-to-child Transmission of HBV in China
An observational study of Hepatitis B, Chronic and Mother to Child Transmission, run by Nanfang Hospital, Southern Medical University at 15 sites in China.
Trial summary
In order to evaluate the feasibility of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) by 2030, a multi-center, prospective cohorts study was conducted to investigate MTCT of HBV in China. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hepatitis B, Chronic, Mother to Child Transmission
- What is being tested?
- comprehensive management algorithm for preventing mother-to-child transmission of HBV
- Type of treatment
- Vaccines
- How many people
- 50,000 participants
- Where
- 15 sitesChina
- Study dates
- 1 Jul 2015to 31 Dec 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with HBV infection in more than 100 hospitals covering 31 regions in China from Jul 2015 to Jun 2021 were enrolled as hospital-based cohort. In addition, pregnant women with HBV infection in Baoan district of Shenzhen, China from Jun 2017 to Dec 2019 were enrolled as community-based cohort.
Who may be able to join
- pregnant women with chronic HBV infection.
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
302 military hospital of China
Beijing
Mei Wang
- Recruiting
Beijing YouAn Hospital, Capital Medical University
Beijing
Hua Zhang
- Recruiting
The First Affiliated Hospital of Jilin University
Changchun
Jing Jiang
- Recruiting
The First People's Hospital of Foshan
Foshan
Honglian Bai
- Recruiting
Jinlin Hou
Guangzhou, Guangdong, 510515
Jinlin Hou, +8613802727354, jlhousmu@163.com
Zhihua Liu, +8618665000386, zhihualiu@126.com
- Recruiting
Fifth Affiliated Hospital of Southern Medical University
Guangzhou
Qing Shan
- Recruiting
Guangdong Maternal and Child Care Hospital
Guangzhou
Jianhong Xia
- Recruiting
Guangzhou No. 8 People's Hospital
Guangzhou
Huiyuan Liu
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou
Xiaozhu Zhong
- Recruiting
Xixi Hospital of Hangzhou
Hangzhou
Chun Zhao
- Recruiting
Third Hospital of Jiujiang
Jiujiang
Guojun Shen
- Recruiting
Second Hospital of Nanjing
Nanjing
Guorong Han
- Recruiting
Shanghai Public Health Clinical Center
Shanghai
Li Yan
- Recruiting
Shenzhen Baoan Maternal and Child Care Hospital
Shenzhen
Wei Wang
- Recruiting
The Third People's Hospital of Shenzhen
Shenzhen
Yingxia Liu
About this study
Official title: A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China
In order to evaluate the feasibility of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) by 2030, a multi-center, prospective cohorts study was conducted to investigate MTCT of HBV in China.
Read the detailed description
A prospective, multicenter study of pregnant women with HBV infection was conducted from July 2015 up to now in a real world setting in the Shield Project stage Ⅱ. Inclusion criteria was any pregnant women with chronic HBV infection. Pregnant women were excluded if they had a positive serologic test for human immunodeficiency virus or hepatitis C virus or any co-morbidity that might reduce compliance or if they were unable or unwilling to use the mobile health application-Shield APP. Enrolled mothers and infants were prospectively followed until infant post-vaccination serologic testing (PVST) was performed at 7-12 months of age.
Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and PVST for infants at 7-12 months of age were collected.
A mobile health application called "SHIELD" was developed and used in the Shield Project stage Ⅱ to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information was uploaded into SHIELD. Participants could consult with their doctors via SHIELD during the follow-up.
- Conditions
- Hepatitis B, Chronic, Mother to Child Transmission
- Being tested
- comprehensive management algorithm for preventing mother-to-child transmission of HBV
- Keywords
- hepatitis B, mother-to-child transmission
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive management algorithm for preventing mother-to-child transmission of HBVOther
To standardize the clinical management of preventing MTCT of HBV and reduce incidences of MTCT, the Chinese Foundation for Hepatitis Prevention and Control (CFHPC) organized experts to compile the "Management algorithm for prevention of mother-to-child transmission of hepatitis B virus" based on the latest research progress and recently published guidelines, which includes 10 steps of pregnancy management and postpartum follow-up, among which screening, antiviral treatment, and infant immunization are its core contents.
| Study group | Role | What they receive |
|---|---|---|
| Nationwide hospital-based cohort | HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide. Receives: Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV | |
| Community-based cohort | HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen Receives: Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of mother-to-child transmission of HBV
compare rate of mother-to-child transmission of HBV among children born to mothers with and without antiviral therapy during pregnancy
Measured: 5 years
rate of birth defect
compare rate of birth defect among children born to mothers with and without antiviral therapy during pregnancy
Measured: 5 years
Secondary outcomes (1)
change of HBV DNA level in mothers with antiviral therapy from baseline to withdrawal of antiviral drugs
compare HBV DNA levels of mothers with antiviral therapy at baseline and after delivery
Measured: from enrollment to delivery, assessed up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Jul 2015
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Foundation for Hepatitis Prevention and Control, Tigermed Consulting Co., Ltd
- Responsible party
- Principal investigator, Jinlin Hou, Nanfang Hospital, Southern Medical University
- Investigators
- Jinlin Hou, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172453
- Sponsor's protocol ID
- shield project 02
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, there is no such plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China
- ClinicalTrials.gov ID
- NCT05172453
- Acronym / sponsor ID
- shield project 02
- Conditions
- Hepatitis B, Chronic, Mother to Child Transmission
- Keywords
- hepatitis B, mother-to-child transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese Foundation for Hepatitis Prevention and Control, Tigermed Consulting Co., Ltd
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Dec 2021 (actual)
- 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.
In order to evaluate the feasibility of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) by 2030, a multi-center, prospective cohorts study was conducted to investigate MTCT of HBV in China.
Detailed description
A prospective, multicenter study of pregnant women with HBV infection was conducted from July 2015 up to now in a real world setting in the Shield Project stage Ⅱ. Inclusion criteria was any pregnant women with chronic HBV infection. Pregnant women were excluded if they had a positive serologic test for human immunodeficiency virus or hepatitis C virus or any co-morbidity that might reduce compliance or if they were unable or unwilling to use the mobile health application-Shield APP. Enrolled mothers and infants were prospectively followed until infant post-vaccination serologic testing (PVST) was performed at 7-12 months of age.
Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and PVST for infants at 7-12 months of age were collected.
A mobile health application called "SHIELD" was developed and used in the Shield Project stage Ⅱ to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information was uploaded into SHIELD. Participants could consult with their doctors via SHIELD during the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nationwide hospital-based cohort | – | Other: comprehensive management algorithm for preventing mother-to-child transmission of HBVHBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide. |
| Community-based cohort | – | Other: comprehensive management algorithm for preventing mother-to-child transmission of HBVHBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with HBV infection in more than 100 hospitals covering 31 regions in China from Jul 2015 to Jun 2021 were enrolled as hospital-based cohort. In addition, pregnant women with HBV infection in Baoan district of Shenzhen, China from Jun 2017 to Dec 2019 were enrolled as community-based cohort.
Key inclusion criteria (1 listed)
- pregnant women with chronic HBV infection.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive management algorithm for preventing mother-to-child transmission of HBVTo standardize the clinical management of preventing MTCT of HBV and reduce incidences of MTCT, the Chinese Foundation for Hepatitis Prevention and Control (CFHPC) organized experts to compile the "Management algorithm for prevention of mother-to-child transmission of hepatitis B virus" based on the latest research progress and recently published guidelines, which includes 10 steps of pregnancy management and postpartum follow-up, among which screening, antiviral treatment, and infant immunization are its core contents. | Other | Community-based cohort, Nationwide hospital-based cohort |
Primary outcome
rate of mother-to-child transmission of HBV
Time frame: 5 years
compare rate of mother-to-child transmission of HBV among children born to mothers with and without antiviral therapy during pregnancy
rate of birth defect
Time frame: 5 years
compare rate of birth defect among children born to mothers with and without antiviral therapy during pregnancy
1 secondary outcome
change of HBV DNA level in mothers with antiviral therapy from baseline to withdrawal of antiviral drugs
Time frame: from enrollment to delivery, assessed up to 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Undecided. Currently, there is no such plan to make IPD available to other researchers.
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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.
Jinlin Hou principal investigator
Nanfang Hospital, Southern Medical University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic and Mother to Child Transmission, run by Nanfang Hospital, Southern Medical University at 15 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinlin Hou (+86 13802727354, jlhousmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of mother-to-child transmission of HBV (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2021.