Hepatitis B, ChronicNCT03539016
Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants
An observational study of Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 10 sites in China.
Trial summary
The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- Jul 2015to May 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant woman
Who may be able to join
- Gestation of 4-32 weeks
- HBsAg+ > 6 months, HBeAg+/-
- Informed consent signed voluntarily
- Good compliance and able to be followed up as planned
Who cannot join
- Coinfection with hepatitis C virus or human immunodeficiency virus;
- Comorbidities of other severe conditions that hinder compliance with follow ups and because of that, the subjects are anticipated to be unable to complete the project.;
- Unable or unwilling to use mobile health tools.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
302 military hospital of China
Beijing
Beijing YouAn Hospital
Beijing
Nanfang Hospital
Guangzhou, Guangdong
Fifth Affiliated Hospital of Southern Medical University
Guangzhou
Guangzhou No. 8 People's Hospital
Guangzhou
Third Affiliated Hospital of Southern Medical University
Guangzhou
Zhujiang Hospital
Guangzhou
Jiujiang Maternal and Child Care Service Centre
Jiujiang
Third Hospital of Jiujiang
Jiujiang
Second Hospital of Nanjing
Nanjing
About this study
Official title: Epidemiological Study on Clinical Features of Chronic Hepatitis B Virus Infection During Pregnancy and Hepatitis B Virus Mother-to-child Transmission (Shield Study Phase Ⅰ)
The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic hepatitis B, Mother-to-child transmission
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mother-to-child transmission
Measured: Infants from 7 to 12 months of age
Rate of hepatitis flare during pregnancy and postpartum
Measured: up to postpartum weeks 6-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study startJul 2015
- Primary completionFeb 2018
- Study completionMay 2018 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539016
- Sponsor's protocol ID
- SHIELD-01
- Status last verified
- Apr 2018
- First submitted
- 16 May 2018
- Last updated
- 29 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Clinical Features of Chronic Hepatitis B Virus Infection During Pregnancy and Hepatitis B Virus Mother-to-child Transmission (Shield Study Phase Ⅰ)
- ClinicalTrials.gov ID
- NCT03539016
- Acronym / sponsor ID
- SHIELD-01
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic hepatitis B, Mother-to-child transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- Jul 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 29 May 2018 (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.
The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant woman
Key inclusion criteria (4 listed)
- Gestation of 4-32 weeks
- HBsAg+ > 6 months, HBeAg+/-
- Informed consent signed voluntarily
- Good compliance and able to be followed up as planned
Key exclusion criteria (3 listed)
- Coinfection with hepatitis C virus or human immunodeficiency virus;
- Comorbidities of other severe conditions that hinder compliance with follow ups and because of that, the subjects are anticipated to be unable to complete the project.;
- Unable or unwilling to use mobile health tools.
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
Rate of mother-to-child transmission
Time frame: Infants from 7 to 12 months of age
Rate of hepatitis flare during pregnancy and postpartum
Time frame: up to postpartum weeks 6-8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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, run by Nanfang Hospital, Southern Medical University at 10 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 4 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
Rate of mother-to-child transmission (time frame: Infants from 7 to 12 months of age). 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 May 2018.