HepacivirusNCT05929963
Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
An observational study of Hepacivirus and Pregnancy, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question[s] it aims to answer are: Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepacivirus, Pregnancy
- What is being tested?
- HCV infection status
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to 1 Jan 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with hepatitis C:RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
Who may be able to join
- normal (anti-HCV negative) or RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
- pregnant women aged 20-45 years
- complete pregnancy data available
Who cannot join
- Combination of other liver diseases such as viral hepatitis (hepatitis A, B, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease
- Combination of other viral infections with potential loss of liver function
- Mental illness
- Patients with immunosuppression
- Mother with cirrhosis or liver tumour
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question[s] it aims to answer are:
Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C
Read the detailed description
This study aims to collect demographic data, biochemical indicators during pregnancy, pregnancy complications, and fetal outcomes through the hospital HIS and LIS systems to investigate the impact of HCV infection on pregnancy outcomes, mother-to-child transmission, and long-term child development, and to provide assistance in the clinical management of pregnant women with HCV infection.
- Conditions
- Hepacivirus, Pregnancy
- Being tested
- HCV infection status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV infection statusOther
Divided into 3 groups based on HCVAb and HCVRNA status
| Study group | Role | What they receive |
|---|---|---|
| HCV Ab(+）HCVRNA（-） | HCV Ab（+） HCVRNA(-) in pregnant women Receives: Other: HCV infection status | |
| HCV Ab(+）HCVRNA（+） | HCV Ab(+）HCVRNA（+）in pregnant women Receives: Other: HCV infection status | |
| HCVAb(-) HCVRNA(-) | HCV Ab(-）HCVRNA（-）in pregnant women Receives: Other: HCV infection status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of various adverse pregnancy outcomes
The probability of postpartum haemorrhage, gestational diabetes mellitus and gestational hypertension in pregnant women infected with hepatitis C virus and the associated factors affecting them
Measured: 2023-2025
Secondary outcomes (2)
Mother-to-child transmission rate of HCV
Mother-to-child transmission rate of HCV in pregnant women and correlation with HCV RNA viral load
Measured: 2023-2025
Development of children born to HCV pregnant women
We will follow up on the child's weight (weight in kilograms）, heigh（height in meters）,Body mass index（BMI described in kg/m^2) ,head circumference（Head circumference described in metres），Head up, roll over, sit, crawl, stand and talk start time（Describe time in months）.
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start9 May 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepacivirusStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
- Investigators
- Yao Xie, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929963
- Sponsor's protocol ID
- DTXY28
- Status last verified
- Jun 2023
- First submitted
- 8 May 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
- ClinicalTrials.gov ID
- NCT05929963
- Acronym / sponsor ID
- DTXY28
- Conditions
- Hepacivirus, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Jul 2023 (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 goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question[s] it aims to answer are:
Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C
Detailed description
This study aims to collect demographic data, biochemical indicators during pregnancy, pregnancy complications, and fetal outcomes through the hospital HIS and LIS systems to investigate the impact of HCV infection on pregnancy outcomes, mother-to-child transmission, and long-term child development, and to provide assistance in the clinical management of pregnant women with HCV infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCV Ab(+）HCVRNA（-） | – | Other: HCV infection statusHCV Ab（+） HCVRNA(-) in pregnant women |
| HCV Ab(+）HCVRNA（+） | – | Other: HCV infection statusHCV Ab(+）HCVRNA（+）in pregnant women |
| HCVAb(-) HCVRNA(-) | – | Other: HCV infection statusHCV Ab(-）HCVRNA（-）in pregnant women |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with hepatitis C:RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
Key inclusion criteria (3 listed)
- normal (anti-HCV negative) or RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
- pregnant women aged 20-45 years
- complete pregnancy data available
Key exclusion criteria (5 listed)
- Combination of other liver diseases such as viral hepatitis (hepatitis A, B, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease
- Combination of other viral infections with potential loss of liver function
- Mental illness
- Patients with immunosuppression
- Mother with cirrhosis or liver tumour
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 |
|---|---|---|
| HCV infection statusDivided into 3 groups based on HCVAb and HCVRNA status | Other | HCV Ab(+）HCVRNA（+）, HCV Ab(+）HCVRNA（-）, HCVAb(-) HCVRNA(-) |
Primary outcome
Incidence of various adverse pregnancy outcomes
Time frame: 2023-2025
The probability of postpartum haemorrhage, gestational diabetes mellitus and gestational hypertension in pregnant women infected with hepatitis C virus and the associated factors affecting them
2 secondary outcomes
Mother-to-child transmission rate of HCV
Time frame: 2023-2025
Development of children born to HCV pregnant women
Time frame: 2023-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
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.
Yao Xie, Doctor principal investigator
Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepacivirus and Pregnancy, run by Beijing Ditan Hospital at 1 site 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 3 inclusion and 5 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 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of various adverse pregnancy outcomes (time frame: 2023-2025). 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 5 Jul 2023.