Pregnancy Clinical Trial
Official title:
Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
Verified date | June 2023 |
Source | Beijing Ditan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | January 1, 2025 |
Est. primary completion date | February 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Ditan Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Ditan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2023-2025 | |
Secondary | Mother-to-child transmission rate of HCV | Mother-to-child transmission rate of HCV in pregnant women and correlation with HCV RNA viral load | 2023-2025 | |
Secondary | 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). | 2023-2025 |
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