Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HCV Ab(+）HCVRNA（-） HCV Ab（+） HCVRNA(-) in pregnant women |
Other: HCV infection status
Divided into 3 groups based on HCVAb and HCVRNA status
|
| HCV Ab(+）HCVRNA（+） HCV Ab(+）HCVRNA（+）in pregnant women |
Other: HCV infection status
Divided into 3 groups based on HCVAb and HCVRNA status
|
| HCVAb(-) HCVRNA(-) HCV Ab(-）HCVRNA（-）in pregnant women |
Other: HCV infection status
Divided into 3 groups based on HCVAb and HCVRNA status
|
Outcome Measures
Primary Outcome Measures
- Incidence of various adverse pregnancy outcomes [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
Secondary Outcome Measures
- Mother-to-child transmission rate of HCV [2023-2025]
Mother-to-child transmission rate of HCV in pregnant women and correlation with HCV RNA viral load
- Development of children born to HCV pregnant women [2023-2025]
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）.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Ditan Hospital | Beijing | China |
Sponsors and Collaborators
- Beijing Ditan Hospital
Investigators
- Principal Investigator: Yao Xie, Doctor, Beijing Ditan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DTXY28