Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy

Conditions
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Hepacivirus, Pregnancy

Intervention / Treatment
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* Other: HCV infection status


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV Ab(+）HCVRNA（-）<br>HCV Ab（+） HCVRNA(-) in pregnant women | Other: HCV infection status<br>* Divided into 3 groups based on HCVAb and HCVRNA status<br>|
| HCV Ab(+）HCVRNA（+）<br>HCV Ab(+）HCVRNA（+）in pregnant women | Other: HCV infection status<br>* Divided into 3 groups based on HCVAb and HCVRNA status<br>|
| HCVAb(-) HCVRNA(-)<br>HCV Ab(-）HCVRNA（-）in pregnant women | Other: HCV infection status<br>* Divided into 3 groups based on HCVAb and HCVRNA status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |