Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of various adverse pregnancy outcomes
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of various adverse pregnancy outcomes
时间窗: 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
次要结局
- Development of children born to HCV pregnant women(2023-2025)
- Mother-to-child transmission rate of HCV(2023-2025)
研究者
Yao Xie
Head of Department
Beijing Ditan Hospital