Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HCV status in children born from chronically HCV infected pregnant women
研究概览
简要总结
Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.
详细描述
Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive HCV RNA during pregnancy. Risk factors include: HCV RNA load level, HIV-HCV co-infection, duration of labour, HCV genotype, child gender, and invasive procedures either during pregnancy or at birth. Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) mainly occurs during the last trimester of pregnancy or at birth or around the birth (El-Shabrawi et al., World Journal of Gastroenterology 2013). Currently, using caesarian section to reduce the risk of Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) is still debated and not recommended in International Guidelines (EASL 2012). Spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (Ruiz-Extremera A et al. Hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (Rerksuppaphol S et al. J Gastroenterol Hepatol 2004), justifying the study.
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
- 9 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV chronically infected pregnant women
- •with a positive HCV RNA
- •who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France
排除标准
- •negative HCV RNA during pregnancy
- •acute HCV infection during pregnancy (previous negative HCV test during pregnancy)
- •MTCT not to be tested (early child death for instance)
结局指标
主要结局
HCV status in children born from chronically HCV infected pregnant women
时间窗: up to 10 years (expected average: 5 years)
次要结局
- HCV RNA in children with positive HCV antibodies (Ab)(up to 10 years (expected average: 5 years))
研究者
Stephane Mouly, MD PhD
Professor at University Paris VII Denis Diderot, physician
Hopital Lariboisière