The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- the blocking successful rate of HBV mother-to-child transmission
研究概览
简要总结
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.
详细描述
This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No nucleoside analog antiviral drugs have been used in the past.
- •HBsAg and HBeAg double positive, HBV DNA>106 IU/mL.
- •Fully inform the risk to voluntarily join the study and sign the informed consent form.
排除标准
- •Combine other viral infections: such as HCV, HIV, CMV, etc.;
- •amniocentesis during pregnancy;
- •Liver cirrhosis and liver cancer;
- •Other autoimmune diseases and liver diseases;
- •fetal ultrasound screening in early and middle pregnancy found deformity.
研究组 & 干预措施
TAF group
take propofol fumarate for Maternal and child blockade treatment
干预措施: TAF (Drug)
TDF group
take difenofurate fumarate for Maternal and child blockade treatment
干预措施: TDF (Drug)
结局指标
主要结局
the blocking successful rate of HBV mother-to-child transmission
时间窗: 7 months after birth
HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth)
次要结局
- The incidence of abnormal growth(at birth, at the 7 months after birth)
- The incidence of abnormal development(at birth, at the 7 months after birth)
研究者
Wei Yi
Director, Head of Obstetrics and Gynecology
Beijing Ditan Hospital