Incidence and Predictors of Elevated Alanine Aminotransferase in Postpartum Chronic Hepatitis B Mothers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
- 主要终点
- The incidence of ALT elevation within 28 weeks postpartum in CHB pregnant women after 24 weeks of gestation in the antiviral treatment group and the non-antiviral treatment group
研究概览
简要总结
China currently has about 86 million people with chronic hepatitis B virus infection, and infections caused by mother-to-child transmission account for 40% to 50% of new hepatitis B infections. Domestic and international guidelines both recommend that for pregnant women with high viral loads at 24-28 weeks of gestation, oral antiviral therapy should be administered based on a balance of risks and benefits and informed consent, continuing until after delivery, which can significantly reduce the rate of HBV mother-to-child transmission. Studies have reported that antiviral drugs such as tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) can reduce mother-to-child transmission rates in pregnant women with hepatitis B.
It has been reported that among pregnant women with hepatitis B infection and high viral loads but no obvious hepatitis, the incidence of postpartum hepatitis ranges from 15% to 35%. Among pregnant women who received antiviral therapy during pregnancy, 36.3% developed postpartum hepatitis. In a multicenter prospective randomized controlled trial (RCT), Pan and colleagues observed that the proportion of mothers with elevated ALT levels postpartum was 45% for those treated with tenofovir disoproxil fumarate (TDF) during pregnancy versus 30% for those untreated. A large retrospective cohort study involving 4,236 hepatitis B mothers in China found that the rate of postpartum ALT elevation in chronic hepatitis B pregnant women who did not receive antiviral therapy during pregnancy was 28.27%. This study also identified independent risk factors for postpartum ALT elevation, including high viral load during pregnancy. The peak periods of ALT elevation occurred between 4-6 weeks and 9-12 weeks postpartum, showing a bimodal distribution.
To explore the differences in prognosis between groups that did and did not receive antiviral therapy, we will conduct a prospective cohort study to assess the incidence of postpartum ALT elevation in mothers with chronic hepatitis B and identify independent risk factors that can predict postpartum ALT elevation. Our data will help healthcare providers better manage pregnant women with chronic hepatitis B.
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
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female; Between 20-40 years old; HBsAg positive for more than 6 months; ALT ≤40 U/L; Any time point from 24 weeks of pregnancy to delivery; For HBV viral load >2x10^5 IU/ml, regular TDF medication is required and should be stopped immediately after delivery; For HBV viral load <2x10^5 IU/ml, antiviral treatment is not needed; All patients should have good adherence.
排除标准
- •Accompanied by hepatitis A, C, E viruses or other hepatotropic viral infections or AIDS; accompanied by cirrhosis, liver cancer, or other chronic liver diseases; accompanied by diseases of vital organs such as heart, lungs, or kidneys; accompanied by autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, thyroid diseases; previous pregnancy with complications; previous pregnancy with fetal or neonatal growth and developmental defects; previous or current use of nephrotoxic drugs, glucocorticoids, cytotoxic drugs, or immunomodulators; ultrasound before medication indicates fetal malformations, abnormal fetal development, placental abnormalities, or threatened miscarriage; use of anti-hepatitis B virus drugs within six months before pregnancy; failure to follow up regularly according to the study plan.
结局指标
主要结局
The incidence of ALT elevation within 28 weeks postpartum in CHB pregnant women after 24 weeks of gestation in the antiviral treatment group and the non-antiviral treatment group
时间窗: 2024-07-01 to 2029-12-31
次要结局
未报告次要终点
