Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 491
- 试验地点
- 1
- 主要终点
- To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women.
研究概览
简要总结
Hepatitis E virus is a public health problem in several countries of the world where safe drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general population. HEV infection occurs most frequently in rainy season. The disease affects mainly young adults in the age of 15-40 years.HEV viral infection is of particular concern in pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is fulminant and fatal especially if it occurs in third trimester. The mortality in the second trimester is around 20% and reaches upto 45% in the third trimester.
详细描述
The study will include pregnant women with acute viral hepatitis and fulminant hepatic failure (jaundice). The women with FHF will be recruited from the medical wards and antenatal wards as all such patients are routinely admitted in the hospital.
The pregnant women with acute viral hepatitis will be recruited either from antenatal clinic and medical outpatient, or from the medical and antenatal wards because pregnant women with AVH are admitted if they have serum bilirubin levels > 15- 20 mg / dl, persistently high bilirubin levels for more than 2-3 weeks, abnormal prothrombin time, evidence of progression of the disease, need parenteral therapy (because of excessive vomiting).
The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested proforma with respect to history and clinical examination, obstetrics examination and ultrasonography. Ten ml venous blood sample will be drawn from the patient at the time of enrollment detection of hepatotropic viruses (Various serological markers of hepatitis will be done which includes: IgM anti-HAV, HBsAg, IgM anti-HBc, HBeAg, anti-HCV Ab and IgM anti-HEV would be done using commercially available ELISA kits and Extraction of HEV-RNA from serum will be done) & levels of cytokines (IL-6, TGF-beta, IFN-g and TNF-α). All the subjects will be followed- up till delivery. The promoter region of cytokine gene will be amplified by PCR in appropriate reaction conditions using suitable sets of primers. PCR product will be used for studying the polymorphisms by restriction fragment length polymorphism.
The control group would comprise of age and POG matched healthy asymptomatic pregnant women
Follow up
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnostic criteria of acute viral hepatitis - Patients having acute self-limited disease and a serum aspartate aminotransferase elevation of at least 5 fold or clinical jaundice or both.
- •Diagnostic criteria of acute liver failure - When after a typical acute onset, the patient becomes deeply jaundiced and goes into hepatic encephalopathy within 4 weeks of the onset of disease with no past history of chronic liver disease.
- •Diagnostic criteria of Hepatitis E infection - The serum sample showing HEV IgM positivity and/or HEV-RNA positivity would be considered as HEV infected cases.
排除标准
- •Patients with co-infection with other hepatitis virus.
- •Patients with any other associated diseases.
- •Patients with history of pre-existing liver disease.
结局指标
主要结局
To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women.
时间窗: 3 years
次要结局
- To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms.(3 years)
研究者
Ashok Kumar
Director Professor
Maulana Azad Medical College