Role of Cytokines in Hepatitis E Virus Infection During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062321
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : April 13, 2015
Indian Council of Medical Research
Information provided by (Responsible Party):
Ashok Kumar, Maulana Azad Medical College

February 3, 2010
February 4, 2010
April 13, 2015
August 2009
July 2012   (Final data collection date for primary outcome measure)
To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women. [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01062321 on Archive Site
To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms. [ Time Frame: 3 years ]
Same as current
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Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
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.

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

All participants will be followed up till delivery for obstetrical complications, medical complications and pregnancy outcome.

Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Pregnant women of 18-40 years with jaundice and Healthy pregnant women as controls
  • Hepatitis
  • Cytokines
  • Pregnancy
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Hepatitis-E, Pregnant & Non-pregnant
Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.

Exclusion Criteria:

1. Patients with co-infection with other hepatitis virus. 2. Patients with any other associated diseases. 3. Patients with history of pre-existing liver disease.

Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Ashok Kumar, Maulana Azad Medical College
Maulana Azad Medical College
Indian Council of Medical Research
Principal Investigator: Dr. Ashok Kumar, MD Maulana Azad Medical College, New Delhi-110002
Maulana Azad Medical College
July 2011