Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Information source: Maulana Azad Medical College
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis; Cytokines; Pregnancy
Phase: N/A
Status: Completed
Sponsored by: Maulana Azad Medical College Official(s) and/or principal investigator(s):
Dr. Ashok Kumar, MD, Principal Investigator, Affiliation: Maulana Azad Medical College, New Delhi-110002
Summary
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.
Clinical Details
Official title: Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women.
Secondary outcome: To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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.
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Locations and Contacts
Dr. Ashok Kumar, New Delhi, Delhi 110002, India
Additional Information
Starting date: August 2009
Last updated: April 10, 2015
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