Role of Cytokines in Hepatitis E Virus Infection During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maulana Azad Medical College.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by:
Maulana Azad Medical College
ClinicalTrials.gov Identifier:
NCT01062321
First received: February 3, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition
Hepatitis
Cytokines
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Cytokines in Hepatitis E Virus Infection During Pregnancy

Resource links provided by NLM:


Further study details as provided by Maulana Azad Medical College:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatitis-E
Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women of 18-40 years with jaundice and Healthy pregnant women as controls

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062321

Contacts
Contact: Dr. Ashok Kumar, MD 91-11-23232400 ext 4400 ash64kr@yahoo.com

Locations
India
Dr. Ashok Kumar Recruiting
New Delhi, Delhi, India, 110002
Contact: Dr. Ashok Kumar, MD    91-11-23232400 ext 4400    ash64kr@yahoo.com   
Principal Investigator: Dr. Ashok Kumar, MD         
Sponsors and Collaborators
Maulana Azad Medical College
Indian Council of Medical Research
Investigators
Principal Investigator: Dr. Ashok Kumar, MD Maulana Azad Medical College, New Delhi-110002
  More Information

Publications:
Responsible Party: Professor Ashok Kumar, Department of Obstetrics and Gynecology, Maulana Azad Medical College
ClinicalTrials.gov Identifier: NCT01062321     History of Changes
Other Study ID Numbers: 5/7/239/07/RHN
Study First Received: February 3, 2010
Last Updated: July 20, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Maulana Azad Medical College:
Hepatitis E Virus
Cytokines
Pregnancy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Virus Diseases
Hepatitis E
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 30, 2014