Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Role of Cytokines in Hepatitis E Virus Infection During Pregnancy|
- 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 ]
- 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 ]
|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)|
Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure
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
All participants will be followed up till delivery for obstetrical complications, medical complications and pregnancy outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062321
|Contact: Dr. Ashok Kumar, MD||91-11-23232400 ext email@example.com|
|Dr. Ashok Kumar||Recruiting|
|New Delhi, Delhi, India, 110002|
|Contact: Dr. Ashok Kumar, MD 91-11-23232400 ext 4400 firstname.lastname@example.org|
|Principal Investigator: Dr. Ashok Kumar, MD|
|Principal Investigator:||Dr. Ashok Kumar, MD||Maulana Azad Medical College, New Delhi-110002|