Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
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|ClinicalTrials.gov Identifier: NCT01062321|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : April 13, 2015
|Condition or disease|
|Hepatitis Cytokines Pregnancy|
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.
|Study Type :||Observational|
|Actual Enrollment :||491 participants|
|Observational Model:||Case Control|
|Official Title:||Role of Cytokines in Hepatitis E Virus Infection During Pregnancy|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Hepatitis-E, Pregnant & Non-pregnant
Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure
- 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 ]
- To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062321
|Dr. Ashok Kumar|
|New Delhi, Delhi, India, 110002|
|Principal Investigator:||Dr. Ashok Kumar, MD||Maulana Azad Medical College, New Delhi-110002|