- ICH GCP
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- Klinische proef NCT01062321
Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Delhi
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New Delhi, Delhi, Indië, 110002
- Dr. Ashok Kumar
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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.
- 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.
- 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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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Hepatitis-E, Pregnant & Non-pregnant
Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women.
Tijdsspanne: 3 years
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3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms.
Tijdsspanne: 3 years
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3 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Dr. Ashok Kumar, MD, Maulana Azad Medical College, New Delhi-110002
Publicaties en nuttige links
Algemene publicaties
- Dahiya M, Kumar A, Kar P, Gupta RK, Kumar A. Acute viral hepatitis in third trimester of pregnancy. Indian J Gastroenterol. 2005 May-Jun;24(3):128-9. No abstract available.
- Beniwal M, Kumar A, Kar P, Jilani N, Sharma JB. Prevalence and severity of acute viral hepatitis and fulminant hepatitis during pregnancy: a prospective study from north India. Indian J Med Microbiol. 2003 Jul-Sep;21(3):184-5.
- Hussaini SH, Skidmore SJ, Richardson P, Sherratt LM, Cooper BT, O'Grady JG. Severe hepatitis E infection during pregnancy. J Viral Hepat. 1997 Jan;4(1):51-4. doi: 10.1046/j.1365-2893.1997.00123.x.
- Navaneethan U, Al Mohajer M, Shata MT. Hepatitis E and pregnancy: understanding the pathogenesis. Liver Int. 2008 Nov;28(9):1190-9. doi: 10.1111/j.1478-3231.2008.01840.x. Epub 2008 Jul 25.
- Barrett S, Collins M, Kenny C, Ryan E, Keane CO, Crowe J. Polymorphisms in tumour necrosis factor-alpha, transforming growth factor-beta, interleukin-10, interleukin-6, interferon-gamma, and outcome of hepatitis C virus infection. J Med Virol. 2003 Oct;71(2):212-8. doi: 10.1002/jmv.10472.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 5/7/239/07/RHN
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