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Role of Cytokines in Hepatitis E Virus Infection During Pregnancy

10. april 2015 opdateret af: Ashok Kumar, Maulana Azad Medical College
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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

491

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Delhi
      • New Delhi, Delhi, Indien, 110002
        • Dr. Ashok Kumar

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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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Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Hepatitis-E, Pregnant & Non-pregnant
Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women.
Tidsramme: 3 years
3 years

Sekundære resultatmål

Resultatmål
Tidsramme
To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms.
Tidsramme: 3 years
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Dr. Ashok Kumar, MD, Maulana Azad Medical College, New Delhi-110002

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først indsendt

3. februar 2010

Først indsendt, der opfyldte QC-kriterier

3. februar 2010

Først opslået (Skøn)

4. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2015

Sidst verificeret

1. juli 2011

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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