Contact information
Type
Scientific
Primary contact
Dr Nely Shrestha Khatri
ORCID ID
Contact details
Patan Hospital
GPO BOX 252
Kathmandu
-
Nepal
+977 (0)1 984 128 9212
nelykhatri@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ctu01hlmar08
Study information
Scientific title
A prospective study of admitted women patients with hepatitis E to Patan Hospital
Acronym
Study hypothesis
By identifying the cause for increased morbidity and mortality of hepatitis E virus (HEV) in pregnancy, we may be able to come up with reinforced strategies to prevent this disease.
Ethics approval
Ethics approval received from the Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) on the 20th June 2008 (ref: 24/08). Ethics approval pending as of 16/07/2008 from the Nepalese local ethics committee.
Study design
A prospective descriptive epidemiology study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hepatitis E virus
Intervention
Routine tests:
The following tests will be taken at baseline as this is routinely done at Patan Hospital:
1. Haematology: full blood count including white blood differential counts, reticulocytes, platelets. Further tests day 8 - 28 and 6 months or as clinically indicated.
2. Coagulation tests: prothrombin time/international normalised ratio (INR) on admission, then alternate days to daily accordingly
3. Blood culture at admission, further tests as clinically indicated
4. Biochemistry:
4.1. Liver function tests: total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase; measured weekly until they normalise
4.2. Random blood glucose, as clinically indicated
4.3. Creatinine, sodium/potassium; weekly or as clinically indicated
4.4. Serology: hepatitis A immunoglobulins G and M (HepA IgG/M), hepatitis B surface antigen (HBsAg), anti-HBs and anti-core, hepatitis C IgG and hepatitis E IgG/M at admission
4.5. Urine analysis
4.6. Ultrasound; an abdominal ultrasound scan will be performed routinely for all patients to assess gestational age, liver texture, ascites, etc on admission and to obstetric demand
Tests for research study:
1. Viral polymerase chain reaction (PCR) for hepatitis A, B, C, D and E. EDTA blood sample on days 1, 2, 3, 7, 14, 28 and 6 months
2. Serology: hepatitis A IgG/M, HBsAg, anti-HBs and anti-core, hepatitis C IgG and hepatitis E IgG/M. Serology for toxoplasma, syphilis, typhoid, scrub typhus on days 1, 7, 14, 28 and 6 months
3. Immunology: EDTA blood for CD3, CD4, CD8, CD25 T cell counts on days 1, 7, 28 and 6 months
4. Ribonucleic acid (RNA) expression profiling: blood collection for the transcriptional profiling of cytokine levels and markers of immune activation/suppression on days 1, 7, 28 and 6 months (2 ml of blood needed) in the pregnant and non-pregnant patients
Subsidary genetic study:
To understand why some patients become infected with HEV and why some patients develop fuminant hepatitis, an understanding of the genetic variation in the host is necessary. We can investigate the host genetic factors that are important in HEV infection by analysing deoxyribonucleic acid (DNA) (from 2 ml of blood) from 100 pregnant patients with symptoms of acute hepatitis and 100 non-pregnant patients with acute hepatitis. 2 ml of blood are necessary for this protocol.
Rectal swabs for viral PCR will be performed on admission and day 1, 2, 3, 7 and 14, 28 and 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Clinical, virological and immunological features of HEV infection in pregnant women in Patan Hospital will be studied, with particular reference to maternal and neonatal morbidity and mortality (in the pregnant patients only):
1. Mechanism of inducing high morbidity and mortality in pregnancy
2. Maternal death
3. The rate of preterm labour
4. Stillbirth
5. Intrauterine foetal death
6. Neonatal death
7. Post-partum haemorrhage
8. Rate of vertical transmission
Secondary outcome measures
We will be studying and recording the following outcomes in the pregnant and non-pregnant group:
1. Proportion of patients infected with HEV
2. Proportion of patients developing fulminant hepatitis in the two groups
3. Death
4. Correlation between viral loads, liver enzymes, liver activity scores, T-cell counts and clinical outcome
5. The route of infection in pregnant and non-pregnant women using GPS mapping and epidemiological data
Overall trial start date
01/08/2008
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. All pregnant women aged greater than or equal to 15 years presenting to Patan Hospital with elevated liver enzymes and/or jaundice will be invited to participate in the study (100 patients)
2. All non-pregnant women aged greater than or equal to 15 years presenting to Patan Hospital with elevated liver enzymes and/or jaundice will be invited to participate in the study (100 patients)
3. Informed written consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Maximum of 100 patients
Participant exclusion criteria
1. No consent
2. Other co-morbidities: chronic liver disease, chronic renal disease, cardiac disease
3. Alcohol abuse
Recruitment start date
01/08/2008
Recruitment end date
31/07/2011
Locations
Countries of recruitment
Nepal
Trial participating centre
Patan Hospital
Kathmandu
-
Nepal
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 077078)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary