Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Nely Shrestha Khatri


Contact details

Patan Hospital
+977 (0)1 984 128 9212

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A prospective study of admitted women patients with hepatitis E to Patan Hospital


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


Secondary study design

Cross-section survey

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Hepatitis E virus


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment


Trial participating centre

Patan Hospital

Sponsor information


University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
United Kingdom

Sponsor type




Funder type


Funder name

The Wellcome Trust (UK) (grant ref: 077078)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes