Condition category
Infections and Infestations
Date applied
16/07/2008
Date assigned
17/07/2008
Last edited
26/01/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ox.ac.uk/

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

Publication citations

Additional files

Editorial Notes