A descriptive study of the epidemiology and pathophysiology of hepatitis E infection in pregnant and non-pregnant women admitted to Patan Hospital, Kathmandu

ISRCTN ISRCTN81625832
DOI https://doi.org/10.1186/ISRCTN81625832
Secondary identifying numbers ctu01hlmar08
Submission date
16/07/2008
Registration date
17/07/2008
Last edited
26/01/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nely Shrestha Khatri
Scientific

Patan Hospital
GPO BOX 252
Kathmandu
-
Nepal

+977 (0)1 984 128 9212
nelykhatri@gmail.com

Study information

Study designA prospective descriptive epidemiology study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective study of admitted women patients with hepatitis E to Patan Hospital
Study objectivesBy 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(s)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.
Health condition(s) or problem(s) studiedHepatitis E virus
InterventionRoutine 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 typeOther
Primary outcome measureClinical, 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 measuresWe 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 study start date01/08/2008
Completion date31/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsMaximum of 100 patients
Key inclusion criteria1. 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
Key exclusion criteria1. No consent
2. Other co-morbidities: chronic liver disease, chronic renal disease, cardiac disease
3. Alcohol abuse
Date of first enrolment01/08/2008
Date of final enrolment31/07/2011

Locations

Countries of recruitment

  • Nepal

Study participating centre

Patan Hospital
Kathmandu
-
Nepal

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom

http://www.ox.ac.uk/
ROR logo https://ror.org/052gg0110

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
BMC - Part of Springer Nature Springer Nature