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 |
| Protocol serial number | ctu01hlmar08 |
| Sponsor | University of Oxford (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 077078) |
- 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
Scientific
Patan Hospital
GPO BOX 252
Kathmandu
-
Nepal
| Phone | +977 (0)1 984 128 9212 |
|---|---|
| nelykhatri@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | A prospective descriptive epidemiology study |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | A prospective study of admitted women patients with hepatitis E to Patan Hospital |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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): |
| Key secondary outcome measure(s) |
We will be studying and recording the following outcomes in the pregnant and non-pregnant group: |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key 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 |
| Key exclusion criteria | 1. No consent 2. Other co-morbidities: chronic liver disease, chronic renal disease, cardiac disease 3. Alcohol abuse |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Patan Hospital
Kathmandu
-
Nepal
-
Nepal
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
