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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN81625832
Enrollment
100
Registered
2008-07-17
Start date
2008-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis E virus Infections and Infestations Other acute viral hepatitis

Interventions

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, pla
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
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. Vira

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. No consent 2. Other co-morbidities: chronic liver disease, chronic renal disease, cardiac disease 3. Alcohol abuse

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026