HBV DNA Variability in pregnancy
Research type
Research Study
Full title
Investigation of the variability of maternal hepatitis B DNA levels between the first and second trimesters of pregnancy.
IRAS ID
275065
Contact name
stephen barclay
Contact email
Sponsor organisation
NHS GG&C
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Hepatitis B virus (HBV) is a viral infection that is transmitted by blood contact. Worldwide, mother to child transmission at the time of birth is the commonest route of infection. Infection acquired early in life is typically chronic (prolonged), and associated with a risk of cirrhosis (bad scarring of the liver) and hepatocellular carcinoma (liver cancer) such that lifelong follow up is required.
The likelihood of transmission from mother to child can be greatly reduced by vaccination immediately after birth. Mothers with a high viral load (level of virus in the blood) are at increased risk of passing the virus to their children despite vaccination, and in these circumstances antiviral therapy is given in the third trimester of pregnancy to reduce this risk.
International guidelines on Hepatitis B either do not specify which stage of pregnancy to assess viral load at, or recommend the 2nd trimester. In NHS Greater Glasgow and Clyde (NHSGGC) , a local protocol reccomends a viral load at week 26. However, the West of Scotland Specialist Virology Centre (WOSSVC) checks a viral load as a reflex response to all new HBV diagnoses. HBV testing in pregnancy is a common point of HBV diagnosis, and hence many patients have 2 HBV viral loads from within the same pregnancy.
This research will identify all patients with 2 viral loads within the same pregnancy occurring between 2010 and 2019 in NHSGGC. We will examine for any significant variability in viral load between booking and week 26, and examine the utility of a viral load from booking to guide treatment decisions in the third trimester. If there is no significant variability, then it may be possible to make treatment decisions earlier in pregnancy allowing for simpler protocols of care.REC name
West of Scotland REC 3
REC reference
21/WS/0029
Date of REC Opinion
2 Mar 2021
REC opinion
Favourable Opinion