A clinical trial for group B Streptococcus (GBS) screening in pregnant women, aiming to prevent life-threatening infections in newborn babies, has been announced in the UK
Group B Streptococcus is a bacteria that can cause a range of serious and life-threatening infections in newborn babies including pneumonia, meningitis and sepsis.
The trial will involve a large-scale cluster-randomised trial and will examine the effectiveness of two different tests. The first test is a lab-based test at 35 to 37 weeks into pregnancy. The second test is a ‘bedside test’ at the start of labour as it is known that some women who have tested positive for GBS during pregnancy do not carry the bacteria by the time they give birth. The results from the clinical trial will be compared to the current recommended approach which is to identify women who have ‘risk factors’ that could lead to their babies developing the infection.
Research has shown that the current approach is not very accurate. 65 per cent of newborn babies in the UK who developed GBS infections have mothers who did not have any risk factors and 70 per cent of women are unnecessarily given antibiotics after being identified as having risk factors despite not carrying the bacteria. In 2003, ‘risk-based’ prevention guidelines were introduced but despite this there has been an increase by almost a third in the number of babies aged under three months who are infected with GBS since 2000.
GBS infections in newborn babies can usually be prevented by giving IV antibiotics, usually penicillin, during labour, which reduces the risk of the bacteria by up to 90 per cent.
The clinical trial will take place in 80 hospitals in England, Scotland and Wales and is being led by The University of Nottingham’s research team in partnership with the NCT, Group B Strep Support and the Department of Health and Social Care. The trial is being funded by the National Institute for Health.
“We welcome the announcement that clinical trials for group B Streptococcus screening in pregnant women will take place.
“Group B Streptococcus is responsible for the death of one baby a week in the UK. The current approach means a lot of expectant mums who do not have any ‘risk factor’ but have the bacteria are not being treated with IV antibiotic in labour. We look forward to the results from this trial informing and improving group B Streptococcus prevention policy in pregnancy in the UK.”