New GBS Clinical Trial in the UK
Updated: Jul 21, 2020
22 May 2019
A really important clinical trial has been announced in the UK, looking at whether the public health system can improve the prevention of early-onset Group B Streptococcus (GBS) infections in babies.
The trial will be the first worldwide to compare the UK’s current ‘risk factor’ approach to preventing GBS, to the option of routine testing of women for GBS, either during late pregnancy or labour. Both approaches involve giving intravenous antibiotics to mothers during labour to prevent GBS passing on to their babies. The research will examine whether and by how much each policy reduces cases of early-onset neonatal sepsis. Involving 80 hospitals in England, Wales and Scotland the results of this study will inform future policy in order to improve maternal and neonatal outcomes.
GBS is a bacterium that normally resides in either the gut or the vagina and is carried by 20-40% of adults. One-in-four to one-in-five pregnant women are carriers and may unknowingly pass it along to their babies during birth and, while there are usually no negative repercussions to this, one-in-1,750 newborn babies will develop a GBS infection. Unfortunately, one-in-19 of these babies will die and one in 14 will develop a long-term disability. Two babies a day develop GBS in the UK and one a week dies. Up to two thirds of GBS disease is early-onset and it usually presents as sepsis with pneumonia, it can also present as meningitis.
Current UK policy to tackle early-onset GBS involves identifying pregnant women with 'risk factors' and then giving antibiotics to mothers who are likely to be carrying GBS. This policy has been criticised however for missing out some women who do carry the bacteria, while also unnecessarily prescribing antibiotics to women who do not carry the bacteria. Ever since the risk-based policy was enacted in 2003, its effectiveness has been called into question, as 65% of newborn babies in the UK who developed GBS infections have mothers with no risk factors. This may explain why the UK rate of potentially preventable early-onset (age 0-6) GBS infection has not fallen. Indeed the rate actually rose by 19% between 2000 and 2015.
The Royal College of Obstetricians & Gynaecologists has recommended that selected women should be offered the ECM (enriched culture medium) test in their guideline on group B Strep, a test that is not currently offered by the NHS. The UK National Screening Committee however does not recommend routine testing for GBS, despite many developed countries having successfully used this screening approach to reduce the number of cases and deaths attributed to GBS. Patient advocacy groups, like Group B Strep Support, recommend that every pregnant woman receives information on GBS as part of her routinized antenatal care and that all women be offered sensitive tests for GBS colonisation.
Babies affected by GBS can lose their lives or have permanent life-changing after effects. Considering that it is potentially preventable with early treatment, CoMO hopes that the trial will lead to policy improvements and gains in neonatal health.
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