Health Minister Nadine Dorries has announced that the GBS3 trial has been granted ethical approval.
Having made my first speech on this years ago, I’m especially thrilled to announce this.— Nadine Dorries (@NadineDorries) November 1, 2019
Approval for new trial to prevent Group B Strep in newborn babies - https://t.co/CxPKLIJmsu https://t.co/ggcs6ONBR1
The major clinical trial is designed to improve prevention of potentially fatal group B Strep infection in newborn babies. The multi-million pound trial, which will involve 80 hospitals in England, Wales and Scotland, received the go-ahead from the Health Research Authority in England and Health & Care Research in Wales. The trial will involve at least 320,000 women, with recruitment beginning in Spring 2020.
Group B Strep is the most common cause of life-threatening infection in newborn babies, causing a range of serious infections including pneumonia, meningitis and sepsis. The results of this ground-breaking trial will be used to inform the future of pregnancy care across the United Kingdom and could help save babies’ lives every year.
The £2.8 million trial, funded by the National Institute for Health Research (NIHR), will look at the effectiveness of two different tests compared with standard care – a lab-based test, the Enriched Culture Medium (ECM) test at 35 to 37 weeks of pregnancy, and a ‘bedside test’ at the start of labour. The ECM test is currently recommended for use on high-risk groups in late pregnancy by the Royal College of Obstetricians and Gynaecologists’ clinical guidelines.
Group B Strep infections in newborn babies can usually be prevented by giving antibiotics through a vein to women during labour, which reduces the risk by up to 90%.
The UK currently does not routinely test pregnant women for group B Strep, and instead identifies pregnant women with ‘risk factors’ for their newborn developing the infection.
“We are delighted that the GBS3 trial is progressing and has the support of the Government. The results of this major trial will drive improvements in UK and international policy and lead to fewer babies and their families suffering the trauma that group B Strep infection can bring.
We are delighted that the GBS3 trial is progressing and has the support of the Government. The results of this major trial will drive improvements in UK and international policy and lead to fewer babies and their families suffering the trauma that group B Strep infection can bring.
After routine testing was introduced in the United States, the rate of early-onset group B Strep infection dropped by over 80 per cent and is now less than half that of the UK. Were the same to happen in the UK, approximately 350 babies every year would be protected from group B Strep infections, saving 15 babies’ lives and preventing another 15 from developing life-changing disability. We have to do this.”Jane Plumb Chief Executive, Group B Strep Support
We very much look forward to the results from this pivotal GBS3 trial which may be able to improve the prevention of early-onset group B Strep infections in babies in the UK. If group B Strep carriage is diagnosed during pregnancy, compared with the current risk based approach in labour, then a significant number of babies lives could be saved.
In the meantime, we encourage all maternity units to consider testing women as recommended in the RCOG clinical guideline, including the use of the ECM test. Early-onset group B Strep infection is rare, but the complications can be serious, and further research is urgently needed to improve diagnosis.”Mr Edward Morris MD FRCOG, Vice President of Clinical Quality at the Royal College of Obstetricians and Gynaecologists and President Elect:
At the moment, we’re in a situation where we’re missing lots of babies whose mums don’t have risk factors but do carry the bacteria and giving antibiotics to women who don’t carry the bacteria.Dr Kate Walker, Clinical Assistant Professor of Obstetrics and GBS3 Trial Co-Lead
We want to answer the question for the NHS — should you test pregnant women for group B Strep or not, and if you’re going to test, is it better to do a culture test at 35 to 37 weeks pregnancy or a bedside test? Hopefully, the trial will answer these questions.
We believe that, if testing is proved effective, this would mean that the right women get the right antibiotics.”Prof Jane Daniels, Professor of Clinical Trials and GBS3 Trial Co-Lead
The announcement was covered in the MailOnline: