More than 1,100 pregnant women on the North Manchester site of Saint Mary’s Managed Clinical Service, part of Manchester University NHS Foundation Trust (MFT)), have taken part in a rapid beside test to protect newborns from life-threatening illnesses which can be passed onto babies during birth.
Group B Streptococcus (GBS), a type of bacteria, is the most common cause of life-threatening infection in newborn babies in the UK.
Approximately one in four pregnant women in the UK carry GBS, often without realising it, and there is a 50 per cent chance that the baby will be exposed to GBS during birth. While most of these babies will not get sick, around one in 1,750 newborns develop early onset GBS infection, such as sepsis (blood infection), pneumonia (infection in the lungs) or meningitis (infection of the fluid and lining around the brain), with potentially devastating outcomes.
The current UK strategy for testing for GBS is ‘risk factor-based screening’ which offers antibiotics to women during labour, who have had GBS detected during pregnancy or have had a previous baby who has been unwell with GBS. This approach means that many women who carry GBS are not identified. Sixty-five per cent of UK newborn babies who develop early onset GBS infection have mothers who had no risk factor.
The GBS3 study, funded by the National Institute for Health and Care Research (NIHR) and sponsored by the University of Nottingham, aims to learn if testing all pregnant women to see if they carry GBS, reduces the risk of infection in newborn babies.
Mr Sachchidananda Maiti, Consultant Obstetrician, who is leading the study in North Manchester maternity unit, said: “This is the first trial of its kind in the world and the results will help to determine whether routine testing should be introduced in the UK. We are incredibly pleased to be part of this study at MFT and have received a great response and feedback from pregnant women involved in the rapid bedside testing. So far, more than 223 of 1123 women (20 per cent) have tested positive at North Manchester maternity unit.
“Identifying women with GBS with greater accuracy and treating them with antibiotics at the optimum time, could prevent approximately 40 newborn deaths and 25 cases of disability in the UK each year.”
As part of the study at North Manchester maternity unit, a swab is taken from the mother at the start of labour to test for GBS and the results are received within 40 minutes. If the mother is positive, antibiotics are offered to protect the newborn from potential illness. Sixteen per cent of the 1123 women who had a swab taken at North Manchester maternity unit had GBS, that had not previously been detected during pregnancy.
Amy’s story
Mum of two, Amy Winters, 29 from Middleton, Greater Manchester, took part in the bedside test at North Manchester maternity unit, earlier this year.
Amy had no risk factors but tested positive for GBS before her induced labour to her second child, Lilah and was given antibiotics immediately.
Amy said: “Taking part in this research was an easy decision for me, knowing that taking this test could help to prevent my baby becoming poorly.
“My brother and I were both premature babies and my mum was given antibiotics during labour, due to the likelihood of us being exposed to GBS. When I gave birth to my son Leo, three years ago, I knew about the risks of passing GBS but there was no test available then. This swab is a fantastic step forward in reassuring mums and protecting newborns from infection.
“It was a really simple process, the test took seconds, and the results came back very quickly. It was comforting to know that because of this I could be treated with antibiotics straightaway, to minimise the risk to my daughter Lilah.
“Lilah is now six months old; she was absolutely fine after she was born, which is such a relief, she didn’t become ill, and she is doing brilliantly.
“This research is great because if you could easily find out from this test if you had an infection that could be passed to your baby, so you could do something to help protect them, I’m sure every pregnant woman would take it.”
The research
The study is investigating two different tests, which will be compared against the current standard practice: a test at an antenatal appointment at approximately 36 weeks of pregnancy, or a rapid bedside test where a swab is taken at the start of labour, which is being carried out at NMGH.
Sophie Glynn, midwife at in the maternity unit on the North Manchester site, who carried out the 1,000th swab test, said: “I’m pleased to be able to contribute to the GBS3 study as it has potential to improve care for women and babies and give women peace of mind that their baby is getting protection from GBS when needed.
“Giving antibiotics to pregnant women who are known to carry GBS has been shown to reduce the risk of babies developing early onset GBS infection, so it’s great that through this test we can provide more targeted antibiotic treatment.”
The GBS3 study is running in all three maternity units across the Saint Mary’s Managed Clinical Service (MCS). The Oxford Road and Wythenshawe maternity units, also part of the Saint Mary’s MCS were randomly assigned to follow usual care (risk factor-based testing) with North Manchester maternity unit randomly assigned to the rapid bedside test.
Professor Jane Daniels, Faculty of Medicine and Health Sciences, University of Nottingham and Chief Investigator for GBS3, said: “The GBS3 trial will provide crucial information to help the UK National Screening Committee decide whether to roll out GBS testing nationwide, once the trial comes to an end.
The study will be recruiting until March 2024 and involves 71 hospitals in England, Wales and Scotland, 17 of which are rapid testing sites.