Health Minister announces GBS3 trial has been granted ethical approval
Published on: 06/11/2019
Health Minister Nadine Dorries has announced that ethical approval has been given for a £2.8 million trial to prevent Group B Strep being passed on to newborn babies. The decision was made by the Health Research Authority in England and Health and Care Research in Wales.
What is Group B Strep?
Group B Streptococcus (also known as ‘Group B Strep’ or ‘GBS’) is a natural bacterium that is commonly found in the intestines of up to one in every three adults as well as in the vaginas of one in four women. Even though Group B Strep is a natural bacterium, it can occasionally cause infection, most commonly in newborn babies. Newborn babies do not have well developed immune systems because they have not had the chance to build them up and are susceptible to some bacteria. Whilst the large majority of babies born to mums carrying group B Strep at the time of delivery are absolutely fine, if a baby does develop a GBS infection, it can be very serious.
For more information on the infection and how it can affect a pregnancy and newborn baby please see our page explaining GBS here
What will the trial include?
The trial will involve 80 hospitals in England, Wales and Scotland and at least 320,000 women will take part. Recruitment of pregnant ladies with the infection, or the potential risk of infection will start in spring 2020.
The trial will be funded by the National Institute for Health Research (NIHR). It will look at the effectiveness of 2 different tests compared with standard care:
- A lab-based test (ECM) at 35 to 37 weeks of pregnancy
- 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. The results of the trial will be used to inform the future of pregnancy care across the United Kingdom and could help save babies’ lives. 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.
Nadine Dorries shared the news on Twitter:
“Having made my first speech on this years ago, I’m especially thrilled to announce this. We want the NHS to be the safest place in the world to give birth and this trial will be an important step in understanding if universal screening of Group B Strep can save the lives of more babies.”
The response from Jane Plumb MBE, Chief Executive of Group B Strep Support shows how thrilled health professionals are at the progress being made to help save little lives:
“We are delighted that the GBS3 trial is progressing and has the support of the government. This major trial is comparing 2 types of testing versus a risk-factor approach. The results 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”
Routine testing is already established in the United States and has given positive results so it is refreshing news that the UK are ready to implement this effective testing for GBS.
“After routine testing was introduced in the United States, the rate of early-onset Group B Strep infection dropped by over 80% 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”