Ethical approval given for new trial to prevent Group B Strep in newborn babies

05 November 2019

Article: 53/4402

On 1 November 2019, the UK Health Minister announced that a new trial, named the Group B Streptococcus (Group B Strep) trial, has been given ethical approval by the Health Research Authority in England and Health and Care Research in Wales.

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 trial will involve 80 hospitals in England, Wales and Scotland and at least 320,000 women will take part, with recruitment starting in spring 2020. The results of the trial will be used to inform the future of pregnancy care across the UK and aims to help save babies’ lives.

The 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 35-37 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.

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.

Research has shown: 

  • A 31% rise in the prevalence of Group B Strep infections in babies under three months old since 2000 in the UK and Ireland with 65% of the mothers of affected babies showing no risk factors. 
  • The bacteria are present in approximately one-in-five pregnant women, usually causing no harm to the carrier, but may be passed unknowingly from a mother to her baby around birth. 
  • One in 1,750 newborn babies will develop a Group B Strep infection. Of these, one in 19 of these babies will die and one in 14 survivors will be left with a long-term disability.

Source: Department of Health and Social Care (SHSC), 1 November 2019