MAGIC (MAternal Gbs IdentifiCation) study

• Research type

  Research Study

• Full title

  Molecular detection of Group B Streptococcus (GBS, Streptococcus agalactiae) in pregnant women: study of a novel diagnostic test.

• IRAS ID

  307873

• Contact name

  Gordon C. S. Smith

• Contact email

  gcss2@cam.ac.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

• Duration of Study in the UK

  4 years, 11 months, 31 days

• Research summary

  A bug called GBS (Group B Streptococcus) is a common cause of severe infections in newborns, and can result in significant disability or death. Around 1 in 5 pregnant women carry GBS in their bodies and, while the presence of GBS may be unknown to the mother, some babies will catch the bug from the mother during birth and so become at risk of developing a dangerous illness. Women carrying the bug are given antibiotics in labour to protect the baby. The current methods used to detect GBS in pregnant women either take a few days to produce a result or are not very accurate, so no one method of screening for the bug is ideal. This research will compare current diagnostic methods with a new test which we have developed which can rapidly detect tiny quantities of GBS. We believe that the new test may combine high accuracy with rapid turnaround of results.
  Women eligible to participate in the study are pregnant and 16 years old or older. Eligible women will be approached in clinics in the Rosie Hospital where they are due to have a vaginal examination and vaginal swabs taken; if agreeing to be in the study the research team will perform the examination and take the swabs necessary for the clinical care as well as the research. The new diagnostic test will then be performed on the research swabs, and data about the women participating (and their pregnancies) will be gathered remotely. We plan to store the samples and data collected for 5 years to be able to perform further tests if appropriate, however we will store the data only for as long as needed and destroy the data earlier if it is thought to be no longer useful.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  22/PR/1045

• Date of REC Opinion

  4 Aug 2022

• REC opinion

  Favourable Opinion