Routine testing for Group B Streptococcus
Research type
Research Study
Full title
The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)
IRAS ID
263682
Contact name
Jane Daniels
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN49639731
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Group B Streptococcus (GBS) is a bacterium present in the vagina of approximately 1 in 4 pregnant women.
Giving women antibiotics in labour reduces the risk of their babies developing GBS infection. Current UK practice is to offer antibiotics when the baby is at higher risk of developing the infection based on maternal risk factors. This “risk factor” screening is imperfect: some babies born to mothers without risk factors still develop an infection and many women with risk factors do not carry GBS but receive antibiotics unnecessarily. A better solution is “routine testing” of every pregnant woman, and offering antibiotics in labour to those who are carrying GBS. There are two methods available.
80 maternity units will be randomly allocated to the “risk factor” or the “routine testing” approach. Those allocated to the “routine testing” approach will be further randomly divided into testing women using a vaginal-rectal swab either a) at 35-37 weeks of pregnancy, or b) in labour, using a rapid test. Women with a positive test result will be offered antibiotics in labour. We will compare the number of babies who develop serious infection. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the approaches. We will use routinely collected data from national systems. We will also interview women and healthcare professionals about the acceptability of the testing approaches. We will collect individual level detailed data for 100 women at each of the 80 sites to inform the economic evaluation of the trial and for monitoring purposes. Finally, we will compare the overall costs of each strategy to ascertain which represents the best value for money for the NHS.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0253
Date of REC Opinion
16 Sep 2019
REC opinion
Further Information Favourable Opinion