GBS2
Research type
Research Study
Full title
Accuracy of a rapid intrapartum test for maternal group B streptococcal colonisation and its potential to reduce antibiotic usage in mothers with risk factors.
IRAS ID
180476
Contact name
Sally Burtles
Contact email
Sponsor organisation
Joint Research Management Office (JRMO), Queen Mary (University of London)
ISRCTN Number
ISRCTN74746075
Duration of Study in the UK
2 years, 6 months, 3 days
Research summary
Group B streptococcus (GBS) is a bug which is found everywhere but which does not affect those with a mature, functioning immune system. GBS can be transmitted to babies at birth if the mother has this bug in their vagina or lower gut. Giving the mother antibiotics during labour reduces the chance of transmission but guidelines recommend that these are only used if the mother has risk factors associated with GBS colonisation.
As GBS colonisation is asymptomatic having a risk factor does not necessarily mean that the bug is present, and thus the woman may have received antibiotics unnecessarily. This can promote the evolution of antibiotic resistant strains of bacteria, so called “superbugs” as well as, in extreme cases, potentially causing harm to the newborn.
GBS2 will see if a rapid test to detect GBS can be used in the labour ward to better direct the administration of preventative antibiotics.
1340 women presenting to the labour ward with GBS risk factors will be recruited from at least 16 hospitals in the West Midlands and London during a 4-6 week study period. Half the hospitals will retain with their current practice of giving antibiotics according to the guidelines. In other hospitals women will have their lower vagina and rectum lightly swabbed and antibiotics will only be given if they test positive for GBS colonisation.
We will compare whether giving antibiotics in labour based on the rapid test result, rather than giving antibiotics to all those with risk factors results in a reduction in antibiotic usage.
In addition GBS2 will also:
Confirm and estimate the vertical transmission rate between women recruited to the GBS2 study and their newborn for certain bacteria of interest (GBS, MRSA, VRE and ESβL).Gather information on peri-partum risk factors for transmission (mode of delivery, maternal co-morbidities, colonising species).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0036
Date of REC Opinion
9 Mar 2016
REC opinion
Further Information Favourable Opinion