Condition category
Pregnancy and Childbirth
Date applied
15/04/2015
Date assigned
16/04/2015
Last edited
06/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Group B streptococcus (GBS) is the leading cause of serious infection in newborn babies in developed countries. It is transmitted to babies around birth from mothers who carry the bacterium (bug) in their bowels and vagina without any symptoms. Antibiotics given to the mother from the start of labour reduces the risk of the newborn baby developing early onset GBS disease, both by reduction of the chance of transmission and by giving the baby protective antibiotics before birth, providing they are given for long enough before delivery. Medical bodies recommend that preventative antibiotics should only be given in labour to mothers with risk factors for transmitting the infection to their baby. The babies of these mothers may then be investigated and some may be treated with antibiotics for GBS infection, particularly where more than one risk factor is present. The vast majority of these babies do not have GBS infection and are unnecessarily exposed to antibiotics, separated from their mothers for investigations and kept in hospital. Unnecessary use of antibiotics can also promote the evolution of antibiotic resistant strains of bacteria, so called “superbugs”. The aim of this study is to establish whether rapid testing technology which determines whether the mother is carrying GBS can be used to direct the appropriate and timely administration of preventative antibiotics.

Who can participate?
We will identify around 1,340 mothers in labour who have risk factors for GBS infection in their newborn babies in at least 16 hospitals in the West Midlands and London during a 4-6 week study period.

What does the study involve?
In half of the hospitals, all higher-risk women will be cared for as per current guidance, which would be with antibiotics. In the other hospitals, all women with GBS risk factors will have a swab taken from their vagina and rectum, to be used in the rapid test. In these hospitals, antibiotics will only be given in labour if the rapid test result is positive. If the rapid test result fails to deliver a result within 55 minutes, or the woman's care team suspect an infection then women will be given antibiotics as per national GBS guidelines. In another aspect of the study we will assess the accuracy of the rapid testing, namely does it always give a positive result for women carrying GBS and negative results for those who are not. We will also determine whether the test is practical to use on a busy labour ward and give results in time for antibiotics to be given to those who need them. We will compare whether using 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. The impact of the two antibiotic strategies will be evaluated by measuring how many babies are found to be carrying GBS at birth and the rates of GBS infection in the first six days of the babies’ lives. We will determine which strategy offers the best value for money by calculating the costs and benefits of each. Finally, we will grow any GBS bacteria collected from mothers and their babies in laboratory and test whether any antibiotic resistant strains are found.

What are the possible benefits and risks of participating?
This study is looking to see if a small enhancement to the normal treatment pathway allows better direction of antibiotic administration to women in labour. As the normal treatment pathway is still largely followed, and the clinicians can prescribe antibiotics at any time they wish, there are no real risks in taking part. The benefit of taking part in the test group is that you are unlikely to be prescribed antibiotics if you are not colonised with GBS.

Where is the study run from?
At least 16 hospitals in the West Midlands and London (UK).

When is the study starting and how long is it expected to run for?
From May 2016 to October 2018.

Who is funding the study?
National Institute for Health Research (UK).

Who is the main contact?
Dr William McKinnon
w.mckinnon@bham.ac.uk  

Trial website

Contact information

Type

Public

Primary contact

Dr William McKinnon

ORCID ID

Contact details

Birmingham Clinical Trials Unit
School of Health and Population Sciences
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8335
w.mckinnon@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/82/04

Study information

Scientific 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

Acronym

GBS2

Study hypothesis

To see if a rapid test for GBS used in pregnant women with risk factors for colonisation with GBS2 undergoing a trial of labour will reduce the use of intrapartum antibiotics.

Ethics approval

The West Midlands – Edgbaston Research Ethics Committee, 09/03/2016, ref: 16/WM/0036

Study design

A prospective test accuracy cohort study, a cluster randomised controlled trial, and a health economic evaluation

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Early onset group B streptococcus infection in the neonate

Intervention

We will identify around 1,340 mothers in labour who have risk factors for GBS infection in their newborn babies in at least 16 hospitals in the West Midlands and London during a 4-6 week study period. In half of the hospitals, all higher-risk women will be cared for as per current guidance, which would be with antibiotics. In the other hospitals, all women with GBS risk factors will have a swab taken from their vagina and rectum, to be used in the rapid test. In these hospitals, antibiotics will only be given in labour if the rapid test result is positive. If the rapid test result fails to deliver a result within 55 minutes, or the woman's care team suspect an infection then women will be given antibiotics as per national GBS guidelines.

In another aspect of the study we will assess the accuracy of the rapid testing, namely does it always give a positive result for women carrying GBS and negative results for those who are not. We will also determine whether the test is practical to use on a busy labour ward and give results in time for antibiotics to be given to those who need them. We will compare whether using 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. The impact of the two antibiotic strategies will be evaluated by measuring how many babies are found to be carrying GBS at birth and the rates of GBS infection in the first six days of the babies’ lives. We will determine which strategy offers the best value for money by calculating the costs and benefits of each. Finally, we will grow any GBS bacteria collected from mothers and their babies in laboratory and test whether any antibiotic resistant strains are found.

Intervention type

Other

Phase

Drug names

Primary outcome measures

To evaluate if rapid intrapartum GBS testing reduces maternal and neonatal antibiotic usage, compared with usual care where Intrapartum Antibiotic Prophylaxis (IAP) is directed based on maternal risk factors alone.

Secondary outcome measures

1. To establish the real time accuracy of the rapid test for GBS colonisation among women in labour with risk factors for GBS transmission, comparing against the reference standard of selective enrichment culture
2. To establish a standard operating procedure for use of a rapid, point-of-care intrapartum test for GBS colonisation (GeneXpert) on a labour ward with turnaround times compatible with provision of a suitable duration of antibiotic exposure to test positive mothers
2. To determine the time to availability of test results in practice and the time remaining before birth are suffcient to give an adequate antibiotic exposure for effective prevention of GBS transmission from colonised mothers to their newborn child
3. To explore the impact of testing strategies on neonatal outcomes
4. To determine the effect of peripartum antibiotic exposure on the risk of carriage of antibiotic resistant bacteria in infants at up to 6 weeks of age
5. To determine the cost and cost-effectiveness of rapid intrapartum GBS testing for preventing early-onset neonatal GBS disease in women with risk factors for GBS transmission against usual care of risk factor directed IAP

Overall trial start date

01/05/2016

Overall trial end date

31/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Presence of one or more of the following risk factors will define inclusion of the mother and baby into the study:
1. The mother has delivered a previous baby who developed neonatal GBS disease (early or later onset), as reported by the mother and documented in the maternal notes
2. GBS bacteriuria during the current pregnancy, as documented in the maternal notes, irrelevant of whether the GBS bacteriuria was treated at the time of diagnosis with antibiotics
3. GBS colonisation of the vagina and/or the rectum (determined from a recto/vaginal swab) in current pregnancy, as documented in the maternal notes
4. Maternal pyrexia (>38°C) observed at any point in labour, or clinically suspected/confirmed chorioamnionitis
5. Preterm labour with prelabour rupture of membranes of any duration
6. Preterm labour if there is suspected or confirmed intrapartum rupture of membranes lasting more than 18 hours

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1328 (83 per cluster, 8 clusters per arm, 2 arms to the trial)

Participant exclusion criteria

Those who do not present with any of the risk factors associated with an increased risk of being colonised by GBS

Recruitment start date

01/11/2016

Recruitment end date

30/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal London Hospital
Whitechapel Road Whitechapel
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Queen Mary & Westfield College, University of London

Sponsor details

Mile End Road
London
E1 4NS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/05/2016: Changed recruitment start date from 01/05/2015 to 01/11/2016. Changed recruitment end date from 31/10/2-16 to 30/09/2017 07/04/2016: Ethics approval information added. Overall study start date was changed from 01/05/2015 to 01/05/2016. Overall study end date was changed from 30/11/2017 to 31/10/2018. Recruitment start date was changed from 01/12/2015 to 01/05/2016.