Routine testing for Group B Streptococcus in pregnancy (GBS3 trial)

ISRCTN	ISRCTN49639731
DOI	https://doi.org/10.1186/ISRCTN49639731
IRAS number	263682
Secondary identifying numbers	CPMS 42782, IRAS 263682

Submission date: 19/08/2019
Registration date: 23/08/2019
Last edited: 16/04/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Current plain English summary as of 27/03/2024:

Background and study aims
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.

Who can participate?
All pregnant women giving birth at 24 or more weeks gestation within their maternity unit’s recruitment period can be included in the data collection. Up to 50 women over 16 years old and 30 healthcare professionals at some sites will be asked to take part in the qualitative sub-study.

What does the study involve?
We will work with up to 80 hospitals/ boards or trusts. Hospitals will be randomly allocated to the “risk factor” or the “routine testing” approach. Hospitals allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, or b) in labour, using a rapid test machine. Women with a positive test result will be offered antibiotics in labour. All mothers in preterm labour or who had a previous baby with a GBS infection will be offered antibiotics as per current guidance. We will compare the number of babies who develop serious infections born in all “routine testing” hospitals and birth centres with those using the “risk factor” approach. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. We will use routinely collected data from national systems to avoid burdening busy clinical staff. We will also interview women and healthcare professionals about the acceptability of the testing approaches. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS.

What are the possible benefits and risks of participating?
The trial does not benefit women directly but the information we get from this trial may help us to treat pregnant women with Group B Streptococcus in future

Where is the study run from?
The trial is managed by the Nottingham Clinical Trials Unit which is part of the University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
April 2019 to August 2025

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)

Who is the main contact?
Joanne Brooks
gbs3@nottingham.ac.uk

_____

Previous plain English summary as of 30/03/2022:

Background and study aims
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.

Who can participate?
All pregnant women giving birth at 24 or more week’s gestation within her maternity unit’s recruitment period can be included in the data collection. Up to 50 women over 16 years old and 30 health care professionals at some sites will be asked to take part in the qualitative sub study.

What does the study involve?
We will work with 80 hospitals/ boards or trusts. Hospitals will be randomly allocated to the “risk factor” or the “routine testing” approach. Hospitals allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, or b) in labour, using a rapid test machine. Women with a positive test result will be offered antibiotics in labour. All mothers in preterm labour or who had a previous baby with GBS infection will be offered antibiotics as per current guidance. We will compare the number of babies who develop serious infection born in all “routine testing” hospitals and birth centres with those using the “risk factor” approach. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. We will use routinely collected data from national systems to avoid burdening busy clinical staff. We will also interview women and healthcare professionals about the acceptability of the testing approaches. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS.

What are the possible benefits and risks of participating?
The trial does not benefit women directly but the information we get from this trial may help us to treat pregnant women with Group B Streptococcus in future

Where is the study run from?
The trial is managed by the Nottingham Clinical Trials Unit which is part of the University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
April 2019 to August 2025

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)

Who is the main contact?
Eleanor Harrison
gbs3@nottingham.ac.uk

_____

Previous plain English summary as of 24/08/2021:

Background and study aims
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.

Who can participate?
All pregnant women giving birth at 24 or more week’s gestation within her maternity unit’s recruitment period can be included in the data collection.
Up to 50 women over 16 years old and 30 health care professionals at some sites will be asked to take part in the qualitative sub study.

What does the study involve?
We will work with 80 hospitals/ boards or trusts. Hospitals will be randomly allocated to the “risk factor” or the “routine testing” approach. Hospitals allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, or b) in labour, using a rapid test machine. Women with a positive test result will be offered antibiotics in labour. All mothers in preterm labour or who had a previous baby with GBS infection will be offered antibiotics as per current guidance. We will compare the number of babies who develop serious infection born in all “routine testing” hospitals and birth centres with those using the “risk factor” approach. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. We will use routinely collected data from national systems to avoid burdening busy clinical staff. We will also interview women and healthcare professionals about the acceptability of the testing approaches. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS.

What are the possible benefits and risks of participating?
The trial does not benefit women directly but the information we get from this trial may help us to treat pregnant women with Group B Streptococcus in future

Where is the study run from?
The trial is managed by the Nottingham Clinical Trials Unit which is part of the University of Nottingham

When is the study starting and how long is it expected to run for?
The first site is due to open in November 2020 and the last site will close 24 months later.

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme

Who is the main contact?
Sarah Craig
gbs3@nottingham.ac.uk

_____

Previous plain English summary as of 27/10/2020:

Background and study aims
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.

Who can participate?
All pregnant women giving birth at 24 or more week’s gestation within her maternity unit’s recruitment period.
Up to 50 women over 16 years old and 30 health care professionals at some sites will be asked to take part in the qualitative sub study.

What does the study involve?
We will work with 80 hospitals and birth centres. Hospitals will be randomly allocated to the “risk factor” or the “routine testing” approach. Hospitals allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, or b) in labour, using a rapid test machine. Women with a positive test result will be
offered antibiotics in labour. All mothers in preterm labour or who had a previous baby with GBS infection will be offered antibiotics as per current guidance. We will compare the number of babies who develop serious infection born in all “routine testing” hospitals and birth centres with those using the “risk factor” approach. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. We will use routinely collected data from national systems to avoid burdening busy clinical staff. We will also interview women and healthcare professionals about the acceptability of the testing approaches. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS.

What are the possible benefits and risks of participating?
The trial does not benefit women directly but the information we get from this trial may help us to treat pregnant women with Group B Streptococcus in future

Where is the study run from?
The trial is managed by the Nottingham Clinical Trials Unit which is part of the University of Nottingham

When is the study starting and how long is it expected to run for?
The first site is due to open in November 2020 and the last site will close 24 months later.

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme

Who is the main contact?
Sarah Craig
gbs3@nottingham.ac.uk

_____

Previous plain English summary:

Background and study aims
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.

Who can participate?
All pregnant women giving birth at 24 or more week’s gestation within her maternity unit’s recruitment period.
Up to 50 women over 16 years old at some sites will be asked to take part in the qualitative sub study.

What does the study involve?
We will work with 80 hospitals and birth centres. Hospitals will be randomly allocated to the “risk factor” or the “routine testing” approach. Hospitals allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at 35-37 weeks of pregnancy, or b) in labour, using a rapid test kit. Women with a positive test result will be
offered antibiotics in labour. All mothers in preterm labour or who had a previous baby with GBS infection will be offered antibiotics as per current guidance. We will compare the number of babies who develop serious infection born in all “routine testing” hospitals and birth centres with those using the “risk factor” approach. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. We will use routinely collected data from national systems to avoid burdening busy clinical staff. We will also interview women and healthcare professionals about the acceptability of the testing approaches. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for
the NHS.

What are the possible benefits and risks of participating?
The trial does not benefit women directly but the information we get from this trial may help us to treat pregnant women with Group B Streptococcus in future

Where is the study run from?
The trial is managed by the Nottingham Clinical Trials Unit which is part of the University of Nottingham

When is the study starting and how long is it expected to run for?
April 2020 to September 2022

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme

Who is the main contact?
Sarah Craig
gbs3@nottingham.ac.uk

Study website

Contact information

Ms Eleanor Harrison
Public

Nottingham Clinical Trials Unit
Applied Health Research Building
University Park
Nottingham
NG7 2RD
United Kingdom

ORCID ID	0000-0003-0652-3980
Phone	+44115 8231608
Email	Gbs3@nottingham.ac.uk

Prof Jane Daniels
Scientific

Nottingham Clinical Trials Unit
University of Nottingham
Building 42 Room BO4
University Park
Nottingham
NG7 2RD
United Kingdom

ORCID ID	0000-0003-3324-6771
Phone	+44115 82 31619
Email	jane.daniels@nottingham.ac.uk

Dr Kate Walker
Scientific

Nottingham Clinical Trials Unit
Building 42 Room B03
University Park
University of Nottingham
Nottingham
NG7 2RD
United Kingdom

ORCID ID	0000-0001-5794-7324
Phone	+441158231581
Email	kate.walker@nottingham.ac.uk

Study information

Study design	Randomized qualitative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please email GBS3@nottingham.ac.uk to request a patient information sheet
Scientific title	The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)
Study acronym	GBS3
Study hypothesis	Does routine testing of women for GBS colonisation either in late pregnancy or during labour reduce the occurrence of early-onset neonatal sepsis, compared to the current risk factor based strategy?
Ethics approval(s)	Approved 23/10/2019, East Midlands - Derby Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +442071048036; derby.rec@hra.nhs.uk), ref: 19/EM/0253, 19/CAG/0139
Condition	Group B streptococcus infection in pregnancy
Intervention	Current interventions as of 27/03/2024: We will work with up to 80 maternity units in England and Wales. Maternity units will be randomly allocated to the “risk factor” or the “routine testing” approach. Maternity units allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, using a lab-based test or b) in labour, using a rapid test machine. So, all eligible women at the same hospital will receive the same treatment. Information for the trial will be displayed on posters in the maternity units, on patient information sheets (Available upon request), and on the website. Women in risk-factors sites will also be provided with the leaflet ‘Group B Streptococcus in pregnancy and newborn babies’ (produced by the Royal College of Obstetricians & Gynaecologists and the Group B Strep Support charity) at approximately their 28-week antenatal appointment. Women in either of the two testing arms will be provided with an adapted version of the leaflet at approximately their 28-week antenatal appointment which also contains information on the GBS3 trial and the vaginal-rectal swab. Women will not be routinely given a trial-specific patient information sheet, and written informed consent will not be received. If the maternity unit has been randomised to routine testing the swab process will be explained to the women, and verbal consent will be sought for taking the swab. Bedside Test at the start of labour (Known as Intrapartum Rapid Testing): A swab will be taken from both the vagina and rectum (back passage) whilst the woman is in labour. This is taken by a healthcare professional. The procedure will not hurt but it may be slightly uncomfortable. The swab will be put immediately into a machine by a member of the woman’s care team and the results will be available within one hour. If the result is positive for Group B Streptococcus, the woman will be offered antibiotics immediately. Women planning to give birth at home or in a midwife-only-led unit (which is not unable to offer antibiotics during labour) will be offered the option of a rapid test antenatally in the hospital in or after the 35th week of pregnancy. Lab-Based Test (Known as Antenatal Enriched Culture Medium Test): A swab from both the vagina and rectum (back passage) will be taken approximately 3-5 weeks before the expected due date. This can be taken by a healthcare professional or by the woman herself. The procedure will not hurt but it may be slightly uncomfortable. The swab will be sent to the woman’s hospital laboratory for testing and women will be informed if the test is positive. If the result is positive for Group B Streptococcus, the woman will be offered antibiotics during labour. Usual care (Known as Risk Factor Based Strategy): Sites will follow their current risk factor-based screening and treatment approach. The RCOG Greentop Guideline No. 36 states women with the following risk factors for EOGBS infection should be offered IAP: •Having a previous baby with a GBS infection •Discovery of maternal GBS carriage incidentally during pregnancy •Preterm labour •Suspected maternal intrapartum infection, including suspected chorioamnionitis •Intrapartum pyrexia (raised temperature) •Women who are known to be colonised with GBS in a previous pregnancy should be offered the option of IAP or ECM testing in late pregnancy with the offer of IAP if GBS is detected. The risk of colonisation in subsequent pregnancies described in the RCOG guidelines should be discussed with the woman. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. For the main study, routine data about the woman and her baby will be obtained from different routine data sources such as NHS England, Public Health England, National Neonatal Research Database, Paediatric Intensive Care Audit Network, Badgernet and other devolved nation equivalents. Data will also be collected from medical notes as some outcomes cannot be obtained from Routine Data Sources. This information will have all patient identifiers removed after the information has been linked by a researcher. If women do not want their data to be used/don’t want their baby’s data to be used they can ensure this by using the national data opt-out (or equivalent in Scotland and Wales). This is a service which allows you to opt out of all your health information being used for all future research and planning, (not just for this trial). In all of the maternity units, posters will be displayed which will give details of how to opt out. This information will also be present on the website, and on the trial patient information sheets, which will be available upon request. We will also interview some women and healthcare professionals about the acceptability of the testing approaches, via the qualitative sub-study. In 4 maternity units, randomised to “routine testing”, women and healthcare professionals will be asked to take part in the qualitative sub-study. They may be approached by a member of their local usual care team (including the local Research Team) or may be able to refer themselves. These women and staff members will be provided with an information sheet and written informed consent will be received before the interviews are undertaken. We will also collect individual-level detailed data for at least 100 consecutive women per site to inform the economic evaluation of the trial and for monitoring purposes. Neonatal adjudication will be conducted on a sample of clinically suspected sepsis cases and any cases of maternal intrapartum anaphylaxis will be reported by sites quarterly. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS, via the economic evaluation sub-study. _____ Previous interventions as of 24/08/2021: We will work with 80 maternity units in England, Scotland and Wales. Maternity units will be randomly allocated to the “risk factor” or the “routine testing” approach. Maternity units allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, using a lab based test or b) in labour, using a rapid test machine. So, all eligible women at the same hospital will receive the same treatment. Information for the trial will be displayed on posters in the maternity units, on patient information sheets (Available upon request), and the website. Women in risk-factors sites will also be provided with the leaflet ‘Group B Streptococcus in pregnancy and newborn babies’ (produced by the Royal College of Obstetricians & Gynaecologists and the Group B Strep Support charity) at approximately their 28 week antenatal appointment. Women in either of the two testing arms will be provided with an adapted version of the leaflet at approximately their 28 week antenatal appointment which also contains information on the GBS3 trial and the vaginal-rectal swab. Women will not be routinely given a trial specific patient information sheet, and written informed consent will not be received. If the maternity unit has been randomised to routine testing the swab process will be explained to the women, and verbal consent will be sought for taking the swab. Bedside Test at start of labour (Known as Intrapartum Rapid Testing): A swab will be taken from both the vagina and rectum (back passage) whilst the woman is in labour. This is taken by a healthcare professional. The procedure will not hurt but it may be slightly uncomfortable. The swab will be put immediately into a machine by a member of the woman’s care team and the results will be available within one hour. If the result is positive for Group B Streptococcus, the woman will be offered antibiotics immediately. Women planning to give birth at home or in a midwife only led unit (which is not unable to offer antibiotics during labour) will be offered the option of a rapid test antenatally in hospital in or after the 35th week of pregnancy. Lab Based Test (Known as Antenatal Enriched Culture Medium Test): A swab from both the vagina and rectum (back passage) will be taken at approximately 3-5 weeks before the expected due date. This can be taken by a healthcare professional or by the woman herself. The procedure will not hurt but it may be slightly uncomfortable. The swab will be sent to the woman’s hospital laboratory for testing and women will be informed if the test is positive. If the result is positive for Group B Streptococcus, the woman will be offered antibiotics during labour. Usual care (Known as Risk Factor Based Strategy): Sites will follow their current risk factor based screening and treatment approach. The RCOG Greentop Guideline No. 36 states women with the following risk factors for EOGBS infection should be offered IAP: •Having a previous baby with GBS infection •Discovery of maternal GBS carriage incidentally during pregnancy •Preterm labour •Suspected maternal intrapartum infection, including suspected chorioamnionitis •Intrapartum pyrexia (raised temperature) •Women who are known to be colonised with GBS in a previous pregnancy should be offered the options of IAP or ECM testing in late pregnancy with the offer of IAP if GBS is detected. The risk of colonisation in subsequent pregnancies described in the RCOG guidelines should be discussed with the woman. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. For the main study, routine data about the woman and her baby will be obtained from different routine data sources such as NHS Digital, Public Health England, National Neonatal Research Database, Paediatric Intensive Care Audit Network, Badgernet and other devolved nation equivalents. Data will also be collected from medical notes as some outcomes cannot be obtained from Routine Data Sources. This information will have all patient identifiers removed after information has been linked by researcher. If women do not want their data to be used/don’t want their baby’s data to be used they can ensure this by using the national data opt-out (or equivalent in Scotland and Wales). This is a service which allows you to opt out of all your health information being used for all future research and planning, (not just for this trial). In all of the maternity units, posters will be displayed which will give details of how to opt-out. This information will also be present on the website, and on the trial patient information sheets, which will be available upon request. We will also interview some women and healthcare professionals about the acceptability of the testing approaches, via the qualitative sub-study. In 4 maternity units, randomised to “routine testing”, women and healthcare professionals will be asked to take part in the qualitative sub-study. They may be approached by a member of their local usual care team (including local Research Team), or may be able to refer themselves. These women and staff members will be provided with an information sheet and written informed consent will be received before the interviews are undertaken. We will also collect individual-level detailed data for 100 consecutive women at each of the 80 sites to inform the economic evaluation of the trial and for monitoring purposes. Neonatal adjudication will be conducted on a sample of clinically suspected sepsis cases and any cases of maternal intrapartum anaphylaxis will be reported by sites on a quarterly basis. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS, via the economic evaluation sub-study. _____ Previous interventions as of 27/10/2020: We will work with 80 maternity units in England, Scotland and Wales. Maternity units will be randomly allocated to the “risk factor” or the “routine testing” approach. Maternity units allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at approximately 35-37 weeks of pregnancy, using a lab based test or b) in labour, using a rapid test machine. So, all eligible women at the same hospital will receive the same treatment. Information for the trial will be displayed on posters in the maternity units, on patient information sheets (Available upon request), and the website. Women in risk-factors sites will also be provided with the leaflet ‘Group B Streptococcus in pregnancy and newborn babies’ (produced by the Royal College of Obstetricians & Gynaecologists and the Group B Strep Support charity) at approximately their 28 week antenatal appointment. Women in either of the two testing arms will be provided with an adapted version of the leaflet at approximately their 28 week antenatal appointment which also contains information on the GBS3 trial and the vaginal-rectal swab. Women will not be routinely given a trial specific patient information sheet, and written informed consent will not be received. If the maternity unit has been randomised to routine testing the swab process will be explained to the women, and verbal consent will be sought for taking the swab. Bedside Test at start of labour (Intrapartum Rapid Testing)A swab will be taken from both the vagina and rectum (back passage) whilst the woman is in labour. This is taken by a healthcare professional. The procedure will not hurt but it may be slightly uncomfortable. The swab will be put immediately into a machine by a member of the woman’s care team and the results will be available within one hour. If the result is positive for Group B Streptococcus, the woman will be offered antibiotics immediately. Women planning to give birth at home or in a midwife only led unit will be offered the option of a rapid test antenatally in hospital in or after the 35th week of pregnancy. Antenatal Enriched Culture Medium Test (Lab Based Test) : A swab from both the vagina and rectum (back passage) will be taken at approximately 3-5 weeks before the expected due date. This can be taken by a healthcare professional or by the woman herself. The procedure will not hurt but it may be slightly uncomfortable. The swab will be sent to the woman’s hospital laboratory for testing and women will be informed if the test is positive. If the result is positive for Group B Streptococcus, the woman will be offered antibiotics during labour. Usual care: Sites will follow their current risk factor based screening and treatment approach. The RCOG Greentop Guideline No. 36 states women with the following risk factors for EOGBS infection should be offered IAP: •Having a previous baby with GBS infection •Discovery of maternal GBS carriage incidentally during pregnancy •Preterm labour •Suspected maternal intrapartum infection, including suspected chorioamnionitis •Intrapartum pyrexia (raised temperature) •Women who are known to be colonised with GBS in a previous pregnancy should be offered the options of IAP or ECM testing in late pregnancy with the offer of IAP if GBS is detected. The risk of colonisation in subsequent pregnancies described in the RCOG guidelines should be discussed with the woman. As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. For the main study, routine data about the woman and her baby will be obtained from different routine data sources such as NHS Digital, Public Health England, National Neonatal Research Database, Paediatric Intensive Care Audit Network and other devolved nation equivalents. Data will also be collected from medical notes as some outcomes cannot be obtained from Routine Data Sources. This information will have all patient identifiers removed after information has been linked by researcher. If women do not want their data to be used/don’t want their baby’s data to be used they can ensure this by using the national data opt-out (or equivalent in Scotland and Wales). This is a service that allows you to opt out of all your health information being used for all future research and planning, (not just for this trial) In all of the maternity units, posters will be displayed which will give details of how to opt-out. This information will also be present on the website, and on the trial patient information sheets, which will be available upon request. We will also interview some women and healthcare professionals about the acceptability of the testing approaches, via the qualitative sub-study. In 4 maternity units, randomised to “routine testing”, women and healthcare professionals will be asked to take part in the qualitative sub-study. They may be approached by a member of their local usual care team (including local Research Team), or may be able to refer themselves. These women and staff members will be provided with an information sheet and written informed consent will be received before the interviews are undertaken. We will also collect individual-level detailed data for 100 consecutive women at each of the 80 sites to inform the economic evaluation of the trial and for monitoring purposes. Neonatal adjudication will be conducted on a sample of clinically suspected sepsis cases and any cases of maternal intrapartum anaphylaxis will be reported by sites on a quarterly basis. Finally, we will compare the overall costs of each strategy and work out which represents the best value for money for the NHS, via the economic evaluation sub-study _____ Previous interventions: We will work with 80 maternity units. Maternity units will be randomly allocated to the “risk factor” or the “routine testing” approach. Maternity units allocated to the “routine testing” approach will be further randomly divided into testing women using a swab taken from the vagina and rectum either a) at 35-37 weeks of pregnancy, using a lab based test or b) in labour, using a rapid test kit. So all eligible women at the same hospital will receive the same treatment. Information for the trial will be displayed on posters in the maternity units, and on patient information sheets (Available upon request), and the website. Women will not be routinely given a patient information sheet, and written informed consent will not be received. If the maternity unit has been randomised to routine testing the swab process will be explained to the women, and verbal consent will be sought for taking the swab. Bedside Test: A swab will be taken from both the vagina and rectum (back passage) whilst the women is in labour. This can be taken by a healthcare professional or the women herself. The procedure will not hurt but it may be slightly uncomfortable. The swab will be put immediately into a machine by a member of the women’s care team and the results will be available within one hour. If the result is positive for Group B Streptococcus, the women will be offered antibiotics during labour. Lab Based Test: A swab from both the vagina and rectum (back passage) when the women is 35-37 weeks pregnant will be taken. This can be taken by a healthcare professional or by the women herself. The procedure will not hurt but it may be slightly uncomfortable. The swab will be sent to the women’s hospital laboratory for testing and results will be sent to the women within 3 days. If the result is positive for Group B Streptococcus, the women will be offered antibiotics during labour. Usual care: Sites will follow the current risk factor based screening and treatment approach. The RCOG Greentop Guideline No. 36 states women with the following risk factors for EOGBS infection should be offered IAP: •Having a previous baby with GBS disease •Discovery of maternal GBS carriage incidentally during pregnancy •Preterm birth •Suspected maternal intrapartum infection, including suspected chorioamnionitis •Intrapartum raised temperature •Women colonised in a previous pregnancy should have intrapartum prophylaxis discussed As infections are relatively rare, we will need to collect information on 320,000 women to be able to see a difference between the two main approaches. For the main study, routine data about the woman and her baby will be obtained from different NHS databases through NHS digital. This information will have all patient identifiers removed after information has been linked. If women do not want to take part in the study/don’t want their baby to take part in the study they can do so by the national data opt-out. In all of the maternity units, posters will be displayed explaining the trial, and what it will entail including details of how to opt-out. This information will also be present on the website, and on the patient information sheets, which will be available upon request. We will also interview some women and healthcare professionals about the acceptability of the testing approaches, via the qualitative sub-study. In 4 maternity units women and healthcare professionals will be asked to take part in the qualitative sub-study. They will be approached by a member of their local usual care team (including local Research Team if local operating policies permit this), or may be able to refer themselves. These women and staff members will be provided with an information sheet and written informed consent will be received before the interviews are undertaken. 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 and work out which represents the best value for money for the NHS, via the economic evaluation sub-study.
Intervention type	Other
Primary outcome measure	Current primary outcome measure as of 27/03/2024: All-cause early neonatal sepsis defined as starting at < 7 days of birth. Cases will be identified from national data sources, a sample of which will be reviewed by a blinded adjudication panel. Early neonatal sepsis will be defined as: 1. A positive culture of a pathogenic bacteria from blood or cerebrospinal fluid taken at <7 days of birth, or 2. Death <7 days if infection or sepsis was recorded on the death certificate, or 3. Negative/ unknown culture status with ≥3 agreed clinical signs or symptoms (see list below), for which intravenous antibiotics are given for ≥5 days, starting within 7 days of birth. _____ Previous primary outcome measure as of 30/03/2022: All-cause early neonatal sepsis, defined as: 1. Either culture-positive (blood or cerebrospinal fluid) taken at <7 days of birth, or 2. Negative/ unknown culture status with ≥3 agreed clinical signs or symptoms, for which intravenous antibiotics are given for ≥5 days, starting within 7 days of birth. _____ Previous primary outcome measure as of 27/10/2020: Early neonatal sepsis, defined as: 1. Either culture-positive (blood or cerebrospinal fluid) taken at <7 days of birth or 2. Negative/ unknown culture status with ≥3 agreed clinical signs or symptoms, for which intravenous antibiotics are given for ≥5 days, starting within 7 days of birth. _____ Previous primary outcome measure: All-cause early neonatal sepsis: either culture-positive (blood or cerebrospinal fluid) or negative/ unknown culture status with ≥ 3 agreed clinical signs or symptoms, for which antibiotics are given for ≥ 5 days, within 7 days of birth
Secondary outcome measures	Current secondary outcome measures as of 27/03/2024: 1. Neonatal 1.1 Birth Weight 1.2. Perinatal mortality (a stillbirth or early neonatal death, <7 days) 1.3. Extended perinatal mortality (a stillbirth or neonatal death, <28 days) 1.4. Baby death before discharge 1.5. 5-minute Apgar 1.6. Fetal acidaemia, defined as cord arterial pH < 7.05 1.7. Gestational age at birth 1.8. Admission for neonatal specialist care (length of stay, level of care) 1.9. Seizures 1.10. Abnormal neurological signs (hypotonia or abnormal level of consciousness) at > 24 hours of age 1.11. Late onset culture-positive (blood or cerebrospinal fluid taken from 7 days to ≤ 28 days of birth) neonatal sepsis including clearly pathogenic organisms and excluding skin organisms (e.g. coagulase-negative staphylococci). 2. Maternal 2.1. Mode of onset of labour 2.2. Mode of delivery 2.3. Duration of time from ruptured membranes to delivery 2.4. Duration of hospital stay 2.5. Change of intended location of childbirth 2.6. Maternal intrapartum anaphylaxis due to IAP 2.7. In a subset of participants for whom detailed data is collected, systemic infection confirmed with a positive blood culture (blood taken from the onset of labour to within 42 days of birth) or suspected maternal sepsis within 42 days of birth as defined by ≥ 1 of the following: A new prescription of IV antibiotics for presumed perineal wound-related infection, endometritis or uterine infection, urinary tract infection with systemic features (pyelonephritis or sepsis) or other systemic infection (clinical sepsis),but NOT antibiotics for any other indication. 2.8. Maternal death, from onset of labour to within 42 days post-partum 2.9. Cause of maternal death 3. Safety Outcome 3.1. The main safety outcome we seek to avoid is neonatal sepsis, which is also the primary outcome that GBS testing aims to reduce. Cases of neonatal sepsis will be collected regularly from routine data sources and an independent neonatal adjudication panel will confirm the diagnosis in a sample of cases. 3.2. Cases of maternal intrapartum anaphylaxis due to IAP will be regularly collected by the teams of participating sites and reported to the trial team on a quarterly basis. 4. Process Outcomes 4.1. Number of women with risk factors for EOGBS infection developing in the baby and which risk factors they have. 4.2. Number of women having a swab taken (of all those eligible for testing), including site of swab (vaginal-rectal, vaginal only) and person performing the swab (self-swab, health care professional swab). 4.3. Number of women who decline a swab when offered (and reasons why) 4.4. Number of women having a swab taken at the appropriate time (of all those swabbed and all those eligible) 4.4.1. For women in antenatal ECM sites: The target time window is > 35 weeks gestation for women without a planned delivery date OR 3-5 weeks prior to the planned delivery date for those women with a planned induction of labour prior to 40 weeks’ gestation 4.4.2. For women in intrapartum rapid test sites who are planning to deliver in an obstetric unit (OU) or eligible alongside midwifery-led unit (AMU), the target time window is upon admission, in labour or for induction 4.4.3. For women planning home or freestanding midwifery unit (FMU) deliveries in sites that are allocated to intrapartum rapid testing the target time window is > 35 weeks. See section 11.4 for further details. 4.5. Number of women with a test result available ≥ 4 hours before time of birth 4.6. Number of women with a test result available ≥ 2 hours before time of birth 4.7. Number of women receiving GBS-specific IAP 4.8. Number of women receiving antibiotics for prophylaxis before operative (Caesarean or instrumental) birth 4.9. Number of women receiving intrapartum antibiotics for any other reason 4.10. Number of women with first dose of GBS-specific IAP administered at least 4 hours before childbirth 4.11. Number of women with first dose of GBS-specific IAP administered at least 2 hours before childbirth 4.12. Total dose of administered IAP per woman 4.13. The proportion of women who tested positive for GBS, tested negative for GBS or who did not have an available test result. 4.14. The proportion of failed tests. (For intrapartum rapid testing sites, the number of failed tests will be available from the GeneXpert machine, for ECM sites this may include mislabelled or lost tests) 4.15. Of those who should have been offered IAP according to a positive test result or risk factors, the number of women offered IAP, and the number of women who were not offered IAP 4.16. Number of women declining IAP when offered and reason why. 4.17. Number of women with a negative test result or no documented risk factors who are offered and accept IAP (and reasons) 4.18. Number of babies of mothers who A) tested positive for GBS (testing sites) or B) with documented risk factors (risk factor sites) o whose vital signs and clinical condition were observed for at least 12 hours 4.19. Number of babies of mothers who A) tested positive for GBS (testing sites) or B) with documented risk factors (risk factor sites) o who were investigated for infection and/or had intravenous antibiotics commenced 5. Qualitative Outcomes 5.1. Acceptability, barriers and facilitators to implementation 5.2. The influence of site-specific context and process mechanisms on GBS testing Qualitative outcomes are further described in Section 15.3 6. Economic Outcomes 6.1. Incremental cost per case of early-onset neonatal infection avoided as a result of alternative testing strategies for GBS in pregnancy or labour 6.2. Incremental cost per quality-adjusted life year (QALY) gained as a result of alternative testing strategies for GBS in pregnancy or labour 7. Additional Descriptors 7.1. Descriptors of the dataset population as listed below will be collected and compared: 7.1.1. Maternal age at booking 7.1.2. Parity at booking 7.1.3. Ethnicity 7.1.4. Smoking at booking 7.1.5. Index of Multiple Deprivation for maternal home at the time of childbirth 7.1.6. Number of fetuses (seen at dating ultrasound scan) 7.1.7. Birth order 7.1.8. Neonatal sex 8. Long Term Outcomes 8.1. The exact nature and source of the long-term outcomes will be defined considering current knowledge at the point where further analysis is considered. This would not be before the last baby born within the GBS3 trial has reached 2 years of age and could continue throughout childhood. _____ Previous secondary outcome measures as of 30/03/2022: 1. Neonatal: 1.1 Birth weight 1.2 Perinatal mortality 1.3 Baby death before discharge 1.4 5 minute Apgar 1.5 Gestational age at birth 1.6 Fetal acidaemia (cord arterial pH <7.05) 1.7 Admission for neonatal specialist care (length of stay, level of care) 1.8 Seizures 1.9 Abnormal neurological signs at >24 hours of age (hypotonia or abnormal level of consciousness). 1.10 Late onset culture-positive (blood or cerebrospinal fluid taken from 7 days to ≤ 28 days of birth) neonatal sepsis including clearly pathogenic organisms and excluding skin organisms (e.g. coagulase-negative staphylococci) 2. Maternal: 2.1 Mode of onset of labour 2.2 Mode of delivery 2.3 Duration of time from ruptured membranes to delivery 2.4 Duration of hospital stay 2.5 Change of intended location of childbirth 2.6 Maternal intrapartum anaphylaxis due to intrapartum antibiotic prophylaxis 2.7 In a subset of participants, systemic infection confirmed with a positive blood culture (blood taken from the onset of labour to within 42 days of birth) or suspected maternal sepsis within 42 days of birth as defined by ≥ 1 clinical signs. 2.8 Maternal death, from onset of labour to within 42 days 2.9 Cause of maternal death 3. Safety: The main safety outcome we seek to avoid is neonatal sepsis, which is also the primary outcome that GBS testing aims to reduce. Cases of neonatal sepsis will be collected regularly from routine data sources and an independent neonatal adjudication panel will confirm the diagnosis in a sample of cases. Cases of maternal intrapartum anaphylaxis due to IAP will be regularly collected by the teams of participating sites and reported to the trial team on a quarterly basis. 4. Process: 4.1 Number of women with risk factors for EOGBS infection developing in the baby (and which risk factgor) 4.2 Number of women having a swab taken (of all eligible for testing), including site of swab (vaginal-rectal, vaginal only) and person performing the swab (self-swab, health care professional swab). 4.3 Number of women who decline a swab when offered (and reasons why) 4.4 Number of women having a swab taken at the appropriate time (of all those swabbed and all those eligible) 4.5 Number of women with a test result available ≥4 hours before childbirth 4.6 Number of women with a test result available ≥2 hours before childbirth 4.7 Number of women receiving GBS-specific IAP 4.8 Number of women receiving antibiotics for prophylaxis before operative (Caesarean or instrumental) birth 4.9 Number of women receiving intrapartum antibiotics for any other reason 4.10 Number of women with first dose of GBS-specific IAP administered at least 4 hours before childbirth 4.11 Number of women with first dose of GBS-specific IAP administered at least 2 hours before childbirth 4.12 Total dose of administered IAP per woman. 4.13 The proportion of women who tested positive for GBS, tested negative for GBS, or did not have an available test result. 4.14 Proportion of failed tests 4.15 Of those who should have been offered IAP according to a positive test result or risk factors, the number of women offered IAP, and the number of women who were not offered IAP 4.16 Number of women declining IAP when offered (and reasons why) 4.17 Number of women with a negative test or no documented risk factors who are offered and accept IAP (and reasons) 4.18 Number of babies of mothers who tested positive for GBS or had documented risk factors whose vital signs were observed for at least 12 hours 4.19 Number of babies of mothers who tested positive for GBS or had documented risk factors and/or were investigated for infection or had intravenous antibiotics commenced 5. Economic: 5.1 Incremental cost per case of early neonatal sepsis avoided as a result of alternative testing strategies for GBS in pregnancy or labour 5.2 Incremental cost per quality adjusted life year (QALY) gained, as a result of alternative testing strategies for GBS in pregnancy or labour 6. Qualitative: 6.1 Acceptability, barriers and facilitators to implementation, 6.2 The influence of site-specific context and process mechanisms on GBS testing _____ Previous secondary outcome measures as of 24/08/2021: 1. Neonatal: 1.1 Birth weight 1.2 Perinatal mortality 1.3 Baby death before discharge 1.4 5 minute Apgar 1.5 Gestational age at birth 1.6 Fetal acidaemia (cord arterial pH <7.05) 1.7 Admission for neonatal specialist care (length of stay, level of care) 1.8 Seizures 1.9 Abnormal neurological signs at >24 hours of age (hypotonia or abnormal level of consciousness). 1.10 Late onset culture-positive (blood or cerebrospinal fluid taken from 7 days to ≤ 28 days of birth) neonatal sepsis including clearly pathogenic organisms and excluding skin organisms (e.g. coagulase-negative staphylococci) 2. Maternal: 2.1 Mode of onset of labour 2.2 Mode of delivery 2.3 Duration from ruptured membranes to delivery 2.4 Duration of hospital stay 2.5 Change of intended location of childbirth 2.6 Maternal intrapartum anaphylaxis due to intrapartum antibiotic prophylaxis 2.7 Intrapartum or postnatal sepsis within 42 days 3. Safety: The main safety outcome we seek to avoid is neonatal sepsis, which is also the primary outcome that GBS testing aims to reduce. Cases of neonatal sepsis will be collected regularly from routine data sources and a neonatal adjudication panel will confirm the diagnosis in a sample of cases. 4. Process: 4.1 Number of women with risk factors for EOGBS infection developing in baby 4.2 Number of women having a swab taken (of all eligible for testing) 4.3 Number of women who decline a swab when offered (and reasons why) 4.4 Number of women having a swab taken at the appropriate time (of all those swabbed and all those eligible) 4.5 Number of women with a test result available ≥4 hours before childbirth 4.6 Number of women with a test result available ≥2 hours before childbirth 4.7 Number of women receiving GBS-specific IAP 4.8 Number of women receiving antibiotics for prophylaxis before operative (Caesarean or instrumental) birth 4.9 Number of women receiving antibiotics for any other reason 4.10 Number of women with first dose of GBS-specific IAP administered at least 4 hours before childbirth 4.11 Number of women with first dose of GBS-specific IAP administered at least 2 hours before childbirth 4.12 Total dose of administered IAP per woman. 4.13 The proportion of women who tested positive for GBS, tested negative for GBS, or did not have an available test result. 4.14 Proportion of failed tests 4.15 Of those who should have been offered IAP according to a positive test result or risk factors, the number of women offered IAP, and the number of women who were not offered IAP 4.16 Number of women declining IAP when offered (and reasons why) 4.17 Number of women offered and accepting IAP, of those with a negative test or no documented risk factors 4.18 Number of babies of mothers who tested positive for GBS or had documented risk factors whose vital signs were observed for at least 12 hours 4.19 Number of babies of mothers who tested positive for GBS or had documented risk factors and had IAP commenced and/or were investigated for infection or had intravenous antibiotics commenced 5. Economic: 5.1 Incremental cost per case of early neonatal sepsis avoided as a result of alternative testing strategies for GBS in pregnancy or labour 5.2 Incremental cost per quality adjusted life year (QALY) gained associated with each strategy, as a result alternative testing strategies for GBS in pregnancy or labour 6. Qualitative: 6.1 Acceptability, barriers and facilitators to implementation, 6.2 The influence of site-specific context and process mechanisms on GBS testing _____ Previous secondary outcome measures as of 27/10/2020: 1. Neonatal: 1.1 Birth weight 1.2 Perinatal mortality 1.3 Baby death before discharge 1.4 5 minute Apgar 1.5 Gestational age at birth 1.6 Fetal acidaemia (cord arterial pH <7.05) 1.7 Admission for neonatal specialist care (length of stay, level of care) 1.8 Seizures 1.9 Abnormal neurological signs at >24 hours of age (hypotonia or abnormal level of consciousness). 1.10 Late onset culture-positive (blood or cerebrospinal fluid taken from 7 days to ≤ 28 days of birth) neonatal sepsis including clearly pathogenic organisms and excluding skin organisms (e.g. coagulase-negative staphylococci) 2. Maternal: 2.1 Mode of onset of labour 2.2 Mode of delivery 2.3 Duration from ruptured membranes to delivery 2.4 Duration of hospital stay 2.5 Change of intended location of childbirth 2.6 Maternal intrapartum anaphylaxis due to intrapartum antibiotic prophylaxis 2.7 Intrapartum or postnatal sepsis within 42 days 3. Safety: The main safety outcome we seek to avoid is neonatal sepsis, which is also the primary outcome that GBS testing aims to reduce. Cases of neonatal sepsis will be collected regularly from routine data sources and a neonatal adjudication panel will confirm the diagnosis in a sample of cases. 4. Process: 4.1 Number of women with risk factors for EOGBS infection developing in baby 4.2 Number of women having a swab taken (of all eligible for testing) 4.3 Number of women who decline a swab when offered (and reasons why) 4.4 Number of women having a swab taken at the appropriate time (of all those swabbed and all those eligible) 4.5 Number of women with a test result available ≥4 hours before childbirth 4.6 Number of women with a test result available ≥2 hours before childbirth 4.7 Number of women receiving GBS-specific IAP 4.8 Number of women receiving antibiotics for any other reason (except prophylaxis for caesarean delivery) 4.9 Number of women with first dose of antibiotics administered at least 4 hours before childbirth 4.10 Number of women with first dose of antibiotics administered at least 2 hours before childbirth 4.11 Total dose of administered IAP per woman. 4.12 The proportion of women who tested positive for GBS, tested negative for GBS, or did not have an available test result. 4.13 Proportion of failed tests 4.14 Of those who should have been offered IAP according to a positive test result or risk factors, the number of women offered IAP, and the number of women who were not offered IAP 4.15 Number of women declining IAP when offered (and reasons why) 4.16 Number of women offered and accepting IAP, of those with a negative test or no documented risk factors 4.17 Number of babies of mothers who tested positive for GBS or had documented risk factors whose vital signs were observed for at least 12 hours 4.18 Number of babies of mothers who tested positive for GBS or had documented risk factors and had IAP commenced and/or were investigated for infection or had intravenous antibiotics commenced 5. Economic: 5.1 Incremental cost per case of early neonatal sepsis avoided as a result of alternative testing strategies for GBS in pregnancy or labour 5.2 Incremental cost per quality adjusted life year (QALY) gained associated with each strategy, as a result alternative testing strategies for GBS in pregnancy or labour 6. Qualitative: 6.1 Acceptability, barriers and facilitators to implementation, 6.2 The influence of site-specific context and process mechanisms on GBS testing _____ Previous secondary outcome measures: 1. Neonatal: 1.1 Birth weight 1.2 Perinatal mortality 1.3 5 minute Apgar 1.4 Gestational age at birth 1.5 Fetal acidaemia (cord arterial pH <7.05 or first neonatal pH) 1.6 Neonatal specialist care (length of stay, highest level of care) 1.7 Seizures 1.8 Abnormal neurological signs at >24 hours of age (hypotonia or abnormal level of consciousness). 2. Maternal: 2.1 Mode of onset of labour 2.2 Mode of delivery 2.3 Duration of hospital stay 2.4 Change of intended location of childbirth 2.5 Maternal intrapartum anaphylaxis. 3. Process: 3.1 Maternal risk factors for EOGBS infection developing in baby 3.2 Testing coverage 3.3 Testing at appropriate time 3.4 Test result available at least 4 hours before childbirth 3.5 GBS-specific IAP coverage 3.6 Timing of IAP 3.7 Number of doses of IAP 3.8 Proportion of women who tested negative, positive or had no test 3.9 Identified maternal risk factors at all sites 3.10 Declines and acceptances of IAP 3.11 Number of babies of mothers who tested positive for GBS and had IAP commenced 3.12 Observation time following positive GBS result 3.13 Maternal intrapartum or postnatal sepsis 4. Economic: 4.1 Incremental cost per case of early neonatal sepsis avoided as a result of alternative testing strategies for GBS in pregnancy or labour 4.2 Incremental cost per quality adjusted life year gained associated with each strategy, as a result alternative testing strategies for GBS in pregnancy or labour 5. Qualitative: 5.1 Acceptability, barriers and facilitators to implementation, and on the influence of site-specific context and process mechanisms on GBS testing
Overall study start date	01/04/2019
Overall study end date	31/08/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Both
Target number of participants	Planned Sample Size: 320,000; UK Sample Size: 320,000
Participant inclusion criteria	Current participant inclusion criteria as of 30/03/2022: 1. Inclusion criteria – site level 1.1 Obstetric-led maternity units, and alongside midwifery-led units (AMUs) if able to accept women requiring IAP 1.2 Capable of implementing either the antenatal enriched culture or intrapartum rapid testing strategies with training and support There will be two levels of eligibility for individual women: • Testing level – eligibility to have an ECM or rapid test, or be reviewed for risk factors • Dataset level – eligibility to be included in the dataset for analysis, regardless of whether test performed. There is no exclusion based on age of women or multiple births. 2. Inclusion criteria – testing level 2.1 In ECM units, all women attending an antenatal clinic at ≥35 weeks’ gestation without a planned delivery date, or 3-5 weeks prior to planned induction date for those women with a scheduled induction of labour prior to 40 weeks’ gestation. Women booked for an elective caesarean section should be offered the opportunity of an antenatal ECM test in recognition that a small percentage of women will spontaneously labour and progress to a vaginal delivery before their elective date. 2.2 In rapid test units, all women who experience labour or prelabour rupture of membranes at ≥37 weeks’ gestation. Women planning a home birth or in a freestanding midwifery unit (which is not able to offer IAP) can be offered an antenatal rapid test which will be processed on the maternity unit/labour suite at ≥ 35 weeks gestation 2.3 In risk factor units, all pregnant women at ≥24 weeks’ gestation 3. Inclusion criteria – dataset level 3.1 In all units, all women giving birth ≥24 weeks’ gestation within their unit’s study period, regardless of mode of delivery and all her babies 3.2 Women who experience an intrapartum or antepartum stillbirth will be included as they may have had testing for GBS and GBS may be implicated in the aetiology of their stillbirth 4. Inclusion criteria-qualitative study 4.1 Women will be eligible if they are up to 12 weeks postpartum, 16 years of age or older, and reasonably fluent in English 4.2 Women giving birth at: • a maternity unit allocated a testing strategy, and not a risk factor site. • FMU/AMU and home births. 4.3 Health Care Professionals will be eligible if they are a registered health professional working in an NHS maternity or neonatal service in one of the 4 NHS recruitment sites ______ Previous participant inclusion criteria as of 24/08/2021: 1. Inclusion criteria – site level 1.1 Obstetric-led maternity units, and alongside midwifery-led units (AMUs) if able to accept women requiring IAP 1.2 Capable of implementing either the antenatal enriched culture or intrapartum rapid testing strategies with training and support There will be two levels of eligibility for individual women: • Testing level – eligibility to have an ECM or rapid test, or be reviewed for risk factors • Dataset level – eligibility to be included in the dataset for analysis, regardless of whether test performed. There is no exclusion based on age of women or multiple births. 2. Inclusion criteria – testing level 2.1 In ECM units, all women attending an antenatal clinic at ≥35 weeks’ gestation without a planned delivery date, or 3-5 weeks prior to planned induction date for those women with a scheduled induction of labour prior to 40 weeks’ gestation 2.2 In rapid test units, all women who experience labour or prelabour rupture of membranes at ≥37 weeks’ gestation. Women planning a home birth or in a freestanding midwifery unit (which is not able to offer IAP) can be offered an antenatal rapid test which will be processed on the maternity unit/labour suite at ≥ 35 weeks gestation 2.3 In risk factor units, all women who experience labour or prelabour rupture of membranes at ≥24 weeks’ gestation 3. Inclusion criteria – dataset level 3.1 In all units, all women giving birth ≥24 weeks’ gestation within their unit’s study period, regardless of mode of delivery and all her babies 3.2 Women who experience an intrapartum or antepartum stillbirth will be included as they may have had testing for GBS and GBS may be implicated in the aetiology of their stillbirth 4. Inclusion criteria-qualitative study 4.1 Women will be eligible if they are up to 12 weeks postpartum, 16 years of age or older, and reasonably fluent in English 4.2 Women giving birth at: • a maternity unit allocated a testing strategy, and not a risk factor site. • FMU/AMU and home births. 4.3 Health Care Professionals will be eligible if they are a registered health professional working in an NHS maternity or neonatal service in one of the 4 NHS recruitment sites ______ Previous inclusion criteria as of 27/10/2020: 1. Inclusion criteria – site level 1.1 Obstetric-led maternity units, and alongside midwifery-led units (AMUs) if able to accept women requiring IAP 1.2 Capable of implementing either the antenatal enriched culture or intrapartum rapid testing strategies with training and support There will be two levels of eligibility for individual women: • Testing level – eligibility to have an ECM or rapid test, or be reviewed for risk factors • Dataset level – eligibility to be included in the dataset for analysis, regardless of whether test performed. There is no exclusion based on age of women or multiple births. 2. Inclusion criteria – testing level 2.1 In ECM units, all women attending an antenatal clinic at ≥35 weeks’ gestation without a planned delivery date, or 3-5 weeks prior to planned delivery date for those women with a planned induction of labour prior to 40 weeks’ gestation 2.2 In rapid test units, all women who experience labour or prelabour rupture of membranes at ≥37 weeks’ gestation. Women planning a home birth or in a freestanding midwifery unit (which is not able to offer IAP) can be offered an antenatal rapid test on the maternity unit/labour suite at ≥ 35 weeks gestation 2.3 In risk factor units, all women who experience labour or prelabour rupture of membranes at ≥24 weeks’ gestation 3. Inclusion criteria – dataset level 3.1 In all units, all women giving birth ≥24 weeks’ gestation within their unit’s study period, regardless of mode of delivery and all her babies 3.2 Women who experience an intrapartum or antepartum stillbirth will be included as they may have had testing for GBS and GBS may be implicated in the aetiology of their stillbirth 4. Inclusion criteria-qualitative study 4.1 Women will be eligible if they are up to 12 weeks postpartum, 16 years of age or older, and reasonably fluent in English 4.2 Women giving birth at: • a maternity unit allocated a testing strategy, and not a risk factor site. • FMU/AMU and home births. 4.3 Health Care Professionals will be eligible if they are a registered health professional working in an NHS maternity or neonatal service in one of the 4 NHS recruitment sites _____ Previous inclusion criteria: There are eligibility criteria at a site level, which determine which maternity units can participate; at a testing level for women giving birth in testing maternity units; and at a data set level. 1. Inclusion criteria – site level 1.1 Consultant-led maternity units, and alongside midwifery-led units (AMUs) if able to accept women requiring IAP 1.2 Capable of implementing either the antenatal enriched culture or intrapartum rapid testing strategies with training and support 2. Inclusion criteria – testing level 2.1 In ECM units, all women attending an antenatal clinic after 35 weeks’ gestation 2.2 In rapid test units, all women who experience labour or prelabour rupture of membranes at > = 37 weeks’ gestation 2.3 In risk factor units, all women who experience labour or prelabour rupture of membranes at > = 24 weeks’ gestation 3. Inclusion criteria – dataset level 3.1 In all units, all women giving birth > = 24 weeks’ gestation within their unit’s study period, regardless of mode of delivery and all her live born babies 3.2 Women who experience an intrapartum stillbirth will be included as they may have had testing for GBS and GBS may be implicated in the aetiology of their stillbirth 4. Inclusion criteria-qualitative study 4.1 Women will be eligible if they are up to 12 weeks postpartum, 16 years of age or older, and reasonably fluent in English 4.2 Women giving birth in a maternity unit allocated a testing strategy, and not a usual care unit 4.3 Clinicians will be eligible if they are a registered health professional working in an NHS maternity or neonatal service in one of the 4 NHS recruitment sites
Participant exclusion criteria	Current participant exclusion criteria as of 30/03/2022: 1. Exclusion criteria – testing level 1.1 Women who do not provide verbal consent to provide a swab 1.2 Previous baby with GBS infection (early or late onset) and who want IAP (These women can still be offered a test and be given IAP regardless of the result, if requested by the woman) 1.3 Women in preterm labour (suspected, diagnosed, established) at ≤37 weeks gestation should be offered IAP routinely 1.4 In rapid test sites, women who have been admitted for a planned elective caesarean birth, unless labour spontaneously at >=37 weeks and plan not to proceed with elective caesarean birth. 1.5 Known congenital anomaly incompatible with survival at birth, of a singleton or all multiple fetuses 1.6 Known prelabour intrauterine death in the current pregnancy, of a singleton or all multiple fetuses 1.7 In rapid test sites, women who require an emergency caesarean birth but who have intact membranes and are not in labour 2. Exclusion criteria – dataset level 2.1 Known congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses 2.2 Withdrawal of consent to use data, through the NHS data-opt out (or devolved nation equivalent) 3. Exclusion criteria-qualitative study 3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent 3.2 Health Care Professionals will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service 3.3 Women and Health Care Professionals not receiving care or working in the NHS sites taking part in this study will not be eligible _____ Previous participant exclusion criteria as of 24/08/2021: 1. Exclusion criteria – testing level 1.1 Women who do not provide verbal consent to provide a swab 1.2 Previous baby with GBS infection (early or late onset) and who want IAP (These women can still be offered a test and be given IAP regardless of the result, if requested by the woman) 1.3 Women in preterm labour (suspected, diagnosed, established) at ≤37 weeks gestation should be offered IAP routinely 1.4 Women who have been admitted for a planned elective caesarean birth (Women who have a planned caesarean birth but labour spontaneously should still be offered a test) 1.5 Known congenital anomaly incompatible with survival at birth, of a singleton or all multiple fetuses 1.6 Known prelabour intrauterine death in the current pregnancy, of a singleton or all multiple fetuses 1.7 Women who require an emergency caesarean birth but who have intact membranes and are not in labour 2. Exclusion criteria – dataset level 2.1 Known congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses 2.2 Withdrawal of consent to use data, through the NHS data-opt out (or devolved nation equivalent) 3. Exclusion criteria-qualitative study 3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent 3.2 Health Care Professionals will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service 3.3 Women and Health Care Professionals not receiving care or working in the NHS sites taking part in this study will not be eligible _____ Previous exclusion criteria as of 27/10/2020: 1. Exclusion criteria – testing level 1.1 Women who do not provide verbal consent to provide a swab 1.2 Previous baby with GBS infection (early or late onset) and who want IAP (These women can still be offered a test and be given IAP regardless of the result, if requested by the woman) 1.3 Women in preterm labour (suspected, diagnosed, established) at ≤37 weeks gestation should be offered IAP routinely 1.4 Women who have been admitted for a planned elective caesarean birth (Women who have a planned caesarean birth but labour spontaneously should still be offered a test) 1.5 Known congenital anomaly incompatible with survival at birth, of a singleton or all multiple fetuses 1.6 Known prelabour intrauterine death, of a singleton or all multiple fetuses 1.7 Women who require an emergency caesarean birth but who have intact membranes and are not in labour 2. Exclusion criteria – dataset level 2.1 Known congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses 2.2 Withdrawal of consent to use data, through the NHS data-opt out (or devolved nation equivalent) 3. Exclusion criteria-qualitative study 3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent 3.2 Health Care Professionals will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service 3.3 Women and Health Care Professionals not receiving care or working in the NHS sites taking part in this study will not be eligible _____ Previous exclusion criteria: 1. Exclusion criteria – testing level 1.1 Decline clinical consent to provide a swab 1.2 Previous baby with GBS disease (early or late onset) and who want IAP 1.3 In rapid test units, women who on arrival at the maternity unit are considered likely to deliver they baby within the next hour 1.4 In rapid test units, women in preterm labour (suspected, diagnosed, established), who should be offered IAP routinely 1.5 Known congenital anomaly incompatible with survival at birth, of a singleton or all multiple fetuses 1.6 Known prelabour intrauterine death, of a singleton or all multiple fetuses 2. Exclusion criteria – dataset level 2.1 Congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses 2.2 Prelabour intrauterine death, of singleton or all multiple fetuses. 2.3 Withdrawal of consent to use data, through the NHS data-opt out 3. Exclusion criteria-qualitative study 3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent 3.2 Clinicians will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service 3.3 Women and clinicians not receiving care or working in the NHS sites taking part in this study will not be eligible
Recruitment start date	01/10/2021
Recruitment end date	31/03/2024

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Northwick Park Hospital

LNWH NHS Trust Watford Road
Harrow
London
HA1 3UJ
United Kingdom

Royal Devon and Exeter Hospital

Royal Devon and Exeter NHS Hospital Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom

University Hospitals Coventry and Warwickshire

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

University Hospital of North Durham

County Durham and Darlington NHS Foundation Trust
North Road
Durham
DH1 5TW
United Kingdom

University Hospital of North Tees

North Tees and Hartlepool NHS Foundation Trust
Hardwick Road
Stockton-on-Tees
TS19 8PE
United Kingdom

The James Cook University Hospital

South Tees Hospitals NHS Foundation Trust
Cheriton House
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Northumbria Specialist Emergency Care Hospital

Northumbria Healthcare Foundation Trust
Northumbria Way
Cramlington
NE23 6NZ
United Kingdom

Derriford Hospital

University Hospitals Plymouth NHS Trust
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom

West Middlesex University Hospital

Chelsea and Westminster Hospital NHS Foundation Trust
Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Milton Keynes University Hospital

Milton Keynes University Hospital NHS Foundation Trust
Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

King's Mill Hospital

Sherwood Forest Hospitals NHS Foundation Trust
Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom

Royal United Hospital Bath

The Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom

Peterborough City Hospital

North West Anglia NHS Foundation Trust
Edith Cavell Campus
Peterborough
PE3 9GZ
United Kingdom

Queen's Medical Centre

Nottingham University Hospitals NHS Trust Derby Road
Nottingham
NG7 2UH
United Kingdom

Nottingham City Hospital

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Darlington Memorial Unit

University Hospital of North Durham
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

University Hospital of Hartlepool

North Tees and Hartlepool NHS Foundation Trust
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom

Friarage Hospital

South Tees Hospitals NHS Foundation Trust
Northallerton
DL6 1JG
United Kingdom

Hinchingbrooke Hospital

North West Anglia NHS Foundation Trust
Hinchingbrooke Park
Huntingdon
PE29 6NT
United Kingdom

Chelsea and Westminster Hospital

369 Fulham Road
London
SW10 9NH
United Kingdom

Lister Hospital

East and North Hertfordshire NHS Trust
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Royal Derby Hospital

University Hospital of Derby and Burton NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Queen's Hospital Burton

Belvedere Road
Burton-On-Trent
DE13 0RB
United Kingdom

Royal Oldham Hospital

Northern Care Alliance
Victoria Unit
Rochdale Rd
Oldham
OL1 2JH
United Kingdom

Princess Royal University Hospital

King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom

The Tunbridge Wells Hospital and Maidstone Birth Unit

Maidstone and Tunbridge Wells NHS Trust
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Leeds General Infirmary

Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom

St James's Hospital

Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom

Warrington Hospital

Warrington and Halton Hospitals NHS Foundation Trust
Lovely Lane
Warrington
WA5 1QG
United Kingdom

Homerton University Hospital NHS Foundation Trust

Homerton Row
London
E9 6SR
United Kingdom

Whittington Hospital

Whittington Health NHS Trust
Magdala Avenue
London
N19 5NF
United Kingdom

Royal Blackburn Hospital

East Lancashire Hospitals NHS Trust
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

East Surrey Hospital

Surrey and Sussex Healthcare NHS Trust
Canada Avenue
Redhill
RH1 5RH
United Kingdom

Kettering General Hospital

Rothwell Road
Kettering
NN16 8UZ
United Kingdom

Mid and South Essex NHS Foundation Trust

Prittlewell Chase
Westcliff-on-Sea
Southend-on-Sea
SS0 0RY
United Kingdom

Sunderland Royal Hospital

South Tyneside and Sunderland NHS Foundation Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom

The Royal Bolton Hospital

Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom

St. Marys Hospital

Imperial College Healthcare NHS Trust
Praed Street
London
W2 1NY
United Kingdom

Lewisham and Greenwich NHS Trust

University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom

Mid Cheshire Hospitals NHS Foundation Trust

Leighton Hospital
Leighton
Crewe
CW1 4QJ
United Kingdom

Royal Berkshire NHS Foundation Trust

Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

South Warwickshire University NHS Foundation Trust

Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom

Barts Health NHS Trust

The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom

Medway NHS Foundation Trust

Medway Maritime Hospital
Windmill Road
Gillingham
ME7 5NY
United Kingdom

University Hospitals of Leicester NHS Trust

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

St Georges University Hospitals NHS Foundation Trust

Blackshaw Rd
London
SW17 0QT
United Kingdom

East Suffolk and North Essex NHS Foundation Trust

Colchester Dist General Hospital
Turner Road
Colchester
CO4 5JL
United Kingdom

Birmingham Women's NHS Foundation Trust

Birmingham Womens Hospital
Metchley Park Road
Birmingham
B15 2TG
United Kingdom

University Hospitals Sussex NHS Foundation Trust

Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Whipps Cross University Hospital NHS Trust

Whipps Cross Hospital
Whipps Cross Road
London
E11 1NR
United Kingdom

Newham University Hospital NHS Trust

Newham General Hospital
Glen Road
London
E13 8SL
United Kingdom

Leicester General Hospital

Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Countess of Chester Hospital

Countess of Chester Health Park
Liverpool Road
Chester
CH2 1UL
United Kingdom

Chelsea & Westminster Hospital Laboratory

Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

West Suffolk Hospital

Hardwick Lane
Bury Saint Edmunds
IP33 2QZ
United Kingdom

Epsom and St Helier University Hospitals NHS Trust

St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Mersey and West Lancashire Teaching Hospitals NHS Trust

Whiston Hospital
Warrington Road
Prescot
L35 5DR
United Kingdom

University of Wales and Llandough Hospital NHS Trust

Heath Park
Cardiff
CF14 4XW
United Kingdom

Hywel Dda Health Board (pembrokeshire Office)

Unit 5
Haverfordwest Business Centre
Haverfordwest
SA61 1SB
United Kingdom

Worcestershire Acute Hospitals NHS Trust

Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Calderdale and Huddersfield NHS Foundation Trust

Trust Headquarters
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom

Chesterfield Royal Hospital NHS Foundation Trust

Chesterfield Road
Calow
Chesterfield
S44 5BL
United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust

Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Manchester University NHS Foundation Trust

Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom

Guys and St Thomas' NHS Foundation Trust

249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Airedale NHS Trust

Airedale General Hospital
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom

Ashford and St Peter's Hospitals NHS Foundation Trust

St Peters Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom

The Princess Alexandra Hospital NHS Trust

Hamstel Road
Harlow
CM20 1QX
United Kingdom

Pinderfields Hospitals NHS Trust

Trust Hq, Rowan House
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

North Manchester General Hospital

Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Birmingham Heartlands Hospital

Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom

Good Hope Hospital

Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

Southport and Ormskirk Hospital NHS Trust

Town Lane
Southport
PR8 6PN
United Kingdom

Stockport NHS Foundation Trust

Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom

Frimley Health NHS Foundation Trust

Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom

Royal Free London NHS Foundation Trust

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Betsi Cadwaladr Uhb

Royal Alexandra Hospital
Marine Drive
Rhyl
LL18 3AS
United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust

Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom

Bedford Hospital

Kempston Road
Bedford
MK42 9DJ
United Kingdom

Sponsor information

University of Nottingham
University/education

Research and Innovation
University of Nottingham
East Atrium, Jubilee Conference Centre
Triumph
Nottingham
NG8 1DH
England
United Kingdom

Phone	+44115 84 67906
Email	sponsor@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/86/06

No information available

Results and Publications

Intention to publish date	31/12/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The comprehensive project results will be reported in the journal Health Technology Assessment. The individual component studies will be published together or individually in high-impact peer reviewed journals and by presentation at medical and midwifery conferences locally, nationally and internationally.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from the Nottingham Clinical Trials Unit (ctu@nottingham.ac.uk). Participant-level data will not be available, as it is not permitted by the routine data providers under the terms and conditions under which NCTU receives the data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version v1.0	02/09/2019	06/01/2020	No	No
Protocol file	version v2.0	17/07/2020	23/10/2020	No	No
Protocol file	version 3.0	26/03/2021	14/09/2021	No	No
Protocol file	version 4.0	15/10/2021	30/03/2022	No	No
HRA research summary			28/06/2023	No	No
Other publications	qualitative study	12/06/2024	20/06/2024	Yes	No
Protocol file	version 5.2	26/07/2023	12/09/2024	No	No
Protocol file	version 6.0	13/12/2023	12/09/2024	No	No
Statistical Analysis Plan	version 1.0	28/02/2024	12/09/2024	No	No
Protocol file	version 6.1	02/07/2024	19/09/2024	No	No

Additional files

ISRCTN49639731_PROTOCOL_v1.0_02Sep19.pdf: uploaded 06/01/2020
ISRCTN49639731_PROTOCOL_v2.0_17Jul20.pdf: uploaded 23/10/2020
37080 GBS3 Protocol_v3.0_26Mar2021.pdf
ISRCTN49639731_Protocol_v4.0_15Oct21.pdf
ISRCTN49639731 Protocol V5.2 26Jul2023.pdf
ISRCTN49639731 GBS3_Protocol_Version 6.0_13Dec2023.pdf
ISRCTN49639731 GBS-3 SAP final v1.0 28Feb2024.pdf
ISRCTN49639731_PROTOCOL_V6.1_02Jul24.pdf

Editorial Notes

16/04/2025: The intention to publish date was changed from 31/03/2025 to 31/12/2025.
19/09/2024: Uploaded protocol v6.1 (not peer-reviewed).
12/09/2024: The following changes were made to the trial record:
1. Uploaded protocols v5.2, v6.0 (not peer-reviewed) as additional files.
2. The statistical analysis plan was uploaded as an additional file.
20/06/2024: Publication reference added.
27/03/2024: The following changes have been made:
1. The overall study end date was changed from 31/05/2024 to 31/08/2025.
2. The interventions were changed.
3. The primary outcome measures were changed.
4. The secondary outcome measures were changed.
5. The following participating study centres were added: Lewisham and Greenwich NHS Trust, Mid Cheshire Hospitals NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, South Warwickshire University NHS Foundation Trust, Barts Health NHS Trust, Medway NHS Foundation Trust, University Hospitals of Leicester NHS Trust, St Georges University Hospitals NHS Foundation Trust, East Suffolk and North Essex NHS Foundation Trust, Birmingham Women's NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust, Whipps Cross University Hospital NHS Trust, Newham University Hospital NHS Trust, Leicester General Hospital, Countess of Chester Hospital, Chelsea & Westminster Hospital Laboratory, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, West Suffolk Hospital, Epsom and St Helier University Hospitals NHS Trust, Mersey and West Lancashire Teaching Hospitals NHS Trust (formerly known as St Helens & Knowsley Teaching Hospitals NHS FT), University of Wales and Llandough Hospital NHS Trust, Hywel Dda Health Board (pembrokeshire Office), Worcestershire Acute Hospitals NHS Trust, Calderdale and Huddersfield NHS Foundation Trust, Chesterfield Royal Hospital NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Guys and St Thomas' NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, Airedale NHS Trust, Ashford and St Peter's Hospitals NHS Foundation Trust, The Princess Alexandra Hospital NHS Trust, Pinderfields Hospitals NHS Trust, The Newcastle upon Tyne Hospitals NHS Foundation Trust, North Manchester General Hospital, Birmingham Heartlands Hospital, Good Hope Hospital, Southport and Ormskirk Hospital NHS Trust, Stockport NHS Foundation Trust, Frimley Health NHS Foundation Trust, Royal Free London NHS Foundation Trust, Betsi Cadwaladr uhb, Lancashire Teaching Hospitals NHS Foundation Trust, and Bedford Hospital.
6. The plain English summary was changed.
10/10/2023: The following changes have been made:
1. The recruitment end date was changed from 31/10/2023 to 31/03/2024
2. The overall study end date was changed from 30/04/2024 to 31/05/2024.
12/06/2023: The following changes have been made to the study record:
1. The overall study end date has been changed from 31/01/2024 to 31/04/2024.
2. The intention to publish date has been changed from 31/12/2022 to 31/03/2025.
01/04/2022: The trial participating centres: Nottingham City Hospital, Darlington Memorial Unit, University Hospital of Hartlepool, Friarage Hospital, Hinchingbrooke Hospital, Chelsea and Westminster Hospital, Lister Hospital, Royal Derby Hospital, Queen's Hospital Burton, Royal Oldham Hospital, Princess Royal University Hospital , The Tunbridge Wells Hospital and Maidstone Birth Unit, Leeds General Infirmary, St James's Hospital, Warrington Hospital, Homerton University Hospital NHS Foundation Trust, Whittington Hospital, Royal Blackburn Hospital, East Surrey Hospital, Kettering General Hospital, Mid and South Essex NHS Foundation Trust, Sunderland Royal Hospital, The Royal Bolton Hospital, St. Marys Hospital, were added.
30/03/2022: The following changes have been made:
1. The protocol (not peer reviewed) has been uploaded as an additional file.
2. The public contact has been updated.
3. The recruitment end date has been changed from 01/04/2022 to 31/10/2023.
4. The overall trial end date has been changed from 30/09/2022 to 31/01/2024.
5. The primary outcome measure has been updated.
6. The secondary outcome measures have been updated.
7. The participant inclusion criteria have been updated.
8. The participant exclusion criteria have been updated.
9. The plain English summary has been updated.
14/09/2021: The following changes were made to the trial record:
1. The interventions were changed.
2. The recruitment start date was changed from 01/04/2020 to 01/10/2021.
3. The secondary outcome measures were changed.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
6. The trial participating centres Northwick Park Hospital, University Hospitals Coventry and Warwickshire, University Hospital of North Durham, University Hospital of North Tees, The James Cook University Hospital, Northumbria Specialist Emergency Care Hospital, Derriford Hospital, West Middlesex University Hospital, Milton Keynes University Hospital, King's Mill Hospital, Peterborough City Hospital were added.
7. The plain English summary was updated to reflect these changes.

27/10/2020: The following changes were made to the trial record:
1. The IRAS and CPMS numbers were added to the protocol/serial number field.
2. The email address for the ethics committee was changed from NRESCommittee.eastmidlands-derby@nhs.net to derby.rec@hra.nhs.uk
3. The interventions were changed.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The inclusion criteria were changed.
7. The exclusion criteria were changed.
8. The plain English summary was updated to reflect these changes.
23/10/2020: The following changes were made to the trial record:
1. Uploaded protocol (not peer reviewed) Version 2.0 17 July 2020.
2. The recruitment resumed.
3. The trial participating centres were added.
21/04/2020: Due to current public health guidance, recruitment for this study has been paused.
06/01/2020: The protocol (not peer reviewed) has been uploaded as an additional file.
10/12/2019: The following changes were made to the trial record:
1. The trial website was added.
2. The ethics approval was added.
27/08/2019: Internal review.
19/08/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)