Routine testing for Group B Streptococcus in pregnancy (GBS3 trial)
| ISRCTN | ISRCTN49639731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49639731 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 263682 |
| Protocol serial number | CPMS 42782, IRAS 263682 |
| Sponsor | University of Nottingham |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/86/06 |
- Submission date
- 19/08/2019
- Registration date
- 23/08/2019
- Last edited
- 02/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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?
gbs3@nottingham.ac.uk
Contact information
Public, 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 |
| jane.daniels@nottingham.ac.uk |
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 |
| kate.walker@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized qualitative study |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Current primary outcome measure as of 27/03/2024: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 27/03/2024: |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 320000 |
| Total final enrolment | 317000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 31/03/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Harrow
London
HA1 3UJ
England
Barrack Road
Exeter
EX2 5DW
England
Coventry
CV2 2DX
England
North Road
Durham
DH1 5TW
England
Hardwick Road
Stockton-on-Tees
TS19 8PE
England
Cheriton House
Marton Road
Middlesbrough
TS4 3BW
England
Northumbria Way
Cramlington
NE23 6NZ
England
Derriford Road
Crownhill
Plymouth
PL6 8DH
England
Twickenham Road
Isleworth
TW7 6AF
England
Standing Way Eaglestone
Milton Keynes
MK6 5LD
England
Mansfield Road
Sutton-in-Ashfield
NG17 4JL
England
Combe Park
Bath
BA1 3NG
England
Edith Cavell Campus
Peterborough
PE3 9GZ
England
Nottingham
NG7 2UH
England
Nottingham
NG5 1PB
England
Hollyhurst Road
Darlington
DL3 6HX
England
Holdforth Road
Hartlepool
TS24 9AH
England
Northallerton
DL6 1JG
England
Hinchingbrooke Park
Huntingdon
PE29 6NT
England
London
SW10 9NH
England
Coreys Mill Lane
Stevenage
SG1 4AB
England
Uttoxeter Road
Derby
DE22 3NE
England
Burton-On-Trent
DE13 0RB
England
Victoria Unit
Rochdale Rd
Oldham
OL1 2JH
England
Denmark Hill
London
SE5 9RS
England
Hermitage Lane
Maidstone
ME16 9QQ
England
Great George Street
Leeds
LS1 3EX
England
Beckett Street
Leeds
LS9 7TF
England
Lovely Lane
Warrington
WA5 1QG
England
London
E9 6SR
England
Magdala Avenue
London
N19 5NF
England
Haslingden Road
Blackburn
BB2 3HH
England
Canada Avenue
Redhill
RH1 5RH
England
Kettering
NN16 8UZ
England
Westcliff-on-Sea
Southend-on-Sea
SS0 0RY
England
Kayll Road
Sunderland
SR4 7TP
England
Farnworth
Bolton
BL4 0JR
England
Praed Street
London
W2 1NY
England
Lewisham High Street
London
SE13 6LH
England
Leighton
Crewe
CW1 4QJ
England
London Road
Reading
RG1 5AN
England
Lakin Road
Warwick
CV34 5BW
England
80 Newark Street
London
E1 2ES
England
Windmill Road
Gillingham
ME7 5NY
England
Infirmary Square
Leicester
LE1 5WW
England
London
SW17 0QT
England
Turner Road
Colchester
CO4 5JL
England
Metchley Park Road
Birmingham
B15 2TG
England
Lyndhurst Road
Worthing
BN11 2DH
England
Whipps Cross Road
London
E11 1NR
England
Glen Road
London
E13 8SL
England
Leicester
LE5 4PW
England
Liverpool Road
Chester
CH2 1UL
England
369 Fulham Road
London
SW10 9NH
England
Armthorpe Road
Doncaster
DN2 5LT
England
Bury Saint Edmunds
IP33 2QZ
England
Wrythe Lane
Carshalton
SM5 1AA
England
Warrington Road
Prescot
L35 5DR
England
Cardiff
CF14 4XW
Wales
Haverfordwest Business Centre
Haverfordwest
SA61 1SB
Wales
Charles Hastings Way
Worcester
WR5 1DD
England
Acre Street
Lindley
Huddersfield
HD3 3EA
England
Calow
Chesterfield
S44 5BL
England
Whinney Heys Road
Blackpool
FY3 8NR
England
Oxford Road
Manchester
M13 9WL
England
London
SE1 7EH
England
Duckworth Lane
Bradford
BD9 6RJ
England
Skipton Road
Steeton
Keighley
BD20 6TD
England
Guildford Road
Chertsey
KT16 0PZ
England
Harlow
CM20 1QX
England
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
England
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Crumpsall
Manchester
M8 5RB
England
Bordesley Green
Birmingham
B9 5SS
England
Sutton Coldfield
B75 7RR
England
Southport
PR8 6PN
England
Poplar Grove
Stockport
SK2 7JE
England
Frimley
Camberley
GU16 7UJ
England
Pond Street
London
NW3 2QG
England
Marine Drive
Rhyl
LL18 3AS
Wales
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
Bedford
MK42 9DJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 17/06/2025 | 18/06/2025 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | qualitative study | 12/06/2024 | 20/06/2024 | Yes | No |
| Other publications | Universal maternal testing for group B streptococcus in late pregnancy: process outcomes and alongside qualitative study for the GBS3 trial | 17/11/2025 | 02/12/2025 | Yes | No |
| 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 |
| 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 |
| Protocol file | version 6.1 | 02/07/2024 | 19/09/2024 | No | No |
| Statistical Analysis Plan | version 1.0 | 28/02/2024 | 12/09/2024 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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
- Protocol file
- ISRCTN49639731_Protocol_v4.0_15Oct21.pdf
- Protocol file
- ISRCTN49639731 Protocol V5.2 26Jul2023.pdf
- Protocol file
- ISRCTN49639731 GBS3_Protocol_Version 6.0_13Dec2023.pdf
- Protocol file
- ISRCTN49639731 GBS-3 SAP final v1.0 28Feb2024.pdf
- Statistical Analysis Plan
- ISRCTN49639731_PROTOCOL_V6.1_02Jul24.pdf
- Protocol file
Editorial Notes
02/12/2025: Publication reference added.
19/08/2025: The following changes were made to the trial record:
1. Contact details updated.
2. The total final enrolment was added.
3. The IPD sharing plan was updated.
18/06/2025: Publication reference added.
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)
