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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Kate
Walker
+441158231581
kate.walker@nottingham.ac.uk
Prof
Jane
Daniels
+44115 82 31619
jane.daniels@nottingham.ac.uk
Ms
Eleanor
Harrison
+44115 8231608
Gbs3@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Group B streptococcus infection in pregnancy
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Other publications in https://doi.org/10.1016/j.midw.2024.104063 qualitative study (added 20/06/2024)
You can take part if:
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 Profes
You may not be able to take part if:
Current participant exclusion criteria as of 30/03/2022:
1. Exclusion criteria – testing level1.1 Women who do not provide verbal consent to provide a swab1.2 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 routinely1.4 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 fetuses1.6 Known prelabour intrauterine death in the current pregnancy, of a singleton or all multiple fetuses1.7 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 level2.1 Known congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses2.2 Withdrawal of consent to use data, through the NHS data-opt out (or devolved nation equivalent)
3. Exclusion criteria-qualitative study3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent3.2 Health Care Professionals will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service3.3 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 level1.1 Women who do not provide verbal consent to provide a swab1.2 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 routinely1.4 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 fetuses1.6 Known prelabour intrauterine death in the current pregnancy, of a singleton or all multiple fetuses1.7 Women who require an emergency caesarean birth but who have intact membranes and are not in labour
2. Exclusion criteria – dataset level2.1 Known congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses2.2 Withdrawal of consent to use data, through the NHS data-opt out (or devolved nation equivalent)
3. Exclusion criteria-qualitative study3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent3.2 Health Care Professionals will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service3.3 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 level1.1 Women who do not provide verbal consent to provide a swab1.2 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 routinely1.4 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 fetuses1.6 Known prelabour intrauterine death, of a singleton or all multiple fetuses1.7 Women who require an emergency caesarean birth but who have intact membranes and are not in labour
2. Exclusion criteria – dataset level2.1 Known congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses2.2 Withdrawal of consent to use data, through the NHS data-opt out (or devolved nation equivalent)
3. Exclusion criteria-qualitative study3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent3.2 Health Care Professionals will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service3.3 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 level1.1 Decline clinical consent to provide a swab1.2 Previous baby with GBS disease (early or late onset) and who want IAP1.3 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 routinely1.5 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 level2.1 Congenital anomaly incompatible with survival at birth, of singleton or all multiple fetuses2.2 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 study3.1 Women will be excluded if their baby died prior to birth or if they lack capacity to give informed consent3.2 Clinicians will be excluded if they are not currently practising and/or working in an NHS maternity or neonatal service3.3 Women and clinicians not receiving care or working in the NHS sites taking part in this study will not be eligible
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Kate
Walker
+441158231581
kate.walker@nottingham.ac.uk
Prof
Jane
Daniels
+44115 82 31619
jane.daniels@nottingham.ac.uk
Ms
Eleanor
Harrison
+44115 8231608
Gbs3@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Nottingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/86/06.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 42782
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
