Group B streptococcus infection in pregnancy Infections and Infestations Group B streptococcus infection in pregnancy
Conditions
Interventions
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” approa
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
16 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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, 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 tho | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactJane Daniels
Outcome results
None listed