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

Not Applicable

• Conditions: Group B streptococcus infection in pregnancy; Infections and Infestations

• Registration Number: ISRCTN49639731
• Lead Sponsor: niversity of Nottingham

Brief Summary

2024 Other publications in https://doi.org/10.1016/j.midw.2024.104063 qualitative study (added 20/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-23
• Last Update Posted: 8 July 2024
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 320000

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

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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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified