ISRCTN49639731进行中（未招募）未知
The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 320,000
研究概览
简要总结
2024 Other publications in https://doi.org/10.1016/j.midw.2024.104063 qualitative study (added 20/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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