CompletedPregnancy, Children & Inherited ConditionsPublic Health & Healthcare
The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)
Around 320,000 women giving birth in 65 UK maternity units will be randomly assigned to either the current risk-based strategy for Group B Streptococcus (GBS) or routine testing, to settle a decades-old question about whether universal screening prevents newborn sepsis. GBS bacteria harmlessly colonise about one in five pregnant women but can cause life-threatening infections in newborns if passed during labour. The UK National Screening Committee has never recommended routine testing because no large randomised trial has proved it works better than the current approach—checking for risk factors such as fever or prolonged membrane rupture and treating only those women with intravenous antibiotics during labour. If the trial shows routine testing cuts early-onset neonatal sepsis by 40 percent—the reduction the study is powered to detect—the National Screening Committee will have the evidence it needs to decide whether to implement universal GBS screening across the UK. That could change standard maternity care for hundreds of thousands of women each year, potentially preventing dozens of serious newborn infections and reducing the anxiety that surrounds the current risk-factor approach. The economic analysis will tell the NHS whether the testing is worth the cost.
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RESEARCH QUESTION Does “routine testing” of women for GBS colonisation in late pregnancy OR labour reduce the occurrence of early-onset neonatal sepsis, compared to the current “risk factor“ based strategy? BACKGROUND The UK National Screening Committee (NSC) does not recommend “routine testing” for GBS due to the absence of randomised data on either clinical or cost-effectiveness. METHODS DESIGN: A multi-centre prospective two-arm parallel cluster randomised, superiority trial, with an internal pilot and feasibility evaluation and parallel economic modelling. Data will come from NHS Digital, National Neonatal Research Database, Health Episode Statistics and Public Health England, or devolved nation equivalents. SETTING: 65 maternity units in England, Scotland, Wales. STUDY POPULATIONS: All women who experience labour or prelabour rupture of membranes, at any gestational age =24 weeks. Purposive sampling of women and health care professionals for qualitative study. SCREENING STRATEGIES Primary comparison: “risk-factor” directed strategy (current practice) or a “routine testing” strategy. Sub-randomisation of “routine testing” strategies: Intrapartum testing at greater than 37 weeks of vaginal-rectal swab with the GBS GeneXpert rapid test, or antenatal testing of veginal-rectal swab at 35-37 weeks with enrichment culture. PRIMARY OUTCOME: 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 OUTCOMES: Neonatal: Birth weight, perinatal mortality, 5 minute Apgar, gestational age at birth, fetal acidaemia, neonatal specialist care (length of stay, highest level of care), seizures, abnormal neurological signs at >24 hours of age (hypotonia or abnormal level of consciousness). Maternal: Mode of onset of labour, mode of delivery, duration of hospital stay, change of intended location of childbirth, maternal intrapartum anaphylaxis. Process: Maternal risk factors for EOGBS infection developing in baby, testing coverage, testing at appropriate time, test result available at least 4 hours before childbirth, GBS-specific IAP coverage, timing of IAP, number of doses of IAP, proportion of women who tested negative, positive or had no test, identified maternal risk factors at all sites, declines and acceptances of IAP, number of babies of mothers who tested positive for GBS and had IAP commenced, observation time following positive GBS result, maternal intrapartum or postnatal sepsis. Economic: Incremental cost per case of early neonatal sepsis avoided as a result of alternative testing strategies for GBS in pregnancy or labour, incremental cost per quality adjusted life year gained associated with each strategy, as a result alternative testing strategies for GBS in pregnancy or labour. Qualitative: Acceptability, barriers and facilitators to implementation, and on the influence of site-specific context and process mechanisms on GBS testing. SAMPLE SIZE 320,000 women accrued over 3 years from 65 units will enable detection of a 40% relative reduction in the primary outcome of early-onset neonatal sepsis with 90% power. TIMELINES FOR DELIVERY Milestone completed Collaboration agreements in place. Protocol development. Sites identified. Favourable ethical opinion. Access to routine data sources gained. Training packages developed. Database and data collection tools produced, statistical analysis plan generated. Sites open and testing according to allocation, 100 individual-level datasets collected, database populated, acceptability data analysed. Future milestones Completion of accrual, completion of individual-level data, routine data retrieval. Data analysis of RCT and economic evaluation, write-up of draft final report. ANTICIPATED IMPACT AND DISSEMINATION This project will provide the National Screening Committee with the evidence required to decide whether universal GBS screening should be implemented in the UK. GBS Support and the National Childbirth Trust will use their extensive network of social and mainstream media connections to disseminate the results.
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