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A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design.<\/jats:p>\n <\/jats:sec>\n \n Outcomes<\/jats:title>\n The primary outcome is all-cause early (<7\u2009days of birth) neonatal sepsis, defined as either a positive blood\/cerebrospinal fluid culture, early neonatal death from infection or a negative\/unknown culture status with \u22653 agreed clinical signs or symptoms, who receive intravenous antibiotics \u22655\u2009days. All women giving birth \u226524 weeks\u2019 gestation, regardless of mode of birth, and all her babies will be included in the dataset. Cost-effectiveness will be expressed in terms of incremental cost per case of early neonatal sepsis avoided and incremental cost per quality-adjusted life-year associated with each strategy.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19\/EM\/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n ISRCTN49639731<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-087887","type":"journal-article","created":{"date-parts":[[2025,6,17]],"date-time":"2025-06-17T06:20:15Z","timestamp":1750141215000},"page":"e087887","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Routine testing for group B streptococcus in pregnancy: protocol for a UK cluster randomised trial (GBS3)"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"isrctn49639731","registry":"10.18810\/isrctn"}],"author":[{"given":"Jane","family":"Daniels","sequence":"first","affiliation":[{"name":"Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, 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