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dc.contributor.authorDaniels, Jane P.
dc.contributor.authorSaeed Khan, Khalid 
dc.contributor.authorGBS2 Collaborative Group
dc.date.accessioned2022-02-03T13:00:04Z
dc.date.available2022-02-03T13:00:04Z
dc.date.issued2022-01-14
dc.identifier.citationDaniels, J.P... [et al.]. Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study. BMC Med 20, 9 (2022). [https://doi.org/10.1186/s12916-021-02202-2]es_ES
dc.identifier.urihttp://hdl.handle.net/10481/72651
dc.descriptionGBS2 was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (13/82/04). The funder had no role in the design and conduct of the study; the collection, management, analysis and interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. JJD is supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. KSK is a Distinguished Investigator funded by the Beatriz Galindo (senor modality) Program grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.es_ES
dc.description.abstractBackground: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-ofcare rapid intrapartum test to detect maternal GBS colonisation reduces maternal antibiotic exposure compared with usual care, where antibiotics are administered due to those risk factors. We assessed the accuracy of the rapid test in diagnosing maternal GBS colonisation, against the reference standard of selective enrichment culture. Methods: We undertook a parallel-group cluster randomised trial, with nested test accuracy study and microbiological sub-study. UK maternity units were randomised to a strategy of rapid test (GeneXpert GBS system, Cepheid) or usual care. Within units assigned to rapid testing, vaginal-rectal swabs were taken from women with risk factors for vertical GBS transmission in established term labour. The trial primary outcome was the proportion of women receiving intrapartum antibiotics to prevent neonatal early-onset GBS infection. The accuracy of the rapid test was compared against the standard of selective enrichment culture in diagnosing maternal GBS colonisation. Antibiotic resistance profiles were determined in paired maternal and infant samples. Results: Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units; 906 mothers (951 babies) were in usual care units. There was no evidence of a difference in the rates of intrapartum antibiotic prophylaxis (relative risk 1.16, 95% CI 0.83 to 1.64) between the rapid test (41%, 297/716) and usual care (36%, 328/906) units. No serious adverse events were reported. The sensitivity and specificity measures of the rapid test were 86% (95% CI 81 to 91%) and 89% (95% CI 85 to 92%), respectively. Babies born to mothers who carried antibiotic-resistant Escherichia coli were more likely to be colonised with antibiotic-resistant strains than those born to mothers with antibiotic-susceptible E. coli. Conclusion: The use of intrapartum rapid test to diagnose maternal GBS colonisation did not reduce the rates of antibiotics administered for preventing neonatal early-onset GBS infection than usual care, although with considerable uncertainty. The accuracy of the rapid test is within acceptable limits.es_ES
dc.description.sponsorshipNational Institute for Health Research (NIHR) 13/82/04es_ES
dc.description.sponsorshipNIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust University of Birminghames_ES
dc.description.sponsorshipBeatriz Galindo (senor modality) Programes_ES
dc.language.isoenges_ES
dc.publisherBMCes_ES
dc.rightsAtribución 3.0 España*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/es/*
dc.subjectGroup B Streptococcuses_ES
dc.subjectColonisationes_ES
dc.subjectRandomised controlled triales_ES
dc.subjectAccuracyes_ES
dc.subjectLaboures_ES
dc.subjectPregnancy es_ES
dc.subjectAntibiotics es_ES
dc.titleRapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy studyes_ES
dc.typejournal articlees_ES
dc.rights.accessRightsopen accesses_ES
dc.identifier.doi10.1186/s12916-021-02202-2
dc.type.hasVersionVoRes_ES


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Atribución 3.0 España
Except where otherwise noted, this item's license is described as Atribución 3.0 España