BMJ Open (Jun 2025)

Routine testing for group B streptococcus in pregnancy: protocol for a UK cluster randomised trial (GBS3)

  • ,
  • Shalini Ojha,
  • Jon Dorling,
  • Stavros Petrou,
  • Soo Downe,
  • Rabia Zill-E-Huma,
  • Sarah Lee,
  • Jane Daniels,
  • Paul Ayuk,
  • Trudy Smith,
  • Lucy Bradshaw,
  • Tracey Cooper,
  • Janine Abramson,
  • Hannah Mitchell,
  • Joanna Gibson,
  • Sarah Watson,
  • Heather Ward,
  • Kate Walker,
  • Jim Thornton,
  • Reuben Ogollah,
  • Jason Madan,
  • Jenny Butler,
  • Louise Page,
  • Guduru Gopal Rao,
  • Susan Ayers,
  • Felix Achana,
  • Asma Khalil,
  • Eleanor J Mitchell,
  • Rachel Plachcinski,
  • Laura Johnson,
  • Anna Williams,
  • Hannah Parker,
  • Rebecca Haydock,
  • Julie Walker,
  • Jonathan Ford,
  • Elena Greco,
  • Janet Phipps,
  • Kim Hinshaw,
  • Hilary Owen,
  • Alex Taylor,
  • Jane Plumb,
  • James Gray,
  • Joanna Clark,
  • Kate Young,
  • Anna Campbell,
  • Erum Khan,
  • Manjula Samyraju,
  • Harry Gibson,
  • Linda Johnson,
  • Jessica Wilson,
  • Sarah Moore,
  • David Ankers,
  • Michelle Anderson,
  • Laura Veal,
  • Ramesh Ganapathy,
  • Ferha Saeed,
  • Philip Banfield,
  • Shabina Sadiq,
  • Helen Preston,
  • Lisa Ditchfield,
  • Anne-Marie Jones,
  • Emily Marler,
  • Phillip Bennett,
  • Janet Cresswell,
  • Stephy Mathen,
  • Anam Fayadh,
  • Louise Swaminathan,
  • Emily Scriven,
  • Sangeeta Pathak,
  • Hazel Alexander,
  • Jodi Carpenter,
  • Sharon Gowans,
  • Lesley Hewitt,
  • Emma Meadows,
  • Tommy Mousa,
  • Lisa Evans,
  • Laura Johns,
  • Catherine Stone,
  • Charlotte Goumalatsou,
  • Maggie Lai,
  • Lola Oshodi,
  • Georgie Constantinou,
  • Nicola Grace,
  • Eleanor Harrison,
  • Joanne Brooks,
  • Kerry Barker-Williams,
  • Heidi Hollands,
  • Sarah-Kate Mcleavey,
  • Seren Willson,
  • Sophie Webster,
  • Meg Hyslop-Peart,
  • Louise Wills,
  • Rachel Haines,
  • Linda Fiaschi,
  • Jay Seale,
  • Susanne Spas,
  • Lixiao Huang,
  • Sebastian Moody,
  • Ihab Abbasi,
  • Rezan Abdul-Kadir,
  • Phern Adams,
  • Rebecca Adcock,
  • Dipika Aggarwal,
  • Dawn Althorn,
  • Sarah-Jayne Ambler,
  • Rita Arya,
  • Karen Austin Smith,
  • Angela Ayuk,
  • Jade Barnes,
  • Abbie Berry,
  • Linda Bishop,
  • Patrick Bose,
  • Nichola Brannen,
  • Catherine Bressington,
  • Janet Brown,
  • Lorraine Bullett,
  • Anneka Burch,
  • Jennifer Burrage,
  • Viv Cannons,
  • Philippa Cansell,
  • Cristina CarballoDe Dios,
  • Gail Castle,
  • Yee Yin Chan,
  • Floria Cheng,
  • Naomi Coleman,
  • Rachael Copley,
  • Yvette Davis,
  • Bashir Dawlaty,
  • Kara Dent,
  • Caroline Dixon,
  • Kerry Dooley,
  • Milli Edwards,
  • Sue Fagg,
  • Jo Ficquet,
  • Nicola Flint,
  • Natasha Ford,
  • Lily French,
  • Edward Frew,
  • Rachel Frowd,
  • Ruta Gada,
  • Emma Gammin,
  • Caitlin Giles,
  • Mandy Gill,
  • Coralie Glenn-Sansum,
  • Julie Goddard,
  • Jenna Gould,
  • Naomi Grimes,
  • Zoe Grindley,
  • Katherina Gross-Gibbs,
  • Liliana Grosu,
  • Lara Robles Gutierrez,
  • Bev Hammond,
  • Latifah Harris,
  • Kathryn Haviland,
  • Holly Hawkesford,
  • Carly Hayton,
  • Miss Mandira Hazra,
  • Anne Marie Henshaw,
  • Jemima Hepburne-Scott,
  • Stephanie Horridge,
  • Victoria Hodgson,
  • Rhiannon Hurll,
  • Alison Hylton-Potts,
  • Karen Ixer,
  • Sara Jaarour,
  • Andie Johnson,
  • Prudence Jones,
  • Kelly Jukes,
  • Sumit Kar,
  • Pallavi Karkhanis,
  • Tracey Kay,
  • Stephen Keay,
  • Alex Keen,
  • Joanne Kellett,
  • Mary Kelly- Baxter,
  • Teresa Kelly,
  • Vanessa Kemp,
  • Magdalena Kierzenkowska,
  • Aly Kimber,
  • Eva Kisakye,
  • Sarah Knights,
  • Wiece Koniman,
  • Emmanouil Kountouris,
  • Egi Krasniqi,
  • Katie Lang,
  • Rebecca Leon,
  • Isabel Llopis,
  • Leanne Lowe,
  • Saswati Maitra,
  • Jodie Manning,
  • Sarah Mapplebeck,
  • Cathryn Marsh,
  • Ruth Mason,
  • Ilenia Mazzoli,
  • Joanna Mead,
  • Michal Rosie Meroz,
  • Hannah Mugford,
  • Hannah Mullins,
  • Eric Mutema,
  • Bonilla Nayar,
  • Jonathan Nelson,
  • Rachel Newport,
  • Shari Noraiee,
  • Justine Nugent,
  • Nzoputa Nwabueze,
  • Chinwe Obiozo-Jumbo,
  • Clare O’Brien-Hirst,
  • Anne-Marie O’Brien,
  • Tanwa Ogbara,
  • Chloe O’Hara,
  • Oyinlola Okungade,
  • Chidera Onyeagor,
  • Sam Parlapalli,
  • Leia Parry,
  • Nikky Passmore,
  • Tara Pauley,
  • Linda Peacock,
  • Carol Percy,
  • Ella Proctor,
  • Emma Pugh,
  • Madhavi Pureti,
  • Eleanor Pyart,
  • Vinita Raheja,
  • Clair Rainford,
  • Miss Jyothi Rajeswary,
  • Lindsay Roughley,
  • Ruth Ryder,
  • Maiti Sachchidananda,
  • Beena Saji,
  • Jess Sellick,
  • Ellie Didier Serre,
  • Erikka Siddall,
  • Jonathan Slack,
  • Delphine Strub,
  • Emma Tanton,
  • Vasso Terzidou,
  • Niki Thatcher,
  • Catherine Townsend,
  • Lydia Ufton,
  • Lilian Ugwumadu,
  • Ureh Umeh-John,
  • Husswan Yasmin WanHussein,
  • Annie Warrington,
  • Sharon Westcar,
  • Hayley Wheeler,
  • Sonia White,
  • Miss Frances Wood,
  • Julie Woollaston,
  • Janet Wright,
  • Priti Wuppalapati,
  • Cheryl Wyatt,
  • Jemma Yorke

DOI
https://doi.org/10.1136/bmjopen-2024-087887
Journal volume & issue
Vol. 15, no. 6

Abstract

Read online

Introduction It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy.Methods and analysis Cluster randomised trial.Sites and participants 320 000 women from up to 80 hospital maternity units.Strategies Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. 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.Outcomes The primary outcome is all-cause early (<7 days 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 ≥3 agreed clinical signs or symptoms, who receive intravenous antibiotics ≥5 days. All women giving birth ≥24 weeks’ 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.Ethics and dissemination 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.Trial registration number ISRCTN49639731.