The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial
Matias C. Vieira,
Sophie Relph,
Andrew Copas,
Andrew Healey,
Kirstie Coxon,
Alessandro Alagna,
Annette Briley,
Mark Johnson,
Deborah A. Lawlor,
Christoph Lees,
Neil Marlow,
Lesley McCowan,
Louise Page,
Donald Peebles,
Andrew Shennan,
Baskaran Thilaganathan,
Asma Khalil,
Jane Sandall,
Dharmintra Pasupathy,
on behalf of the DESiGN Collaborative Group
Affiliations
Matias C. Vieira
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Sophie Relph
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Andrew Copas
Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London
Andrew Healey
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Kirstie Coxon
Faculty of Health, Social Care and Education, Kingston and St. George’s University
Alessandro Alagna
The Guy’s and St Thomas’ Charity, 9 King’s Head Yard
Annette Briley
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Mark Johnson
Department of Surgery and Cancer, Imperial College London
Deborah A. Lawlor
Population Health Science, Bristol Medical School, University of Bristol
Christoph Lees
Department of Surgery and Cancer, Imperial College London
Neil Marlow
UCL Institute for Women’s Health, University College London
Lesley McCowan
Faculty of Medical and Health Sciences, University of Auckland
Louise Page
West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
Donald Peebles
UCL Institute for Women’s Health, University College London
Andrew Shennan
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Baskaran Thilaganathan
Fetal Medicine Unit, St George’s University Hospitals NHS Foundation Trust
Asma Khalil
Fetal Medicine Unit, St George’s University Hospitals NHS Foundation Trust
Jane Sandall
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Dharmintra Pasupathy
Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, Women’s Health Academic Centre KHP
Abstract Background Stillbirth rates in the United Kingdom (UK) are amongst the highest of all developed nations. The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observational studies suggest that improved antenatal detection of SGA babies may halve the stillbirth rate. The Growth Assessment Protocol (GAP) describes a complex intervention that includes risk assessment for SGA and screening using customised fundal-height growth charts. Increased detection of SGA from the use of GAP has been implicated in the reduction of stillbirth rates by 22%, in observational studies of UK regions where GAP uptake was high. This study will be the first randomised controlled trial examining the clinical efficacy, health economics and implementation of the GAP programme in the antenatal detection of SGA. Methods/design In this randomised controlled trial, clusters comprising a maternity unit (or National Health Service Trust) were randomised to either implementation of the GAP programme, or standard care. The primary outcome is the rate of antenatal ultrasound detection of SGA in infants found to be SGA at birth by both population and customised standards, as this is recognised as being the group with highest risk for perinatal morbidity and mortality. Secondary outcomes include antenatal detection of SGA by population centiles, antenatal detection of SGA by customised centiles, short-term maternal and neonatal outcomes, resource use and economic consequences, and a process evaluation of GAP implementation. Qualitative interviews will be performed to assess facilitators and barriers to implementation of GAP. Discussion This study will be the first to provide data and outcomes from a randomised controlled trial investigating the potential difference between the GAP programme compared to standard care for antenatal ultrasound detection of SGA infants. Accurate information on the performance and service provision requirements of the GAP protocol has the potential to inform national policy decisions on methods to reduce the rate of stillbirth. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered on 2 November 2016.
