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, DESiGN Collaborative GroupPeter Brocklehurst, Susan Tebbs, Caroline Doré, Paul Seed, Louisa Delaney, Janet Cresswell, Sarah Petty, Bini Ajay, Beverley Wright, Hannah O'Donnell, Melissa Howard, Emma Wayman, Paula Galea, Mandish Dhanjal, Elisa Iaschi, Vanessa Hodge, Hiran Samarage, Sunder Chita, Raffaele Napolitano, Iris Tsikimi, Fiona Ghalustians, Spyros Bakalis, Simona Cicero, Elisabeth Peregrine, Lyndsey Smith, Deepa Janga, Renata Hutt, Edwin Chandraharan

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

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.

Original languageEnglish
Article number154
Number of pages14
JournalTrials
Volume20
DOIs
Publication statusPublished - 4 Mar 2019
Externally publishedYes

Keywords

  • Customised growth centiles
  • Health economics
  • Implementation research
  • Small-for-gestational-age foetus
  • Stillbirth

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