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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Ultrasound | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2019

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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.
Appendix
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Metadata
Title
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
Authors
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
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3242-6

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