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. 2019 Mar 4;20(1):154.
doi: 10.1186/s13063-019-3242-6.

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  1 , Sophie Relph  1 , Andrew Copas  2 , Andrew Healey  1 , Kirstie Coxon  3 , Alessandro Alagna  4 , Annette Briley  1 , Mark Johnson  5 , Deborah A Lawlor  6   7 , Christoph Lees  5 , Neil Marlow  8 , Lesley McCowan  9 , Louise Page  10 , Donald Peebles  8 , Andrew Shennan  1 , Baskaran Thilaganathan  11   12 , Asma Khalil  11   12 , Jane Sandall  1 , Dharmintra Pasupathy  13 ; DESiGN Collaborative Group
Collaborators, Affiliations

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 et al. Trials. .

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.

Keywords: Customised growth centiles; Health economics; Implementation research; Small-for-gestational-age foetus; Stillbirth.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this trial has been obtained through the Health Research Authority (HRA) Integrated Research Applications System (IRAS) from the London Bloomsbury Research Ethics Committee (Ref. 15/LO/1632) and the Confidentiality Advisory Group (Ref. 15/CAG/0195). King’s College London is the sponsor for this trial.

Consent for publication

Not applicable.

Competing interests

DAL receives funding from national government and charitable funders, as well as from Medtronic and Roche Diagnostics for research unrelated to this study. The other investigators named on the protocol have no financial or other competing interests that impact on their responsibilities towards the scientific value or potential publishing activities associated with the trial.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Diagram of expected procedures in participating clusters in the intervention and standard care arms
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) table for the timeline of study enrolment, intervention and assessment
Fig. 3
Fig. 3
Diagram of individual management within participating clusters
Fig. 4
Fig. 4
NHS England protocol for screening small-for-gestational-age (SGA) foetuses
Fig. 5
Fig. 5
Proportion of small-for-gestational-age (SGA) babies defined by population references, customised standards or both
See this image and copyright information in PMC

References

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