TY - JOUR
T1 - The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP)
T2 - Study protocol for a randomised controlled trial
AU - DESiGN Collaborative Group
AU - Vieira, Matias C.
AU - Relph, Sophie
AU - Copas, Andrew
AU - Healey, Andrew
AU - Coxon, Kirstie
AU - Alagna, Alessandro
AU - Briley, Annette
AU - Johnson, Mark
AU - Lawlor, Deborah A.
AU - Lees, Christoph
AU - Marlow, Neil
AU - McCowan, Lesley
AU - Page, Louise
AU - Peebles, Donald
AU - Shennan, Andrew
AU - Thilaganathan, Baskaran
AU - Khalil, Asma
AU - Sandall, Jane
AU - Pasupathy, Dharmintra
AU - Brocklehurst, Peter
AU - Tebbs, Susan
AU - Doré, Caroline
AU - Seed, Paul
AU - Delaney, Louisa
AU - Cresswell, Janet
AU - Petty, Sarah
AU - Ajay, Bini
AU - Wright, Beverley
AU - O'Donnell, Hannah
AU - Howard, Melissa
AU - Wayman, Emma
AU - Galea, Paula
AU - Dhanjal, Mandish
AU - Iaschi, Elisa
AU - Hodge, Vanessa
AU - Samarage, Hiran
AU - Chita, Sunder
AU - Napolitano, Raffaele
AU - Tsikimi, Iris
AU - Ghalustians, Fiona
AU - Bakalis, Spyros
AU - Cicero, Simona
AU - Peregrine, Elisabeth
AU - Smith, Lyndsey
AU - Janga, Deepa
AU - Hutt, Renata
AU - Chandraharan, Edwin
PY - 2019/3/4
Y1 - 2019/3/4
N2 - 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.
AB - 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.
KW - Customised growth centiles
KW - Health economics
KW - Implementation research
KW - Small-for-gestational-age foetus
KW - Stillbirth
UR - http://www.scopus.com/inward/record.url?scp=85062414162&partnerID=8YFLogxK
U2 - 10.1186/s13063-019-3242-6
DO - 10.1186/s13063-019-3242-6
M3 - Article (Academic Journal)
C2 - 30832739
VL - 20
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 154
ER -