PLoS Medicine (Jun 2022)

Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial.

  • Matias C Vieira,
  • Sophie Relph,
  • Walter Muruet-Gutierrez,
  • Maria Elstad,
  • Bolaji Coker,
  • Natalie Moitt,
  • Louisa Delaney,
  • Chivon Winsloe,
  • Andrew Healey,
  • Kirstie Coxon,
  • Alessandro Alagna,
  • Annette Briley,
  • Mark Johnson,
  • Louise M Page,
  • Donald Peebles,
  • Andrew Shennan,
  • Baskaran Thilaganathan,
  • Neil Marlow,
  • Lesley McCowan,
  • Christoph Lees,
  • Deborah A Lawlor,
  • Asma Khalil,
  • Jane Sandall,
  • Andrew Copas,
  • Dharmintra Pasupathy,
  • DESiGN Collaborative Group

DOI
https://doi.org/10.1371/journal.pmed.1004004
Journal volume & issue
Vol. 19, no. 6
p. e1004004

Abstract

Read online

BackgroundAntenatal detection and management of small for gestational age (SGA) is a strategy to reduce stillbirth. Large observational studies provide conflicting results on the effect of the Growth Assessment Protocol (GAP) in relation to detection of SGA and reduction of stillbirth; to the best of our knowledge, there are no reported randomised control trials. Our aim was to determine if GAP improves antenatal detection of SGA compared to standard care.Methods and findingsThis was a pragmatic, superiority, 2-arm, parallel group, open, cluster randomised control trial. Maternity units in England were eligible to participate in the study, except if they had already implemented GAP. All women who gave birth in participating clusters (maternity units) during the year prior to randomisation and during the trial (November 2016 to February 2019) were included. Multiple pregnancies, fetal abnormalities or births before 24+1 weeks were excluded. Clusters were randomised to immediate implementation of GAP, an antenatal care package aimed at improving detection of SGA as a means to reduce the rate of stillbirth, or to standard care. Randomisation by random permutation was stratified by time of study inclusion and cluster size. Data were obtained from hospital electronic records for 12 months prerandomisation, the washout period (interval between randomisation and data collection of outcomes), and the outcome period (last 6 months of the study). The primary outcome was ultrasound detection of SGA (estimated fetal weight ConclusionsIn this study, we observed no effect of GAP on antenatal detection of SGA compared to standard care. Given variable implementation observed, future studies should incorporate standardised implementation outcomes such as those reported here to determine generalisability of our findings.Trial registrationThis trial is registered with the ISRCTN registry, ISRCTN67698474.