The DESiGN Trial - Detection of small for gestational age fetus (SGA)
Research type
Research Study
Full title
The DESiGN Trial - Detection of small for gestational age fetus (SGA) – a cluster randomised controlled trial to evaluate the effect of the Growth Assessment Protocol (GAP) programme
IRAS ID
180646
Contact name
Dharmintra Pasupathy
Contact email
Sponsor organisation
King College London
ISRCTN Number
ISRCTN67698474
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
This is a resubmission of the original application.
In the UK the number of babies stillborn has not fallen in the past 20 years. Most babies that die before birth are normal, but many weigh less than expected. A small baby in the womb may reflect suboptimal placental (afterbirth) function . However, some babies are small and are normally grown reflecting the constitution of the parents. The Growth Assessment Programme (GAP) aims to improve the identification of small babies by considering maternal characteristics such as size and ethnicity when assessing growth. Evidence from only observational studies suggest that GAP is better at identifying babies at risk. However, a key concern is that adjustment for maternal ethnicity, some very small or very large babies might be missed or wrongly identified. Correct identification of small babies is fundamental as appropriate management and follow up reduces their risk of a stillbirth. Therefore, a well-designed clinical trial is needed to assess if GAP is better in identifying small babies.
This is a cluster randomized trial. Hospitals are randomised, rather than individual women who will receive the care allocated to their hospital avoiding contamination of the intervention. All maternity units in the trial will introduce the GAP programme eventually, but one group will use GAP immediately, while the other group will delay implementation of GAP. The time before the introduction of GAP in the delayed arm means we can compare maternity units using GAP with those continuing with usual care.
In the end of the trial we will be able to inform the best way to identify small babies. We will also look at stillbirth and other important outcomes. We will also ask women about their experiences of care. Finally, we will estimate the impact of GAP on clinical service provision and health economics.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1632
Date of REC Opinion
20 Nov 2015
REC opinion
Further Information Favourable Opinion