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The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment
Matias C Vieira1, Sophie Relph1, Andrew Copas2
1Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Women's Health Academic Centre KHP, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Insights
This study evaluates the Growth Assessment Protocol (GAP) to improve antenatal detection of small-for-gestational-age (SGA) babies, aiming to reduce stillbirth rates in the UK. The first randomized controlled trial will assess its clinical efficacy and health economics.
Area of Science:
- Obstetrics and Gynecology
- Fetal Medicine
- Public Health
Background:
- UK stillbirth rates are among the highest in developed nations.
- Small-for-gestational-age (SGA) fetuses are strongly associated with stillbirth.
- Observational studies suggest improved antenatal detection of SGA may significantly reduce stillbirths.
Purpose of the Study:
- To conduct the first randomized controlled trial on the Growth Assessment Protocol (GAP) for antenatal detection of SGA.
- To evaluate the clinical efficacy, health economics, and implementation of the GAP programme.
- To provide data informing national policy on stillbirth reduction strategies.
Main Methods:
- Cluster randomized controlled trial comparing the GAP programme to standard care.
- Primary outcome: antenatal ultrasound detection rate of SGA infants identified at birth (population and customized standards).
- Secondary outcomes: detection rates by centiles, maternal/neonatal outcomes, resource use, economic consequences, and implementation process evaluation.
Main Results:
- This section is to be filled after the study's completion.
Conclusions:
- This trial is the first to compare the GAP programme against standard care for antenatal SGA detection.
- Findings will offer crucial data on GAP's performance and service needs.
- Results have the potential to influence national policies aimed at reducing stillbirth rates.
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.
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