Improving detection of small infants during pregnancy

ISRCTN ISRCTN67698474
DOI https://doi.org/10.1186/ISRCTN67698474
Secondary identifying numbers 20296
Submission date
27/06/2016
Registration date
02/11/2016
Last edited
09/01/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Stillbirth is when a baby dies in the womb and has to be delivered. It is a tragedy with lifelong consequences for parents and their family and friends. In the UK the number of babies stillborn has not fallen in the past 20 years, and currently affects 1 in every 200 pregnancies. This means that stillbirth in the UK is amongst the highest in Europe. Doctors, midwives and politicians want to change this, and recently reducing stillbirths has been identified as a priority. Most babies that die before birth are normal, but many weigh less than expected. One of the most common reasons for these baby deaths is poor growth in the womb. Often this has gone unnoticed by the doctors and midwives. A baby’s growth in the womb relies on the placenta (afterbirth) working well and providing all the nutrients the baby needs. There are many reasons why the placenta does not work well, and in most cases, with the exception of stopping cigarette smoking, there is little the mother can do to improve this. But most small babies are healthy and growing normally. They are small because of genes inherited from their parents. Factors like parents’ body size and ethnic background are likely to help doctors and midwives work out which babies are small but growing normally and which are small because their placenta is not working well. These babies could be at risk of being stillborn. Previously, a large study has suggested that a package known as Growth Assessment Protocol (GAP), which takes these factors into account, has reduced the stillbirth rates in three regions of the UK. However, there are many other possible reasons other than the GAP that could have led to the reduction in stillbirths in this study. The aim of this study is to look at the impact of the GAP, and whether it really does reduce stillbirths, so that doctors, midwives and policy makers will know whether they should put resources in place to use GAP in all NHS hospitals.

Who can participate?
Pregnant women delivering their baby at a participating hospital.

What does the study involve?
Participating maternity units are randomly allocated to one of two groups. Those in the first group will provide care according to the GAP programme (immediate implementation). For participating women, this involves a standardized way of having their risk of having a baby that is too small for its age assessed at 12 weeks and screening for small infants after 24 weeks using customized centiles (measurements) according to GAP principles. Those in the second group receive usual care, which could involve having their risk of having a baby that is too small for its age assessed at 12 weeks and screening methods for small babies after 24 weeks bases as per routine care. Participants in both groups are followed up until delivery by the clinical team in their hospital to find out if they had a small baby.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Maternity units across 13 NHS Trusts in England (UK)

When is the study starting and how long is it expected to run for?
January 2015 to October 2018

Who is funding the study?
Tommys (UK)

Who is the main contact?
Dr Matias Costa Vieira
matias.vieira@kcl.ac.uk

Contact information

Dr Matias Costa Vieira
Scientific

Division of Women's Health
King's College London
10th Floor North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

ORCiD logoORCID ID 0000-0002-8076-4275
Phone +44 7188 7188 ext. 52545
Email matias.vieira@kcl.ac.uk

Study information

Study designRandomised; Interventional; Design type: Screening, Diagnosis, Complex Intervention
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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
Study acronymDESiGN
Study hypothesisThe GAP programme improves the detection of small for gestational age fetuses when compared to currant clinical practice.
Ethics approval(s)London - Bloomsbury Research Ethics Committee, 29/02/2016, ref: 15/LO/1632
ConditionSpecialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine
InterventionHospitals will be randomized to one of two groups. The method of allocation is the random permutation of clusters within each of two equally sized strata; clusters are divided in the two strata according to their size (deliveries per year in 2013-2014) and then randomized to either early or delayed implementation.

Early implementation arm: The GAP programme will be immediately implemented with training and the use of protocols consistent with the principles of GAP. Women in this study arm will be risk assessed for SGA and managed as per GAP protocol. Low risk women will be seen routinely in antenatal clinic. At these visits standardised FH measurements will be performed from 28 weeks. In high risk women serial ultrasounds after 24 weeks will be recommended. Customised FH and ultrasound charts will be generated at the first trimester ultrasound visit. FH measurements will be plotted on the customised FH chart. In low risk women any deviation in growth on these charts will result in recommendation for ultrasound measurement. Estimated fetal weight (EFW) from ultrasound measurements will be plotted on customised EFW charts for both low or high risk women whenever an ultrasound is done.

Delayed implementation arm: Women will have a risk assessment according to routine practice (if available) and screening for SGA according to local protocol (if available) and use of population charts as reference for diagnosis of SGA in antenatal ultrasounds. GAP will be introduced after the data collection for outcomes.

Majority of participating women will not be required to return for additional research visits but some women in the study will be approached by the research team and invited to take part in interviews to explore the experience of receiving care in line with GAP programme. Source of data will vary according to the outcome assessed. Most of the data will be acquired from routine hospital data. This will include manly electronic records but also review of some clinical notes. Data will be obtained from hospital maternity electronic systems which record antenatal, ultrasound, intrapartum, postnatal and neonatal information. Data obtained manually from clinical notes will be entered into a trial database. For the implementation component of the study primary data collection from interviews and focus groups will be performed.
Intervention typeOther
Primary outcome measureDetection rate of SGA infants measured by ultrasound after 24 weeks* is assessed using data from the maternity and ultrasound system between months 13 to 18 of study.

* The antenatal charts used for ultrasound detection (numerator) will depend on the allocation arm of the trial. The denominator for the estimation of detection in each arm of the trial will be the same population of SGA infants (birthweight <10th centile) by both customised and population
Secondary outcome measures1. Detection rate (sensitivity), specificity, false positive and false negative of SGA by customised centiles measured by ultrasound after 24 weeks
2. Detection rate (sensitivity), specificity, false positive and false negative of SGA by population centiles measured by ultrasound after 24 weeks

Clinical outcomes:
Neonatal:
1. Gestational age measured in weeks at birth
2. Birthweight measured in grams at birth
3. Head circumference measured in centimeters at birth
4. Apgar score <7 measured using Apgar scale at birth
5. Metabolic acidosis defined as an arterial cord ph<7.1 at birth
6. Rate or need of respiratory support in delivery room at birth
7. Rate of neonatal intensive care after birth
8. Length of stay in neonatal intensive care unit (NICU) measured in days
9. Level of care needed in NICU
10. Rate of major neonatal morbidity defined as one or more of the following: intraventricular haemorrhage, supplementary oxygen requirements > 28 days, necrotizing enterocolitis, sepsis, retinopathy of prematurity
11. Length of stay in transitional care measured in days
12. Rate of neonatal morbidity defined as one or more of the following: hypothermia, hypoglycaemia, nasogastric tube feeding
13. Rate or stillbirth (antepartum and intrapartum)
14. Rate of neonatal death (early and late)
15. Rate of neonatal death before discharge (after 28 days of birth)

Maternal:
1. Rate of induction of labour measured at birth
2. Rate of caesarean section measured at birth
3. Rates of postpartum haemorrhage (>1000ml) measured at birth
4. Rate of severe perineal trauma (3rd / 4th degree tear) measured at birth
5. Length of stay in hospital measured in days
6. Method of breast feeding measured at discharge

Health economics outcomes:
1. Number of ultrasound scans after 24 weeks measured at delivery (as average of ultrasound per women)
2. Number of antenatal clinic / antenatal day unit measured at delivery (as average of ultrasound per women)

Process evaluation of implementation outcomes:
1. Proportion of staff trained measured at the end of training period (expected to be at month 6 of study)
2. Proportion of staff assessed for GAP training at the end of training period (expected to be at month 6 of study)
3. Proportion of women assessed with GAP programme measured throughout the study by review of notes of a sample of participants
4. Adherence to SGA risk stratification and management protocols and missed case analysis measured throughout the study and assessed by hospital level data (data available from risk assessment)

Outcomes for other methods of assessments of antenatal detection of SGA:
1. Detection rate of SGA (birthweight<5th centile) measured by ultrasound after 24 weeks
2. Detection of SGA infants measured as clinical detection before birth (review of notes)
Overall study start date01/01/2015
Overall study end date30/11/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 108; UK Sample Size: 108
Participant inclusion criteriaHospitals:
1. Willing to implement GAP
2. Willing to participate in the trial

Patients:
1. Pregnant women
2. Delivering at one of the participating hospitals during the study period
Participant exclusion criteriaHospitals that have fully implemented or will not be introducing GAP.
Recruitment start date01/12/2016
Recruitment end date30/04/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Guy's and St Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom
Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom
University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom
St George's Healthcare NHS Trust
Blackshaw Road
London
SW17 0QT
United Kingdom
Kingston Hospital NHS Trust
Galsworthy Road
Kingston upon Thames
KT2 7QB
United Kingdom
Croydon Health Services NHS Trust
London Road
Thornton Heath
CR7 7YE
United Kingdom
Imperial College Healthcare NHS Trust
Pread Street
London
W2 1NY
United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
North West London Hospitals NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom
West Middlesex University Hospital NHS Trust
Twickenham Road
Isleworth
TW7 6AF
United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom
North Middlesex University Hospital NHS Trust
Sterling Way
London
N18 1QX
United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield Road
Chesterfield
S44 5BL
United Kingdom

Sponsor information

Comprehensive Clinical Trials Unit at UCL
Hospital/treatment centre

University College London
Gower Street
London
WC1E 6BT
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Tommy's Baby Charity
Private sector organisation / Other non-profit organizations
Location
United Kingdom
Stillborn and Neonatal Death Charity
Private sector organisation / Associations and societies (private and public)
Alternative name(s)
SANDS
Location
United Kingdom
Guy's and St Thomas' Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location
United Kingdom

Results and Publications

Intention to publish date28/02/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planThe results of the trial will be disseminated regardless of the direction of effect to the scientific and non-scientific community. The main results will be presented in a scientific conference and published in a peer-reviewed journal. The plan is to submit the main results for publication within 2 months of the end of the trial.
IPD sharing planThe anonymised data will be stored centrally by the sponsor (Clinical Trials Unit at University College London).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 04/03/2019 07/03/2019 Yes No
Interim results article sub-study results 08/03/2021 10/03/2021 Yes No
Results article 05/09/2022 06/09/2022 Yes No
HRA research summary 28/06/2023 No No
Results article Health economics outcomes 07/07/2022 09/01/2024 Yes No

Editorial Notes

09/01/2024: Publication reference added.
06/09/2022: Publication reference added.
10/03/2021: Publication reference added.
07/03/2019: Publication reference added.
30/11/2018: The overall trial end date has been changed from 30/11/2018 to 30/11/2019.
08/08/2018: The following changes have been made:
1. SANDS and Guy's and St Thomas' Charity have been added as funders.
2. The overall trial end date has been changed from 31/10/2018 to 30/11/2018.
3. The intention to publish date has been changed from 31/12/2018 to 28/02/2020.