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Trial registered on ANZCTR


Registration number
ACTRN12612001215819
Ethics application status
Approved
Date submitted
2/11/2012
Date registered
16/11/2012
Date last updated
11/02/2021
Date data sharing statement initially provided
18/06/2019
Date results information initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the utility of the customised fetal growth chart: a randomised controlled trial
Scientific title
Does a customised fetal growth chart compared to a non-customised fetal growth chart for use in routine antenatal care in singleton pregnancies reduce adverse perinatal outcome?
Secondary ID [1] 281493 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal outcomes 287764 0
Condition category
Condition code
Reproductive Health and Childbirth 288105 288105 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A customised fetal growth chart that is individualised for the specific pregnancy using maternal and pregnancy characteristics and can be used with routine measurements of fundal height. The intervention will be used at each antenatal visit after 24 weeks gestation by entering the fundal height measurement into the system, which will then plot it on the chart, with all previous measurements. The charts will be used up until delivery of the baby.
Intervention code [1] 286006 0
Early detection / Screening
Comparator / control treatment
A non-customised fetal growth chart that can be used with routine measurements of fundal height. The intervention will be used at each antenatal visit after 24 weeks gestation by entering the fundal height measurement into the system, which will then plot it on the chart, with all previous measurements. The charts will be used up until delivery of the baby.
Control group
Active

Outcomes
Primary outcome [1] 288309 0
Composite perinatal morbidity/mortality outcome (stillbirth, neonatal death, Apgar score at 5 minutes < 4, hypoglycaemia, stages 2-3 necrotizing enterocolitis [NEC] according to Bell's Criteria, hypoxic ischaemic encephalopathy [HIE] Sarnat stages 2 and 3, neonatal seizures, intraventricular haemorrhage [IVH] graded according to Papile's classification, admission to neonatal intensive care unit [NICU] > 4 days)
Timepoint [1] 288309 0
Discharge of baby from hospital
Secondary outcome [1] 299820 0
Proportion of babies confirmed as SGA on ultrasound of those referred
Timepoint [1] 299820 0
Discharge of baby from hospital
Secondary outcome [2] 299821 0
Proportion of babies confirmed as large-for-gestational age (LGA) on ultrasound of these referred
Timepoint [2] 299821 0
Discharge of baby from hospital
Secondary outcome [3] 299822 0
Classification of SGA by Birthweight Appropriateness Quotient and/or population based charts
Timepoint [3] 299822 0
Discharge of baby from hospital
Secondary outcome [4] 299823 0
Classification of LGA by Birthweight Appropriateness Quotient and/or population based charts
Timepoint [4] 299823 0
Discharge of baby from hospital
Secondary outcome [5] 299824 0
Preterm birth (defined as birth less than <37 weeks and <34 weeks); identified from routinely collected data
Timepoint [5] 299824 0
Discharge of baby from hospital
Secondary outcome [6] 299825 0
Proportion of caesarean sections (CS)/inductions for SGA/LGA; identified from routinely collected data
Timepoint [6] 299825 0
Discharge of baby from hospital
Secondary outcome [7] 299826 0
Individual perinatal outcomes that comprise the primary outcome measure; identified from routinely collected data
Timepoint [7] 299826 0
Discharge of baby from hospital
Secondary outcome [8] 299827 0
Perineal trauma; identified from routinely collected data
Timepoint [8] 299827 0
Discharge of baby from hospital
Secondary outcome [9] 299828 0
Cost of interventions (such as ultrasound scans and antenatal/neonatal admissions); identified from routinely collected data
Timepoint [9] 299828 0
Discharge of baby from hospital
Secondary outcome [10] 299892 0
Fetal distress; identified from routinely collected data
Timepoint [10] 299892 0
Discharge of baby from hospital
Secondary outcome [11] 299893 0
Resuscitation (such as need for intubation); identified from routinely collected data
Timepoint [11] 299893 0
Discharge of baby from hospital
Secondary outcome [12] 299894 0
Mechanical ventilation; identified from routinely collected data
Timepoint [12] 299894 0
Discharge of baby from hospital
Secondary outcome [13] 299895 0
Chronic neonatal lung disease; identified from routinely collected data
Timepoint [13] 299895 0
Discharge of baby from hospital
Secondary outcome [14] 299896 0
Shoulder dystocia; identified from routinely collected data
Timepoint [14] 299896 0
Discharge of baby from hospital

Eligibility
Key inclusion criteria
All women receiving routine antenatal care
Minimum age
13 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple gestation
Participation in GP shared care

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To generate the growth chart to be used, the required parameters for the customisation process will be entered during the booking interview with the midwife. Once the first doctor’s visit has occurred, and the model of care (i.e. to exclude women accessing GP shared care) and plurality (i.e. to exclude multiple pregnancies) have been entered, the chart will be produced and saved in the electronic obstetric clinical system. The randomisation schedule will be saved into this same system and the chart (either standard or customised) will be generated based on the next allocation in the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule will be generated prior to study commencement that will be used to allocate patients to either the standard chart or customised chart. Variable block randomisation will be used, as well as stratification by pregnancy risk (low risk and high risk). Women who are allocated to the obstetric model of care at the first doctor’s visit will be classified as high risk; all others will be low risk.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
26/03/2014
Date of last participant enrolment
Anticipated
31/07/2019
Actual
29/11/2017
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
4020
Accrual to date
Final
3993
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2582 0
Mater Mother's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 286272 0
Hospital
Name [1] 286272 0
Mater Mothers Golden Casket Research Grant
Country [1] 286272 0
Australia
Primary sponsor type
Hospital
Name
Mater Medical Research Institue
Address
Raymond Terrace, South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 285069 0
None
Name [1] 285069 0
Address [1] 285069 0
Country [1] 285069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288344 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 288344 0
Raymond Terrace, South Brisbane, QLD, 4101
Ethics committee country [1] 288344 0
Australia
Date submitted for ethics approval [1] 288344 0
05/09/2012
Approval date [1] 288344 0
08/10/2012
Ethics approval number [1] 288344 0
1925M

Summary
Brief summary
Adverse fetal growth is strongly associated with adverse pregnancy outcome for the fetus and newborn. Close monitoring of fetal growth is an essential component of antenatal care in order to try and reduce the resultant risks associated with adverse growth. It is standard practice to
assess fetal growth by measuring symphyseal fundal height (SFH) at each antenatal visit and assessing the growth in line with a standard non-individualised growth chart. We have
developed a customised growth chart that we hypothesise that when compared to a standard growth chart, reduces the risk of adverse pregnancy outcome through increased detection of adverse growth. Therefore, this study is a single centre, blinded, two-arm, randomised controlled trial to compare the detection rates of adverse growth (both slowed growth and accelerated growth) and adverse fetal and neonatal outcomes when using a customised fetal growth chart compared with a standard growth chart. The study will be run at the Mater Mothers’ Hospital Antenatal Clinic, with women randomly allocated to receive either the standard chart or customised chart. This chart will then be used throughout pregnancy to plot serial measurements of SFH to monitor fetal growth. We aim to reduce the rate of our
composite perinatal morbidity outcome measure from 10% to 7.5%, which will require randomising 4,010 women. If our study hypothesis is proven, the low cost nature of this tool
allows for the possibility of implementation into developing countries, as well as rural and remote Australian settings, that do not have sophisticated monitoring equipment. By
implementing such a low cost solution to the difficult task of monitoring growth, there are potentially very large human and economic benefits from this research.
Trial website
Trial related presentations / publications
Gibbons K, Beckmann M, Flenady V, Gardener G, Gray P. Investigating the utility of the customised fetal growth chart: a randomised controlled trial. 8th International Conference on Fetal Growth; Berlin 2019.
Public notes

Contacts
Principal investigator
Name 34916 0
A/Prof Kristen Gibbons
Address 34916 0
Level 2, Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country 34916 0
Australia
Phone 34916 0
+61407966708
Fax 34916 0
Email 34916 0
kristen.gibbons@mater.uq.edu.au
Contact person for public queries
Name 18163 0
A/Prof Kristen Gibbons
Address 18163 0
Level 2, Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country 18163 0
Australia
Phone 18163 0
+61407966708
Fax 18163 0
Email 18163 0
kristen.gibbons@mater.uq.edu.au
Contact person for scientific queries
Name 9091 0
A/Prof Kristen Gibbons
Address 9091 0
Level 2, Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country 9091 0
Australia
Phone 9091 0
+61407966708
Fax 9091 0
Email 9091 0
kristen.gibbons@mater.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is confidential health data and IPD was not in the protocol


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.