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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perinatal outcomes

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

Discharge of baby from hospital

Secondary outcome [1]

Proportion of babies confirmed as SGA on ultrasound of those referred

Timepoint [1]

Discharge of baby from hospital

Secondary outcome [2]

Proportion of babies confirmed as large-for-gestational age (LGA) on ultrasound of these referred

Timepoint [2]

Discharge of baby from hospital

Secondary outcome [3]

Classification of SGA by Birthweight Appropriateness Quotient and/or population based charts

Timepoint [3]

Discharge of baby from hospital

Secondary outcome [4]

Classification of LGA by Birthweight Appropriateness Quotient and/or population based charts

Timepoint [4]

Discharge of baby from hospital

Secondary outcome [5]

Preterm birth (defined as birth less than <37 weeks and <34 weeks); identified from routinely collected data

Timepoint [5]

Discharge of baby from hospital

Secondary outcome [6]

Proportion of caesarean sections (CS)/inductions for SGA/LGA; identified from routinely collected data

Timepoint [6]

Discharge of baby from hospital

Secondary outcome [7]

Individual perinatal outcomes that comprise the primary outcome measure; identified from routinely collected data

Timepoint [7]

Discharge of baby from hospital

Secondary outcome [8]

Perineal trauma; identified from routinely collected data

Timepoint [8]

Discharge of baby from hospital

Secondary outcome [9]

Cost of interventions (such as ultrasound scans and antenatal/neonatal admissions); identified from routinely collected data

Timepoint [9]

Discharge of baby from hospital

Secondary outcome [10]

Fetal distress; identified from routinely collected data

Timepoint [10]

Discharge of baby from hospital

Secondary outcome [11]

Resuscitation (such as need for intubation); identified from routinely collected data

Timepoint [11]

Discharge of baby from hospital

Secondary outcome [12]

Mechanical ventilation; identified from routinely collected data

Timepoint [12]

Discharge of baby from hospital

Secondary outcome [13]

Chronic neonatal lung disease; identified from routinely collected data

Timepoint [13]

Discharge of baby from hospital

Secondary outcome [14]

Shoulder dystocia; identified from routinely collected data

Timepoint [14]

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]

Mater Mother's Hospital - South Brisbane

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mater Mothers Golden Casket Research Grant

Address [1]

Raymond Terrace, South Brisbane, QLD, 4101

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mater Medical Research Institue

Address

Raymond Terrace, South Brisbane, QLD, 4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services Human Research Ethics Committee

Ethics committee address [1]

Raymond Terrace, South Brisbane, QLD, 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/09/2012

Approval date [1]

08/10/2012

Ethics approval number [1]

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

A/Prof Kristen Gibbons

Address

Level 2, Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101

Country

Australia

Phone

+61407966708

Fax

Email

kristen.gibbons@mater.uq.edu.au

Contact person for public queries

Name

Kristen Gibbons

Address

Level 2, Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101

Country

Australia

Phone

+61407966708

Fax

Email

kristen.gibbons@mater.uq.edu.au

Contact person for scientific queries

Name

Kristen Gibbons

Address

Level 2, Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101

Country

Australia

Phone

+61407966708

Fax

Email

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.