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Investigating the utility of the customised fetal growth chart: a randomised controlled trial

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?

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001215819
Enrollment
3993
Registered
2012-11-16
Start date
2014-03-26
Completion date
2017-11-29
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Mater Medical Research Institue
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
13 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

All women receiving routine antenatal care

Exclusion criteria

Multiple gestation Participation in GP shared care

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026