ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001558213

Ethics application status

Approved

Date submitted

13/09/2018

Date registered

18/09/2018

Date last updated

10/05/2021

Date data sharing statement initially provided

23/08/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Observations of Maternal Creatine Levels Throughout Gestation in Low Risk Pregnant Women. The Creatine and Pregnancy Outcomes (CPO) Study.

Scientific title

Creatine and Pregnancy Outcomes (CPO) - A Prospective Cohort Study of Maternal Creatine Homeostasis in Low Risk Pregnant Women

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Pregnancy

Diet and Nutrition

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is an observational study across gestation. It involves the collection of blood and urine samples, and dietary information from pregnant women at 6 time-points during gestation, [1] 10-20 weeks, [2] 21-23 weeks, [3] 24-27 weeks, [4] 28-32 weeks, [5] 33-36 weeks & [6] Birth.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Concentrations of creatine in maternal blood throughout pregnancy.

Timepoint [1]

10-20 weeks, 21-23 weeks, 24-27 weeks, 28-32 weeks, 33-36 weeks & Birth.

Primary outcome [2]

Concentrations of creatine in maternal urine throughout pregnancy

Timepoint [2]

10-20 weeks, 21-23 weeks, 24-27 weeks, 28-32 weeks, 33-36 weeks & Birth.

Primary outcome [3]

Concentrations of creatine in cord blood.

Timepoint [3]

Birth

Secondary outcome [1]

Dietary nutrient intake of women whilst pregnant (composite of macro and micro nutrient), based on data collected from Cancer Council's Dietary Questionaire for Epidemiological studies and 24 hour food recalls, analysed using Foodworks 8 (Xyris software).

Timepoint [1]

10-20 weeks, 21-23 weeks, 24-27 weeks, 28-32 weeks, 33-36 weeks & Birth.

Secondary outcome [2]

Placental creatine content, measured from a punch biopsy from placental tissue, using LC-MS/MS

Timepoint [2]

Birth

Secondary outcome [3]

Placental creatine synthesis at term (composite of mRNA and protein expression of synthesising enzymes AGAT and GAMT). mRNA will be measured using RT-qPCR. Protein measurements will be conducted using western blot.

Timepoint [3]

Birth

Eligibility

Key inclusion criteria

Pregnant women attending low risk antenatal clinics and planning to birth at Monash Health, Melbourne, Victoria

Minimum age

18 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Women who have a known significant pre-existing major medical condition or who have been assessed as high risk or have a multiple pregnancy

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

All data will be assessed for normality. Appropriate descriptive statistics of the study sample with be tabulated. The association between maternal age group (<20 years, 20-30 years and 30plus), BMI (<19, 19-24.9, 25-29.9 and >=30), maternal ethnicity, diet, GWG, and urine and plasma creatine over pregnancy will be determined using linear mixed models. Maternal concentrations of creatine, creatine kinase, arginine, glycine and methionine in blood and urine samples will be summarized and graphically presented over the 5 time points. The correlation between circulating and excreted creatine, amino acids and metabolites, at each of the gestation points, will also be determined. As this is the first prospective human work on the creatine kinase circuit at birth in both cord blood and the placenta, we will also determine the correlation and agreement (ICC) between placental and cord creatine concentrations at birth. Placental and cord blood concentrations of creatine, creatine kinase, arginine, glycine and methionine, along with molecular analysis of the creatine transporter (SLC6A8) and synthesising enzymes arginine: glycine aminotransferase (AGAT) and guanidinoacetate methyltransferase (GAMT) in placental tissues will be graphically determined at birth. The association between potential confounders such as dietary intake, body mass index (BMI), physical activity level (PAL), and gestational weight gain, (GWG) across each time point in pregnancy and maternal creatine (plasma and urine) over pregnancy will be assessed. Multivariate linear mixed models will be used to determine the associations between creatine concentrations (and associated factors), maternal diet over pregnancy as well as with growth outcomes adjusting for potential confounders.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/12/2015

Date of last participant enrolment

Anticipated

Actual

15/11/2017

Date of last data collection

Anticipated

31/12/2019

Actual

31/03/2021

Sample size

Target

284

Accrual to date

Final

224

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Dandenong Hospital - Dandenong

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3175 - Dandenong

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Stillbirth Foundation Australia

Address [1]

PO Box 135, Annandale NSW 2038

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Stacey Ellery

Address

Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Monash Health

Address [1]

Monash Medical Centre
246 Clayton Road,
Clayton Victoria 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

246 Clayton Road, 
Clayton Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2014

Approval date [1]

05/11/2014

Ethics approval number [1]

14140B

Summary

Brief summary

Creatine is a dietary metabolite responsible for buffering quick changes in cellular energy supply and demand. We hypothesise that maintaining a particular level of circulating creatine during pregnancy can help ensure proper development and function of the placenta, and assist in fetal growth and development. 

The Creatine and Pregnancy Outcomes Study - CPO - has been specifically designed to provide thorough understanding of maternal creatine metabolism across gestation, including the placenta's contribution to maternal and fetal creatine levels. We will also collect nutrition data to enhance our understanding of how differing dietary habits over pregnancy may impact on creatine levels, and if these differences affect pregnancy outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Stacey Ellery

Address

Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168

Country

Australia

Phone

+61 (03) 85722870

Fax

stacey.ellery@hudson.org.au

Contact person for public queries

Name

Deborah De Guingand

Address

Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168

Country

Australia

Phone

+61 (03) 85722819

Fax

deborah.deguingand@hudson.org.au

Contact person for scientific queries

Name

Stacey Ellery

Address

Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168

Country

Australia

Phone

+61 (03) 85722870

Fax

stacey.ellery@hudson.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4195	Study protocol	De Guingand, D. L., Ellery, S. J., Davies-Tuck, M. L., & Dickinson, H. (2019). Creatine and pregnancy outcomes, a prospective cohort study in low-risk pregnant women: study protocol. BMJ open, 9(1), e026756	https://bmjopen.bmj.com/content/9/1/e026756.full			375994-(Uploaded-20-08-2019-15-50-47)-Study-related document.pdf

Results publications and other study-related documents

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