Trial Review

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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] 296073 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy
 309634 0
Diet and Nutrition 309636 0
Condition category
Condition code
Reproductive Health and Childbirth 308444 308444 0 0
Normal pregnancy
Diet and Nutrition 308463 308463 0 0
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] 312409 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307420 0
Concentrations of creatine in maternal blood throughout pregnancy.
Timepoint [1] 307420 0
10-20 weeks, 21-23 weeks, 24-27 weeks, 28-32 weeks, 33-36 weeks & Birth.
Primary outcome [2] 307421 0
Concentrations of creatine in maternal urine throughout pregnancy
Timepoint [2] 307421 0
10-20 weeks, 21-23 weeks, 24-27 weeks, 28-32 weeks, 33-36 weeks & Birth.
Primary outcome [3] 307422 0
Concentrations of creatine in cord blood.
Timepoint [3] 307422 0
Birth
Secondary outcome [1] 351867 0
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] 351867 0
10-20 weeks, 21-23 weeks, 24-27 weeks, 28-32 weeks, 33-36 weeks & Birth.
Secondary outcome [2] 351868 0
Placental creatine content, measured from a punch biopsy from placental tissue, using LC-MS/MS
Timepoint [2] 351868 0
Birth
Secondary outcome [3] 351869 0
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] 351869 0
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?
No
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] 11839 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 11840 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 23977 0
3168 - Clayton
Recruitment postcode(s) [2] 23978 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 300665 0
Charities/Societies/Foundations
Name [1] 300665 0
Stillbirth Foundation Australia
Country [1] 300665 0
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] 300184 0
Hospital
Name [1] 300184 0
Monash Health
Address [1] 300184 0
Monash Medical Centre
246 Clayton Road,
Clayton Victoria 3168
Country [1] 300184 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301447 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 301447 0
Ethics committee country [1] 301447 0
Australia
Date submitted for ethics approval [1] 301447 0
15/05/2014
Approval date [1] 301447 0
05/11/2014
Ethics approval number [1] 301447 0
14140B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87034 0
Dr Stacey Ellery
Address 87034 0
Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168
Country 87034 0
Australia
Phone 87034 0
+61 (03) 85722870
Fax 87034 0
Email 87034 0
[email protected]
Contact person for public queries
Name 87035 0
Deborah De Guingand
Address 87035 0
Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168
Country 87035 0
Australia
Phone 87035 0
+61 (03) 85722819
Fax 87035 0
Email 87035 0
[email protected]
Contact person for scientific queries
Name 87036 0
Stacey Ellery
Address 87036 0
Hudson Institute of Medical Research
27-31 Wright Street
Clayton Victoria 3168
Country 87036 0
Australia
Phone 87036 0
+61 (03) 85722870
Fax 87036 0
Email 87036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4195Study protocolDe 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), e026756https://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

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

Documents added automatically
No additional documents have been identified.