Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000756426
Ethics application status
Approved
Date submitted
2/06/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mothers Heart Study: an observational study of early pregnancy cardiometabolic risk factors and risk for cardiovascular diseases in later life
Scientific title
Determining predispositions and impact of pregnancy on future cardiovascular risk of young Australian women
Secondary ID [1] 314429 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiometabolic risk factors 337475 0
Metabolic Syndrome (MetS) 337474 0
Condition category
Condition code
Reproductive Health and Childbirth 333843 333843 0 0
Childbirth and postnatal care
Metabolic and Endocrine 333842 333842 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
This study includes 4 study visits.
Visit 1 (prior to 16 weeks gestation) - At the first antenatal appointment, patients are asked questions about their demographics, current and past medical history, family history of hypertension, type 2 diabetes, ischemic heart disease and stroke. They are also asked about current health conditions, smoking, and level of physical activity. Some information, such as previous pregnancies and oral glucose test results are collected from the hospital’s medical records. Height and weight are measured and hemodynamic profile is assessed using USCOM BP+. The first visit will take approximately 20 to 25 minutes, as it includes signing consent forms and completing self-contained questionnaires.

Visit 2 (24-28 weeks' gestation)
During this visit, any change of data obtained at the interview during visit 1 will be re-assessed. Weight is measured and hemodynamic profile is assessed using USCOM BP+. It will take approximately 10 -15 min to obtain the above data.

Visit 3 (after 34 weeks' gestation)
During this visit, any change of data obtained at the interview during visit 2 will be re-assessed. Weight is measured and hemodynamic profile is assessed using USCOM BP+. It will take approximately 10 -15 min to obtain the above data.

Visit 4 (6 months postpartum)
During this visit, any change of data obtained at the interview during visit 3 will be re-assessed. Weight is measured and hemodynamic profile is assessed using USCOM BP+. A retinal image is taken, TANITA bioimpedance scale is used to assess segmental fat distribution. A fasting blood sample is taken to assess blood glucose and lipids. It will take approximately 25 - 30 min to obtain the above data.

Exposure group: Women with 2 or more risk factors will be allocated to group 2 (Exposure group).
Intervention code [1] 331063 0
Not applicable
Comparator / control treatment
We will classify women according to the presence or absence of pre-defined cardio metabolic risk factors prior to 16 weeks’ gestation

(BMI => 30kg/m2, systolic blood pressure => 130mmHg, diastolic blood pressure => 85mmHg, total cholesterol =>5.5mmol/L, triglycerides =>1.7mmol/l, HDL cholesterol < 1.2mmol/l, random plasma glucose =>5.6 mmol/L and smoking).

Comparator group: Women with none of the above risk factors will be allocated to group 1 (Comparator group).
Control group
Active

Outcomes
Primary outcome [1] 341462 0
Metabolic syndrome will be defined using Harmonizing definition as below, The presence of any three out of five risk factors. These risk factors are abdominal obesity waist circumference>=80 cm for women, elevated triglycerides >=150 mg/dL or 1.7 mmol/L, low HDL cholesterol =130/85 mmHg, and increased fasting glucose >=100 mg/dL or 5.6 mmol/L.
Timepoint [1] 341462 0
Six months postpartum.
Secondary outcome [1] 449197 0
Smoking
Timepoint [1] 449197 0
Prior to 16 weeks of gestation (Visit 1)
Secondary outcome [2] 449228 0
Pregnancy Complication (Preeclampsia): Preeclampsia is defined based on the revised ISSHP definition of gestational hypertension or postpartum hypertension with proteinuria (24-h urinary protein 300 mg or spot urine protein : creatinine ratio =30 mg/mmol creatinine or urine dipstick protein =++) or any multisystem complication of preeclampsia or utero-placental dysfunction as evidenced by intrauterine growth restriction. Multisystem complications include any of acute renal insufficiency defined as a new increase in serum creatinine concentration =100 µmol/L antepartum or >130 µmol/L postpartum; effects on liver, defined as raised aspartate transaminase or alanine transaminase concentration, or both, >45 IU/L and/or severe right upper quadrant or epigastric pain or liver rupture; neurological effects included eclampsia, imminent eclampsia (severe headache with hyper-reflexia and persistent visual disturbance), or cerebral haemorrhage; and haematological effects included thrombocytopenia (platelets <100×109/L), disseminated intravascular coagulation, or haemolysis.
Timepoint [2] 449228 0
After 20 weeks gestation
Secondary outcome [3] 448323 0
High blood pressure – Systolic >130 mmHg and/or diastolic >85 mmHg.
Timepoint [3] 448323 0
Prior to 16 weeks' gestation (Visit 1)
Secondary outcome [4] 448322 0
Abdominal Obesity (Waist circumference)
Timepoint [4] 448322 0
Prior to 16 weeks' gestation (Visit 1)
Secondary outcome [5] 447585 0
Obesity
Timepoint [5] 447585 0
Prior to 16 weeks' gestation (Visit 1)
Secondary outcome [6] 449227 0
Metabolic syndrome will be defined using Harmonizing definition as below, The presence of any three out of five risk factors. These risk factors are abdominal obesity waist circumference>=80 cm for women, elevated triglycerides >=150 mg/dL or 1.7 mmol/L, low HDL cholesterol =130/85 mmHg, and increased fasting glucose >=100 mg/dL or 5.6 mmol/L.
Timepoint [6] 449227 0
Prior to 16 weeks gestation (Visit 1)
Secondary outcome [7] 449233 0
Augmentation index
Timepoint [7] 449233 0
24 to 28 weeks gestation (Visit 2)
Secondary outcome [8] 449232 0
Augmentation index
Timepoint [8] 449232 0
Prior to 16 weeks gestation (Visit 1)
Secondary outcome [9] 449230 0
Small for gestational age is defined as birth weight below the 10th customised centile adjusted for maternal height, weight, parity and ethnicity, gestational age at delivery and infant sex
Timepoint [9] 449230 0
At the time of delivery
Secondary outcome [10] 449196 0
Dyslipidemia
Timepoint [10] 449196 0
Prior to 16 weeks of gestation (Visit 1)
Secondary outcome [11] 449235 0
Augmentation Index
Timepoint [11] 449235 0
At six months postpartum
Secondary outcome [12] 449198 0
Family history of type 2 diabetes, stroke, hypertension, ischemic heart diseases, thromboembolism.
Timepoint [12] 449198 0
Prior to 16 weeks of gestation (Visit 1)
Secondary outcome [13] 449229 0
Gestational diabetes mellitus is defined as fasting glucose = 5.1 mmol/L or a 1 hour 10.6mmol/L or a 2 h level of = 8.5 mmol/L following an Oral Glucose Tolerance Test.
Timepoint [13] 449229 0
Between 24 to 28 weeks gestation (Visit 2)
Secondary outcome [14] 449234 0
Augmentation Index
Timepoint [14] 449234 0
After 34 weeks of gestation (Visit 3)
Secondary outcome [15] 449231 0
Preterm Birth is defined as spontaneous preterm labour or preterm premature rupture of membranes resulting in a preterm birth at <37 weeks
Timepoint [15] 449231 0
At the time of delivery

Eligibility
Key inclusion criteria
All pregnant women attending antenatal clinics at Lyell McEwin Hospital prior to 16 weeks' gestation are eligible
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women who attend the first antenatal clinic appointment after 16 week's gestation

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A total of 127 women need to complete the fourth study visit to achieve 80% power to detect a significant difference (p < 0.05) in the prevalence of metabolic syndrome in the two groups, With an estimated 60% of women completing all the assessments including blood tests at the first visit and an estimated ~35% lost to follow up at the six months postpartum visit, we will recruit 325 pregnant women to this study. For categorical variables, Chi-square test will be used to compare the groups and the Fisher’s exact test will be used when the expected frequencies are below five. For continuous variables, student’s t-test will be used. Multivariable logistic regression will be used to calculate risk for MetS at 6 months postpartum among women who had 2 or more cardio metabolic risk factor prior to 16 weeks' gestation compared to those who had no risk factors adjusting for confounders.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
25/12/2023
Date of last participant enrolment
Anticipated
Actual
19/02/2025
Date of last data collection
Anticipated
16/03/2026
Actual
Sample size
Target
325
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27947 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 44140 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 318956 0
Hospital
Name [1] 318956 0
Lyell McEwin Hospital
Country [1] 318956 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 321595 0
Hospital
Name [1] 321595 0
Lyell McEwin Hospital
Address [1] 321595 0
Country [1] 321595 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317567 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 317567 0
Ethics committee country [1] 317567 0
Australia
Date submitted for ethics approval [1] 317567 0
04/04/2023
Approval date [1] 317567 0
27/06/2023
Ethics approval number [1] 317567 0
HREC/2022/00084

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

Contacts
Principal investigator
Name 141450 0
Dr Dr. Prabha Andraweera
Address 141450 0
Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112 (Since this is a hospital, there is no street number)
Country 141450 0
Australia
Phone 141450 0
+61881618117
Fax 141450 0
Email 141450 0
[email protected]
Contact person for public queries
Name 141451 0
Aasiya Mohebi
Address 141451 0
Lyell McEwin Hosptal, Haydown Road, Elizabeth Vale, SA 5112 (Since this is a hospital, there is no street number)
Country 141451 0
Australia
Phone 141451 0
+61881618117
Fax 141451 0
Email 141451 0
[email protected]
Contact person for scientific queries
Name 141452 0
Dr. Prabha Andraweera
Address 141452 0
Lyell McEwin Hosptal, Haydown Road, Elizabeth Vale, SA 5112 (Since this is a hospital, there is no street number)
Country 141452 0
Australia
Phone 141452 0
+61881618117
Fax 141452 0
Email 141452 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    WCHN HREC approval.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.