Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001351505
Ethics application status
Approved
Date submitted
17/10/2024
Date registered
8/11/2024
Date last updated
8/11/2024
Date data sharing statement initially provided
8/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lactation Intensity and reduction in the prevalence of metabolic syndrome after a maternal complication of pregnancy: an observational cohort analysis
Scientific title
Lactation Intensity and reduction in the prevalence of metabolic syndrome after a maternal complication of pregnancy: an observational cohort analysis in women with a previous pregnancy complication.
Secondary ID [1] 313210 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertensive disorders of pregnancy 335505 0
Gestational diabetes 335506 0
Spontaneous preterm birth/intrauterine growth restriction 335507 0
Placental abruption 335508 0
Metabolic syndrome 335509 0
Condition category
Condition code
Cardiovascular 332065 332065 0 0
Hypertension
Metabolic and Endocrine 332066 332066 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligible women who are referred to COFFEE (Cardiovascular Assessment After Obstetric Complications: Follow-Up For Education and Evaluation) clinic are included in this study. COFFEE clinic is a postpartum cardiovascular preventative service at the Lyell McEwin Hospital for women with previous complications of pregnancy. They are routinely assessed by a cardiac nurse practitioner at 6 months, 18 months and 5 years post-pregnancy for cardiovascular disease risk and primary prevention through lifestyle modification. Women at the time of their antenatal discharge will be contacted by the researcher either at time of discharge or within 5 weeks of discharge via telephone to participate in the study. Upon informed consent and enrollment to the study, participants will be asked to complete short, online questionnaires once a month on breastfeeding difficulties, and infant feeding patterns. They will complete 1 questionnaire a month for the period of 6 months. Data from their COFFEE clinic postpartum appointment at 6 months will be collected to assess cardio-metabolic risk factors including weight, blood pressure and biochemical markers.
Intervention code [1] 329783 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339660 0
Metabolic syndrome
Assessment method [1] 339660 0
Metabolic syndrome as defined by The Harmonizing The Metabolic Syndrome Definition (Alberti 2009) : Any woman must have 3 of the following 5 cardiometabolic risk factors to be diagnosed with Metabolic Syndrome: • Elevated waist circumference > 80 cm (measured with measuring tape (midway between the lowest ribs and the iliac crest in standing participants to the nearest centimetre using a measuring tape). • Elevated triglycerides > 1.7 mmol/L; or drug treatment for elevated triglycerides (based on blood test result and/or patient self-report) • Reduced HDL-C < 1.3mmol/L; or drug treatment for reduced HDL-C (based on blood test result and/or patient self-report) • Elevated systolic blood pressure > 130 mmHg and or diastolic blood pressure > 85 mmHg; or use of antihypertensive medication in a patient with a history of hypertension (based on blood pressure measurement after two repeated measures and/or patient self-report) • Elevated fasting glucose; or drug treatment of elevated glucose (based on blood test result and/or patient self-report)
Timepoint [1] 339660 0
6 months postpartum, 18 months postpartum
Secondary outcome [1] 440784 0
Hypertension
Assessment method [1] 440784 0
As per Harmonizing the Metabolic syndrome definition Systolic >130 and/or diastolic >85 mm Hg or drug treatment for hypertension. Blood pressure will be taken using a Supra-systolic oscillometric central blood pressure monitoring device after the patient is seated for a minimum of 20 minutes, with the appropriate sized cuff placed on the left upper arm.
Timepoint [1] 440784 0
6 and 18 months postpartum
Secondary outcome [2] 440785 0
Dyslipidemia
Assessment method [2] 440785 0
As per Harmonizing the Metabolic syndrome definition: Elevated Triglycerides >150 mg/dL (1.7 mmol/L) and/or HDL-C <50 mg/dL (1.3 mmol/L) in females or drug treatment for either, confirmed through blood test or patient self-report of use of medications for lipid management.
Timepoint [2] 440785 0
6 and 18 months postpartum
Secondary outcome [3] 440786 0
Waist circumference
Assessment method [3] 440786 0
Population- and country-specific definitions (i.e. >=80cm) (measured with measuring tape (midway between the lowest ribs and the iliac crest in standing participants to the nearest centimetre using a measuring tape).
Timepoint [3] 440786 0
6 and 18 months postpartum
Secondary outcome [4] 440787 0
dysglycemia
Assessment method [4] 440787 0
>100 mg/dL or drug treatment of elevated glucose, confirmed by either fasting blood test and/or self-report of using drug treatment for elevated glucose.
Timepoint [4] 440787 0
6 and 18 months postpartum
Secondary outcome [5] 440788 0
Insulin resistance
Assessment method [5] 440788 0
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Timepoint [5] 440788 0
6 and 18 months postpartum

Eligibility
Key inclusion criteria
Women with a previous pregnancy complication who are referred to a postpartum cardiovascular preventative clinic at 6 months postpartum:
• Hypertensive disorders of pregnancy (including gestational hypertension, preeclampsia, eeclampsia and HELLP syndrome), requiring medical therapy or resulting in <37 weeks’ gestation;
• Gestational diabetes mellitus requiring metformin or insulin therapy;
• Preterm delivery at <35 weeks’ gestation;
• Delivery of a small for gestational age infant;
• Placental abruption
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients without ability to provide informed consent
• Patients <18 years of age

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant characteristics will be summarised using means and standard deviations, or median and interquartile range for continuous variables, and frequencies and percentages for categorical variables.
A point bi-serial correlation coefficient will be calculated to measure the strength of the association between the lactation intensity ratio and prevalence of metabolic syndrome at 6 months postpartum (binary = Yes or No).
Logistic regression will be used to explore the effect of breastfeeding intensity score on metabolic syndrome. The model will be adjusted for age, SES, BMI and smoking status. The model will be based on both the continuous breastfeeding intensity score and dichotomised ratio, where score >=0.80.
With 80% power, sample size of 250 women is required to detect an absolute reduction of 16.9% (from 38.1% to 21.2%) in the proportion of women who have metabolic syndrome who breastfeed at 6 months postpartum compared to non-breastfeeding women in the study cohort.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
250
Accrual to date
91
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27248 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 43329 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 317652 0
University
Name [1] 317652 0
University of Adelaide
Country [1] 317652 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Country
Australia
Secondary sponsor category [1] 319968 0
Government body
Name [1] 319968 0
Northern Adelaide Local Health Network
Country [1] 319968 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316351 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316351 0
Ethics committee country [1] 316351 0
Australia
Date submitted for ethics approval [1] 316351 0
20/07/2023
Approval date [1] 316351 0
01/08/2023
Ethics approval number [1] 316351 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 137622 0
A/Prof Margaret Arstall
Address 137622 0
Department of Cardiology, Lyell McEwin Hospital, Elizabeth Vale SA 5112
Country 137622 0
Australia
Phone 137622 0
+61 0881829439
Email 137622 0
margaret.arstall@sa.gov.au
Contact person for public queries
Name 137623 0
Dr Maleesa Pathirana
Address 137623 0
Department of Cardiology, Lyell McEwin Hospital, Elizabeth Vale SA 5112
Country 137623 0
Australia
Phone 137623 0
+61 088133214
Email 137623 0
maleesa.pathirana@adelaide.edu.au
Contact person for scientific queries
Name 137624 0
Dr Maleesa Pathirana
Address 137624 0
Department of Cardiology, Lyell McEwin Hospital, Elizabeth Vale SA 5112
Country 137624 0
Australia
Phone 137624 0
+61 088133214
Email 137624 0
maleesa.pathirana@adelaide.edu.au

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


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.