Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001344583
Ethics application status
Approved
Date submitted
3/07/2024
Date registered
6/11/2024
Date last updated
6/11/2024
Date data sharing statement initially provided
6/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
PROMOTE Cohort Study: maternal & PeRinatal Outcomes aMongst wOmen with and without obEsity – a personalised and acceptable approach of risk assessment and stratification using social, clinical, nutritional and physical activity data
Scientific title
PROMOTE Cohort Study: maternal & PeRinatal Outcomes aMongst wOmen with and without obEsity – a personalised and acceptable approach of risk assessment and stratification using social, clinical, nutritional and physical activity data.
Secondary ID [1] 309222 0
None
Universal Trial Number (UTN)
U1111-1289-8516
Trial acronym
PROMOTE Cohort Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 329363 0
Obesity 329364 0
Gestational diabetes 329365 0
Hypertensive disorders of pregnancy 329366 0
Large for gestational age 329367 0
Cardiometabolic disease 329368 0
Mood disorders 329369 0
Breastfeeding 329370 0
Condition category
Condition code
Reproductive Health and Childbirth 326306 326306 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 326307 326307 0 0
Normal pregnancy
Reproductive Health and Childbirth 326308 326308 0 0
Other reproductive health and childbirth disorders
Diet and Nutrition 326309 326309 0 0
Obesity
Diet and Nutrition 326310 326310 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 326311 326311 0 0
Diabetes
Metabolic and Endocrine 326312 326312 0 0
Metabolic disorders
Cardiovascular 326313 326313 0 0
Hypertension
Public Health 326314 326314 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study design: Prospective cohort study.
Study setting/population: Pregnant women booking/attending for antenatal care (<16 weeks gestation) at Westmead Hospital will be recruited.
(i) Exposures of interest collected from routine clinical data (electronic maternity records) will include: sociodemographic, clinical history (including past medical history, medical co-morbidities – particularly pre-existing diabetes / hypertension, medical complications in pregnancy, weight gain between pregnancy), obstetric history (e.g. parity, previous obstetric complications), weight, height and BMI, mental health screening, and breastfeeding history using the BLISS score, all currently measured as part of routine care.
(ii) Participants will complete surveys at booking that will take the participants approximately 15-30 minutes to complete.
All participants will be requested to:
• Record self-reported physical activity levels using the Australia Active Survey (5-15 minutes)
• Complete a dietary assessment using a validated short screening tool, based on state nutrition monitoring assessment questions from the Centre for Epidemiology and Evidence, NSW Ministry of Health (5-15 minutes)
• Complete the Depression, Anxiety and Stress Scale (DASS) (5-15 minutes)
• Provide socioeconomic information, including household structure, educational attainment, employment status and income (5-15 minutes)
Furthermore, a subgroup cohort will be requested to sign a separate PICF and complete the following additional 3 surveys:
• The Pregnancy Physical Activity Questionnaire (5-15 minutes)
• A 50-item Food Frequency Questionnaire (10-15 minutes)
• Vulnerable Personality Style Questionnaire (5-15 minutes)
Study recruitment acceptance rate and questionnaire completion rate will be collected.
(iii) An optional request for participants to consent for the collection of a maternal blood sample, to perform a limited range of blood tests on this sample when funding becomes available, and consent for biobanking. Samples will be collected via the hospital’s pathology service, or by study recruitment staff where appropriately qualified. Blood tests we wish to perform are related to cardiometobolic risk and include: glucose level, HbA1c, glycated albumin, lipid profile (total cholesterol, triglycerides, low density lipoprotein, high density lipoprotein), liver function tests and inflammatory markers (C-reactive protein and erythrocyte sedimentation rate). Where tests are part of routine care, results will be obtained from routine data. Where tests are not part of routine care (e.g. lipid profile and inflammatory markers) we seek permission for the collection of samples. We also seek permission for biobanking. The aims of biospecimen collection and biobanking are to better understand the biochemical indicators of metabolic and placental related adverse outcomes in pregnancy in this population. Ethics approval and further funding will be sought for any additional future analysis on biobanked samples, beyond the scope of what has been described above.
During pregnancy (subgroup) –
The subgroup of women consenting to longitudinal data collection will be asked to undergo their routine 20 week morphology scan at Westmead Hospital. Such scans form part of routine care, but are often performed externally by private radiology services. The participants in the substudy will be invited to have their routine scans at Westmead Hospital itself. They will be asked to perform the following at their routine antenatal care visits at two additional timepoints during pregnancy at 24-28 weeks’ and 34-39 weeks’ gestation.
(i) Participants will be asked to repeat the four surveys completed in early pregnancy:
(ii) Collection of maternal blood samples for biobanking and to later perform a limited range of tests related to cardiometabolic risk as detailed above. These will be collected by the hospital’s pathology service or by appropriately qualified study recruitment staff. They will be performed at the same time as routine pathology collection wherever possible (for example, at the same time as routine oral glucose tolerance test).
(iii) Fetal ultrasounds for routine biometry and investigational measures potentially related to fetal growth and perinatal outcomes. These will be performed by a qualified member of the study team at Westmead Hospital. Any concerns raised at any ultrasound visit will be escalated to the clinical teams as per routine clinical pathways.
At delivery –
(iv) We will also request participant consent for the collection of a blood sample from the umbilical cord and biobanking this blood sample. Samples will be collected by appropriately trained recruitment midwife or study staff. Ethics approval and further funding will be sought for any future study on biobanked samples.
The intended goal of the biobank maternal and fetal cord blood would be to better understand biomarkers of cardiometabolic risk, both well known variables and also newer potential markers of cardiometabolic health. These will include glucose level, glycated albumin, glycated haemoglobin F by modified methods, c-peptide, insulin, lipid profile and inflammatory markers.
After delivery (subgroup only) –
(i) The subgroup of women consenting to longitudinal data collection will be asked to consent to measurement of neonatal anthropometry. This will be performed by study staff within three days of delivery and while the infant remains admitted at Westmead Hospital. Measurements will not be performed if the infant is clinically unsuitable as deemed by study, medical or nursing staff or the participant (for example, infant in neonatal intensive care). There will be no follow-up requirements following hospital discharge after delivery.
Pregnancy and birth outcomes –routine data on the maternity information systems:
(i) Progress in pregnancy: e.g longitudinal BP and weight gain in pregnancy, fetal growth;
(ii) Complications: e.g glycaemic problems and gestational diabetes, pregnancy induced hypertension (PIH), pre-eclampsia (PET), fetal growth anomalies, and their associated morbidity;
(iii) Birth onset: e.g preterm induction of labour, and outcomes: e.g live birth, mode of delivery, neonatal condition at birth;
Intervention code [1] 325664 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334173 0
Incidence of gestational diabetes
Timepoint [1] 334173 0
Oral glucose tolerance test during pregnancy
Primary outcome [2] 334174 0
Incidence of hypertensive disorder of pregnancy collected from routine clinical record, and measurement conducted under circumstances of usual clinical care
Timepoint [2] 334174 0
During pregnancy
Primary outcome [3] 334175 0
Preterm birth, extracted from routine clinical record by way of gestational age at delivery
Timepoint [3] 334175 0
Gestation at birth
Secondary outcome [1] 419651 0
Sociodemographic determinants of health behaviours in pregnancy.. This will be extracted from routinely collected clinical data, and via a bespoke study-specific sociodemographic questionnaire.
Timepoint [1] 419651 0
At early antenatal visit(s), usually <16 weeks
Secondary outcome [2] 419652 0
Birth onset outcomes: Weight at birth. Extracted from routine clinical record.
Timepoint [2] 419652 0
At birth.
Secondary outcome [3] 437882 0
Birth onset outcomes: live birth. Extracted from routine clinical record.
Timepoint [3] 437882 0
At delivery
Secondary outcome [4] 437883 0
Birth onset outcomes: mode of delivery. Extracted from routine clinical record.
Timepoint [4] 437883 0
At birth
Secondary outcome [5] 437884 0
Birth onset outcomes: neonatal condition at birth. Extracted from routine clinical record, including APGAR score.
Timepoint [5] 437884 0
At birth

Eligibility
Key inclusion criteria
Pregnant women enrolling for antenatal care who are able to give informed consent will be invited for participation. Participation will include data about both the mother and offspring. Pregnant people unable to provide informed consent will not be eligible.
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
This study will have ongoing assessment of the completeness of routinely collected data for the exposures of interest, pregnancy and birth outcomes and the completeness of detailed assessment of physical activity, dietary, mental health and socioeconomic assessments described above.

The rates of gestational diabetes and other birth and pregnancy outcomes will be determined within various subgroups of the population and models developed to determine relationships between the risk factors and the development of GDM and other outcomes. Other pregnancy and birth outcomes include pregnancy induced hypertension (PIH) and preeclampsia, and composite neonatal morbidity.

Existing research has identified likely sources of variation between subgroups of women at risk of GDM, namely age, BMI, and ethnicity. Concurrent research by this group is aiming to identify and characterise subgroups of women at differing risk for GDM using retrospectively collected routine clinical data. These studies will form a set of a priori hypotheses that can be prioritised in the analysis of the present cohort.

Summary statistics will describe the characteristics of the PROMOTE cohort. To understand representativeness, characteristics will be compared against the background population. Descriptive statistics will be presented on the relationship between outcomes of interest and baseline risk factors. Exercise and nutritional information, as newly collected variables, will be incorporated into assessment of risk. Continuous variables will be summarised as mean ± standard deviation if normally distributed, and median and interquartile range if not. Categorical variables will be presented as frequency (%) in relevant categories.

Variable selection for multivariable models will be based on the relationships between variables observed on summary statistics. We anticipate that these models will utilise either a set of interaction terms or a risk-classification variable. In each instance significance of a particular variable (or combination thereof) will be assessed via a likelihood ratio test. An automatic stepwise selection procedure will not currently be pursued as an assumption of this study is that GDM risk factors are likely multifactorial, interact with each other, and the underlying causal pathways of those interactions are not necessarily known. We believe that a focussed analysis will achieve a better understanding of the underlying mechanisms contributing to GDM and other outcomes of interest. The complete list of interaction terms tested, membership rules for any risk-classification variable, and substantive justification for the inclusion of each hypothesis will be detailed per prospective analysis plans and reported with each publication.

Statistical analysis will be conducted in R Studio Version 4. Hypotheses will be conducted at a family-wise significance level of 0.05 with a two-sided alternative. Appropriate Bonferroni corrections will be made to the significance level of individual hypotheses. Inevitably this study contains an appreciable risk of false discoveries, but we believe our careful approach to hypothesis selection will mitigate the consequences and improve transparency.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
500
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39844 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 313410 0
University
Name [1] 313410 0
Reproduction and Perinatal Centre, University of Sydney
Country [1] 313410 0
Australia
Primary sponsor type
University
Name
Professor Dharmintra Pasupathy, Director, Reproduction and Perinatal Centre, University of Sydney
Address
Westmead Clinical School, University of SydneyWestmead Hospital NSW 2145
Country
Australia
Secondary sponsor category [1] 315176 0
Hospital
Name [1] 315176 0
Westmead Hospital
Address [1] 315176 0
Westmead HospitalHawkesbury Road, Westmead NSW 2145
Country [1] 315176 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312627 0
Western Sydney Local Health District Human Research Ethics Committee (HREC)
Ethics committee address [1] 312627 0
Ethics committee country [1] 312627 0
Australia
Date submitted for ethics approval [1] 312627 0
18/02/2021
Approval date [1] 312627 0
07/06/2021
Ethics approval number [1] 312627 0
2021/ETH00287

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

Contacts
Principal investigator
Name 125334 0
Prof Dharmintra Pasupathy
Address 125334 0
L6 Block K Westmead Hospital, Cnr Hawkesbury Road and Darcy Rd, PO Box 533 Westmead NSW 2145, Australia
Country 125334 0
Australia
Phone 125334 0
+610288904851
Fax 125334 0
Email 125334 0
[email protected]
Contact person for public queries
Name 125335 0
Dharmintra Pasupathy
Address 125335 0
L6 Block K Westmead Hospital, Cnr Hawkesbury Road and Darcy Rd, PO Box 533 Westmead NSW 2145, Australia
Country 125335 0
Australia
Phone 125335 0
+610288904851
Fax 125335 0
Email 125335 0
[email protected]
Contact person for scientific queries
Name 125336 0
Dharmintra Pasupathy
Address 125336 0
L6 Block K Westmead Hospital, Cnr Hawkesbury Road and Darcy Rd, PO Box 533 Westmead NSW 2145, Australia
Country 125336 0
Australia
Phone 125336 0
+610288904851
Fax 125336 0
Email 125336 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers with appropriate Human Research Ethics approval

Conditions for requesting access:
• -

What individual participant data might be shared?
• Anonymised data may be made available after application to the Principal Investigator.

What types of analyses could be done with individual participant data?
• Epidemiological

When can requests for individual participant data be made (start and end dates)?
From:
From mid-2025, available for 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By application to the PI directly - Professor Dharmintra Pasupathy via email [email protected]

Are there extra considerations when requesting access to 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.