Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001595808
Ethics application status
Approved
Date submitted
13/08/2021
Date registered
22/11/2021
Date last updated
22/11/2021
Date data sharing statement initially provided
22/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the impact of maternal diseases in pregnancy
Scientific title
Understanding the impact of maternal chronic and acquired diseases in pregnancy: a cohort study
Secondary ID [1] 305039 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac disease 323213 0
Kidney disease 323214 0
Pregnancy 323215 0
Condition category
Condition code
Cardiovascular 320794 320794 0 0
Other cardiovascular diseases
Renal and Urogenital 320795 320795 0 0
Kidney disease
Reproductive Health and Childbirth 321305 321305 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
This study will prospectively record the incidence, prevalence, etiology, outcomes, and follow up of maternal cardiac disease and chronic kidney disease (CKD) in the obstetric population of South Australia. No active participation will be required to participate in this study, as only clinical data from medical records will be collected. Not additional testing or interventions are required for participants. After the index pregnancy, participants will be contacted for follow-up annually for ten years postpartum.
Intervention code [1] 321431 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328608 0
Incidence of maternal cardiac or renal disease
Data pertaining to this outcome will be collected using medical record review.
Timepoint [1] 328608 0
Baseline (time of enrolment), time of delivery of index pregnancy, 6-months postpartum, 1-year postpartum, 2-years postpartum, 3-years postpartum, 4-years postpartum, 5-years postpartum, 6-years postpartum, 7-years postpartum, 8-years postpartum, 9-years postpartum, 10-years postpartum
Primary outcome [2] 329086 0
Etiology of maternal cardiac or renal disease
Data pertaining to this outcome will be collected using medical record review.
Timepoint [2] 329086 0
Baseline (time of enrolment), time of delivery of index pregnancy, 6-months postpartum, 1-year postpartum, 2-years postpartum, 3-years postpartum, 4-years postpartum, 5-years postpartum, 6-years postpartum, 7-years postpartum, 8-years postpartum, 9-years postpartum, 10-years postpartum
Primary outcome [3] 329087 0
Maternal hospitalisations after index pregnancy
Data pertaining to this outcome will be collected using medical record review and follow-up of participants.
Timepoint [3] 329087 0
Time of delivery of index pregnancy, 6-months postpartum, 1-year postpartum, 2-years postpartum, 3-years postpartum, 4-years postpartum, 5-years postpartum, 6-years postpartum, 7-years postpartum, 8-years postpartum, 9-years postpartum, 10-years postpartum
Secondary outcome [1] 401388 0
Infant mortality
Timepoint [1] 401388 0
Time of birth, 6-months postpartum, 1-year postpartum, 2-years postpartum, 3-years postpartum, 4-years postpartum, 5-years postpartum, 6-years postpartum, 7-years postpartum, 8-years postpartum, 9-years postpartum, 10-years postpartum
Secondary outcome [2] 403035 0
Maternal mortality
Timepoint [2] 403035 0
Time of birth, 6-months postpartum, 1-year postpartum, 2-years postpartum, 3-years postpartum, 4-years postpartum, 5-years postpartum, 6-years postpartum, 7-years postpartum, 8-years postpartum, 9-years postpartum, 10-years postpartum

Eligibility
Key inclusion criteria
1) Are pregnant AND
2) Present with at least one of the following:
a. Congenital cardiac disease
b. Valvular heart disease
c. Cardiomyopathy
d. Ischaemic heart disease
e. Arrhythmia
f. Pulmonary hypertension
g. Aortic pathology
h. Pre-conception diagnosis of CKD of any stage (including dialysis and transplant recipients)
i. Newly identified kidney impairment in pregnancy, defined by any one of the following:
-Two or more serum creatinine readings above the normal local laboratory reference range for pregnancy
-Significant proteinuria during pregnancy (urine PCR> 30 mg/L), not in the context of pre-eclampsia
j. Strong clinical suspicion of underlying CKD in women with acute kidney injury or other comorbidity
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Physiological palpitations of pregnancy
• Sinus tachycardia without evidence of other cardiac disease
• Pre-eclampsia with proteinuria, but no other features or clinical suspicion of underlying kidney disease or kidney impairment
• Uncomplicated hypertension with no other features of kidney disease

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A variety of techniques will be used, as the different hypotheses and data structures require different approaches. The nature of this study is one that involves multiple endpoints and a complex data structure. For many predictors and outcomes there will be multiple measurements for each woman over time, as well as changing patterns of comorbidities. Descriptive techniques and multivariate analysis will determine odds ratio/relative risk of adverse maternal and fetal outcomes, adjusted for maternal demographic and disease-specific parameters. Chi-squared tests, Student’s t-test, Fisher’s exact tests and multivariate logistic regression will be used as appropriate. Analyses will be performed using SPSS V.27.0.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20238 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 20239 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 34970 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 34971 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 309427 0
Hospital
Name [1] 309427 0
Lyell McEwin Hospital
Country [1] 309427 0
Australia
Primary sponsor type
Individual
Name
Margaret Arstall
Address
Department of Cardiology
Level 2, Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 310399 0
Individual
Name [1] 310399 0
Shilpa Jesudason
Address [1] 310399 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country [1] 310399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309229 0
Women's and Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 309229 0
72 King William Rd
North Adelaide
SA
5006
Ethics committee country [1] 309229 0
Australia
Date submitted for ethics approval [1] 309229 0
12/10/2021
Approval date [1] 309229 0
08/11/2021
Ethics approval number [1] 309229 0
2021/HRE00344

Summary
Brief summary
Chronic kidney disease (CKD) and cardiac disease are two significant health conditions that can influence a woman’s pregnancy, however little is known about their prevalence and health impact within the South Australian population. These pregnancies are associated with significant risks of morbidity and mortality and propose a challenge to clinicians who manage them. The aim of this study is to prospectively record the incidence, prevalence, etiology, outcomes and follow up of maternal chronic diseases in the obstetric population of South Australia. This is a prospective cohort study of pregnant women with acquired or chronic cardiac or kidney disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113422 0
A/Prof Margaret Arstall
Address 113422 0
Department of Cardiology
Level 1, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 113422 0
Australia
Phone 113422 0
+61881332134
Fax 113422 0
Email 113422 0
[email protected]
Contact person for public queries
Name 113423 0
Ms Emily Aldridge
Address 113423 0
Robinson Research Institute
Level 2, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 113423 0
Australia
Phone 113423 0
+61881332134
Fax 113423 0
Email 113423 0
[email protected]
Contact person for scientific queries
Name 113424 0
Ms Emily Aldridge
Address 113424 0
Robinson Research Institute
Level 2, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 113424 0
Australia
Phone 113424 0
+61881332134
Fax 113424 0
Email 113424 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
12856Study protocol    Not yet available (manuscript for publication in p... [More Details]



Results publications and other study-related documents

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