Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000417381
Ethics application status
Approved
Date submitted
20/02/2017
Date registered
23/03/2017
Date last updated
23/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Mother’s heart beats for two: to explore the current provision of evidence based practice, outcomes and ‘lived experience’ for women with cardiovascular disease during pregnancy.
Scientific title
Retrospective longitudinal analysis of women with cardiac disease during pregnancy (2004-2014) to evaluate evidence based practice.
Secondary ID [1] 291223 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease
 302143 0
Ischaemic Heart Disease 302166 0
Heart Failure 302369 0
Arrhythmias 302370 0
Rheumatic heart disease 302371 0
Condition category
Condition code
Reproductive Health and Childbirth 301753 301753 0 0
Childbirth and postnatal care
Cardiovascular 301754 301754 0 0
Coronary heart disease
Cardiovascular 301755 301755 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective Medical Records Review (MRR).
2 groups defined as :
1. Pre-existing cardiac condition
2. Newly acquired cardiac condition during course of pregnancy.
Observations will include documented pre-conception care i.e. clinical , medication ,physical and psychosocial assessment, relevant history, cardiac investigations, cardiac education, planned care and delivery management (evidence based practice), through the continuum of pregnancy.

In this study the continuum of care will be identified as the women’s journey in pregnancy through the healthcare system specifically , ante partium natal, intrapartium and post partium including any outpatient appointments with cardiac health practitioner. De identified data collected electronically via Auditmaker Data abstraction (collection) tool DAT that was developed based on SA perinatal guidelines. The tool was reviewed by experts and then pilot tested on 4 medical records.
The kind of data collected will include: static, evolving, or cumulative data and therefore the structure of the DAT will need be reflective of this information.
1.Static data: snapshot in time, i.e. demographic data ( PC , Age , ethnicity, )and medical history therefore reflected as single record ( past medical and obstetric history ).
2.Evolving data: the information is collected over time, repeated measurement, vital signs and daily medication orders and so may require single records /pages per time interval ( labour and delivery stages and medications required at birth)
3.Cumulative data: collected over time, but not linked to specific points in time ( 12 lead ECGS and echocardiograms required during course of pregnancy, number and follow up in post natal period .
Intervention code [1] 297224 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301154 0
The reported number of medical record cases had documented evidence of routine appropriate education and preconception counselling had been undertaken in group 1 where women had a pre-existent congenital cardiac condition.
The group 2 where women had an acquired heart condition that was diagnosed or occurred during pregnancy that routine appropriate education and counselling was offered.
Timepoint [1] 301154 0
Entry point 1 Pre-existing congenital condition pre-conception counselling prior to pregnancy.
Entry point 2 : Acquired heart condition from diagnosis and occurrence during pregnancy that includes first trimester through to postpartum.
Primary outcome [2] 301171 0
The reported number of medical record cases that had documented evidence of a patient and cardiac specific management strategy for treatment during pregnancy that defines labour , birth plan , and postpartum follow up and is available to the relevant multidisciplinary team members.
Timepoint [2] 301171 0
The reported number of medical record cases had documented evidence of cardiac specific management strategy for treatment during pregnancy available for both groups in ante natal period .
Primary outcome [3] 301172 0
The reported number of medical record cases that had documented evidence of compliance / completion of perinatal guidelines for cardiac disease in pregnancy in both groups in relation to a patient and cardiac specific management strategy for treatment during pregnancy that defines labour , birth plan , and postpartum follow up and is available to the relevant multidisciplinary team members.
Timepoint [3] 301172 0
Documented evidence in medical records from antepartium through intrapartium to postpartum
Secondary outcome [1] 331874 0
The reported number of medical record cases where women were not identified with a cardiac condition in antepartium period however developed cardiac complications during intrapartium and post partium.
Timepoint [1] 331874 0
Documented evidence in medical records from antepartium through intrapartium to postpartum.

Eligibility
Key inclusion criteria
Patients will be identified as women with newly acquired heart disease or pre-existent congenital heart disease.
Women with the specific cardiac conditions will also be identified and documentation of the following : Ischemic heart disease( IHD) may include acute myocardial infarction (AMI) acute coronary syndrome (ACS) and angina, heart failure and cardiomyopathy, presence of arrhythmias during course of pregnancy and up to 12 months post delivery.
The MRR will include patients admitted to the three SA health metropolitan tertiary hospitals where management of women with cardiac disease in pregnancy occurs during 2004 and 2014
Minimum age
17 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical records where patient is male gender.
Convenience sampling of the available medical records within the specific time frame with women identified with cardiac disease in pregnancy within the three SA health metropolitan tertiary hospitals where management of these women occurs only. Private hospital :-unable to access medical records.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics will be used to analyse data such as demographics collected from the MRR that describe and give meaning to quantitative data. Correlation will be used where appropriate to explore relationships between the variables (external and/or personal factors that influence variables between two principal groups of congenital heart disease and newly acquired heart disease). For example, Chi Square will be used to explore relationships between nominal data sets.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/12/2013
Date of last participant enrolment
Anticipated
Actual
24/06/2016
Date of last data collection
Anticipated
Actual
24/06/2016
Sample size
Target
400
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7512 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 7513 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 7514 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 15338 0
5006 - North Adelaide
Recruitment postcode(s) [2] 15336 0
5042 - Bedford Park
Recruitment postcode(s) [3] 15339 0
5112 - Elizabeth
Recruitment postcode(s) [4] 15337 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 295673 0
University
Name [1] 295673 0
University of Adelaide
Country [1] 295673 0
Australia
Primary sponsor type
Individual
Name
Sandra (Sindy) Kay Millington
Address
The University of Adelaide
Adelaide Health & Medical Sciences Building,
Level 4
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 294520 0
None
Name [1] 294520 0
Address [1] 294520 0
Country [1] 294520 0
Other collaborator category [1] 279440 0
University
Name [1] 279440 0
University of Adelaide
Address [1] 279440 0
The University of Adelaide
SA 5005
AUSTRALIA
Country [1] 279440 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296987 0
Human Reserach Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 296987 0
Basil Hetzel Institute DX465101
The Queen Elizabeth Hospital
28 Woodville Road
Woodville south SA 5011
Ethics committee country [1] 296987 0
Australia
Date submitted for ethics approval [1] 296987 0
04/09/2013
Approval date [1] 296987 0
04/11/2013
Ethics approval number [1] 296987 0
HREC/13/TQEHLMH/226

Summary
Brief summary
Title: A Mother’s heart beats for two: to explore the current provision of evidence based practice, outcomes and ‘lived experience’ for women with cardiovascular disease during pregnancy.
Background: Although cardiac disease complicates approximately 1% to 3% of pregnancies it is responsible for 10% to 15% of maternal mortality. This rate is expected to increase in the current environment of elderly primigravida and increased obesity and diabetes in pregnancy. This study will evaluate the current care and outcomes for women with pre-existent or newly acquired cardiac disease during pregnancy.
Methods: The proposed research will include phase 1 :-an analysis of the documented care and outcomes from a retrospective medical record review (MRR) for women with congenital and / or newly acquired heart disease during pregnancy and postnatal follow-up.
Aims:
1. Describe the current the clinical course, appropriateness of care, referral and outcomes for these women and babies in relation to evidence based clinical practice guidelines
2. Identify gaps in the clinical management across the course of pregnancy, delivery and on-going care.
3. Elucidate and describe the experience of women with cardiac disease during pregnancy, delivery and on-going care.
a. Articulate the difficulties encountered by women with cardiac disease in pregnancy.
b. Identify elements that will facilitate improved clinical course and positive outcomes for women with cardiac disease in pregnancy
Conclusion: The outcomes of this project will provide baseline data for further research, recommendations for practice change and strategies to improvement the uptake of evidence based guidelines.
Trial website
Trial related presentations / publications
articles submitted for peer review. Analysis in progress.
Public notes
Attachments [1] 1513 1513 0 0
/AnzctrAttachments/372394-HREC13TQEHLMH226finalapproval.pdf (Ethics approval)
Attachments [2] 1514 1514 0 0
/AnzctrAttachments/372394-HREC13TQEHLMH226 - 03.08.2015 Extension to Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 72634 0
Mrs Sandra (known as Sindy) Millington
Address 72634 0
Adelaide Nursing School
Faculty of Health & Medical Sciences
The University of Adelaide
Adelaide Health & Medical Sciences Building
Adelaide SA 5005
Country 72634 0
Australia
Phone 72634 0
+61 88313 2996
Fax 72634 0
Email 72634 0
sindy.millington@adelaide.edu.au
Contact person for public queries
Name 72635 0
A/Prof Judy Magarey
Address 72635 0
Adelaide Nursing School
Faculty of Health & Medical Sciences
The University of Adelaide
Adelaide Health & Medical Sciences Building
Adelaide SA 5005
Country 72635 0
Australia
Phone 72635 0
+61 8 8313 6055
Fax 72635 0
Email 72635 0
judy.magarey@adelaide.edu.au
Contact person for scientific queries
Name 72636 0
A/Prof Judy Magarey
Address 72636 0
Adelaide Nursing School
Faculty of Health & Medical Sciences
The University of Adelaide
Adelaide Health & Medical Sciences Building
Adelaide SA 5005
Country 72636 0
Australia
Phone 72636 0
+61 8 8313 6055
Fax 72636 0
Email 72636 0
judy.magarey@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23493Clinical study reportMillington S, Arstall M, Magarey J, Clark R, Dekker G. Adherence to clinical practice guidelines for South Australian pregnant women with cardiac conditions between 2003 and 2013. Original research PLoS One. 2020;15(3):e0230459. DOI: 10.1371/journal.pone.0230459https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230459sindy.millington@adelaide.edu.au 372394-(Uploaded-15-11-2021-11-25-10)-Study-related document.pdf
23494Clinical study reportMillington S, Edwards S, Clark R, Dekker G, Arstall M. The association between guidelines adherence and clinical outcomes during pregnancy in a cohort of women with cardiac comorbidities. Original research PLoS One. 2021; 16(7):e0255070. DOI:/ journal.pone.0255070.https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255070sindy.millington@adelaide.edu.au

Results publications and other study-related documents

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

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe association between guidelines adherence and clinical outcomes during pregnancy in a cohort of women with cardiac co-morbidities.2021https://dx.doi.org/10.1371/journal.pone.0255070
N.B. These documents automatically identified may not have been verified by the study sponsor.