Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000853943
Ethics application status
Approved
Date submitted
9/08/2011
Date registered
10/08/2011
Date last updated
10/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac function in women with preeclampsia
Scientific title
Left ventricular systolic and diastolic function and structure using transthoracic echocardiography in women with untreated preeclampsia compared to healthy pregannt women and non-pregnant women
Secondary ID [1] 262811 0
Nil
Universal Trial Number (UTN)
U1111-1123-5962
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with Preeclampsia 270521 0
Healthy pregnant women 270530 0
Healthy non-pregnant women 270531 0
Condition category
Condition code
Cardiovascular 270689 270689 0 0
Hypertension
Reproductive Health and Childbirth 270693 270693 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observations of cardiac function using transthoracic echocardiography at the time of the diagnosis of preeclampsia. Transthoracic echocardiography will also be perfomred in healthy pregnant women and in non-pregnant women. Transthoracic echocardiography examination will take approximately 15 minutes
Intervention code [1] 269160 0
Not applicable
Comparator / control treatment
Observations of cardiac function using transthoracic echocardiography in gestationally matched healthy pregnant women
Control group
Active

Outcomes
Primary outcome [1] 269400 0
systolic function assessed by transthoracic echocardiography
Timepoint [1] 269400 0
at the time of diagnosis of preeclampsia
Primary outcome [2] 269404 0
diastolic function assessed by transthoracic echocardiography
Timepoint [2] 269404 0
at the time of diagnosis of preeclampsia
Primary outcome [3] 269405 0
cardiac structure assessed by transthoracic echocardiography
Timepoint [3] 269405 0
at the time of diagnosis of preeclampsia
Secondary outcome [1] 287556 0
type of birth
Timepoint [1] 287556 0
post birth data obtained from medical record
Secondary outcome [2] 287568 0
postpartum haemorrhage
Timepoint [2] 287568 0
post birth data obtained from medical record
Secondary outcome [3] 287569 0
intensive care admission
Timepoint [3] 287569 0
post birth data obtained from medical record
Secondary outcome [4] 287570 0
hospital length of stay
Timepoint [4] 287570 0
post birth data obtained from medical record
Secondary outcome [5] 287571 0
birth weight
Timepoint [5] 287571 0
post birth data obtained from medical record
Secondary outcome [6] 287572 0
neonatal admission to special care nurseryor neonatal intensive care unit
Timepoint [6] 287572 0
post birth data obtained from medical record
Secondary outcome [7] 287573 0
breastfeeding on discharge from hospital
Timepoint [7] 287573 0
post birth data obtained from medical record

Eligibility
Key inclusion criteria
non-labouring women with a diagnosis of preeclampsia, non-smokers
healthy pregnant women without diagnosis of preeclampsia
healthy non-pregnant women
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous cardiac disease including hypertension, uterine abnormality, receiving vasoactive drugs

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4341 0
3052

Funding & Sponsors
Funding source category [1] 269635 0
Charities/Societies/Foundations
Name [1] 269635 0
Australian Society of Anaesthetists
Country [1] 269635 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The Department of Pharmacology
Level 8, Medical Building (No. 181)
Corner of Grattan Street and Royal Parade
University of Melbourne
Victoria 3010 Australia
Country
Australia
Secondary sponsor category [1] 266664 0
Hospital
Name [1] 266664 0
Mercy Hospital for Women
Address [1] 266664 0
163 Studley Road, Heidelberg Vic 3084
Country [1] 266664 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269580 0
Mercy Hospital for Women Human Research and Ethics Committee
Ethics committee address [1] 269580 0
163 Studley Road, Heidelberg Vic 3084
Ethics committee country [1] 269580 0
Australia
Date submitted for ethics approval [1] 269580 0
Approval date [1] 269580 0
03/03/2009
Ethics approval number [1] 269580 0
R09/02

Summary
Brief summary
The purpose of this study is to determine cardiac function in pregnant women at the time of the diagnosis of preeclampsia and before any treatment is commenced. The cardiac function at this time will be compared to healthy gestationally matched pregnant women and also to non-pregnant healthy women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32999 0
Address 32999 0
Country 32999 0
Phone 32999 0
Fax 32999 0
Email 32999 0
Contact person for public queries
Name 16246 0
Dr Alicia Dennis
Address 16246 0
The Royal Women's Hospital, Locked Bag 300, Corner Flemington Road and Grattan Street, Parkville, Victoria, 3052
Country 16246 0
Australia
Phone 16246 0
+ 61 3 8345 2381
Fax 16246 0
+ 61 3 8345 2379
Email 16246 0
[email protected]
Contact person for scientific queries
Name 7174 0
Dr Alicia Dennis
Address 7174 0
The Royal Women's Hospital, Locked Bag 300, Corner Flemington Road and Grattan Street, Parkville, Victoria, 3052
Country 7174 0
Australia
Phone 7174 0
+61 3 8345 3281
Fax 7174 0
+ 61 3 8345 2379
Email 7174 0
[email protected]

No information has been provided regarding IPD availability


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.