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Trial registered on ANZCTR


Registration number
ACTRN12612000661875
Ethics application status
Approved
Date submitted
17/06/2012
Date registered
20/06/2012
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Heart function in women with preeclampsia after treatment
Scientific title
Cardiac function in women with preeclampsia after treatment interventions
Secondary ID [1] 280686 0
Nil
Universal Trial Number (UTN)
U1111-1131-9053
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preeclampsia 286713 0
cardiac function 286749 0
Condition category
Condition code
Cardiovascular 287014 287014 0 0
Hypertension
Reproductive Health and Childbirth 287015 287015 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 treatment interventions. Transthoracic echocardiography will be performed prior to and after treatment interventions and also after the intervention of passive leg raising to assess stroke volume changes. Transthoracic echocardiography will also be performed in healthy pregnant women at rest and during passive leg raising. Transthoracic echocardiography examination will take approximately 15 minutes. The post-intervention measurements will occur within 60 minutes of the drug being administered.
Intervention code [1] 285097 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] 287347 0
systolic function assessed by transthoracic echocardiography
Timepoint [1] 287347 0
at the time of diagnosis of preeclampsia, within 60 minutes of treatment interventions
Primary outcome [2] 287348 0
diastolic function assessed by transthoracic echocardiography
Timepoint [2] 287348 0
at the time of diagnosis of preeclampsia, within 60 minutes of treatment interventions
Secondary outcome [1] 297957 0
cardiac complications - acute pulmonary oedema, arrhythmia, sustained hypertension after treatment, hypotension requiring treatment
Timepoint [1] 297957 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [2] 297958 0
neurological complications - seizure, blindness, intracerebral haemorrhage or infarction
Timepoint [2] 297958 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [3] 297959 0
renal complications - renal failure
Timepoint [3] 297959 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [4] 297960 0
gastrointestinal complications - hepatic rupture, signficantly elevated liver enzymes
Timepoint [4] 297960 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [5] 297961 0
haematological complications - haemolysis, thrombocytopenia
Timepoint [5] 297961 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [6] 297962 0
Intensive care admission
Timepoint [6] 297962 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [7] 297963 0
type of birth
Timepoint [7] 297963 0
during hospital stay - post birth data obtained from medical record
Secondary outcome [8] 297964 0
Postpartum haemorrhage
Timepoint [8] 297964 0
during hospital stay - post birth data obtained from medical record

Eligibility
Key inclusion criteria
Women with preeclampsia - non-labouring women, non-smokers, no vasoactive treatments or intravenous fluids adninstered, no previous cardiac disease or uterine abnormality.

Healthy pregnant women - non-labouring women, no significant medical or surgical illness, non smokers, no uterine abnormalities and normally defined placentation. They will not be receiving any vasoactive medication including salbutamol or thyroid replacement hormones.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
labouring women, current administration of vasoactive drugs including salbutamol and thyroxine, pre-existing or gestational diabetes, smoking, and a known uterine abnormality.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8708 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 16829 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 285452 0
Charities/Societies/Foundations
Name [1] 285452 0
Australian Society of Anaesthetists
Address [1] 285452 0
Suite 603 Eastpoint Tower, 180 Ocean Steet, Edgecliffe, 2027, NSW
Country [1] 285452 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hosptial
Address
Corner Flemington Road and Grattan Street, Parkville, Victoria, 3052, Australia
Country
Australia
Secondary sponsor category [1] 284307 0
University
Name [1] 284307 0
The University of Melbourne
Address [1] 284307 0
The Department of Pharmacology Level 8, Medical Building (No. 181) Corner of Grattan Street and Royal Parade University of Melbourne Victoria 3010 Australia
Country [1] 284307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287467 0
The Royal Women's Hospital, Human Research and Ethics Committee, Parkville, Australia
Ethics committee address [1] 287467 0
The Royal Women's Hospital, Corner Flemington Road and Grattan Street, Parkville, Victoria, 3052, Australia
Ethics committee country [1] 287467 0
Australia
Date submitted for ethics approval [1] 287467 0
Approval date [1] 287467 0
28/10/2010
Ethics approval number [1] 287467 0
10/37

Summary
Brief summary
The purpose of this study is to determine heart function in pregnant women after they are treated for the disease of preeclampsia. The reason to do this is that the drug treatments that are used to control the high blood pressure in this disease have not been examined with respect to how they alter heart function in these sick pregnant women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34323 0
A/Prof A/Prof Alicia Dennis
Address 34323 0
The Royal Women’s Hospital | Locked Bag 300 | Cnr Grattan St & Flemington Rd, Parkville, Australia 3052
Country 34323 0
Australia
Phone 34323 0
+61 3 8345 2000
Fax 34323 0
Email 34323 0
alicia.dennis@thewomens.org.au
Contact person for public queries
Name 17570 0
A/Prof Dr Alicia Dennis
Address 17570 0
The Royal Women's Hospital, Locked Bag 300, Corner Flemington Road and Grattan Street, Parkville, Victoria, 3052
Country 17570 0
Australia
Phone 17570 0
+61 3 8345 3281
Fax 17570 0
+ 61 3 8345 2379
Email 17570 0
alicia.dennis@thewomens.org.au
Contact person for scientific queries
Name 8498 0
A/Prof Dr Alicia Dennis
Address 8498 0
The Royal Women's Hospital, Locked Bag 300, Corner Flemington Road and Grattan Street, Parkville, Victoria, 3052
Country 8498 0
Australia
Phone 8498 0
+61 3 8345 3281
Fax 8498 0
+61 3 8345 2379
Email 8498 0
alicia.dennis@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results