Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000992707
Ethics application status
Approved
Date submitted
3/09/2013
Date registered
5/09/2013
Date last updated
14/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transthoracic echocardiography and ophthalmic artery Doppler measurements in pregnant women
Scientific title
An observational study measuring cardiac output in women with preeclampsia, women with human immunodeficiency virus, healthy pregnant women and women with haemodynamic instability using transthoracic echocardiography and ophthalmic artery Doppler
Secondary ID [1] 283122 0
nil
Universal Trial Number (UTN)
U1111-1147-2431
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 289970 0
Preeclampsia 289971 0
Human immunodeficiency virus (HIV) 289972 0
Pregnancy 289997 0
Condition category
Condition code
Cardiovascular 290342 290342 0 0
Hypertension
Infection 290343 290343 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Reproductive Health and Childbirth 290381 290381 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Weeks
Description of intervention(s) / exposure
Resting blood pressure measurements, resting ECG, resting standardised transthoracic echocardiography scan, resting left eye ophthalmic artery Doppler scanning measured at a single time point at specific to the study groups;
-at diagnosis of preeclampsia prior to treatment
-at diagnosis of preeclampsia after treatment with magnesium sulphate
-at >36 completed weeks in women with HIV
-at any gestation greater than 19 completed weeks in healthy pregnant women
-at the time of haemodynamic instability in pregnant women of any gestation
Intervention code [1] 287842 0
Not applicable
Comparator / control treatment
80 healthy pregnant control women will undergo resting blood pressure and transthoracic echocardiography scanning at
- 40 women > 33 completed weeks gestation
- 40 women < 34 weeks gestation
Control group
Active

Outcomes
Primary outcome [1] 290374 0
Cardiac output measured by transthoracic echocardiography
Timepoint [1] 290374 0
after 5 minutes of rest or at time of diagnosis of preeclampsia
Secondary outcome [1] 304372 0
Systolic and diastolic function and cardiac structure including fractional shortening, ejection fraction, mitral valve E and A velocities, tissue Doppler velocities, isovolumetric relaxation and contraction times, left atrial size, left ventricular end diastolic size, left ventricular mass measured by transthoracic echocardiography
Timepoint [1] 304372 0
after 5 minutes rest or at the time of diagnosis of preeclampsia

Eligibility
Key inclusion criteria
Healthy term and preterm pregnant women
Women with term and preterm preeclampsia
Term pregnant women with HIV
Pregnant women with haemodynamic instability
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
current administration of vasoactive drugs including salbutamol and thyroxine, pre-existing or gestational diabetes, known cardiac disease including pre-existing or gestational hypertension, multiple pregnancy, a known uterine abnormality or abnormal placentation, any woman in labour, inability to consent to the study.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
5/08/2013
Actual
5/08/2013
Date of last participant enrolment
Anticipated
30/07/2014
Actual
11/12/2013
Date of last data collection
Anticipated
Actual
11/12/2013
Sample size
Target
230
Accrual to date
Final
126
Recruitment outside Australia
Country [1] 5352 0
South Africa
State/province [1] 5352 0
Cape Town

Funding & Sponsors
Funding source category [1] 287874 0
University
Name [1] 287874 0
University of Cape Town Visiting Scholars Fund
Country [1] 287874 0
South Africa
Primary sponsor type
University
Name
University of Cape Town
Address
Private Bag X3, Rondebosch 7701, South Africa
Country
South Africa
Secondary sponsor category [1] 286601 0
Hospital
Name [1] 286601 0
Department of Anaesthesia, Groote Schuur Hospital
Address [1] 286601 0
Groote Schuur Hospital, Private Bag, Observatory, 7937
Country [1] 286601 0
South Africa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289817 0
Faculty of Health Sciences, Human Research Ethics Committee
Ethics committee address [1] 289817 0
Room E52-24 Groote Schuur Hospital Old Main Building, Observatory 7925, Cape Town
Ethics committee country [1] 289817 0
South Africa
Date submitted for ethics approval [1] 289817 0
Approval date [1] 289817 0
25/07/2013
Ethics approval number [1] 289817 0
HREC Ref 442/2013

Summary
Brief summary
Cardiovascular disease is a major cause of suffering and death in pregnant women. Diseases that are known to affect the heart and circulation in pregnant women include high blood pressure diseases such as preeclampsia, and infective diseases such as Human Immunodeficiency Virus (HIV). For some women the cardiovascular disease occurs before pregnancy and in others heart disease may occur during pregnancy. Pregnancy itself causes changes in the heart and circulation and therefore it is sometimes it difficult to identify cardiac disease, using routine monitoring techniques, in pregnant women due to these normal changes of pregnancy. Transthoracic echocardiography (TTE) and ophthalmic artery Doppler are ultrasound techniques that can examine a pregnant woman's heart and also her eye to help us understand the changes that occur in these diseases. The aim of this study is to examine women with preeclampsia, women with HIV and women who are critically unwell, as well as healthy pregnant women, using these techniques to understand better the changes that occur when compared with healthy pregnant women.
Trial website
Trial related presentations / publications
Dennis AT, Dyer RA, Gibbs M, Nel L, Castro J, Swanevelder J. Haemodynamics using transthoracic echocardiography in severe pre-eclampsia and HIV in South Africa. Anaesthesia 2015;70(9):1028-38
http://onlinelibrary.wiley.com/doi/10.1111/anae.13038/full

Dennis AT, Dyer RA, Gibbs M, Nel L, Castro C, Swanevelder JL. The use of transthoracic echocardiography to quantify hemodynamics in women with severe preeclampsia. Society of Obstetric Anesthesiologists and Perinatologists United States of America Published Abstract 2014

Dennis AT, Dyer RA, Gibbs M, Nel L, Castro JM, Swanevelder JL. Transthoracic echocardiography in patients with preeclampsia and pulmonary oedema. Obstetric Anaesthetists Association of the United Kingdom. Published Abstract International Journal of Obstetric Anesthesia 2014 23(S1) S13

Dennis AT, Dyer RA, Gibbs M, Nel L, Castro JM, Swanevelder JL. Haemodynamics using transthoracic echocardiography in women with untreated preeclampsia in South Africa. Obstetric Anaesthetists Association of the United Kingdom. Published Abstract International Journal of Obstetric Anesthesia 2014 23(S1) S8

Dennis AT, Dyer RA, Gibbs M, Nel L, Myburgh A, Castro JM, Swanevelder JL. Cardiac function & structure using transthoracic echocardiography in term HIV positive women. Obstetric Anaesthetists Association of the United Kingdom. Published Abstract International Journal of Obstetric Anesthesia 2014 23(S1) S7


Public notes

Contacts
Principal investigator
Name 42410 0
A/Prof Alicia Dennis
Address 42410 0
The Royal Women's Hospital, Locked Bag 300, Parkville, Victoria, Australia 3052
Country 42410 0
Australia
Phone 42410 0
+61 3 8345 2000
Fax 42410 0
Email 42410 0
[email protected]
Contact person for public queries
Name 42411 0
Prof Robert Dyer
Address 42411 0
D23 Department of Anaesthesia, New Groote Schuur Hospital, Anzio Road, Observatory 7925, Cape Town
Country 42411 0
South Africa
Phone 42411 0
+27 21 404 5142/5015
Fax 42411 0
Email 42411 0
[email protected]
Contact person for scientific queries
Name 42412 0
A/Prof Alicia Dennis
Address 42412 0
The Royal Women's Hospital, Locked Bag 300, Parkville, Victoria, Australia 3052
Country 42412 0
Australia
Phone 42412 0
+61 3 8345 2000
Fax 42412 0
Email 42412 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
SourceTitleYear of PublicationDOI
EmbaseTransthoracic echocardiographic assessment of haemodynamics in severe pre-eclampsia and HIV in South Africa.2015https://dx.doi.org/10.1111/anae.13038
N.B. These documents automatically identified may not have been verified by the study sponsor.