ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

nil

Universal Trial Number (UTN)

U1111-1147-2431

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypertension

Preeclampsia

Human immunodeficiency virus (HIV)

Pregnancy

Condition category

Condition code

Cardiovascular

Hypertension

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Reproductive Health and Childbirth

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]

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]

Cardiac output measured by transthoracic echocardiography

Timepoint [1]

after 5 minutes of rest or at time of diagnosis of preeclampsia

Secondary outcome [1]

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]

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?

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]

South Africa

State/province [1]

Cape Town

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Cape Town Visiting Scholars Fund

Address [1]

The University of Cape Town, Private Bag X3, Rondebosch 7701, South Africa

Country [1]

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]

Hospital

Name [1]

Department of Anaesthesia, Groote Schuur Hospital

Address [1]

Groote Schuur Hospital, Private Bag, Observatory, 7937

Country [1]

South Africa

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Faculty of Health Sciences, Human Research Ethics Committee

Ethics committee address [1]

Room E52-24 Groote Schuur Hospital Old Main Building, Observatory 7925, Cape Town

Ethics committee country [1]

South Africa

Date submitted for ethics approval [1]

Approval date [1]

25/07/2013

Ethics approval number [1]

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

A/Prof Alicia Dennis

Address

The Royal Women's Hospital, Locked Bag 300, Parkville, Victoria, Australia 3052

Country

Australia

Phone

+61 3 8345 2000

Fax

alicia.dennis@thewomens.org.au

Contact person for public queries

Name

Robert Dyer

Address

D23 Department of Anaesthesia, New Groote Schuur Hospital, Anzio Road, Observatory 7925, Cape Town

Country

South Africa

Phone

+27 21 404 5142/5015

Fax

robert.dyer@uct.ac.za

Contact person for scientific queries

Name

Alicia Dennis

Address

The Royal Women's Hospital, Locked Bag 300, Parkville, Victoria, Australia 3052

Country

Australia

Phone

+61 3 8345 2000

Fax

alicia.dennis@thewomens.org.au

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

Source	Title	Year of Publication	DOI
Embase	Transthoracic echocardiographic assessment of haemodynamics in severe pre-eclampsia and HIV in South Africa.	2015	https://dx.doi.org/10.1111/anae.13038

N.B. These documents automatically identified may not have been verified by the study sponsor.

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