Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001016729
Ethics application status
Not yet submitted
Date submitted
9/09/2013
Date registered
12/09/2013
Date last updated
12/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The characterisation and correlation of cardiovascular haemodynamics and endothelial function in preeclampsia
Scientific title
An observational study of pregnant women with or without preeclampsia or pre-existing hypertension, examining biomarkers of endothelial and placental function, endothelial function in large and small vessels and echocardiographic parameters during the third trimester and in the post-partum period.
Secondary ID [1] 283169 0
nil
Universal Trial Number (UTN)
U1111-1147-7532
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preeclampsia 290031 0
hypertension in pregnancy 290032 0
Condition category
Condition code
Cardiovascular 290409 290409 0 0
Hypertension
Reproductive Health and Childbirth 290443 290443 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
8
Target follow-up type
Months
Description of intervention(s) / exposure
Observational study of cardiovascular function to be performed in the third trimester of pregnancy and 6 months post-partum period. Pregnant women with preeclampsia, pregant women with pre-existing hypertension and pregnant women without hypertension in preganancy will all be prospectively enrolled to this study.
Parameters to be measured include plasma and urine biomarkers of placental and endothelial function, functional measures of small and large vessel reactivity (using aplanation tanometry and laser doppler iontophoresis) and echocardiogaphical parameters of systolic and diastolic function.
Intervention code [1] 287901 0
Not applicable
Comparator / control treatment
normotensive pregnant women.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290434 0
Changes in diastolic function as measured on echocardiography.
Timepoint [1] 290434 0
6 months post-partum
Secondary outcome [1] 304512 0
Changes in placental angiogenesis biomarkers (sFLt-1 and P-IPG) measured in maternal plasma samples taken in late preganacy and at 6 months post-partum. This is performed using a commercially available assay. Statistical analysis of the change in plasmsa concentrations of each biomarker over time and between the three groups will be performed.
Timepoint [1] 304512 0
6 months post-partum
Secondary outcome [2] 304513 0
Changes in maternal endothelial biomarkers in plasma: hSCRP, ADMA, hydrogen sulfite. These are taken (by venesection) in late pregnancy and at 6 months post-partum. The samples will be analysed using comercially available assays or published methods.
Timepoint [2] 304513 0
6 months post-partum
Secondary outcome [3] 304514 0
Changes in maternal vascular function (microvessels and large capacity vessels). These will be measured using applanation tanometry for large vessel capacitance, laser doppler iontophoresis for microvessel reactivity and function. These measurements will be performed in late pregnancy and repeated at 6 months post-partum.
Timepoint [3] 304514 0
6 months post-partum
Secondary outcome [4] 304515 0
Changes in right heart structure and function as measured on 2D and 3D echocardiography performed in late pregnancy and at 6 months post-partum.
Timepoint [4] 304515 0
6 months post-partum

Eligibility
Key inclusion criteria
Pregnant women more then 32 weeks pregnant. They will be divided into three groups: Those diagnosed with preeclampsia as defined by the "international society for the study of hypertension in pregnancy" guidelines, those with pre-existing hypertension and those who are normotoensive on no antihypertensive medication.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. unable to give informed consent
2. pre-pregnancy cardiovascular disease or diabetes
3. chronic renal disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
1. comparisons between normotensive and hypertensive groups at the two times points will be made by 2 way ANOVA and Chi square testing.
2. correlations will be sought between the placental biomarkers, endothelial biomarkers, measures of vascular reactivity and echocardiographic parameters.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2013
Actual
Date of last participant enrolment
Anticipated
27/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1491 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 1492 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 7333 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 7334 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 287923 0
Hospital
Name [1] 287923 0
Lyell McEwin Hospital special purpose fund for cardiology research
Country [1] 287923 0
Australia
Primary sponsor type
Hospital
Name
Cardiology Unit, Lyell McEwin Hospital, Northern Adelaide Local Health Network
Address
Haydown Rd, Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 286651 0
None
Name [1] 286651 0
Address [1] 286651 0
Country [1] 286651 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289854 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 289854 0
The Queen Elizabeth Hospital
Woodeville Rd,
Woodville South
SA 5011
Ethics committee country [1] 289854 0
Australia
Date submitted for ethics approval [1] 289854 0
23/09/2013
Approval date [1] 289854 0
Ethics approval number [1] 289854 0

Summary
Brief summary
The incidence of preeclampsia is rising in Australia due to increasing numbers of pregnancies in women at high risk for this condition. Our understanding of the pathophysiology is still unclear and the clinical and pathalogical classifications are inconsistent. In particular, the inconsistency in classification makes the management and follow-up of patients with preeclampsia challenging. Various studies have measured haemodynamic, vascular physiology and biochemical markers individually , however studies correlating these measurements are few. This project will comprehensively characterise the cardiovascular haemodynamic and endothelial function changes that occur in preeclampsia. From this we will correlate these changs to the various clnical presentations of preeclampsia in an attempt to find a better way to classify and risk stratify this life threatening condition. The ultimate aim is to gain a better understanding of the pathophysiology of preeclampsia and translate this into better management strategies in the future.
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 42778 0
A/Prof Margaret Arstall
Address 42778 0
Cardiology Unit
Lyell McEwin Hospital
Haydown Road,
Elizabeth Vale
SA
5112
Country 42778 0
Australia
Phone 42778 0
+61881829439
Fax 42778 0
+61882820706
Email 42778 0
[email protected]
Contact person for public queries
Name 42779 0
Dr York Yann Chow
Address 42779 0
Cardiology Unit
Lyell McEwin Hospital
Haydown Road,
Elizabeth Vale
SA
5112
Country 42779 0
Australia
Phone 42779 0
+61881829439
Fax 42779 0
+61882820706
Email 42779 0
[email protected]
Contact person for scientific queries
Name 42780 0
A/Prof Margeret Arstall
Address 42780 0
Cardiology Unit
Lyell McEwin Hospital
Haydown Road,
Elizabeth Vale
SA
5112
Country 42780 0
Australia
Phone 42780 0
+61881829439
Fax 42780 0
+61882820706
Email 42780 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.