The characterisation and correlation of cardiovascular haemodynamics and endothelial function in preeclampsia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613001016729
• Date of registration: 12/09/2013
• Prospective Registration: Yes
• Primary sponsor: Cardiology Unit, Lyell McEwin Hospital, Northern Adelaide Local Health Network
• 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.
• Date of first enrolment: 04/11/2013
• Target sample size: 110
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613001016729.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Margeret Arstall

• Name: Dr York Yann Chow

Key inclusion & exclusion criteria

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.
Exclusion criteria: 1. unable to give informed consent
2. pre-pregnancy cardiovascular disease or diabetes
3. chronic renal disease

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

preeclampsia;hypertension in pregnancy;
preeclampsia
hypertension in pregnancy

Cardiovascular - Hypertension

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Intervention(s)

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.

Primary Outcome(s)

Changes in diastolic function as measured on echocardiography.[6 months post-partum]

Secondary Outcome(s)

Changes in right heart structure and function as measured on 2D and 3D echocardiography performed in late pregnancy and at 6 months post-partum.[6 months post-partum]

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.[6 months post-partum]

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.[6 months post-partum]

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. [6 months post-partum]

Secondary ID(s)

nil

Source(s) of Monetary Support

Lyell McEwin Hospital special purpose fund for cardiology research

Ethics review

Status: Not approved
Approval date:
Contact:

Human Research Ethics Committee (TQEH/LMH/MH)