Biomarkers to improve outcomes of complications in pregnancy – BIOCiP

Ethics Committee Project Number
RES-22-0000-197A
Approved by
Monash Health
Research area
Women's Health
Brief outline of the study
In Australia, 1 in 20 pregnant women are affected by pre-eclampsia, a common condition of pregnancy that can cause significant harm to mother and baby. In the long term, mothers who have had pre-eclampsia are at a higher risk of developing heart disease.
Cardio-metabolic conditions during pregnancy such as gestational diabetes (GDM), placental disorders, fetal growth restriction and spontaneous preterm birth are associated with maternal Type 2 Diabetes and Cardiovascular Disease (CVD) and affect more than a third of women during pregnancy. However, CVD risk prediction tools do not capture these pregnancy-related cardio-metabolic conditions and the risks are generally poorly understood by women and their health practitioners.
We know that these risks can be reduced by preventative screening and optimising lifestyle strategies. This study offers an important opportunity to identify and target these women at risk for early intervention and screening.

Keywords
Pregnancy, pre-eclampsia, cardio-vascular disease, prevention.
Recruitment start date
Monday, 15 August, 2022
Recruitment end date
Friday, 28 February, 2025
Contact person title
Dr
Contact person full name
Yizhen (Amy) Liu
Contact email
Yizhenamy.liu@monashhealth.org
Contact phone number
03 9594 6666
Website link
https://www.monash.edu/medicine/scs/research/womens-health
Current number of recruits:
17
Recruitment target:
600
Principal Investigator title:
Associate Professor
Principal Investigator full name:
Kirsten Palmer
Principal Investigator PURE profile link:
https://research.monash.edu/en/persons/kirsten-palmer
Contact person role:
Study coordinator
Type of study:
PI initiated
Number of study visits:
3 visits
Duration of study visits period:
40 weeks
Inclusion criteria:
- Pregnant women at any gestation in pregnancy AND
- Women who develop elevated blood pressure >130/80 OR
- Women who have developed pregnancy complications (GMD, HDP, FGR and sPTB)

Exclusion criteria:
- Multiple pregnancy
- Pregnancy complicated by major fetal anomaly or genetic syndrome
- Maternal age less than 18 years
- Women incapable of giving valid consent (diminished understanding, non-English speaking and interpreter unavailable)
- Participation in a study where there is a pharmaceutical intervention likely to modify biomarkers under study.

Phase:
N/A
Objective:
Our research aims to identify women with pregnancy related cardio-metabolic disorders who may be at higher risk of long-term cardiovascular disease and will benefit from early preventive strategies. At the same time, we aim to create a model that can better predict the onset, outcomes, and long-term sequelae of pre-eclampsia.
Research question:
Markers of endothelial, placental, inflammatory and cardiac dysfunction can be used to create an algorithm that can better predict: 1. Risk of developing complications in pregnancy. 2. Potential for long-term cardiovascular sequelae in patients with these cardiometabolic conditions.
Study design:
This study will be conducted as a prospective observational cohort study.
Study population:
Women with a singleton pregnancy at risk of developing pregnancy complications in the first or second trimester.
Description of intervention:
No intervention is required.
Outcome measures:
1. Women with demographic or examination (e.g. elevated BP >=130/80) risk factors who go on to develop pregnancy complications. 2. Women with pregnancy complications (GMD, HDP, FGR and sPTB) who have persistent derangement in cardiometabolic markers 6-12 months post-partum
Sponsor:
Monash University