HD2 Study v1.0
Research type
Research Study
Full title
HD2 study: Haemodynamic changes during Delivery in women with Heart Disease
IRAS ID
331359
Contact name
Roshni Patel
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
The number of pregnant women with pre-existing cardiovascular disease is steadily growing due the improved survival among children born with congenital heart disease and the increased prevalence of acquired heart disease in women of childbearing age. Cardiovascular disease is the leading indirect cause of maternal mortality in much of the developed world and obstetricians need to be able to safely manage this unique group. Research in this field is therefore imperative.
Normal pregnancy is associated with substantial maternal cardiovascular alterations initiated by a fall in systemic vascular tone that creates a state of intravascular volume depletion provoking an increase in both cardiac output and plasma volume. To cope with this physiological stress, the maternal heart increases its compliance, contractility, and size, thus modifying the function of the left ventricle. There are limited data on cardiac adaptations in labour and delivery amongst women with heart disease and little is known about the reversibility of haemodynamic adaptation post-pregnancy.
Our aim is to study the maternal cardiovascular adaptation to various forms of delivery (normal or assisted labour, and during Caesarean section) in women with heart disease compared with low-risk pregnant women.
We will perform bedside measurements of heart rate, blood pressure, oxygen saturation and cardiac output (with impedance cardiography using the Physioflow device) during the first, second and third stage of labour and post-delivery.
The overall objective of the study is to investigate the cardiovascular changes during delivery in women with heart disease compared with low-risk pregnant women using continuous non-invasive measurements of cardiac output by Impedance Cardiography.
This research will help improve pre pregnancy counselling as it will help in understanding the impact of labour and delivery on the cardiovascular system. Current risk stratification methods do not include any information about the haemodynamic changes during labour and delivery. An understanding of the impact of delivery on the cardiovascular system may help suggest the best mode of delivery in women with cardiac disease.REC name
London - Central Research Ethics Committee
REC reference
23/PR/1239
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion