INterpregnancy Study of cardIomeTabolic hEalth (INSITE)
Research type
Research Study
Full title
Interpregnancy study of maternal and infant cardiometabolic health
IRAS ID
324150
Contact name
Laura Ormesher
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
This study builds on previous data, which have highlighted the relationship between pre-eclampsia, postnatal abnormalities in heart and vessel function and structure, and death from future heart disease1–3. Women with postnatal heart and vessel abnormalities are then at an increased risk of pre-eclampsia recurrence4. Despite these associations, it is unclear whether heart and vessels diseases are a cause or consequence of pre-eclampsia. Additionally, it is not yet known if improvement in heart and vessel health after a pregnancy complicated by pre-eclampsia, could improve future pregnancy and heart disease risk. Infants exposed to pre-eclampsia in the womb are similarly at an increased risk of future heart and vessel disease5.
Cardiovascular disease (CVD) describes a group of conditions affecting the heart and blood vessels, such as heart disease and stroke. CVD is the leading cause of deaths worldwide6. Babies who are born small are at greater risk of CVD in later-life, likely due to problems that the “fetus” (unborn baby) experienced in the womb. The “placenta” (sometimes called the afterbirth) gives the fetus nutrients and oxygen so placental problems can slow down its growth. However, if a fetus was quite large to start with, it may still have growth problems in the womb and not be picked up as a small baby at birth.
In our previous study (BabyGRO), 70% of children had slowing of growth in the womb but only 10% were born small. We demonstrated value in studying fetal growth and also used blood gene expression (differences in the underlying activity of a gene) to find pathways and possible markers to indicate which children would be at greater risk of CVD in later-life .This study aims to provide detailed profiling of women’s interpregnancy heart and vessel health, in order to investigate the link between interpregnancy health and future pregnancy and long-term health outcomes. This research clinic will take place at St Mary’s Hospital in Manchester and provide postnatal clinical care with a regular clinical research team for women who have had a pregnancy complicated by pre-eclampsia. Women will undergo blood tests and a number of non-invasive tests to measure heart and vessel structure and function, including echocardiography, non-invasive cardiac output monitoring, measurement of arterial stiffness and blood pressure at 3 months and 12-36 months postpartum. Bloods will also be taken at delivery if possible. Infants will undergo blood tests, blood and non-invasive physical measurements including length and weight. The study will run for 6 years (3 years recruitment and 3 years follow-up).
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0262
Date of REC Opinion
19 Dec 2023
REC opinion
Further Information Favourable Opinion