I-TEST V1.0
Research type
Research Study
Full title
I-test: novel retinal biomarkers in pregnancy for early prediction of stillbirth
IRAS ID
332944
Contact name
Rebecca M Reynolds
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
This study aims to further our understanding of why some babies are stillborn and help us identify new tests that we can offer people in pregnancy to identify babies that might be at risk. Our current monitoring looks at pregnant women and babies’ health using blood tests, blood pressure and ultrasound scans during pregnancy but we know this does not provide a complete picture.
In pregnancy there are changes in the structure and function of blood vessels throughout the body. These blood vessel changes may lead to complications such as pre-eclampsia, high blood pressure and stillbirth. Looking at what is happening to the blood vessels at the back of the eye can help us know what is happening to blood vessels in the rest of the body. This is a simple, quick and non-invasive test that you may have previously had during a visit to the optician.
The purpose of the study is to find out whether monitoring changes in the eye’s blood vessels during pregnancy could be a new way of identifying those at risk of pregnancy complications.
For this study we will be recruiting pregnant women in the Lothian region and inviting them to attend for retinal imaging either at 2 time points in pregnancy (early - 12 or 20 weeks of pregnancy; and late ~36 weeks of pregnancy) or just at 36 weeks of pregnancy. We will ask to take some blood samples at 36 weeks and to do some ultrasound measurements of the baby.
We will analyse the data to see if we can see changes in the retinal blood vessels over the time course of pregnancy and/or if we can see differences in these vessels in people with complicated compared to healthy pregnancies.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/PR/1187
Date of REC Opinion
14 Nov 2023
REC opinion
Further Information Favourable Opinion