The Tommy’s Project
Research type
Research Study
Full title
The Tommy’s Project - a coordinated antenatal and tissue data study of pregnancy outcome and related disease
IRAS ID
124307
Contact name
Edward Johnstone
Contact email
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Tommy’s, the baby charity, funds one of three national research centres in Manchester, with the express aim of reducing preventable stillbirth within Greater Manchester by the application of basic science research. \nStillbirth rates are unacceptably high in the UK, but one of the challenges faced in studying this condition is that the incidence is approximately 1:200 3rd trimester births often with little antecedent warning. Many conditions (e.g. pre-eclampsia (PE), fetal growth restriction (FGR) and prematurity) are interrelated with themselves and stillbirth and studying each condition in isolation is therefore ill advised. To address this we propose to collect a large cohort of pregnancy data and standardise tissue collection in this group. This will simplify the research system for patients by within St. Mary’s and improve our chances of successful identifying measures that with lower the rate of stillbirth in Manchester and the UK as a whole. The principal aim of this study is to understand the placental origin(s) of pregnancy diseases that may contribute to stillbirth. [COVID-19 amendment 05/05/2020] This amendment concerns the following changes: 1. The addition of a new study objective to investigate vertical transmission of COVID-19 and the effect on pregnancy on outcomes in women recruited to the Tommy’s project 2. An extension to the study population to include newborn babies from women recruited to the Tommy’s project. The collection of breast milk and amniotic fluid (or surface swabs) from pregnant women. The collection of stool (meconium) and oral and/or nasal swabs from newborn babies. An increase in the sample size. An extension of the study end date. In order do this, we plan to collect maternal blood samples, placental tissues (including cord and membranes), breast milk and amniotic fluid (or surface swabs) at delivery in women with confirmed or clinically suspected COVID- 19. Cord blood, oral and/or nasal swabs and stool samples (first pass meconium) will be collected from newborn babies of infected mothers to investigate transmission.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0829
Date of REC Opinion
15 Dec 2015
REC opinion
Further Information Favourable Opinion