INSIGHT: Investigation into biomarkers to predict preterm birth
Insight: investigation into biomarkers for the prediction of spontaneous preterm birth
Kings College London
There are 12.9 million premature births annually worldwide and despite the magnitude of the problem, there is no established early pregnancy screening test or effective treatment for women once a high risk of preterm birth is ascertained. The causes of early spontaneous preterm labour and birth (SPTB) are likely to be a complex interaction of responses to infections in the mother and/or the baby which could lead to the neck of the uterus (the cervix) shortening and the onset of labour. Women at high risk of SPTB need to be identified as early in pregnancy as possible in order that appropriate clinical care can be arranged and specific treatment to reduce the risk of SPTB evaluated. There is a need to understand the relationship between inflammation, infection, bacterial colonisation and SPTB in order to understand the causes of SPTB and develop new predictive tests.This study will collect biological samples from pregnant women in order to investigate novel biomarkers/biochemical substances to predict preterm birth. Samples will be obtained from high risk (women who have had a previous SPTB) and low risk groups of pregnant women (predominantly first time mothers) with rigorously collected clinical data. Samples to be collected will include cervico-vaginal fluid, vaginal bacterial swabs, saliva and whole blood. The primary biomarkers of interest are elafin and fetal fibronectin (FFN) although a range of other novel biomarkers will be explored. The links with these and bacterial population in the vagina and saliva, and peridontal disease will be explored. The genetic basis of early SPTB in relation to elafin and other biochemical substance will be explored using DNA samples extracted from blood. This study will provide novel data about the innate immune system function and facilitate the identification and development of new accurate predictive tests for spontaneous preterm birth. [COVID-19 amendment 11/05/2020] The amendment is to add a new sub-study (INSIGHT-COVID-19) in order to investigate the immediate and longer-term impact of contracting SARS-CoV-2 and the illness it induces (COVID-19) on pregnant women and their babies.
London - City & East Research Ethics Committee
Date of REC Opinion
17 Apr 2013