Serum and vaginal fluid predictive markers of preterm birth
Research type
Research Study
Full title
IDENTIFYING BIOMARKERS IN MATERNAL BLOOD AND VAGINAL FLUID FOR THE EARLY PREDICTION OF PRETERM BIRTH
IRAS ID
338910
Contact name
Dilly OC Anumba
Contact email
Sponsor organisation
The University of Sheffield
Clinicaltrials.gov Identifier
STH 21990, Sheffield Teaching Hospitals
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Background
Each year, about 15 million children are born preterm worldwide: 1.1 million of them die (1). Preterm birth (PTB) is the leading cause of death of under-5 children. The WHO estimates that three-quarters of PTB-associated deaths could be prevented with existing resources if PTB could be reliably predicted early. There remains a paucity of clinical biomarkers able to predict PTB. Early/accurate PTB risk assessment will enable care stratification of pregnant people to preterm birth prevention/management services, potentially saving millions of lives.Our recent NIHR-funded studies on fresh human placentas have identified several new genes and related proteins with altered expression in preterm placentas. We then confirmed these proteins in maternal vaginal fluid (VF) and observed that their levels are altered in mid-pregnancy in women destined to deliver preterm, uncovering new opportunities to develop point of care (POC) tests for assessing PTB risk.
Methods
We will recruit 300 pregnant women at risk of preterm birth (based on a previous history of PTB) and 50 women presenting in the second half of pregnancy with symptoms of threatened preterm birth. We will take a 10 ml blood sample and triplicate mid-vaginal swabs from each participant between 20- and 28-weeks’ gestation. The blood and swab samples will be stored at -80ºC until analysed. Analysis of samples will employ ELISA multiplex qPCR, microbiome, metabolomics, and proteomics profiling.Descriptive statistics will be employed to summarise all quantitative data. Categorical outcomes such as PTB will be compared using a Chi-squared test. Continuous variables will be compared using parametric (Student t tests) and nonparametric (Mann-Whitney U) tests.
Results
Protein analytes will be compared between women who delivered preterm and those who delivered at term. Analysis will be conducted for secondary outcomes including a composite of neonatal morbidity represented by admission to the neonatal intensive care unit.REC name
Wales REC 5
REC reference
24/WA/0053
Date of REC Opinion
9 Feb 2024
REC opinion
Favourable Opinion