Prediction of preterm labour study (PROPER)
Research type
Research Study
Full title
Prediction of preterm birth study (PROPER)
IRAS ID
261328
Contact name
Phillip Bennett
Contact email
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Preterm labour (PTL; delivery before 37 weeks gestation) occurs in around 10% of all pregnancies. It is a major cause of infant death and illnesses worldwide. We hypothesise that specific changes in the levels of circulating microRNAs and/or vaginal microbiome precedes the changes which are seen in the cervix several weeks before the onset of early PTL in the low risk population as early as 12-14 weeks gestation. Our study objectives are to validate the predictive ability of a panel of microRNA biomarkers to predict PTL and cervical shortening, and to establish whether a low IL-18/IL-8 ratio and/or a Lactobacillus Iners dominated microbiome, or Lactobacillus depletion is a risk factor for PTL in a low risk population and so might be used as additional biomarkers. The study is in two phases. In phase one, blood and vaginal swab samples will be taken from every consenting pregnant woman attending the antenatal clinic in Queen Charlotte’s/Chelsea and Westminster/St.Mary’s Hospital at 12-14 weeks gestation. MicroRNA from plasma and bacterial DNA from vaginal fluid will be stored for analysis. Women will be divided into three groups; those with no cervical change who deliver at term, those with cervical change who are treated (either with cervical cerclage or progesterone) who deliver term, and those who deliver preterm. Samples from each of these groups will be used for biomarker validation. Our ultimate aim is to find a new test to predict PTL in blood and vaginal secretions so that in the future we can screen women early in their pregnancy for their risk of PTL.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0491
Date of REC Opinion
18 Sep 2019
REC opinion
Further Information Favourable Opinion