QUIDS
Research type
Research Study
Full title
Quantitative Fibronectin to help Decision-making in women with Symptoms of Preterm Labour - QUIDS
IRAS ID
199202
Contact name
Chris Coner
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
ISRCTN41598423
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
A test called quantitative fetal Fibronectin (fFN) may help improve diagnosis of preterm labour. The test involves the measurement of fFN in a swab taken at vaginal examination, which is part of routine assessment of a woman presenting with signs and symptoms of preterm labour. The amount of fFN present in the sample can be measured in an analyser that provides results in less than 10 minutes. The lower the concentration of fFN, the less likely preterm delivery is to occur. Although other fFN tests provide a positive or negative result, the ability to measure the absolute amount of fibronectin is new. This gives the potential to more accurately rule out preterm labour. The main aim of this research is to see if qfFN can accurately rule out preterm delivery within 7 days of testing. We will analyse previous research data to see if qfFN is likely to be a useful test on its own, or in combination with other clinical features. We will then determine which combination of features can help diagnose preterm labour most effectively, whilst still being good value to the NHS. We will gather data in a prospective cohort of women to help refine the decision support tool, to help women and clinicians assess how likely preterm delivery is, and decide whether to start treatment or not. We will ask women, their partners and caregivers which outcomes are most important when making decisions, and how best to present this, to make sure it is relevant to them. The decision support will most likely be as a web-based application. The work will be carried out over 30 months, by a team with the necessary expertise to complete the research. Public representatives will be involved in trial design, management and interpretation and dissemination of results. Patient advisory groups will also be regularly consulted, and women and their partners will be involved in the needs assessment to design the decision support.
REC name
West of Scotland REC 5
REC reference
16/WS/0068
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion