QUIDS 2
Research type
Research Study
Full title
Quantitative Fibronectin to help Decision-making in women with Symptoms of Preterm Labour - Comparison with Partosure and Actim Partus - QUIDS 2
IRAS ID
225638
Contact name
Chris Coner
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
ISRCTN41598423
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Currently being evaluated in the QUIDS study, 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. In addition to fFN, there are two further pre-term birth marker tests available for use in the NHS; Actim Partus and Partosure. Both are dipstick tests yielding qualitative positive or negative results. The main aim of this research is to compare the prognostic values of each of the three tests of preterm labour (quantitative fFN; Actim Partus and Partosure) for prediction of preterm birth within seven days of testing. We will firstly, analyse previous research data to develop a prognostic model using clinical risk factors in addition to 1. Actim Partus and 2. Partosure. We will validate and refine the prognostic models using data collected in a prospective cohort study in at least 20 UK sites. An economic analysis will be undertaken from an NHS perspective to assess potential cost-effectiveness of the Actim Partus and Partosure prognostic models, in comparison to the quantitative fetal fibronectin prognostic model developed in the related QUIDS study. This work will be complimentary to, and carried out alongside QUIDS. It will be carried out over 16 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.
REC name
West of Scotland REC 5
REC reference
17/WS/0081
Date of REC Opinion
10 May 2017
REC opinion
Further Information Favourable Opinion