Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study

Stock, S. J. et al. (2018) Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study. BMJ Open, 8(4), e020795. (doi: 10.1136/bmjopen-2017-020795) (PMID:29674373) (PMCID:PMC5914783)

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Abstract

Introduction: The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (fFN) concentration, in combination with clinical risk factors. Methods and analysis: The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts, USA) which quantifies fFN in a vaginal swab. In QUIDS part 2, we will perform a prospective cohort study in at least eight UK consultant-led maternity units, in women with symptoms of preterm labour at 22+0 to 34+6 weeks gestation to externally validate a prognostic model developed in QUIDS part 1. The effects of quantitative fFN on anxiety will be assessed, and acceptability of the test and prognostic model will be evaluated in a subgroup of women and clinicians (n=30). The sample size is 1600 women (with estimated 96–192 events of preterm delivery within 7 days of testing). Clinicians will be informed of the qualitative fFN result (positive/negative) but be blinded to quantitative fFN result. Research midwives will collect outcome data from the maternal and neonatal clinical records. The final validated prognostic model will be presented as a mobile or web-based application. Ethics and dissemination: The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068). Version: Protocol V.2, Date 1 November 2016. Trial registration number: ISRCTN 41598423andCPMS: 31277.

Item Type:Articles
Additional Information:This project was funded by the National Institute of Healthcare Research Health Technology and Assessment (Reference 14/32/01).
Keywords:Pregnancy, diagnostic test, cervix, preterm birth, fetal fibronectin.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Jackson, Dr Lesley and Boyd, Dr Kathleen
Authors: Stock, S. J., Wotherspoon, L. M., Boyd, K. A., Morris, R. K., Dorling, J., Jackson, L., Chandiramani, M., David, A. L., Khalil, A., Shennan, A., Hodgetts Morton, V., Lavender, T., Khan, K., Harper-Clarke, S., Mol, B., Riley, R. D., Norrie, J., and Norman, J.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:19 April 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in BMJ Open 8(4): e020795
Publisher Policy:Reproduced under a Creative Commons License

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