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 |
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| 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, Professor 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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