Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study. Issue 4 (19th April 2018)

• Record Type: Journal Article
• Authors: Stock, Sarah Jane; Wotherspoon, Lisa M; Boyd, Kathleen Anne; Morris, Rachel K; Dorling, Jon; Jackson, Lesley; Chandiramani, Manju; David, Anna L; Khalil, Asma; Shennan, Andrew; Hodgetts Morton, Victoria; Lavender, Tina; Khan, Khalid; Harper-Clarke, Susan; Mol, Ben; Riley, Richard D; Norrie, John; Norman, Jane
• Is Part Of: BMJ open. Volume 8:Issue 4(2018)
• Publication Date: 2018-04-19
• Subjects: pregnancy -- preterm birth -- fetal fibronectin -- cervix -- diagnostic test; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2017-020795
• Languages: English
• ISSNs: 2044-6055

Abstract

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 41598423 andCPMS: 31277 .