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

Sarah Jane Stock, Lisa M Wotherspoon, Kathleen Anne Boyd, Rachel K Morris, Jon Dorling, Lesley Jackson, Manju Chandiramani, Anna L David, Asma Khalil, Andrew Shennan, Victoria Hodgetts Morton, Tina Lavender, Khalid Khan, Susan Harper-Clarke, Ben Mol, Richard D Riley, John Norrie, Jane Norman

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)e020795
JournalBMJ Open
Volume8
Issue number4
Early online date19 Apr 2018
DOIs
Publication statusPublished - 19 Apr 2018

Fingerprint Dive into the research topics of 'Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study'. Together they form a unique fingerprint.

Cite this