TY - JOUR
T1 - Study protocol
T2 - quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study
AU - Stock, Sarah Jane
AU - Wotherspoon, Lisa M.
AU - Boyd, Kathleen Anne
AU - Morris, Rachel K.
AU - Dorling, Jon
AU - Jackson, Lesley
AU - Chandiramani, Manju
AU - David, Anna L.
AU - Khalil, Asma
AU - Shennan, Andrew
AU - Hodgetts Morton, Victoria
AU - Lavender, Tina
AU - Khan, Khalid
AU - Harper-Clarke, Susan
AU - Mol, Ben
AU - Riley, Richard D.
AU - Norrie, John
AU - Norman, Jane
N1 - RIS file
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
U2 - 10.1136/bmjopen-2017-020795
DO - 10.1136/bmjopen-2017-020795
M3 - Article (Academic Journal)
C2 - 29674373
SN - 2044-6055
VL - 8
SP - e020795
JO - BMJ Open
JF - BMJ Open
IS - 4
ER -