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

doi:10.1136/bmjopen-2017-020795

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

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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.

Original language	English
Article number	e020795
Journal	BMJ open
Volume	8
Issue number	4
DOIs	https://doi.org/10.1136/bmjopen-2017-020795
Publication status	Published - 19 Apr 2018

Keywords

pregnancy
preterm birth
fetal fibronectin
cervix
diagnosis test

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10.1136/bmjopen-2017-020795

Stock_et_al_Study_protocol_quantitative_fibronectin_BMJ_Open_2018
Published in BMJ Open on 19/04/2018 DOI: 10.1136/bmjopen-2017-020795
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http://bmjopen.bmj.com/content/8/4/e020795

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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., & Norman, J. (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), Article e020795. https://doi.org/10.1136/bmjopen-2017-020795

@article{1c52edd5954a48bfa38085d331d5fa45,

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

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.",

keywords = "pregnancy , preterm birth , fetal fibronectin , cervix , diagnosis test",

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

note = "{\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",

year = "2018",

month = apr,

day = "19",

doi = "10.1136/bmjopen-2017-020795",

language = "English",

volume = "8",

journal = "BMJ open",

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Stock, SJ, Wotherspoon, LM, Boyd, KA, Morris, RK, Dorling, J, Jackson, L, Chandiramani, M, David, AL, Khalil, A, Shennan, A, Hodgetts Morton, V, Lavender, T, Khan, K, Harper-Clarke, S, Mol, B, Riley, RD, Norrie, J & Norman, J 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, vol. 8, no. 4, e020795. https://doi.org/10.1136/bmjopen-2017-020795

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

PY - 2018/4/19

Y1 - 2018/4/19

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.

KW - pregnancy

KW - preterm birth

KW - fetal fibronectin

KW - cervix

KW - diagnosis test

U2 - 10.1136/bmjopen-2017-020795

DO - 10.1136/bmjopen-2017-020795

M3 - Article

C2 - 29674373

SN - 2044-6055

VL - 8

JO - BMJ open

JF - BMJ open

IS - 4

M1 - e020795

ER -

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

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