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^* (Corresponding Author), 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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

6 Citations (Scopus)

4 Downloads (Pure)

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).

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

Bibliographical note

This project was funded by the National Institute of Healthcare Research
Health Technology and Assessment (Reference 14/32/01). The views expressed
are those of the authors and not necessarily those of the NHS, the NIHR or the
Department of Health.

Keywords

cervix
diagnostic test
fetal fibronectin
pregnancy
preterm birth

Access to Document

10.1136/bmjopen-2017-020795Licence: CC BY

Stock_etal_BMJ_Study_Protocol_Quantitative_VoR
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Final published version, 537 KBLicence: CC BY

Cite this

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

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

@article{6d136ef2262d4bbd9f051c0d2383cc47,

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).",

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

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 = "This project was funded by the National Institute of Healthcare Research Health Technology and Assessment (Reference 14/32/01). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. ",

year = "2018",

month = apr,

day = "19",

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

language = "English",

volume = "8",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "4",

}

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 - This project was funded by the National Institute of Healthcare Research Health Technology and Assessment (Reference 14/32/01). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

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).

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).

KW - cervix

KW - diagnostic test

KW - fetal fibronectin

KW - pregnancy

KW - preterm birth

UR - http://www.scopus.com/inward/record.url?scp=85056994579&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2017-020795

DO - 10.1136/bmjopen-2017-020795

M3 - Article

C2 - 29674373

AN - SCOPUS:85056994579

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

Abstract

Bibliographical note

Keywords

Access to Document

Other files and links

Fingerprint

Cite this