. 2018 Apr 19;8(4):e020795.

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^{1

2}, Lisa M Wotherspoon¹, Kathleen Anne Boyd³, Rachel K Morris⁴, Jon Dorling⁵, Lesley Jackson⁶, Manju Chandiramani⁷, Anna L David^{8

9}, Asma Khalil¹⁰, Andrew Shennan¹¹, Victoria Hodgetts Morton⁴, Tina Lavender¹², Khalid Khan¹³, Susan Harper-Clarke¹⁴, Ben Mol¹⁵, Richard D Riley¹⁶, John Norrie¹⁷, Jane Norman¹

Affiliations

¹ Tommy's Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
² School of Women's and Infants' Health, University of Western Australia, Crawley, Western Australia, Australia.
³ Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
⁴ School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
⁵ Neonatal Unit, Queen's Medical Centre, Nottingham, UK.
⁶ Neonatal Unit, Royal Hospital for Children Glasgow, Glasgow, UK.
⁷ Department of Surgery & Cancer, Reproductive Biology, Imperial College Healthcare NHS Trust, Queen Charlotte's and Chelsea Hospital, London, UK.
⁸ Institute for Women's Health, University College London Medical School, London, UK.
⁹ 86-96 Chenies Mews, University College London Medical School London, London, UK.
¹⁰ St. George's Medical School, University of London, London, UK.
¹¹ Maternal and Fetal Research Unit, King's College London, London, UK.
¹² School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
¹³ Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
¹⁴ Patient and Public Involvement Representative.
¹⁵ Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.
¹⁶ Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
¹⁷ Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.

PMID: 29674373
PMCID: PMC5914783
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 et al. BMJ Open. 2018.

. 2018 Apr 19;8(4):e020795.

doi: 10.1136/bmjopen-2017-020795.

Authors

Affiliations

¹ Tommy's Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
² School of Women's and Infants' Health, University of Western Australia, Crawley, Western Australia, Australia.
³ Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
⁴ School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
⁵ Neonatal Unit, Queen's Medical Centre, Nottingham, UK.
⁶ Neonatal Unit, Royal Hospital for Children Glasgow, Glasgow, UK.
⁷ Department of Surgery & Cancer, Reproductive Biology, Imperial College Healthcare NHS Trust, Queen Charlotte's and Chelsea Hospital, London, UK.
⁸ Institute for Women's Health, University College London Medical School, London, UK.
⁹ 86-96 Chenies Mews, University College London Medical School London, London, UK.
¹⁰ St. George's Medical School, University of London, London, UK.
¹¹ Maternal and Fetal Research Unit, King's College London, London, UK.
¹² School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
¹³ Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
¹⁴ Patient and Public Involvement Representative.
¹⁵ Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.
¹⁶ Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
¹⁷ Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.

PMID: 29674373
PMCID: PMC5914783
DOI: 10.1136/bmjopen-2017-020795

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: cervix; diagnostic test; fetal fibronectin; pregnancy; preterm birth.

PubMed Disclaimer

Conflict of interest statement

Competing interests: SJS and JEN work at the University of Edinburgh, who received £1000 sponsorship from Hologic to support a meeting (The Society of Reproductive Investigation and MRC Centre for Reproductive Health Scientific Symposium on Targeting Inflammation to Improve Reproductive Health across the Lifecourse – August 2017). AS has in the past (over last 5 years; not in the last 3 years) received funding for expenses related to advisory board and internal staff education from Hologic. MC received sponsorship from Hologic to organise an educational teaching focusing on prediction of Preterm Birth at the 2017 annual meeting of the British Maternal and Fetal Medicine Society. Hologic, the makers of fFN have provided analysers and technical support for their use to sites participating in the QUIDS prospective cohort study. They have no access to the data, or other involvement in the conduct, data analysis, interpretation of results or decision to publish the results of the study.

Figures

**Figure 1**
Flow chart illustrating the design of QUIDS study and conceptual division into part 1 and part 2. qfFN, quantitative fetal fibronectin.

See this image and copyright information in PMC

References

1. Stock SJ, Wotherspoon L, Boyd K, et al. . Study Protocol: Quantitative Fibronectin to help Decision-making in women with Symptoms of Preterm Labour (QUIDS) Part One- Individual Patient Data Meta-analysis and Health Economic Analysis. BMJ Open 2017. doi: 10.1136/bmjopen-2017-020796 [Epub ahead of print]. - DOI - PMC - PubMed
1. Honest H, Forbes CA, Durée KH, et al. . Screening to prevent spontaneous preterm birth: systematic reviews of accuracy and effectiveness literature with economic modelling. Health Technol Assess 2009;13:1–627. 10.3310/hta13430 - DOI - PubMed
1. Deshpande SN, van Asselt AD, Tomini F, et al. . Rapid fetal fibronectin testing to predict preterm birth in women with symptoms of premature labour: a systematic review and cost analysis. Health Technol Assess 2013;17:1–138. 10.3310/hta17400 - DOI - PMC - PubMed
1. Roberts D, Brown J, Medley N, et al. . Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev 2017;3:CD004454 10.1002/14651858.CD004454.pub3 - DOI - PMC - PubMed
1. Office for National Statistics (2013). ONS gestation-Specific Infant Mortality in England and Wales 2011. 2017. Cardiff ONS, 2013. Also https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/... (accessed 23 Nov 2017).

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

Grants and funding

HTA/14/32/01/DH_/Department of Health/United Kingdom

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical