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This study developed a prognostic model, including quantitative fetal fibronectin and clinical risk factors, that showed excellent performance in predicting spontaneous preterm birth within 7 days.

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Sarah J Stock 1,*, Margaret Horne 1, Merel Bruijn 1, Helen White 2, Robert Heggie 3, Lisa Wotherspoon 4, Kathleen Boyd 3, Lorna Aucott 5, Rachel K Morris 6, Jon Dorling 7, Lesley Jackson 8, Manju Chandiramani 9, Anna David 10, Asma Khalil 11, Andrew Shennan 12, Gert-Jan van Baaren 13, Victoria Hodgetts-Morton 5, Tina Lavender 2, Ewoud Schuit 14, Susan Harper-Clarke 15, Ben Mol 16, Richard D Riley 17, Jane Norman 4, John Norrie 1

1 Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK
2 Division of Nursing, Midwifery and Social Work, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
3 Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
4 Medical Research Council Centre for Reproductive Health, Queen’s Medical Research Institute, University of Edinburgh, Edinburgh, UK
5 Health Services Research Unit, University of Aberdeen, Aberdeen, UK
6 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
7 Department of Neonatology, IWK Health Centre, Halifax, NS, Canada
8 Department of Neonatology, Queen Elizabeth Hospital, Glasgow, UK
9 Department of Obstetrics and Gynaecology, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
10 Elizabeth Garrett Anderson Institute for Women’s Health, University College London, London, UK
11 Department of Fetal Medicine, St George’s Hospital, St George’s, University of London, London, UK
12 Department of Women and Children’s Health, School of Life Course Sciences, King’s College London, London, UK
13 Department of Obstetrics and Gynaecology, Amsterdam University Medical Center, Amsterdam, the Netherlands
14 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands
15 Public and patient representative, Teddington, UK
16 Department of Obstetrics and Gynaecology, Monash University, Melbourne, VIC, Australia
17 Centre for Prognosis Research, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK
* Corresponding author Email: sarah.stock@ed.ac.uk

Declared competing interests of authors: Sarah J Stock reports grants from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, non-financial support from Hologic, Inc. (Marlborough, MA, USA), non-financial support from Parsagen Diagnostics, Inc. (Boston, MA, USA) and non-financial support from Medix Biochemica Ab (Espoo, Finland) during the conduct of the study. In addition, Sarah J Stock declares membership of the HTA Programme Funding Committee (General) (2016 to present). Kathleen Boyd reports grants from the NIHR HTA programme and NIHR Public Health Research (PHR) programme outside the submitted work during the conduct of the study. Lorna Aucott declares membership of the PHR Research Funding Board (2017 to present). Rachel K Morris reports grants from the NIHR HTA and NIHR Research for Patient Benefit programmes outside the submitted work during the conduct of the study. Jon Dorling reports grants from the NIHR HTA programme and Nutrinia Ltd (Ramat Gan, Israel) outside the submitted work; the grant from Nutrinia Ltd (2017–18) was for part of his salary to work as an expert advisor on a trial. Jon Dorling was a member of the NIHR HTA General Board (2017–18) and the NIHR HTA Maternity, Newborn and Child Health Panel (2013–18). Manju Chandiramani reports that she undertakes unpaid advisory work for Hologic, Inc., unrelated to the submitted work, and has been supported by Hologic, Inc., to attend a conference in the preceding 12 months. Anna David reports personal fees from Hologic, Inc., outside the submitted work, and salary support from the NIHR UCLH/UCL Biomedical Research Centre. Asma Khalil reports grants and prediction tests from Parsagen Diagnostics, Inc., paid to the institution, during the conduct of the study and declares being a member of the HTA Programme Funding Committee (2018 to present). Andrew Shennan reports grants and prediction tests from Hologic, Inc., for basic science on preterm markers, paid to the institution, and was a member of the HTA Funding Committee (Commissioning) during the conduct of the study (2018 to present). Tina Lavender declares membership of the HTA Obesity Themed Call Board (2013). Ben Mol reports a Practitioner Fellowship from the National Health and Medical Research Council, personal fees from ObsEva SA (Geneva, Switzerland), personal fees and other funding from Merck Sharp & Dohme (Kenilworth, NJ, USA), personal fees from Guerbet (Villepinte, France), travel support to present at meetings from Guerbet, and grants from Merck Sharp & Dohme, outside the submitted work. Richard D Riley reports grants from the NIHR HTA programme outside the submitted work during the conduct of the study. Jane Norman reports grants from the NIHR HTA and the NIHR Global Health programmes and the Medical Research Council, and personal fees from Dilafor AB (Solna, Sweden), outside the submitted work, and was a member of the HTA Maternal, Neonatal and Child Health Panel during the conduct of the study (2013–18); she was a member of the NIHR HTA and Efficacy and Mechanism Evaluation (EME) Editorial Board (2012–14). John Norrie reports grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study, and membership of the following NIHR boards: CPR Decision-Making Committee, HTA Programme Funding Committee (Commissioning), HTA Commissioning Sub-Board (Expression of Interest), HTA Funding Boards Policy Group, HTA Programme Funding Committee (General), HTA Post-board funding teleconference, Clinical Trials Unit Standing Advisory Committee, HTA and EME Editorial Board and Pre-exposure Prophylaxis Impact Review Panel during the conduct of the study.

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