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The Arabin cervical pessary plus standard care did not reduce either the rate of preterm birth or adverse neonatal outcomes, compared with standard care alone.

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Jane E Norman 1,*, John Norrie 2, Graeme MacLennan 3, David Cooper 3, Sonia Whyte 4, Sushila Chowdhry 5, Sarah Cunningham-Burley 5, Aileen R Neilson 5, Xue W Mei 6, Joel BE Smith 6, Andrew Shennan 7, Stephen C Robson 8, Steven Thornton 9, Mark D Kilby 10, Neil Marlow 11, Sarah J Stock 5, Philip R Bennett 12, Jane Denton 13

1 Faculty of Health Sciences, University of Bristol, Bristol, UK
2 Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
3 Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
4 Tommy’s Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK
5 Usher Institute, University of Edinburgh, Edinburgh, UK
6 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
7 Tommy’s London Research Centre, King’s College London, London, UK
8 Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
9 Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
10 Fetal Medicine Centre, Birmingham Women’s and Children’s NHS Foundation Trust and College of Medical and Dental Science, University of Birmingham, Birmingham, UK
11 Institute for Women’s Health, University College London, London, UK
12 Department of Surgery and Cancer, Imperial College London, London, UK
13 The Multiple Births Foundation, London, UK
* Corresponding author Email: jane.e.norman@bristol.ac.uk

Declared competing interests of authors: Jane E Norman has received grants from government and charitable bodies for research into understanding the mechanism of term and preterm labour and understanding treatments. Within the last 3 years, Jane E Norman has acted on a Data Safety and Monitoring Board for a study involving a preterm birth therapeutic agent for GlaxoSmithKline plc (GlaxoSmithKline plc, Brentford, UK) and has provided consultancy for a small pharmaceutical company (Dilafor AB, Solna, Sweden) on drugs to alter labour progress. She was on the Health Technology Assessment (HTA) Maternal Neonatal and Child Health Panel (2013–18) and she was a member of the National Institute for Health Research (NIHR) HTA and Efficacy and Mechanism Evaluation (EME) Editorial Board (2012–14). John Norrie reports grants from the University of Edinburgh (Edinburgh, UK) during the conduct of the study, and declares that he is or has been a member of the following: HTA Commissioning Sub-Board (EOI) (2012–16), NIHR CTU Standing Advisory Committee (2017–present), NIHR HTA and EME Editorial Board (2014–19), Pre-Exposure Prophylaxis Impact Review Panel (2017–present), EME Strategy Advisory Committee (2019–present), EME – Funding Committee Members (2019–present), EME Funding Committee Sub-Group Remit & Comp Check (2019–present), HTA General Committee (2016–19), HTA Funding Committee Policy Group (formerly Clinical Studies Group) (2016–19), HTA Commissioning Committee (2010–16) and was a member of the HTA and EME Editorial Board between 2014 and 2019. Sarah Cunningham-Burley reports personal fees and other from the Wellcome Trust (London, UK), other from the University of Copenhagen (Copenhagen, Denmark), other funding from NIHR Global Health Research, personal fees from the French National Cancer Institute (Paris, France) and personal fees from the Health Research Board (Dublin, Ireland), outside the submitted work. Andrew Shennan is a member of the NIHR HTA Commissioning Committee (2018–22). Stephen C Robson was a member of the NIHR EME Funding Committee (2012–15). Steven Thornton is a trustee of a number of charities, including those that fund related research. He reports personal fees from GlaxoSmithKline plc, during the conduct of the study and outside the submitted work, and personal fees from Johnson & Johnson (Johnson & Johnson, Brunswick, NJ, USA) for consulting services. He holds positions in the Royal College of Obstetricians and Gynaecologists (London, UK) and other organisations. He was a member of the NIHR EME Strategy Advisory Committee (2018–19), EME – Funding Committee Members (2015–19), EME Funding Committee Sub-Group Remit & Comp Check (2018–19) and the Medical Research Council Multimorbidity Board (2020). Neil Marlow reports personal fees from Shire-Takeda (London, UK), Novartis Pharmaceuticals UK Ltd (London, UK) and GlaxoSmithKlein plc, outside the submitted work. Sarah J Stock declares that she is a member of the NIHR HTA General Committee (2016–22). In addition, Sarah J Stock received other research funding from the NIHR (14/32/01 QUIDS), Wellcome Trust (209560/Z/17/Z) and Chief Scientist Office (Edinburgh, UK), during the course of the study. Philip R Bennett reports personal fees and membership of a scientific panel from ObsEva (Plan-les-Ouates, Switzerland), outside the submitted work. In addition, Philip R Bennett has a patent PCT/GB1997/000529 WO1997031631 A1 ‘COX-2 selective inhibitors for managing labour and uterine contractions’ issued, a patent PCT/GB2004/001380 WO2005053705 A1 ‘Use of a cyclopentenone prostaglandin for delaying the onset and/or preventing the continuation of labour’ (priority date 2 December 2003) issued, a patent PCT/GB2016/050618 ‘Circulating miRNAs predictive of cervical shortening and preterm birth’ (pending UK filing 6 March 2015/full international filing completed 7 March 2016) issued, a patent PCT/GB2016/050621 ‘Rapid evaporative ionisation mass spectroscopy (REIMS) and desorbtion electrospray ionisation mass spectroscopy (DESI-MS) analysis of swabs and biopsy samples’ (pending UK filing 6 March 2015/full international filing completed 7 March 2016) pending, a patent PCT/GB2019 ‘Desorbtion electrospray ionisation mass spectroscopy (DESI-MS) analysis of swabs to predict vaginal microbiota’ (pending UK filing March 2019) pending, and a patent PCT/GB2019/ ‘Circulating miRNAs predictive of IUGR’ (pending UK filing March 2019) pending.

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