The Arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix: the STOPPIT 2 RCT

Jane E Norman, John Norrie, Graeme MacLennan, David Cooper, Sonia Whyte, Sushila Chowdhry, Sarah Cunningham-Burley, Aileen R Neilson, Xue W Mei, Joel BE Smith, Andrew Shennan, Stephen C Robson, Steven Thornton, Mark D Kilby, Neil Marlow, Sarah J Stock, Philip R Bennett, Jane Denton

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Original languageEnglish
JournalHealth Technology Assessment
Issue number44
Publication statusPublished - 1 Jul 2021

Bibliographical note

Funding Information:
NVivo Pro (version 11; QSR International, Warrington, UK) computer software was used to manage and support the coding of data. Initial codes were created around the main interview questions and comparison made across the women’s experience on each arm of the trial and health-care professionals’ accounts. The research team members were involved in ongoing discussions as data collection and analysis progressed. The use of computer software helped to facilitate a critical and rigorous approach to the assignment and with the interpretation of the codes and emergent themes.21 A two-cycle approach to coding was undertaken.22 First-cycle coding involved applying structural coding, which facilitated an approach whereby the data were coded according to broad topics [i.e. experience of transvaginal ultrasonography (TVU)]. The segments of data were then subject to further analysis and comparison. Analysis and interpretation were supported by analytic memo writing on emergent patterns and themes. Second-cycle coding further refined the original codes and memos into a smaller number of categories that were subject to further analysis and interpretation. This stage of the analysis involved a team approach, helping to improve the rigour of the findings.23

Funding Information:
The research reported in this issue of the journal was funded by the HTA programme as project number 13/04/22. The contractual start date was in November 2014. The draft report began editorial review in September 2020 and was accepted for publication in February 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Funding Information:
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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© 2021 Norman et al. This work was produced by Norman et al.

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