Contributions of authors
Victoria Hodgetts Morton (https://orcid.org/0000-0001-9817-4313) was the research fellow on the trial and was involved with the design, implementation and recruitment, and was responsible for authoring this manuscript.
Catherine A Moakes (https://orcid.org/0000-0002-0473-0532) was the trial statistician and was responsible for the analysis of the trial data and for co-authoring this manuscript.
Jane Daniels (https://orcid.org/0000-0003-3324-6771) was involved with the design of the trial and provided trial oversight and a critical review of the manuscript.
Lee Middleton (https://orcid.org/0000-0003-4621-1922) was the senior statistician for the trial and was responsible for the analysis of the trial data and for co-authoring this manuscript.
Andrew Shennan (https://orcid.org/0000-0001-5273-3132) was involved with recruitment to the trial and provided expert advice on preterm birth prevention and co-authored the manuscript.
Peter Brocklehurst (https://orcid.org/0000-0002-9950-6751) provided senior input to the design of the trial and co-authored the manuscript.
Fidan Israfil-Bayli (https://orcid.org/0000-0002-4751-8857) designed the trial protocol and secured funding for the trial.
Andrew K Ewer (https://orcid.org/0000-0002-3825-4781) was a co-applicant for the trial and was responsible for the design advising on neonatal outcomes and contributed to the critical review of the manuscript.
James Gray (https://orcid.org/0000-0003-4169-3141) provided microbiological advice to the trial and co-authored the manuscript.
Nigel AB Simpson (https://orcid.org/0000-0002-0758-7583) was involved with recruitment to the trial and provided expert advice on preterm birth prevention and co-authored the manuscript.
Jane E Norman (https://orcid.org/0000-0001-6031-6953) was involved with recruitment to the trial and provided expert advice on preterm birth prevention and co-authored the manuscript.
Christoph Lees (https://orcid.org/0000-0002-2104-5561) was involved with recruitment to the trial and provided expert advice on preterm birth prevention and co-authored the manuscript.
Konstatinos Tryposkiadis (https://orcid.org/0000-0002-2516-1180) was the original statistician.
Clive Stubbs (https://orcid.org/0000-0003-2690-6583) provided governance oversight and supported the trial to continue to reopen for recruitment post pandemic.
Max Hughes (https://orcid.org/0000-0001-7058-0109) was the trial co-ordinator for the trial.
R Katie Morris (https://orcid.org/0000-0003-1247-429X) provided senior input into the trial design and delivery and has oversight of the analysis as director of the clinical trials unit.
Philip Toozs-Hobson (https://orcid.org/0000-0002-1859-9934) was the chief investigator for the trial; he conceived the project, supervised the COTS study and was involved with the design, implementation and oversight of the trial, and provided oversight of the manuscript.
Acknowledgements
The final protocol version was v9.0 dated 25 March 2020. The full trial protocol is available online at the NIHR Journals Library and at the C-STICH website.
We would like to thank all the women who agreed to take part in this study, without whom this would not have been possible.
C-STICH has been supported by a trial steering committee and data monitoring committee and we would like to express our sincere thanks for all their guidance, expertise and advice. The TSC members include Professor Harry Gee (chair), Professor Christine Kettle, Professor Jon Dorling, Mr Andrew Elders, Dr Ruth Curry, Ms Sarah Machin and Ms Joanne Deery. The DMC members include Professor Marian Knight (chair), Professor Doug Tincello (withdrew when a potential conflict of interest arose due to working at the recruiting trust), Professor John Norrie, Mr Richard Smith and Professor Graeme Maclennan.
C-STICH has been supported by a large network of sites, principal investigators, research midwives, research nurses, sonographers, clinical data collectors, consultants, specialty doctors, research fellows and lecturers; although too extensive to mention individually, we are extremely grateful for their support.
We would like to personally thank our PPI representatives, Ms Sarah Machin and Ms Joanne Deery.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Ethics statement
The trial had a favourable ethical opinion from the National Research Ethics Service (NRES) Committee Cambridgeshire and Hertfordshire obtained in February 2015.
Information governance statement
Birmingham Women’s Hospital (sponsor) and the University of Birmingham is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, University of Birmingham is the Data Processor; Birmingham Women’s Hospital is the Data Controller and we process personal data in accordance with their instructions. You can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for University of Birmingham’s Data Protection Officer here: https://www.birmingham.ac.uk/documents/university/legal/university-of-birmingham-data-protection-policy.pdf
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/YKTW8402.
Primary conflicts of interest: Victoria Hodgetts Morton is a previous NIHR clinical lecturer, NHS England regional preterm birth lead (Midlands), has received an honorarium from Hologic and is a co-investigator on NIHR grants C-STICH2 (16/141/01) and CHAPTER. Jane Daniels declares membership of the NIHR Clinical Trials Unit Standing Advisory Committee (1/5/2016 to 30/09/2023). Jane E Norman declares membership of the HTA MNCH panel, currently receives funding from the NIHR EME programme, is chair of the Global Health Research Funding committee and Wellcome Trust Science panel and participates in NIHR and Wellcome trust data safety and trial steering committees; she also participates in a data monitoring and ethics committee for GlaxoSmithKline and is a paid consultant for DILAFOR; Jane E Norman is also non-executive director at University Hospitals Bristol and Weston and receives funding from grants for NIHR HTA (17/22/02) and STOPPIT-3. R Katie Morris currently receives funding from NIHR HTA (CSTICH2 16/151/01) and programme grants for applied health research schemes; she is a steering committee member of the Saving Babies Lives Care Bundle and a paid clinical advisory board member for Surepulse (a company designing neonatal monitors). R Katie Morris is also a member of the Tommy’s, RCOG and WOW scientific advisory committees (chair of the Preterm Birth clinical study group) and a member of the RCOG research and academic committees. Andrew K Ewer is President of the Neonatal Society and receives honoraria from Medtronic for educational events. James Gray is a co-investigator on NIHR call 17/86 ‘The clinical and cost effectiveness of screening for Group B Streptococcus (GBS) in pregnancy’ (NIHR HTA reference number: NIHR134534) and a co-investigator with the Healthcare Infection Society [Walker K, et al. (2020) ‘Maternity services response to the COVID-19 pandemic: how PHE guidance was implemented and what we can learn for the future’]. Nigel AB Simpson is a member of the research advisory board for Tommy’s. Andrew Shennan is a previous member of the NIHR commissioning committee. Peter Brocklehurst has been employed by clinical trials units receiving funding from the NIHR and is a past member of several NIHR boards (HTA Efficient Study Designs, HTA MNCH Methods Group, HTA MNCH Panel, HTA Post-funding Committee and HTA Commissioning Committee).
Publication
Hodgetts Morton V, Toozs-Hobson P, Moakes CA, Middleton L, Daniels J, Simpson NAB, et al. Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial. Lancet 2022;400(10361):1426–36.
Disclaimers
This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.