Acknowledgements
The researchers would like to thank all the women who participated in this study during such a distressing time for them and their families. They would also like to thank the members of the Trial Steering Committee (Professor Alan Cameron – Chair, Professor Elizabeth Draper, Professor Paul Clarke, Dr Laura Price, Dr Laura Bonnett, Mr Alex Astor, Ms Louise Hardman, and Miss Karen Wilding), Independent Safety and Data Monitoring Committee (Professor Ed Juszczak – Chair, Professor Christoph Lees and Professor Ben Stenson) and all the individuals who helped with the management and conduct of the STRIDER UK study. The researchers are also grateful to Sharp Clinical Services and The University of British Columbia (UBC), Canada for supporting the provision of blinded drug to research sites and to staff of pharmacy and research and development departments in all of the participating hospitals. The researchers would like to thank UBC for the development and support of the STRIDER randomisation and electronic data capture systems.
The researchers would like to thank the NIHR who funded this programme of work.
Contributions of authors
Andrew Sharp (https://orcid.org/0000-0003-3396-7464) (Senior lecturer in Obstetrics, Obstetrician) wrote the initial submission for funding, wrote the submission for phase 2 funding for the study, supervised the conduct of the RCT and wrote the manuscript.
Christine Cornforth (https://orcid.org/0000-0002-6047-8634) (Director of Partnerships & Programmes, Senior Trial Manager) wrote the submission for Phase 2 funding for the study, supervised the conduct of the RCT, performed neurodevelopmental assessments, reviewed the neurodevelopmental data and wrote the manuscript.
Richard Jackson (https://orcid.org/0000-0002-7814-5088) (Senior Lecturer in Statistics, Statistician) performed statistical analysis.
Jane Harrold (https://orcid.org/0000-0002-9281-1446) (Doctor, Trial Manager) collated trial data.
Mark A Turner (https://orcid.org/0000-0002-5299-8656) (Professor of Neonatology, Neonatologist) supervised neonatal outcomes.
Louise Kenny (https://orcid.org/0000-0002-9011-759X) (Professor of Obstetrics and Executive Pro-Vice-Chancellor, Obstetrician) developed the STRIDER study consortium.
Philip N Baker (https://orcid.org/0000-0002-4592-6427) (Professor of Obstetrics and Pro Vice-Chancellor, Research and Enterprise, Obstetrician) conceived the idea for the study and developed the STRIDER study consortium.
Edward D Johnstone (https://orcid.org/0000-0001-9732-8544) (Professor of Obstetrics, Obstetrician) reviewed trial data.
Asma Khalil (https://orcid.org/0000-0003-2802-7670) (Professor of Fetal Medicine, Obstetrician) assessed the cardiovascular results.
Peter von Dadelszen (https://orcid.org/0000-0003-4136-3070) (Professor of Global Women’s Health, Obstetrician) developed the STRIDER study consortium.
Aris T Papageorghiou (https://orcid.org/0000-0001-8143-2232) (Professor of Fetal Medicine, Obstetrician) developed the STRIDER study consortium.
Brigitte Vollmer (https://orcid.org/0000-0003-4088-5336) (Professor of Perinatal Neurology) provided oversight relating to the neurodevelopmental outcomes assessment and interpretation, reviewed the neurodevelopmental data and wrote the manuscript.
Zarko Alfirevic (https://orcid.org/0000-0001-9276-518X) (Emeritus Professor of Fetal Medicine, Obstetrician) developed the STRIDER study consortium, wrote the initial submission for funding, wrote the submission for phase 2 funding for the study, supervised the conduct of the RCT and wrote the manuscript.
All authors reviewed the final manuscript and prepared the results for publication.
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/WAKV3677.
Primary conflicts of interest: Andrew Sharp, Asma Khalil, Richard Jackson, Edward D Johnstone, Jane Harrold, Louise Kenny, Peter von Dadelszen, Zarko Alfirevic, Christine Cornforth, Mark A Turner, Brigitte Vollmer declare no conflicts of interest.
Philip N Baker is a minority shareholder of Metabolomic Diagnostics, a spin out company which seeks to develop screening tests for pregnancy complications.
Aris T Papageorghiou is a co-founder of and shareholder of Intelligent Ultrasound, a University spin out company.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data may be granted following review.
Ethics statement
Ethical approval for phase 1 of this study was obtained on 20 March 2014, Research Ethics Committee (REC; North East – Newcastle and North Tyneside 2, REC Ref: 14/NE/0011) and for phase 2 was obtained on 21 December 2016 (REC; London – Brent Research Ethics Committee, REC Ref: 16/LO/2225).
Information governance statement
The University of Liverpool and Liverpool Women’s Hospital have a steadfast commitment to adhering to the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679 when it comes to managing personal information. As per the Data Protection legislation, the University of Liverpool serves as the Data Controller. For detailed information on how personal data is handled, including guidance on exercising individual rights and contacting the Data Protection Officer, please refer to this link ([email protected]).
Disclaimers
This article presents independent research. 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 MRC, the EME 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 EME programme or the Department of Health and Social Care.
