Núcleo de la Dignidad

All of the following named authors contributed substantially to the development of the research question and study design, implementation, analysis and/or interpretation of data and submission of the final report. Particular contributions are denoted below:

Professor Arri Coomarasamy(Professor of Gynaecology and PROMISE Trial Manager) designed the study, directed the conduct of the study, chaired the TMG and contributed to the TSC and other meetings, and produced the final draft of the report.

Miss Helen Williams(Research Associate, Women_’s Health) was responsible for completion of data gathering, providing data quality assurance, co-ordination of the analysis and the writing groups, and preparation of the initial draft of the final report.

Dr Ewa Truchanowicz(Clinical Trial Co-ordinator) co-ordinated the practical conduct of the study including the management of follow-up, attended meetings of the TSC and contributed to the TMG and the final report.

Mr Paul T Seed(Senior Lecturer, Medical Statistics) designed and conducted the statistical analysis of primary and secondary trial outcomes, produced reports for the DMC and contributed to the TMG. Ms Rachel Small(Miscarriage Midwife Specialist) conducted PROMISE recruitment and data collection at Birmingham Heartlands Hospital, UK.

Professor Siobhan Quenby(Professor of Obstetrics) was responsible for leading PROMISE recruitment and data collection at Birmingham Heartlands Hospital and Coventry University Hospital, UK.

Dr Pratima Gupta(Consultant in Obstetrics and Gynaecology) was responsible for co-ordinating PROMISE recruitment and data collection at Birmingham Heartlands Hospital, UK.

Dr Feroza Dawood(Consultant Obstetrician and Gynaecologist) was responsible for leading PROMISE recruitment and data collection at Liverpool Women’s Hospital, UK.

Dr Yvonne E Koot(Obstetrics and Gynaecology) was responsible for leading PROMISE recruitment and data collection at University Medical Centre Utrecht, Utrecht, the Netherlands, and assisting in the co-ordination of investigators from the Netherlands.

Ms Ruth Bender Atik(National Director of the Miscarriage Association) provided advice and oversight to conduct PPI activities and contributed to the TSC.

Dr Kitty WM Bloemenkamp(Obstetrics and Gynaecology) was responsible for leading PROMISE recruitment and data collection at Leiden University Medical Centre in Leiden, the Netherlands.

Ms Rebecca Brady(Research Midwife) conducted PROMISE recruitment and data collection at St Mary’s Hospital in London, UK, and participated in the TMG.

Ms Rebecca Cavallaro(Research Midwife) conducted PROMISE recruitment and data collection at St Mary_’s Hospital in London, UK, and participated in the TMG.

Dr Ying C Cheong(Consultant in Obstetrics and Gynaecology) was responsible for leading PROMISE recruitment and data collection at Princess Anne Hospital in Southampton, UK.

Dr Justin Chu(Research Fellow, Obstetrics and Gynaecology) assisted in the preparation of the final report. Dr Abey Eapen(Research Fellow, Obstetrics and Gynaecology) assisted in the preparation of the

final report.

Dr Holly Essex(Research Fellow, Health Sciences) provided advice and assistance to conduct the study, with a focus on health economic elements.

Mr Ayman Ewies(Consultant Gynaecological Surgeon) was responsible for leading PROMISE recruitment and data collection at Birmingham City Hospital, UK.

Dr Annemieke Hoek(Reproductive Medicine and Gynaecology) was responsible for leading PROMISE recruitment and data collection at University Medical Centre Groningen, the Netherlands.

Dr Eugenie M Kaaijk(Obstetrics and Gynaecology) was responsible for leading PROMISE recruitment and data collection at Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.

Dr Carolien A Koks(Obstetrics and Gynaecology) was responsible for leading PROMISE recruitment and data collection at Maxima Medical Centre, Veldhoven, the Netherlands.

Professor Tin-Chiu Li(Consultant Obstetrician and Gynaecologist) provided advice and assistance to design the study, and took responsibility for leading PROMISE recruitment and data collection at Sheffield Royal Hallamshire Hospital, UK.

Dr Marjory MacLean(Consultant Obstetrician) was responsible for leading PROMISE recruitment and data collection at Ayrshire Maternity Unit, UK.

Dr Ben W Mol(Professor of Obstetrics and Gynaecology) provided advice and assistance on the design of the study.

Dr Judith Moore(Consultant Obstetrician and Gynaecologist) was responsible for leading PROMISE recruitment and data collection at Queen’s Medical Centre in Nottingham, UK.

Dr Steve Parrott(Senior Research Fellow, Health Sciences) provided advice and assistance on the conduct of the study, and commented on the final report, with a focus on health economic elements.

Dr Jackie A Ross(Consultant Gynaecologist) was responsible for leading PROMISE recruitment and data collection at King’s College Hospital in London, UK.

Ms Lisa Sharpe(Research Midwife and Deputy Manager of the Women’s Health Research Centre at Imperial College London) conducted PROMISE recruitment and data collection at St Mary’s Hospital in London, UK, and participated in the TMG.

Dr Jane Stewart(Consultant in Reproductive Medicine and Gynaecology) was responsible for leading PROMISE recruitment and data collection at the Royal Victoria Infirmary in Newcastle upon Tyne, UK.

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ACKNOWLEDGEMENTS

Dr Dominic Trépel(Research Fellow, Health Economics) designed and conducted the health economic analysis and contributed to the TMG.

Dr Nirmala Vaithilingam(Consultant in Obstetrics and Gynaecology) was responsible for leading PROMISE recruitment and data collection at the Queen Alexandra Hospital in Portsmouth, UK.

Dr Roy G Farquharson(Consultant Gynaecologist) provided methodological support, strategic advice and oversight to conceive, design and deliver the study.

Professor Mark David Kilby(Professor of Fetal Medicine) was responsible for leading PROMISE

recruitment and data collection at Birmingham Women’s Hospital, UK, and contributed to the final report. Mr Yacoub Khalaf(Consultant in Gynaecology and Reproductive Medicine) provided strategic advice on the design and delivery of the study, and was responsible for leading PROMISE recruitment and data collection at St Thomas’Hospital in London, UK.

Dr Mariëtte Goddijn(Consultant Gynaecologist) was responsible for leading PROMISE recruitment and data collection at the Academic Medical Centre in Amsterdam, administering regulatory activities in the Netherlands and co-ordinating investigators from the Netherlands.

Professor Lesley Regan(Head of Obstetrics and Gynaecology at St Mary’s Hospital Campus) provided methodological support, strategic advice and oversight to conceive, design and deliver the study. As the lead applicant,Dr Rajendra Rai(Consultant Obstetrician and Gynaecologist and PROMISE Chief Investigator) contributed to the design of the study, TSC and TMG, and took overall responsibility for the project, in addition to leading PROMISE recruitment and data collection at St Mary’s Hospital in London, UK.

The report authors gratefully acknowledge the substantial contributions of the following collaborators in the conduct and delivery of the PROMISE study.