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Authors
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O’Brien, Stephen
Hotton, Emily J.
Lenguerrand, Erik
Wade, Julia
Winter, Cathy
Draycott, Tim J.
Crofts, Joanna F. https://orcid.org/0000-0002-0171-7236
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Funding
Funding for this research was provided by:
Bill & Melinda Gates Foundation (OPP1184825)
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Article History
Received: 27 November 2018
Accepted: 16 February 2019
First Online: 5 March 2019
Ethics approval and consent to participate
: Informed consent will be obtained from all study participants. All quantitative and qualitative aspects of the ASSIST Study have been approved by the South Central, Berkshire Research Ethics Committee, UK, on 3 September 2018 (reference number 18/SC/0344). A certificate of non-objection was received from the Medicines and Healthcare products Regulatory Agency on 9 August 2018 and final approval from the Health Research Authority was granted on 3 September 2018 (Additional file ).
: Not required.
: TJD and SA have acted as a consultants for Ferring Pharmaceuticals Ltd. EL is a member of the University of Bristol (UoB) and part of his salary is paid by the Prompt Maternity Foundation (PMF) Registered charity in England & Wales No:1140557 to UoB; CW is employed by North Bristol NHS Trust and seconded to PMF; PMF has received funding from the Saving Lives at Birth Partners via a direct grant from Becton Dickinson (BD) for previously undertaken simulation studies of the BD Odon Device; these funds have been used towards the salary of SOB, TJD, JFC, and CW when undertaking the simulations studies. TJD, CW, and JFC have acted as unpaid consultants to Limbs and Things, Ltd., the manufacturer of the PROMPT Birth Trainer (the mannequin used for simulation training for the Odon Device). All other authors declare that they have no competing interests.BD is providing the BD Odon Device for this study for no fee. They have no say in the design, conduct, or interpretation of the study. Mario Merialdi, MD, Senior Director BD Global Health, provided information about the BD Odon Device and regulatory requirements that were incorporated in the protocol.The views expressed are those of the authors and not necessarily those of the UK National Health Service, National Institute for Health Research, or Department of Health. The authors are responsible for the design of the protocol and the planning, monitoring, and implementation of the study.
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