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Article History

Received: 26 September 2019

Accepted: 8 March 2021

First Online: 19 March 2021

Declarations

:

: Informed consent will be obtained from all study participants. All quantitative and qualitative aspects of the ASSIST II Study have been approved by the South Central – Berkshire Research Ethics Committee, UK on 7th of June 2019, reference number 19/SC/0226. A certificate of non-objection was received from the Medicines and Healthcare products Regulatory Agency on 12th of June 2019 and final approval from the Health Research Authority granted on 19th of June 2019 (Additional file ).

: Not required.

: EL is a member of the University of Bristol (UoB) and part of his salary is paid by the Prompt Maternity Foundation (PMF) to UoB; CW is employed by the North Bristol NHS Trust and seconded to PMF; PMF has received funding from a Saving Lives at Birth award via a subcontract from Becton, Dickinson and Company (BD) to conduct preclinical simulation studies of the Odon Device^TM; these funds have been used towards the salary of SOB, TJD, JFC and CW when undertaking the simulation 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 report no competing interests.BD is providing the 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.