Original ResearchObstetricsOutcomes of the novel Odon Device in indicated operative vaginal birth
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E.L. is a member of the University of Bristol (UoB) and part of his salary is paid by the PROMPT Maternity Foundation (PMF) to UoB; 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; these funds have been used toward the salary of S.O.B., T.J.D., and J.F.C. when undertaking the simulations studies. T.J.D. and J.F.C. 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 conflict of interest.
BD provided the Odon Device for this study with no charge. They had no say in the design, conduct, or interpretation of the study. Mario Merialdi, MD, senior director of BD Global Health, provided certain information about the Odon Device and regulatory requirements relating thereto that were incorporated into the protocol.
The views expressed were those of the authors and not necessarily those of the United Kingdom National Health Service. The authors were responsible for the design of the protocol and the planning, conducting, and analysis of the study.
The ASSIST Study was supported by the Bill & Melinda Gates Foundation (grant number OPP1184825/INV-010180). The Foundation’s role was solely as funder and had no role in the design, planning, conduct, analysis, or publication production of the study.
This study is registered in the ISRCTN registry (ISRCTN10203171).
Cite this article as: Hotton EJ, Lenguerrand E, Alvarez M, et al. Outcomes of the novel Odon Device in indicated operative vaginal birth. Am J Obstet Gynecol 2021;224:607.e1-17.