Funding for this research was provided by:
Saving Lives at Birth partners
Text and Data Mining valid from 2018-03-12
Received: 15 January 2018
Accepted: 22 February 2018
First Online: 12 March 2018
Ethics approval and consent to participate
: The study was approved by the Scientific and Ethical Review Group of the UNDP/UNFPA/UNICEF/ WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction at the Department of Reproductive Health and Research of WHO, and the WHO Research Ethics Review Committee, Geneva, Switzerland, under reference number A65711 in September 2010, and continuing approvals in April 2013 and February 2017. The Ethics Committee in Research of CEMIC (reference number 529, in July 2009, and continuing approval in September 2010, October 2012, August 2013 and March 2017) and the National Drugs, Food, and Technology Administration of Argentina (ANMAT) (reference number 1-47-22,013/09-8 in December 2010, and continuing approval in October 2013 and August 2017) also approved the study in Argentina. The Research Ethics Committee, Faculty Health Sciences, University of Pretoria (reference number 222/2016 in September 2016 and march 2017) and the Medicines Control Council (February 2017) approved the study in South Africa. All women provided written consent for participation in the study.
: All authors reviewed the manuscript, and approved the final version for publication.
: M Merialdi was a WHO employee at the beginning of the study and until December 2013. Since February 2014, he is an employee of BD and provides scientific and technical advice on issues related to device development and evaluation. Since 2013, BD has a temporary exclusivity agreement with the inventor for the licensing of the BD Odon Device.J Requejo is a member of the Becton Dickinson Odon Device Experts’ Group and contributed to the conception and design of the clinical evidence generation plan for the BD Odon Device™. All other authors listed declared that they have no competing interest.
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