Funding for this research was provided by:
Bill and Melinda Gates Foundation (Investment ID OPP 1151718)
Received: 17 December 2019
Accepted: 21 January 2020
First Online: 19 March 2020
Ethics approval and consent to participate
: The study protocol is approved by the WHO Ethics Review Committee (reference number: EC0002910 approved on 6 October 2017). Approvals on the same protocol were also obtained from local institutional review boards in the five sites: Ghana’s School of Medical Science/Komfo Anokye Teaching Hospital (reference number: CHRPE/AP/372/17, initial approval on 30 June 2017), Tanzania’s National Institute for Medical research (reference number: NIMR/HQ/R.8a/Vol. IX/2621, initial approval on 6 November 2017), Malawi’s College of Medicine Research and Ethics Committee (COMREC) (reference number: P.08/17/2235, initial approval on 27 September 2017), Nigeria’s OAUTHC Ethics and Research Committee (reference number: IRB/IEC/0004553 NHREC/27/02/2009a, initial approval on 12 July 2017), Institute of Ethics Committee of VMMC & Safdarjung Hospital (reference number: IEC/SJH/VMMC/Project/August-2017, initial approval on 24 August 2017). Each updated version of the approved protocol will be submitted to the ethics committees above.Written informed consent is taken by study staff from admitted pregnant women who are identified to be at high risk of delivering an LBW infant. The participants’ confidentiality is maintained throughout the trial in line with the standard International Conference on Harmonization - Good Clinical Practice (ICH-GCP) principles. The consent form includes consent for participation in the trial and also for sharing of data with researchers. This study does not involve collection of biological specimens. The consent forms are held by the study teams at the five sites and are available for review by the Editor-in-Chief of this journal.
: Not applicable.
: The authors declare that they have no competing interests.