Document is current

Article History

Received: 7 April 2017

Accepted: 16 March 2018

First Online: 23 April 2018

Ethics approval and consent to participate

: A favourable ethical opinion was granted from:The Liverpool School of Tropical Medicine Research Ethics Committee, UK (reference number LSTM 13.15 10th April 2013) for global oversight.College of Medicine Research Ethics Committee (COMREC, Malawi) (reference number P.06/13/1393 11th October 2013) for Queen Elizabeth Central Hospital, Zomba Central Hospital and Kamuzu Hospital.Aga Khan University, Pakistan (reference number ERC 2756-OBS-ERC-13 12th November 2013) for Garden Hospital, Aga Khan Hospital, Karimabad, Hyderabad, Kharader.Ifakara Health Institute, Tanzania (reference number IRB IHI/IRB/No: 25–2013 30th August 2013), for St Francis Hospital, Mwananyamala Hospital and Bagamoyo Hospital.Uganda National Council for Science and Technology, Uganda (reference number HS1400 28th May 2013), for Mbale hospital and Soroti Hospital.Women are clearly advised that participation is entirely voluntary with the option of withdrawing from the trial at any stage, and that participation or non-participation will not affect their usual care. Participants are provided with a patient information sheet (Additional file ); for those unable to read the patient information sheet, it is read out by a member of trial staff. Eligible women approached for participation in the trial have as much time as they require (though surgery will not be delayed to enable trial participation), to decide whether they wish to take part and consent for the trial (Fig. : participant flow through trial). If participants wish to give consent to participate in the trial, they are asked to sign a consent form (Additional file ). All patient information leaflets and written instructions have been translated into the local languages at each site and have been verified by multiple interpreters. When required, translators are sought to aid in communicating with potential study participants who might not adequately understand the predominant language at each site, or English. If trial staff are not able to adequately communicate with a potential participant they will not be recruited (Additional files and ).

: All data will be analysed and reported in summary format. No individual will be identifiable. This information is conveyed to the participants in the Patient Information Sheet, with explanation that the results will be published, presented and made publicly available via the trial website.The study findings will be presented at or published in peer-reviewed scientific journals and National and International Conferences. The Trial specific website will be maintained for at least 5 years after the end of trial (), with links in the websites of participating organisations. We will submit the findings to patient representative bodies.A “writing group” will be convened to take on the responsibility for writing the paper, and the publication will be in the name of “AIMS Consortium”. All investigators will be named, detailing their role in the study. The composition of the “writing group” will be decided following consultations between the Trial Management Group and Trial Steering Committee, and is likely to include the trial manager, chief investigator, statistician and high-accruing investigators. Individual researchers must not publish data concerning their patients until the primary study question has been answered, and explicit permission has been granted by the Trial Management Group.A dissemination plan has been formulated to lead to the dissemination of our findings and, if appropriate, rapid implementation. We would hope to implement change to national and international guidelines and see clinicians altering their practice.

: The authors declare that they have no competing interests.

: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.