O’Reilly, Sharleen L. https://orcid.org/0000-0003-3547-6634
Burden, Christy
Campoy, Cristina
McAuliffe, Fionnuala M.
Teede, Helena
Andresen, Jesper
Campbell, Karen J.
Geraghty, Aisling A.
Harrison, Cheryce L.
Laws, Rachel
Norman, Jane E.
Maindal, Helle T.
Vrangbæk, Karsten
Segurado, Ricardo
Versace, Vincent L.
Skinner, Timothy C.
,
Funding for this research was provided by:
h2020 societal challenges (847984)
national health and medical research council (APP1194234)
Article History
Received: 1 July 2021
Accepted: 28 November 2021
First Online: 28 December 2021
Declarations
:
: Ethical approval has been granted for all study sites (Dublin: National Maternity Hospital Ethics Committee ref EC18.2020; Bristol: Wales Research Ethics Committee ref /WA/0022; Granada: CEIM/CEI Provincial de Granada; Melbourne: Monash Health Human Research Ethics Committee ref RES-20-0000-892A). Informed, written consent will be obtained from all participants involved in the study.Prior to enrolment, all participants will receive information about the study including information on potential risks and benefits and data protection procedures. There are no particular risks involved in taking part in this trial; however, any events during or after the trial will be recorded and reported to the clinical trials manager and site lead.Any protocol amendments after approval by the ethics committees and steering committee will be communicated by the project manager to the relevant parties (including site leads, investigators, trial registries, regulators).
: Not applicable
: The authors declare that they have no competing interests.