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Article History

Accepted: 25 October 2022

First Online: 14 November 2022

Declarations

:

: Our study received ethical approval from the Research Ethics Committee (Study no 17–2019), Coombe Women and Infant’s University Hospital, Dublin, Ireland (Chairman Professor Jan Miletin) on 25th November 2019. Our trial was registered with clinicaltrials.org (NCT04191694). The study was an investigator-led, single-centre, randomised, unblind double-arm comparator study. It took place between 10th December 2019 and 30th June 2020 with temporary suspension (28th March 2020–20th of April 2020) due to COVID-19 restrictions.

: Consent was sought and obtained by the investigator at admission, prior to arrival in the operating theatre and after all questions or concerns were addressed. All patients were informed of the objectives of the study as well as benefits, risks, obligations and option to withdraw consent at any time.

: Not applicable.

: The authors declare no competing interests.