Protocol updates
Thomas’ NHS
MAY, RECRUITMENT
The study received NHS ethics approval in March 2019 (London – Surrey Borders Research Ethics Committee, REC reference 18/LO/2070). Following ethical approval, recruitment commenced in five maternity units in England: four in inner London (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, St George’s University Hospitals NHS Foundation Trust, Whittington Health NHS Trust), and one in Manchester (Manchester University NHS Foundation Trust). Two further sites were added in 2021 (University Hospitals of Leicester NHS Trust, Leicester; Imperial College Healthcare NHS Trust, London), resulting in a final total of seven participating units.The study started in April 2019 and the first trial participant was recruited in July 2019. In March 2020, recruitment at all active sites was suspended due to the developing COVID-19 pandemic. All sites remained closed to recruitment for a minimum of 4 months, after which individual sites experienced further closures due to the direct and indirect effects of the COVID-19 pandemic. Our planned 18-month recruiting period was adjusted to allow for these pauses in recruitment.A number of changes were made to the protocol to mitigate the impact of COVID-19-related disruption to the study. In October 2020, enrolment procedures were adapted to allow for remote consent. Although we had initially planned to conduct some qualitative interviews face-to-face, we switched to conducting all interviews by telephone. A further amendment was approved in August 2021 allowing the creation of a TAPS2 microsite to aid remote recruitment of potential participants.The TAPS2 study was initially planned to last 24 months. A 12-month costed extension was awarded in May 2021 providing a new study end date of April 2022. An additional non-costed 12-month extension was granted in February 2022 to permit TAPS2 to continue until April 2023.All the above changes to the protocol were submitted and approved as amendments to the original study protocol.