WILL (When to Induce Labour to Limit risk in pregnancy hypertension): a multicentre randomised controlled trial — adaptations to deliver a timing-of-birth trial during the COVID-19 international pandemic
Authors: Magee Laura A. , Tohill Sue , Kirkham Katie , Evans Ruth , Gkini Eleni , Moakes Catherine A. , Stubbs Clive , Thornton Jim , von Dadelszen Peter ,   the WILL Trial Study Group, Brocklehurst Peter , Chappell Lucy , Dorling Jon , Green Marcus , Hardy Pollyanna , Hutcheon Jennifer , Kirkham Katie , Moakes Catherine , Mol Ben , Morris Katie , Riley Paul , Roberts Tracy , Scott Janet , Singer Joel , Unstead-Joss Ruth , Wade Julie , Mol Ben W. , Draycott Tim , MacLennan Graeme , MacKillop Lucy , Mannix Paul , Elbourne Diana , Groen Henk , Murdoch Edile , Stock Sarah , Bhuiya Sumita , Nallapeta Soumendra , Dooks Emma , Packham Sophie , Whitehouse Diane , O’Hara Chloe , Weston Connie , Mellers Diane , Brittain Lesley , Adams Phern , Shakespeare Rebecca , Kakara Sudeepthi , Wright Janet , Mighell Amal , Syson Jennifer , Swettenham Kari , Eedle Jenny , Seraj Shaila , Bray Maryanne , Jones Bethan , Bertorelli Claire , Ritter Hannah , Keeping Vikki , Cresswell Janet , Kelly-Baxter Mary , Yeoh Li-Shan , Bhansali Shailly Sahu , More Vandana , Ajay Bini , Upson Geraldine , Hake Danielle , Opoku Diana , Wayman Emma , Cwiek Natalia , Tregellas Stacy , Lee Nikki , Margarit Lavinia , Pike Joelle , Jones Kate , Wheeler-Davies Sophie-Mae , Ali Meena , Rajkumar Indhuja , Habibi Ruth , Davies Sarah , Kumar Anangsha , Salian Harinakshi , Smith Trudy , Meneni Deepika , Alexander Hazel , Harwood Helen , Hebbron Kerry , Whitecross Lynn , Hodgers Mary , Mahadasu Shilpa , Kametas Nick , Sana Yasmin , Martin Hayley , Jarman Rebecca , Webster Sophie , Rajeswary Jyothi , Gill Mandy , Bambridge Gabrielle , Bradley Isabel , Sexton Kristina , Oshodi Lola , Wiesender Cornelia , Dodd Claire , Modi Rupa , Cowlishaw Beverley , Mulheron Gina , Kierzenkowska Magdalena , Patterson Molly , Amos Patricia , Bates Sharon Marie , Raper Sharon , Agarwal Umber , Cockerill Ruth , Mahdi Amy , Cunningham Caroline , Dower Michelle , Andrews Sian , Holt Siobhan , Williams Carly , Castling Zora , Watkins Linda , Churchill David , McKenzie Ellmina , Icke Julie , Devison Laura , Raheja Vinita , Ayuk Angela , Reynolds Jessica , Wyton Julie , Duffy Stacey , Walker Kate , Cantliffe Jane , Hussain Catriona , Smith Carys , Anderson Harriet , Hodgen Lesley , Brackley Karen , Martin Nicki , Walbridge Fiona , Hampton Rhea , Jones Nia , Bose Patrick , Young Catherine , Lee Fidelma , Peart Rebecca , Tanton Emma , Rhead Kat , Fiedler Kristin , Bowen Ruth , Mathen Stephy , Sarwar Zainab , Rishton Chloe , Scott Chloe , Farey Jane , Verasingam Nisha , Rich Mel , Moreton Annette , Bressington Catherine , Pullen Jennifer , Burnard Sara , Duberry Wendy , Dey Madhuchanda , Jones Sharon , Bird Pauline , Ullal Aarti , Walton Eileen , Price Ashleigh , Scollen Janet , Ormonde Judith , Herdman Kirsten , Hewitt Lesley , Rowland Lucy , Singh Mandeep , Raajkumar Sundararajah , Saji Beena , Khalil Asma , Perry Alice , Marler Emily , Imuzeze Ijeoma , Robinson Sophie , Nelson Jonathan , McNamara Kathryn , Craig Carina , Endersby Del , Wagstaff Jayne , Robinson Kate , Barnes Hannah , Gavin Jane , Myers Jenny , Stanbury Kate , Hughes Christine , Vinayakarao Latha , Melson Louise , Grigsby Stephanie , Blunden Susara , Griffin Melanie , Newell Sarah , Thompson Katharine Jane , Smart Brittany , Payne Elizabeth , Pitchford Marie , Khan Rahila , Stone Sophia , Elgarhy Ahmed , Meadows Emma , Flynn-Batham Marian , Passmore Nikky , Cannons Vivienne , Symington Declan , Lewin Alice , Tarft Hayley , Hunt Jessamine , Vowles Zoe , Slaney Maria , Woodcock Rachel , Van der Meer Alex , Benn Tracey , Davies Ru , Boyd Sophie , Waring Gareth , Riches Jill , Fenn Andrea , Kimber Aly , Harrop Susan , Stott Daniel , Tetteh Amos , Casagrandi Davide , Bourke Miriam , Vaikousi Eirini , Sarquis Rita , Folorunsho Morenike , Newth Olivia , Weist Sarah , Acheampong Yaa , Ravikumar Vidhya , Yorke Jemma , Atkinson Vicki , Wood Shelly , Mengistu Tigist , Chadwick Robert , Haden Helen , Richardson Lisa , Girling Joanna , Barker Amy , Day Andrea , Palmer Elaine , Page Louise , Nwandison Millicent , Osakwe Osaeloke , de Rosnay Philippe , Usman Sana , Barnes Susan , Ryan Grace , Lal Komal , Trepte Lauren , Steele Samantha , Tang Jacqueline , Pearson Harriet , Ingham Jo , Spark Nicola 
Published: October 2022

Abstract
Background
As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology.

Methods
The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference).

Results
Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic.

Conclusions
COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic.

Trial registration
ISRCTN77258279. Registered on 05 December 2018.