No abstract

No 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.

Background Propess is a controlled release pessary which releases 0.3 mg of Dinoprostone per hour. As there is constant release rate, this would ensure steady Progesterone concentration and reduce the risk of hyperstimulation. Also, the need for one vaginal examination as opposed to one every 6 hrs improves patient acceptability. Aim The aim of the audit was to look at the practise of using the first Propess on an out-patient basis with informed consent. We looked at the pregnancy outcomes after the Outpatient use of first Propess. Method Prospective audit was done looking at the practise of using the first Propess. Only low risk patients were given an option for Out-patient Propess. Informed verbal consent was obtained and open access to ward was given after Propess insertion. If anyone needed any further Propess, this was carried out as an in-patient. Initial proforma was filled in by the midwife and the notes were reviewed after delivery. 67% of women who laboured with Propess alone were Nulliparous There were no adverse outcomes. APGARs at 5 min were >9 for all babies No admissions to neonatal unit Avg. blood loss at delivery 388 ml Results We looked the patients between the time period of 15/5/10 to 31/12/10. 57 women opted for Out-patient management. Conclusion Outpatient use of first Propess does not alter pregnancy outcomes and does not increase the risks to baby. When used selectively, the out-patient IOL is safe and effective alternative to patient admission. Out patient use of Propess has decreased hospital stay. 20/57 women did not need a review prior to 24 hrs equalling 480 hours of saved in-patient care.