2 research outputs found
The Preterm Clinical Network (PCN) Database: a web-based systematic method of collecting data on the care of women at risk of preterm birth
Background: Despite much research effort, there is a paucity of conclusive evidence in the field of preterm birth prediction and prevention. The methods of monitoring and prevention strategies offered to women at risk vary considerably around the UK and depend on local maternity care provision. It is becoming increasingly recognised that this experience and knowledge, if captured on a larger scale, could be a utilized as a valuable source of evidence for others. The UK Preterm Clinical Network (UKPCN) was established with the aim of improving care and outcomes for women at risk of preterm birth through the sharing of a wealth of experience and knowledge, as well as the building of clinical and research collaboration. The design and development of a bespoke internet-based database was fundamental to achieving this aim.
Method: Following consultation with UKPCN members and agreement on a minimal dataset, the Preterm Clinical Network (PCN) Database was constructed to collect data from women at risk of preterm birth and their children. Information Governance and research ethics committee approval was given for the storage of historical as well as prospectively collected data. Collaborating centres have instant access to their own records, while use of pooled data is governed by the PCN Database Access Committee. Applications are welcomed from UKPCN members and other established research groups. The results of investigations using the data are expected to provide insights into the effectiveness of current surveillance practices and preterm birth interventions on a national and international scale, as well as the generation of ideas for innovation and research. To date, 31 sites are registered as Data Collection Centres, four of which are outside the UK.
Conclusion: This paper outlines the aims of the PCN Database along with the development process undertaken from the initial idea to live launch
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Comparing cervical cerclage, pessary and vaginal progesterone for prevention of preterm birth in women with a short cervix (SuPPoRT): A multicentre randomised controlled trial.
Acknowledgements: We thank the members of the Trial Steering (Jason Waugh, Melanie Griffin, Su Harper-Clark) and Data Monitoring Committee (Mark Johnson, Brenda Kelly, Vichithranie Madurasinghe) and all the people who helped in the conduct of the study from all the recruiting centres (St Thomas’ Hospital NHS Trust, Cambridge University Hospital, West Middlesex University Hospital, Liverpool Women’s NHS Foundation Trust, Poole Hospital NHS Foundation Trust, Kingston Hospital NHS Foundation Trust, University College Hospital London, Leicester Royal infirmary, Norfolk and Norwich University Hospital NHS Trust, South Tyneside and Sunderland NHS Trust). We specifically thank the members of the ‘SuPPoRT Collaborating Team’ (Manju Chandiramani, Lisa Story, Evonne Chin Smith, Cally Gill, Amirah Mohd Zaki, Naomi Carlisle, Debbie Finucane, Stephanie Grigsby, Elena Romero, Sarah Weist, Kirsten Herdman, Lesley Hewitt, Eileen Walton, Amy Barker, Laura Harris, Kristina Sexton, Isabel Bradley, Siobhan Holt, Michelle Dower, Borna Poljak, Devender Roberts, Sarah Weist, Zarko Afirevic, Angharad Care, Laura Goodfellow, Melissa Whitworth, Nigel Simpson, Penelope McParland, Alexandra Patience, John Lartey, Kim Hinshaw, and the NIHR CRN team). We are grateful to Birgit Arabin who provided the cervical pessaries free of charge. We are also grateful to the many people who helped in this study but who we have been unable to name, and in particular all the women (and their babies) who participated in the trial.BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT "Stitch, Pessary, or Progesterone Randomised Trial" was designed to compare the rate of PTB 14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic. CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix. TRIAL REGISTRATION: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com