@article{aaebf44bfee449d2b0907b0ff4b9ae8b,
title = "The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial",
abstract = "Objectives: To assess the cost-effectiveness of progesterone compared with placebo in preventing pregnancy loss in women with early pregnancy vaginal bleeding. Design: Economic evaluation alongside a large multi-centre randomised placebo-controlled trial. Setting: Forty-eight UK NHS early pregnancy units. Population: Four thousand one hundred and fifty-three women aged 16–39 years with bleeding in early pregnancy and ultrasound evidence of an intrauterine sac. Methods: An incremental cost-effectiveness analysis was performed from National Health Service (NHS) and NHS and Personal Social Services perspectives. Subgroup analyses were carried out on women with one or more and three or more previous miscarriages. Main outcome measures: Cost per additional live birth at ≥34 weeks of gestation. Results: Progesterone intervention led to an effect difference of 0.022 (95% CI −0.004 to 0.050) in the trial. The mean cost per woman in the progesterone group was £76 (95% CI −£559 to £711) more than the mean cost in the placebo group. The incremental cost-effectiveness ratio for progesterone compared with placebo was £3305 per additional live birth. For women with at least one previous miscarriage, progesterone was more effective than placebo with an effect difference of 0.055 (95% CI 0.014–0.096) and this was associated with a cost saving of £322 (95% CI −£1318 to £673). Conclusions: The results suggest that progesterone is associated with a small positive impact and a small additional cost. Both subgroup analyses were more favourable, especially for women who had one or more previous miscarriages. Given available evidence, progesterone is likely to be a cost-effective intervention, particularly for women with previous miscarriage(s). Tweetable abstract: Progesterone treatment is likely to be cost-effective in women with early pregnancy bleeding and a history of miscarriage.",
keywords = "Cost-effectiveness, economic evaluation, miscarriage, progesterone",
author = "{Okeke Ogwulu}, {C. B.} and I. Goranitis and Devall, {A. J.} and V. Cheed and Gallos, {I. D.} and Middleton, {L. J.} and Harb, {H. M.} and Williams, {H. M.} and A. Eapen and Daniels, {J. P.} and A. Ahmed and R. Bender-Atik and K. Bhatia and C. Bottomley and J. Brewin and M. Choudhary and S. Deb and Duncan, {W. C.} and Ewer, {A. K.} and K. Hinshaw and T. Holland and F. Izzat and J. Johns and M. Lumsden and P. Manda and Norman, {J. E.} and N. Nunes and Overton, {C. E.} and K. Kriedt and S. Quenby and S. Rao and J. Ross and A. Shahid and M. Underwood and N. Vaithilingham and L. Watkins and C. Wykes and Horne, {A. W.} and D. Jurkovic and A. Coomarasamy and Roberts, {T. E.}",
note = "Funding Information: The study was funded by the UK NIHR Health Technology Assessment programme (project number HTA 12/167/26). ISRCTN: 14163439. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the Medical Research Council, the Central Commissioning Facility, the NIHR Evaluation, Trials and Studies Coordinating Centre, the Health Technology Assessment Programme, or the Department of Health. We thank all the women who participated in this study; the following investigators for supervising recruitment and randomisation at the study centres: Mr Samson Agwu, Mrs Rita Arya, Miss Miriam Baumgarten, Dr Catey Bass, Miss Sumita Bhuiya, Prof Tom Bourne, Mr James Clark, Mr Samual Eckford, Mr Zeiad El-Gizawy, Mrs Joanne Fletcher, Miss Preeti Gandhi, Dr Mary Gbegaje, Dr Ingrid Granne, Mr Mamdough Guirguis, Dr Pratima Gupta, Dr Hadi Haerizadeh, Dr Laura Hipple, Mr Piotr Lesny, Miss Hema Nosib, Mr Jonathan Pepper, Mr Jag Samra, Ms Jayne Shillito, Dr Rekha Shrestha, Dr Jayasree Srinivasan, Dr Ayman Swidan and Prof Derek Tuffnell; all the PRISM research nurses who assisted in the collection of data and the Early Pregnancy Unit staff who supported the trial; Leanne Beeson, Mary Nulty and Louisa Edwards for their support in managing and coordinating the trial; Prof Siladitya Bhattacharya for chairing the trial steering committee; Prof Andrew Shennan for chairing the data and safety monitoring committee; Dr Javier Zamora and Dr Willem Ankum for participating in the data monitoring committee; Dr Pelham Barton who gave health economics analysis advice; and all those not otherwise mentioned above who have contributed to the PRISM study. Funding Information: In 2012, the National Institute for Health and Care Excellence (NICE) guidelines on {\textquoteleft}Ectopic Pregnancy and Miscarriage{\textquoteright} called for a large randomised clinical trial to explore the potential role of progesterone in women with early pregnancy bleeding. The PRogesterone In Spontaneous Miscarriage (PRISM) trial was funded by the UK National Institute for Health Research (NIHR) to investigate the effectiveness and cost‐effectiveness of progesterone on pregnancy outcomes in women with first‐trimester vaginal bleeding. Funding Information: Inclusion and exclusion criteria are detailed elsewhere and are available in the supporting information (see Supplementary material, Appendix S1 ). Written informed consent was provided by all trial participants. Ethical approval was obtained from the South Central–Oxford C Research Ethics Committee (REC ref: 14/SC/1345) and the UK Health Research Authority. This study is an economic evaluation that used data collected from a Clinical Trial, hence patients were not involved in the development of the study. The study was funded by the UK NIHR Health Technology Assessment programme (project number HTA 12/167/26). Funding Information: The study was funded by the UK NIHR Health Technology Assessment programme (project number HTA 12/167/26). ISRCTN: 14163439. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the Medical Research Council, the Central Commissioning Facility, the NIHR Evaluation, Trials and Studies Coordinating Centre, the Health Technology Assessment Programme, or the Department of Health. Publisher Copyright: {\textcopyright} 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists",
year = "2020",
month = may,
day = "1",
doi = "10.1111/1471-0528.16068",
language = "English (US)",
volume = "127",
pages = "757--767",
journal = "BJOG: An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "Wiley-Blackwell",
number = "6",
}