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Progesterone for the Prevention of Miscarriage. The PRISM Trial: evidence and recommendations. скачать в хорошем качестве

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Progesterone for the Prevention of Miscarriage. The PRISM Trial: evidence and recommendations.
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Progesterone for the Prevention of Miscarriage. The PRISM Trial: evidence and recommendations.

The PRISM trial is the largest ever randomised trial in miscarriage prevention; it recruited more than 4000 women from 48 hospitals in the UK. It evaluated the effects of progesterone hormone in women with early pregnancy bleeding. Overall, there was a 3% increase in live birth rate with progesterone, compared with placebo, but the finding was associated with some statistical uncertainty (RR 1.03, 95% CI 1.00 to 1.07, p = 0.08). However, a clear benefit was found for women with the dual risk factors of early pregnancy bleeding and a history of (any number of) previous miscarriages (RR = 1.09, 95% CI 1.03 to 1.15, p = 0.003). The larger the number of previous miscarriages, the greater the live birth rate, with progesterone treatment. For women who had 1 or 2 previous miscarriages, and have current pregnancy bleeding, progesterone was associated with a 4% increase in live birth. For women with 3 or more previous miscarriages, and have current pregnancy bleeding, progesterone was associated with a 15% increase in live birth. There were no evidence of any safety concern from progesterone use. Our clinical recommendation is that for women with early pregnancy bleeding and a history of any number of previous miscarriages, progesterone treatment should be considered. Our recommended regimen is vaginal Utrogestan 400mg twice daily from the time of presentation with bleeding to 16 weeks of gestation. This trial was funded by the NIHR-HTA programme, and supported by the Tommy's National Centre for Miscarriage Research. The trial was led from the Institute of Metabolism and Systems Research at the University of Birmingham, facilitated by the Birmingham Clinical Trials Unit. Key publications are: A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. Coomarasamy A, Devall AJ, Cheed V, Harb H, Middleton LJ, Gallos ID, Williams H, Eapen AK, Roberts T, Ogwulu CC, Goranitis I, Daniels JP, Ahmed A, Bender-Atik R, Bhatia K, Bottomley C, Brewin J, Choudhary M, Crosfill F, Deb S, Duncan WC, Ewer A, Hinshaw K, Holland T, Izzat F, Johns J, Kriedt K, Lumsden MA, Manda P, Norman JE, Nunes N, Overton CE, Quenby S, Rao S, Ross J, Shahid A, Underwood M, Vaithilingam N, Watkins L, Wykes C, Horne A, Jurkovic D. N Engl J Med. 2019 May 9;380(19):1815-1824. doi: 10.1056/NEJMoa1813730. PMID: 31067371 Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence. Coomarasamy A, Devall AJ, Brosens JJ, Quenby S, Stephenson MD, Sierra S, Christiansen OB, Small R, Brewin J, Roberts TE, Dhillon-Smith R, Harb H, Noordali H, Papadopoulou A, Eapen A, Prior M, Di Renzo GC, Hinshaw K, Mol BW, Lumsden MA, Khalaf Y, Shennan A, Goddijn M, van Wely M, Al-Memar M, Bennett P, Bourne T, Rai R, Regan L, Gallos ID. Am J Obstet Gynecol. 2020 Jan 29. pii: S0002-9378(19)32762-0. doi: 10.1016/j.ajog.2019.12.006. PMID: 32008730 The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM Trial. Okeke Ogwulu CB, Goranitis I, Devall AJ, Cheed V, Gallos ID, Middleton LJ, Harb HM, Williams HM, Eapen A, Daniels JP, Ahmed A, Bender-Atik R, Bhatia K, Bottomley C, Brewin J, Choudhary M, Deb S, Duncan WC, Ewer AK, Hinshaw K, Holland T, Izzat F, Johns J, Lumsden M, Manda P, Norman JE, Nunes N, Overton CE, Kriedt K, Quenby S, Rao S, Ross J, Shahid A, Underwood M, Vaithilingham N, Watkins L, Wykes C, Horne AW, Jurkovic D, Coomarasamy A, Roberts TE. BJOG. 2020 Jan 30. doi: 10.1111/1471-0528.16068. PMID: 32003141

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