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The response to the findings of PRISM has been one of widespread acceptance. Before these results were published, only 13% of a small group of 130 medical professionals in the UK (surveyed by the University of Birmingham, results unpublished) prescribed progesterone for women with early pregnancy bleeding. Post-publication of PRISM results, the figure rose to 75%. Clinical importance
Researcher Adam Devall, Manager of Tommy's National Centre for Miscarriage Research, says, “The PRISM and PROMISE Trials found a small but positive treatment effect, dependent on the number of previous miscarriages. We believe that the dual risk factors of early pregnancy bleeding and a history of one or more previous miscarriages identify high risk women in whom progesterone is of benefit. The question is, how should this affect clinical practice?”
The scientists estimate that this practice could save about 8,500 babies a year in the UK. Despite the small benefit shown in the trials, the researchers favour the use of progesterone based on the possible positive effects. Researchers like Arri Coomarasamy, Director of the Center, agree: “Our suggestion is to consider offering to women with early pregnancy bleeding and a history of one or more previous miscarriages a course of treatment of progesterone 400mg twice daily, started at the time of presentation with vaginal bleeding and continued to 16 completed weeks of gestation.” The need for balance
An alternative is counseling such women and giving them special attention in the next pregnancy to pick up early pregnancy complications for appropriate management. Compared to this expensive process, says Economics expert Tracy Roberts, “progesterone is likely to be considered good value for money in preventing miscarriage.”
Coomarasamy says, “We now urge policy makers and guideline developers to consider the evidence carefully to make a balanced recommendation.” Jane Brewin, Tommy's Chief Executive, goes further, calling the studies “thorough” and the use of progesterone “an effective treatment option which women should be routinely offered.”
The Vice President of The Royal College of Obstetricians and Gynaecologists, Pat O'Brien, sums up: “This treatment offers an increased chance of a successful birth and appears to be cost effective for the NHS, so we hope NICE will consider this important research in their next update of the guidance.” However, she adds a note of balance: “For women with no prior history of miscarriage, there does not appear to be any benefit of the treatment. Reassuringly, most women who have had a miscarriage will have a successful pregnancy and birth in the future.”
The PRISM trial report itself concludes: “Treatment with progesterone did not result in significant improvement in the incidence of live births among women with vaginal bleeding during the first 12 weeks of pregnancy.” Even with only one previous miscarriage, the benefit was very small. Progesterone use should therefore be possibly reserved for women with 3 or more previous miscarriages, since the benefit is highest in this group. Journal references:
Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence Coomarasamy, Arri et al. American Journal of Obstetrics & Gynecology, https://www.ajog.org/article/S0002-9378(19)32762-0/fulltext
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. The cost‐effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM Trial. BJOG 2020; https://doi.org/10.1111/1471-0528.16068.
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