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dc.contributor.authorCoomarasamy, A
dc.contributor.authorHarb, HM
dc.contributor.authorDevall, AJ
dc.contributor.authorCheed, V
dc.contributor.authorRoberts, TE
dc.contributor.authorGoranitis, I
dc.contributor.authorOgwulu, CB
dc.contributor.authorWilliams, HM
dc.contributor.authorGallos, ID
dc.contributor.authorEapen, A
dc.contributor.authorDaniels, JP
dc.contributor.authorAhmed, A
dc.contributor.authorBender-Atik, R
dc.contributor.authorBhatia, K
dc.contributor.authorBottomley, C
dc.contributor.authorBrewin, J
dc.contributor.authorChoudhary, M
dc.contributor.authorCrosfill, F
dc.contributor.authorDeb, S
dc.contributor.authorDuncan, WC
dc.contributor.authorEwer, A
dc.contributor.authorHinshaw, K
dc.contributor.authorHolland, T
dc.contributor.authorIzzat, F
dc.contributor.authorJohns, J
dc.contributor.authorLumsden, M-A
dc.contributor.authorManda, P
dc.contributor.authorNorman, JE
dc.contributor.authorNunes, N
dc.contributor.authorOverton, CE
dc.contributor.authorKriedt, K
dc.contributor.authorQuenby, S
dc.contributor.authorRao, S
dc.contributor.authorRoss, J
dc.contributor.authorShahid, A
dc.contributor.authorUnderwood, M
dc.contributor.authorVaithilingham, N
dc.contributor.authorWatkins, L
dc.contributor.authorWykes, C
dc.contributor.authorHorne, AW
dc.contributor.authorJurkovic, D
dc.contributor.authorMiddleton, LJ
dc.date.accessioned2020-12-14T06:28:01Z
dc.date.available2020-12-14T06:28:01Z
dc.date.issued2020-06
dc.identifier.citationCoomarasamy, A., Harb, H. M., Devall, A. J., Cheed, V., Roberts, T. E., Goranitis, I., Ogwulu, C. B., Williams, H. M., Gallos, I. D., Eapen, A., Daniels, J. P., Ahmed, A., Bender-Atik, R., Bhatia, K., Bottomley, C., Brewin, J., Choudhary, M., Crosfill, F., Deb, S. ,... Middleton, L. J. (2020). Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.. Health Technol Assess, 24 (33), pp.1-70. https://doi.org/10.3310/hta24330.
dc.identifier.issn1366-5278
dc.identifier.urihttp://hdl.handle.net/11343/254231
dc.description.abstractBACKGROUND: Progesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage. OBJECTIVES: (1) To assess the effects of vaginal micronised progesterone in women with vaginal bleeding in the first 12 weeks of pregnancy. (2) To evaluate the cost-effectiveness of progesterone in women with early pregnancy bleeding. DESIGN: A multicentre, double-blind, placebo-controlled, randomised trial of progesterone in women with early pregnancy vaginal bleeding. SETTING: A total of 48 hospitals in the UK. PARTICIPANTS: Women aged 16-39 years with early pregnancy bleeding. INTERVENTIONS: Women aged 16-39 years were randomly assigned to receive twice-daily vaginal suppositories containing either 400 mg of progesterone or a matched placebo from presentation to 16 weeks of gestation. MAIN OUTCOME MEASURES: The primary outcome was live birth at ≥ 34 weeks. In addition, a within-trial cost-effectiveness analysis was conducted from an NHS and NHS/Personal Social Services perspective. RESULTS: A total of 4153 women from 48 hospitals in the UK received either progesterone (n = 2079) or placebo (n = 2074). The follow-up rate for the primary outcome was 97.2% (4038 out of 4153 participants). The live birth rate was 75% (1513 out of 2025 participants) in the progesterone group and 72% (1459 out of 2013 participants) in the placebo group (relative rate 1.03, 95% confidence interval 1.00 to 1.07; p = 0.08). A significant subgroup effect (interaction test p = 0.007) was identified for prespecified subgroups by the number of previous miscarriages: none (74% in the progesterone group vs. 75% in the placebo group; relative rate 0.99, 95% confidence interval 0.95 to 1.04; p = 0.72); one or two (76% in the progesterone group vs. 72% in the placebo group; relative rate 1.05, 95% confidence interval 1.00 to 1.12; p = 0.07); and three or more (72% in the progesterone group vs. 57% in the placebo group; relative rate 1.28, 95% confidence interval 1.08 to 1.51; p = 0.004). A significant post hoc subgroup effect (interaction test p = 0.01) was identified in the subgroup of participants with early pregnancy bleeding and any number of previous miscarriage(s) (75% in the progesterone group vs. 70% in the placebo group; relative rate 1.09, 95% confidence interval 1.03 to 1.15; p = 0.003). There were no significant differences in the rate of adverse events between the groups. The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms. Thus, the incremental cost-effectiveness ratio of progesterone compared with placebo was estimated as £3305 per additional live birth at ≥ 34 weeks of gestation. CONCLUSIONS: Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at ≥ 34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14163439, EudraCT 2014-002348-42 and Integrated Research Application System (IRAS) 158326. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 33. See the NIHR Journals Library website for further project information.
dc.languageeng
dc.publisherNational Institute for Health Research
dc.titleProgesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.
dc.typeJournal Article
dc.identifier.doi10.3310/hta24330
melbourne.affiliation.departmentMelbourne School of Population and Global Health
melbourne.source.titleHealth Technology Assessment
melbourne.source.volume24
melbourne.source.issue33
melbourne.source.pages1-70
melbourne.elementsid1455573
melbourne.openaccess.urlhttp://doi.org/10.3310/hta24330
melbourne.openaccess.pmchttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC7355406
melbourne.openaccess.statusPublished version
melbourne.contributor.authorGoranitis, Ilias
dc.identifier.eissn2046-4924
melbourne.accessrightsAccess this item via the Open Access location


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