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50B - Progesterone Treatment Does Not Help Recurrent Miscarriage Patients

Against

from Section IX - Hormones and the Environment

Published online by Cambridge University Press:  25 November 2021

Roy Homburg
Affiliation:
Homerton University Hospital, London
Adam H. Balen
Affiliation:
Leeds Centre for Reproductive Medicine
Robert F. Casper
Affiliation:
Mount Sinai Hospital, Toronto
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Summary

Progesterone is critical for the maintenance of pregnancy. Several small studies have suggested that progesterone supplementation may reduce the risk of miscarriage in women with recurrent miscarriage. However, given the uncertainty in the evidence, the effect of first trimester use of vaginal micronised progesterone was recently evaluated in a large high-quality multicentre placebo-controlled trial, called the PROMISE trial, which randomised 836 women from 45 hospitals in the UK and the Netherlands. The PROMISE trial found a 3% higher live birth rate with progesterone, but with substantial statistical uncertainty. However, when all the studies of progesterones were combined in a meta-analysis, a clear benefit in favour of progesterone for the outcome of live birth or ongoing pregnancy was identified (RR = 1.08, 95% CI 1.03 to 1.14, I2 = 0%). A key finding, first observed in the PROMISE trial, and then replicated in another large high-quality trial of progesterone in women with early pregnancy bleeding, called the PRISM trial, was that treatment with vaginal micronised progesterone was associated with increasing live birth rates according to the number of previous miscarriages. No short-term safety concerns were identified from the PROMISE and PRISM trials. Women and care providers should use these findings for shared decision-making.

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Chapter
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Publisher: Cambridge University Press
Print publication year: 2021

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References

Haas, DM, Hathaway, TJ, Ramsey, PS. Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology. Cochrane Database Syst Rev. 2018;10:CD003511.Google ScholarPubMed
Coomarasamy, A, Williams, H, Truchanowicz, E, et al. A randomized trial of progesterone in women with recurrent miscarriages. N Engl J Med. 2015;373:2141–8.CrossRefGoogle ScholarPubMed
Coomarasamy, A, Devall, AJ, Brosens, JJ, et al. Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence. Am J Obstet Gynecol. 2020 ;223(2):167–76.Google ScholarPubMed
Coomarasamy, A, Devall, AJ, Cheed, V, et al. A randomized trial of progesterone in women with bleeding in early pregnancy. N Engl J Med. 2019;380:1815–24.CrossRefGoogle ScholarPubMed
Zaqout, M, Aslem, E, Abuqamar, M, Abughazza, O, Panzer, J, De Wolf, D. The impact of oral intake of dydrogesterone on fetal heart development during early pregnancy. Pediatr Cardiol. 2015;36(7):1483–8.CrossRefGoogle ScholarPubMed

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