Imperial College London
Alternate

Professor Tom Bourne

Faculty of Medicine, Department of Metabolism, Digestion and Reproduction

Chair in Gynaecology
 
 
 
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Contact

 

+44 (0)20 3313 5131t.bourne Website

 
 
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Location

 

Early pregnancy and acute gynaecologyInstitute of Reproductive and Developmental BiologyHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Coomarasamy:2020:10.1016/j.ajog.2019.12.006,
author = {Coomarasamy, A and Devall, AJ and Brosens, JJ and Quenby, S and Stephenson, MD and Sierra, S and Christiansen, OB and Small, R and Brewin, J and Roberts, TE and Dhillon-Smith, R and Harb, H and Noordali, H and Papadopoulou, A and Eapen, A and Prior, M and Di, Renzo GC and Hinshaw, K and Mol, BW and Lumsden, MA and Khalaf, Y and Shennan, A and Goddijn, M and van, Wely M and Al-Memar, M and Bennett, P and Bourne, T and Rai, R and Regan, L and Gallos, ID},
doi = {10.1016/j.ajog.2019.12.006},
journal = {American Journal of Obstetrics and Gynecology},
pages = {167--176},
title = {Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence},
url = {http://dx.doi.org/10.1016/j.ajog.2019.12.006},
volume = {223},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone supplementation may reduce the risk of miscarriage in women with recurrent or threatened miscarriage. Cochrane Reviews summarized the evidence and found that the trials were small with substantial methodologic weaknesses. Since then, the effects of first-trimester use of vaginal micronized progesterone have been evaluated in 2 large, high-quality, multicenter placebo-controlled trials, one targeting women with unexplained recurrent miscarriages (the PROMISE [PROgesterone in recurrent MIScarriagE] trial) and the other targeting women with early pregnancy bleeding (the PRISM [PRogesterone In Spontaneous Miscarriage] trial). The PROMISE trial studied 836 women from 45 hospitals in the United Kingdom and the Netherlands and found a 3% greater live birth rate with progesterone but with substantial statistical uncertainty. The PRISM trial studied 4153 women from 48 hospitals in the United Kingdom and found a 3% greater live birth rate with progesterone, but with a P value of .08. A key finding, first observed in the PROMISE trial, and then replicated in the PRISM trial, was that treatment with vaginal micronized progesterone 400 mg twice daily was associated with increasing live birth rates according to the number of previous miscarriages. Prespecified PRISM trial subgroup analysis in women with the dual risk factors of previous miscarriage(s) and current pregnancy bleeding fulfilled all 11 conditions for credible subgroup analysis. For the subgroup of women with a history of 1 or more miscarriage(s) and current pregnancy bleeding, the live birth rate was 75% (689/914) with progesterone vs 70% (619/886) with placebo (rate difference 5%; risk ratio, 1.09, 95% confidence interval, 1.03-1.15; P=.003). The benefit was greater for the subgroup of women with 3 or more previous miscarriages and current pregnancy bleeding; live birth rate was 72% (98/137) with progest
AU  - Coomarasamy,A
AU  - Devall,AJ
AU  - Brosens,JJ
AU  - Quenby,S
AU  - Stephenson,MD
AU  - Sierra,S
AU  - Christiansen,OB
AU  - Small,R
AU  - Brewin,J
AU  - Roberts,TE
AU  - Dhillon-Smith,R
AU  - Harb,H
AU  - Noordali,H
AU  - Papadopoulou,A
AU  - Eapen,A
AU  - Prior,M
AU  - Di,Renzo GC
AU  - Hinshaw,K
AU  - Mol,BW
AU  - Lumsden,MA
AU  - Khalaf,Y
AU  - Shennan,A
AU  - Goddijn,M
AU  - van,Wely M
AU  - Al-Memar,M
AU  - Bennett,P
AU  - Bourne,T
AU  - Rai,R
AU  - Regan,L
AU  - Gallos,ID
DO  - 10.1016/j.ajog.2019.12.006
EP  - 176
PY  - 2020///
SN  - 0002-9378
SP  - 167
TI  - Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence
T2  - American Journal of Obstetrics and Gynecology
UR  - http://dx.doi.org/10.1016/j.ajog.2019.12.006
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32008730
UR  - https://www.sciencedirect.com/science/article/pii/S0002937819327620?via%3Dihub
UR  - http://hdl.handle.net/10044/1/76718
VL  - 223
ER  -
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