A Randomized Trial of Progesterone in Women with Recurrent Miscarriages

被引:188
作者
Coomarasamy, A. [1 ]
Williams, H. [1 ]
Truchanowicz, E. [1 ]
Seed, P. T. [4 ]
Small, R. [2 ]
Quenby, S. [9 ]
Gupta, P. [2 ]
Dawood, F. [10 ]
Koot, Y. E. M. [18 ]
Atik, R. Bender [11 ]
Bloemenkamp, K. W. M. [19 ]
Brady, R. [5 ]
Briley, A. L. [6 ]
Cavallaro, R. [5 ]
Cheong, Y. C. [12 ]
Chu, J. J. [1 ]
Eapen, A. [1 ]
Ewies, A. [3 ]
Hoek, A. [20 ]
Kaaijk, E. M. [21 ]
Koks, C. A. M. [23 ]
Li, T. -C. [13 ]
MacLean, M. [14 ]
Mol, B. W. [24 ]
Moore, J. [15 ]
Ross, J. A. [7 ]
Sharpe, L. [5 ]
Stewart, J. [16 ]
Vaithilingam, N. [17 ]
Farquharson, R. G. [10 ]
Kilby, M. D. [1 ]
Khalaf, Y. [8 ]
Goddijn, M. [22 ]
Regan, L. [5 ]
Rai, R. [5 ]
机构
[1] Univ Birmingham, Coll Med & Dent Sci, Birmingham, W Midlands, England
[2] Heart England NHS Fdn Trust, Birmingham, W Midlands, England
[3] Sandwell & West Birmingham Hosp NHS Teaching Trus, Birmingham, W Midlands, England
[4] St Thomas Hosp, Kings Coll London & Kings Hlth Partners, London, England
[5] Univ London Imperial Coll Sci Technol & Med, St Marys Hosp Campus, Womens Hlth Res Ctr, London, England
[6] St Thomas Hosp, Kings Hlth Partners, London, England
[7] Kings Coll Hosp NHS Fdn Trust, London, England
[8] Guys & St Thomas Fdn Trust, Assisted Concept Unit, London, England
[9] Univ Warwick, Biomed Res Unit Reprod Hlth, Warwick, England
[10] Liverpool Womens NHS Fdn Trust, Liverpool, Merseyside, England
[11] Miscarriage Assoc, Wakefield, England
[12] Univ Southampton, Fac Med, Princess Anne Hosp, Southampton SO9 5NH, Hants, England
[13] Royal Hallamshire Hosp, Sheffield S10 2JF, S Yorkshire, England
[14] Univ Hosp Crosshouse, Ayrshire Matern Unit, Kilmarnock, Scotland
[15] Nottingham Univ Hosp NHS Trust, Nottingham, England
[16] Newcastle Hosp NHS Fdn Trust, Newcastle Upon Tyne, Tyne & Wear, England
[17] Portsmouth Hosp NHS Trust, Portsmouth, Hants, England
[18] Univ Med Ctr Utrecht, Dept Reprod Med, Utrecht, Netherlands
[19] Leiden Univ, Med Ctr, Dept Obstet, Leiden, Netherlands
[20] Univ Groningen, Univ Med Ctr Groningen, Dept Reprod Med & Gynecol, Groningen, Netherlands
[21] Onze Lieve Vrouw Hosp, Dept Obstet & Gynecol, Amsterdam, Netherlands
[22] Univ Amsterdam, Acad Med Ctr, Dept Obstet & Gynecol, Ctr Reprod Med, NL-1105 AZ Amsterdam, Netherlands
[23] Maxima Med Ctr Veldhoven, Dept Obstet & Gynecol, Veldhoven, Netherlands
[24] Univ Adelaide, Sch Pediat & Reprod Hlth, Robinson Inst, Adelaide, SA, Australia
关键词
PRETERM BIRTH; RISK; METAANALYSIS; SUPPORT;
D O I
10.1056/NEJMoa1504927
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Progesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain. METHODS We conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice-daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation. RESULTS A total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, -4.0 to 9.0). There were no significant between-group differences in the rate of adverse events. CONCLUSIONS Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages.
引用
收藏
页码:2141 / 2148
页数:8
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