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A Randomized Trial of Progesterone in Women with Recurrent Miscarriages

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Arri Coomarasamy, Helen Williams, Ewa Truchanowicz, Paul T Seed, Rachel Small, Siobhan Quenby, Pratima Gupta, Feroza Dawood, Yvonne E M Koot, Ruth Bender Atik, Kitty W M Bloemenkamp, Rebecca Brady, Annette L Briley, Rebecca Cavallaro, Ying C Cheong, Justin J Chu, Abey Eapen, Ayman Ewies, Annemieke Hoek, Eugenie M Kaaijk & 15 more Carolien A M Koks, Tin-Chiu Li, Marjory MacLean, Ben W Mol, Judith Moore, Jackie A. Ross, Lisa Sharpe, Jane Stewart, Nirmala Vaithilingam, Roy G Farquharson, Mark D Kilby, Yacoub Khalaf, Mariette Goddijn, Lesley Regan, Rajendra Rai

Original languageEnglish
Pages (from-to)2141-8
Number of pages8
JournalNew England Journal of Medicine
Volume373
Issue number22
Early online date26 Nov 2015
DOIs
Publication statusPublished - 26 Nov 2015

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Abstract

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. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.).

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