A randomized trial of progesterone in women with recurrent miscarriages

Coomarasamy, A., Williams, H. and Truchanowicz, E. et al. (2015) A randomized trial of progesterone in women with recurrent miscarriages. New England Journal of Medicine, 373 (22), 2141-2148. (doi:10.1056/NEJMoa1504927). (PMID:26605928)

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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Contributors

Author: Y.C. Cheong

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