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A randomized trial of progesterone in women with bleeding in early pregnancy

New England Journal of Medicine May 15, 2019

Coomarasamy A, et al. - Since bleeding in early pregnancy is strongly linked to pregnancy loss, researchers desired to know whether progesterone therapy may improve pregnancy outcomes in women who have bleeding in early pregnancy. They sought to assess progesterone, as compared with placebo, in women with vaginal bleeding in early pregnancy. For this multicenter, randomized, double-blind, placebo-controlled trial, women were randomly assigned to receive vaginal suppositories containing either 400 mg of progesterone or matching placebo twice daily from the time of bleeding through 16 weeks of gestation. A total of 4,153 women receiving progesterone (2079 women) or placebo (2074 women) were randomly assigned. Findings revealed that progesterone therapy given during the first trimester did not result in a significantly higher incidence of live births vs placebo among women with bleeding in early pregnancy.
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