1. Women with early pregnancy bleeding administered progesterone experienced similar rates of live births occurring after 34 weeks’ gestation as women treated with placebo.
2. Subgroup analysis was generally inconclusive, though many subgroups had risk ratios approaching significance supporting progesterone use.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Miscarriages are not uncommon in pregnancy and are associated with various adverse outcomes. Progesterone use during pregnancy has been evaluated in various contexts as a possible treatment to support pregnancy viability. The Progesterone in Spontaneous Miscarriage (PRISM) trial evaluated if progesterone treatment for women with early pregnancy bleeding results in a higher incidence of live births than placebo treatment. Women treated with progesterone experienced similar rates of live birth as those treated with placebo. Incidence of adverse events was similar between treatment groups as well.
This large, double-blind study provides further clarity on evidence-based uses for progesterone treatment in pregnancy. Its strengths include its large sample size, randomized design, and extensive subgroup analysis. The study was limited by evaluating a single route and routine of progesterone administration and progesterone was not utilized beyond 16 weeks of gestation.
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