Table 2.
PRISM trial: vaginal micronized progesterone in women with threatened miscarriages
Population | Women with vaginal bleeding during the first 12 weeks of pregnancy |
Intervention | 400 mg of micronized progesterone taken vaginally or rectally twice daily from randomization until 16 weeks of gestation |
Comparison | Placebo |
Primary outcome | Live birth ≥34 weeks |
Sample size and power | 4153 patients randomized, 90% power to pick up a 5% difference in live births |
Hospitals | 48 hospitals in the United Kingdom |
PRISM, PRogesterone In Spontaneous Miscarriage.
Coomarasamy et al. Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence. Am J Obstet Gynecol 2020.