Table 1.
PROMISE trial: vaginal micronized progesterone in women with unexplained recurrent miscarriages
Population | Women with unexplained recurrent miscarriages (≥3 consecutive or nonconsecutive miscarriages), trying to conceive naturally |
Intervention | 400 mg of micronized progesterone taken vaginally twice daily from no later than 6 weeks until 12 weeks of gestation |
Comparison | Placebo |
Primary outcome | Live birth beyond 24 weeks |
Sample size and power | 836 patients randomized; 90% power to detect a 10% difference in live births |
Hospitals and countries | 36 hospitals in the United Kingdom and 9 hospitals in the Netherlands |
PROMISE, PROgesterone in recurrent MIScarriagE.
Coomarasamy et al. Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence. Am J Obstet Gynecol 2020.