Impact of Minority Races on Clinical Trials on Progesterone for the Prevention of Preterm Labor [14C

Abstract

INTRODUCTION: It is unclear if clinical trial populations are adequately diverse to address this concern. The objective of this study was to determine if the study populations in published literature on progesterone effect on preterm labor were diverse enough to demonstrate a benefit for minority races. METHODS: This was a meta-analysis by searching PubMed using the keywords: progesterone, preterm labor, and singleton. Included studies were randomized clinical trials that identified the racial composition and delivery within 48 hours as an outcome of interest. Population level modeling was performed on the pooled result by recalculating the rate of outcome for each study if the rate of outcome of a particular race was the same between intervention and placebo arms. Pooled results that remain statistically significant after race specific adjustments suggest minimal influence from that particular race, whereas a non-significant result suggests stronger influence from that race. RESULTS: There were 52 clinical trials identified, nine of which met requirement for in-depth review. Progesterone decreased risk of preterm labor (RR 0.84, 95% CI [0.76–0.93]). Race adjusted pooled results were significant for Hispanic (RR 0.84, 95% CI [0.76–0.93]) and Asian (RR 0.86, 95% CI [0.78–0.95]), but not significant for white (RR 0.97, 95% CI [0.88–1.07]) or black (RR 0.91, 95% CI [0.82–1.01]). CONCLUSION: In studies on progesterone for preterm labor, Hispanic and Asian races were underrepresented, whereas white and black races were major contributors.