Obstetric Clinical Trial Diversity: Analysis of Trial Focus and Representation From 2007 to 2020

Abstract

Inclusive clinical trials are necessary to improve maternal health equity. We aimed to analyze the current state of race and ethnicity reporting and representation in obstetric trials and the association with trial focus for all U.S.-based obstetric trials between 2007 and 2020. In this cross-sectional, multivariable regression analysis, the exposure variable was clinical trial focus (eg, prematurity), and the outcomes were race and ethnicity reporting and representation of diverse cohorts. Obstetric anesthesia trials reported race and ethnicity the least frequently of all trial foci (adjusted odds ratio 0.2, 95% CI 0.08-0.48). Hypertension and obstetric anesthesia trials enrolled the lowest proportion of Black participants, and prematurity trials enrolled the lowest proportion of Latinx and Asian participants. All researchers should strive to improve measurement and reporting of demographic data as well participation of diverse cohorts.

Fig. 1.. Median racial and ethnic percent representation in U.S.-based obstetric clinical trial publications by trial focus. Each bar represents the median (interquartile range) percent representation. The percentages for the 2010 United States Census population of people who had given birth within the previous year are presented on the far right of the figure. The 2010 and 2020 Census estimates for the population of individuals (aged 15–50 years) who had given birth within the past year were: American Indian Alaska Native 0.95%, uncollected in 2020; Asian 5.79%, 6.80%; Black 15.06%, 15.07%; Latinx 23.08%, 22.77%; and non-Latinx White 55.12%, 55.37% (the margin of error for each of these estimates was less than 1%). *Diabetes includes gestational and nongestational diabetes. Mental health includes trials only on perinatal mental health. Hypertension includes all hypertensive disorders of pregnancy.