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Objective: To determine if the racial and ethnic compositions of the participants in Obstetrics and Gynecology randomized controlled trials (RCTs) conducted in the U.S. match that of the general U.S. population. Design: Retrospective analysis of U.S. RCTs. Setting: United States. Population: Women enrolled in U.S. RCTs. Methods: Racial and ethnic composition of RCT participants published in two premier US journals, Obstetrics and Gynecology and American Journal of Obstetrics and Gynecology, from January 2010 to April 2020 were collected and analyzed. Main outcome measures: Comparison of the racial and ethnic composition of the U.S. RCTs to U.S. General population. Results: Chi-square analysis showed significant deviations from the U.S. general population in both Obstetrics (p<0.001) and Gynecology (p<0.05). We observed an overrepresentation of Black race and an underrepresentation of White and Asian races overall Obstetrics and in most subcategories. We observed an overrepresentation of Black race and an underrepresentation of Asian race in Gynecology overall and in most subcategories. White race representation was similar to the general population on average, but with wide variation across studies especially among the subcategories. Hispanic ethnicity was overall underrepresented. Conclusions: RCTs in the field of Obstetrics and Gynecology conducted in the U.S. deviate from the general population with regard to racial and ethnic distributions. Funding: NC,YW, CP, JG and SL received stipend from University of Chicago Metcalf summer internship program and Odyssey and Empower summer program. Keywords: U.S. Randomized Controlled Trials, Racial and Ethnic Backgrounds, Obstetrics and Gynecology

Objectives To determine the racial and ethnic compositions of the participants in obstetric randomized controlled trials (RCTs) and compare them to the US general population. Methods RCTs published in two premier US journals, American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology from January 2010 to April 2020 were analyzed. The racial and ethnic distributions of the study participants were extracted and expressed as percentages for each article. Obstetrics articles were selected and then further divided into subcategories. Statistical analyses were performed on racial and ethnicity representation in each subcategory compared to a US population norm. Results Overall, a wide variation of racial and ethnic distribution was noted among studies. However, statistically significant overrepresentation of Non-Hispanic Black population and underrepresentation of White and Asian races were noted while Hispanic population’s representation was comparable to the US general population. This observation was persistent across most of the subcategories. Conclusions RCTs in the field of Obstetrics showed an overrepresentation of Black population. This observation was unique when we consider the previous reports in other fields of medicine. These findings should be taken into consideration when interpreting the results of RCTs conducted in US.