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OBJECTIVE: The aim of this study was to examine the relationship between obesity and risk of stillbirth among pregnant women with obesity in the United States, with a focus on racial and ethnic disparities. STUDY DESIGN: We conducted a retrospective cross-sectional analysis of birth and fetal data from the 2014 to 2019 National Vital Statistics System (N = 14,938,384 total births) to examine associations between maternal body mass index (BMI) and risk of stillbirth. Cox's proportional hazards regression model was used to compute adjusted hazard ratios (HR) as a measure of risk of stillbirth in relation to maternal BMI. RESULTS: The stillbirth rate was 6.70 per 1,000 births among women with prepregnancy obesity, while the stillbirth rate among women with a normal (nonobese) prepregnancy BMI was 3.85 per 1,000 births. The risk of stillbirth was greater among women with obesity compared with women without obesity (HR: 1.39; 95% confidence interval [CI]: 1.37-1.41). Compared with non-Hispanic (NH) Whites, women identifying as NH-other (HR: 1.66; 95% CI: 1.61-1.72) and NH-Black (HR: 1.31; 95% CI: 1.26-1.35) were at higher risk of stillbirth, while Hispanic women had a decreased likelihood of stillbirth (HR: 0.38; 95% CI: 0.37-0.40). CONCLUSION: Obesity is a modifiable risk factor for stillbirth. Public health awareness campaigns and strategies targeting weight management in women of reproductive age and racial/ethnic populations at highest risk for stillbirth, are needed. KEY POINTS: · Stillbirth rates differ by race and ethnicity.. · Risk of stillbirth was greatest among women with obesity.. · Stillbirth rates rise with ascending prepregnancy BMI..
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PURPOSE: Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)-approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA's representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate). METHODS: A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA's Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry. RESULTS: Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population. CONCLUSION: BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.
