Subscribe to RSS
DOI: 10.1055/s-0036-1584543
Birth Rates Among Hispanics and Non-Hispanics and their Representation in Contemporary Obstetric Clinical Trials
Publication History
12 May 2016
20 May 2016
Publication Date:
01 July 2016 (online)
![](https://www.thieme-connect.de/media/ajp/201612/lookinside/thumbnails/10-1055-s-0036-1584543_160220-1.jpg)
Abstract
Objective Our study aims were to establish whether subjects enrolled in current obstetric clinical trials proportionately reflects the contemporary representation of Hispanic ethnicities and their birth rates in the United States.
Methods Using comprehensive source data over a defined interval (January 2011–September 2015) on birth rates by ethnicity from the Centers for Disease Control and Prevention (CDC), we evaluated the proportional rate by ethnicity, then analyzed the observed to expected relative ratio of enrolled subjects.
Results Hispanic women comprise a significant contribution to births in the United States (23% of all births). Systematic analysis of 90 published obstetric clinical trials showed a correlation between inclusion of Hispanic gravidae and the corresponding state's birth rates (r = 0.501, p < 0.001). While the mean was strongly correlated, individual clinical trials may have relatively over-enrolled (n = 31, or 34%) or under-enrolled (n = 33, or 37%) relative to their regional population. In 48% of obstetric clinical trials the Hispanic proportion of the study population was not reported.
Conclusion Hispanic gravidae represent a significant number of contemporary U.S. births, and are generally adequately represented as obstetric subjects in clinical trials. However, this is trial-dependent, with significant trial-specific under- and over-enrollment of Hispanic subjects relative to the regional birth population.
Note
This work was presented as abstract #551 at the Society for Maternal-Fetal Medicine's 36th Annual Pregnancy Meeting; February 1 to 6, 2016, Atlanta, Georgia.
-
References
- 1 Hamilton BE, Martin JA, Osterman MJK, Curtin SC, Matthews TJ. Births: Final data for 2014. Natl Vital Stat Rep 2015; 64 (12) 1-64
- 2 U.S. Department of Health and Human Services. Health, United States, 2014: with special feature on adults aged 55–64. Available online at: http://www.cdc.gov/nchs/data/hus/hus14.pdf . Accessed on March 3, 2016
- 3 Bureau USC. Projections of the Size and Composition of the US Population: 2014 to 2060. Bureau USC; 2015: 1-13
- 4 United States Census Bureau. QuickFacts. Available online at http://www.census.gov/quickfacts/table/PST045215/00 . Accessed on March 3, 2016
- 5 United States Census Bureau. Millennials outnumber baby boomers and are far more diverse, census bureau reports. Available online at http://census.gov/newsroom/press-releases/2015/cb15-113.html . Accessed on March 3, 2016
- 6 Goode TD, Carter-Pokras OD, Horner-Johnson W, Yee S. Parallel tracks: reflections on the need for collaborative health disparities research on race/ethnicity and disability. Med Care 2014; 52 (10) (Suppl. 03) S3-S8
- 7 Kwiatkowski K, Coe K, Bailar JC, Swanson GM. Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved?. Cancer 2013; 119 (16) 2956-2963
- 8 Hoel AW, Kayssi A, Brahmanandam S, Belkin M, Conte MS, Nguyen LL. Under-representation of women and ethnic minorities in vascular surgery randomized controlled trials. J Vasc Surg 2009; 50 (2) 349-354
- 9 Stewart JH, Bertoni AG, Staten JL, Levine EA, Gross CP. Participation in surgical oncology clinical trials: gender-, race/ethnicity-, and age-based disparities. Ann Surg Oncol 2007; 14 (12) 3328-3334
- 10 Zhang T, Tsang W, Wijeysundera HC, Ko DT ; BHSc TZ. Reporting and representation of ethnic minorities in cardiovascular trials: a systematic review. Am Heart J 2013; 166 (1) 52-57
- 11 Byrne MM, Tannenbaum SL, Glück S, Hurley J, Antoni M. Participation in cancer clinical trials: why are patients not participating?. Med Decis Making 2014; 34 (1) 116-126
- 12 Langford A, Resnicow K, An L. Clinical trial awareness among racial/ethnic minorities in HINTS 2007: sociodemographic, attitudinal, and knowledge correlates. J Health Commun 2010; 15 (Suppl. 03) 92-101
- 13 Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?. J Womens Health (Larchmt) 2011; 20 (3) 315-320
- 14 Sheikh A. Why are ethnic minorities under-represented in US research studies?. PLoS Med 2006; 3 (2) e49
- 15 Lê Cook B, McGuire TG, Zuvekas SH. Measuring trends in racial/ ethnic health care disparities. Med Care Res Rev 2009; 66 (1) 23-48
- 16 Hussain-Gambles M, Atkin K, Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc Care Community 2004; 12 (5) 382-388
- 17 Bryant AS, Worjoloh A, Caughey AB, Washington AE. Racial/ethnic disparities in obstetric outcomes and care: prevalence and determinants. Am J Obstet Gynecol 2010; 202 (4) 335-343
- 18 Grobman WA, Bailit JL, Rice MM , et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Racial and ethnic disparities in maternal morbidity and obstetric care. Obstet Gynecol 2015; 125 (6) 1460-1467