title: Birth Rates Among Hispanics and Non-Hispanics and their Representation in Contemporary Obstetric Clinical Trials.
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.
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Maike K
authors.initials: MK
authors.lastname: Kahr
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Rosa
authors.initials: R
authors.lastname: De La Torre
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Diana A
authors.initials: DA
authors.lastname: Racusin
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Suter
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Joan M
authors.initials: JM
authors.lastname: Mastrobattista
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Ramin
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Steven L
authors.initials: SL
authors.lastname: Clark
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Gary A
authors.initials: GA
authors.lastname: Dildy
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Belfort
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
authors.forename: Kjersti M
authors.initials: KM
authors.lastname: Aagaard
mesh_terms: D001723:Birth Rate / Q000208:ethnology*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005260:Female; D020073:Gravidity; D006630:Hispanic or Latino / Q000706:statistics & numerical data*; D006801:Humans; D009774:Obstetrics; D018579:Patient Selection; D011153:Population; D011247:Pregnancy; D014481:United States