Tanabe and Colleague Submit NIH UG3 Administrative Supplement Application

Kudos to Paula Tanabe, associate dean for research development and data science; and Nirmish Shah of Duke University School of Medicine; and their entire team for the submission of their NIH UG3 Administrative Supplement application entitled “An Evaluation of Predictors of Maternal Morbidity and Perinatal Morbidity and Mortality among Participants enrolled in the Sickle Cell Disease Implementation Registry." This proposal requests funding for a one-year period with a start date of August 1, 2019.

Sickle cell disease (SCD) is an inherited blood disorder predominantly affecting African-Americans in the US. One in 396 African Americans is born with SCD, and 1 in 14 carry the trait. The disease is associated with multiple complications which negatively impact quality of life. Despite clinical advances and research on the disease, differences in the clinical manifestations and complications of SCD between males and females remains largely unknown. Female specific research in this area mainly focuses on pregnancy related events and has revealed that women living with SCD are at a higher risk of both pregnancy and SCD-related morbidity and mortality. However, those studies are limited by their small sample size and were conducted in single sites. The incidence of adverse maternal and pregnancy outcomes is also higher for women with SCD compared to other women in the general population. Failure to determine the key differences between male and female related disease pathophysiology has limited the ability to determine predictors of SCD related maternal morbidity as well as perinatal morbidity and mortality. Clinical tools to predict and prevent maternal morbidity and perinatal morbidity and mortality are critically needed to allow for targeted interventions tailored towards decreasing adverse maternal and perinatal outcomes in this population. The objectives of the proposed study are to describe and compare SCD biomarkers and clinical outcomes among males and females, and to understand factors that influence the occurrence of maternal morbidity and perinatal morbidity and mortality among females living with SCD. More specifically we aim to: 1) Compare and assess differences in SCD biomarkers, disease severity, healthcare utilization and clinical outcomes among males and females; 2) Determine the prevalence of maternal morbidity and perinatal morbidity and mortality in SCD and 3) Determine the predictors of maternal morbidity and perinatal morbidity and mortality. Methods will include retrospective data analysis of 2420 patients currently enrolled in the first national SCD registry. Key variables that will be utilized to identify predictors of maternal morbidity and perinatal morbidity and mortality include the participant’s socio-demographic characteristics, sickle cell genotypes, SCD biomarkers and clinical outcomes. Findings from this study will guide future research on interventions tailored towards mitigating the incidence of maternal morbidity and perinatal morbidity and mortality in SCD.