Evaluation of progesterone (17-[alpha] hydroxyprogesterone caproate) utilization, adherence and outcomes in women with a high-risk pregnancy

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Zhang, Shiyu, M.S. in Pharmaceutical Sciences

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The aims of this study were to investigate the utilization, adherence, and effectiveness of 17-α hydroxyprogesterone caproate (17-OHPC) for patients with a history of preterm birth (PTB). A retrospective cohort study was conducted using 2012-2017 data from the Decision Recourses Group (DRG) database. The first diagnosis of high-risk pregnancy was the index date. A 6-month pre-index period was applied, and the patients were followed to delivery. Descriptive statistics, chi-square tests, and logistic regressions were used for data analysis. A total of 23,911 patients met criteria, with 2,051 (8.58%) having ≥ 1 claim for 17-OHPC. Patients with commercial insurance were more likely to use 17-OHPC compared with Medicaid patients (p<0.0001); and patients residing in the Southwest were more likely to use 17-OHPC compared with patients residing in other areas of the U.S. (p<0.0001). Of the 2,051 women prescribed 17-OHPC, 407 (19.84%) were adherent using our baseline definition of adherence. No association was found between patients’ adherence rates and their demographic or clinical characteristics. Older patients aged 30-35 and aged ≥35 were 28% (OR=0.72, 95% CI=0.64-0.79) and 34% (OR=0.66, 95% CI=0.59-0.74) less likely to have PTB, respectively, than patients aged <25; patients residing in the Southeast area were 12% less likely to have PTB (OR=0.64, 95% CI=0.54-0.75) than Northeast patients; patients with hypertension were 15% (OR=1.15, 95% CI=1.02-1.29) more likely to have PTB, than patients without hypertension; patients with a CCI score of 1, 2, or ≥3 were 10% (OR=1.10, 95% CI=1.01-1.20), 26% (OR=1.26, 95% CI=1.14-1.41), and 35% (OR=1.35, 95% CI=1.17-1.56) more likely to have PTB, respectively, than patients with a CCI score of 0. After controlling for covariates, the incidence of PTB was not found to be associated with utilization of (p=0.44) or adherence to 17-OHPC (p=0.14). The use of 17-OHPC was not associated with the incidence of diabetes (p=0.21). However, the use of 17-OHPC was shown to be associated with a lower incidence of hypertension (p=0.01). In conclusion, 17-OHPC use was low (<10%), adherence was low (<20%), and there was no evidence of effectiveness


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