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Utilization of Hydroxyprogesterone Caproate among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database

    Basic Details
    Medical Product
    hydroxyprogesterone caproate

    The U.S. Food and Drug Administration (FDA) approved Makena® (hydroxyprogesterone caproate [HPC] injection) in February 2011 for reducing the risk of pre-term birth (PTB) in women with a singleton pregnancy who had a history of singleton spontaneous PTB (sPTB). Makena was approved under accelerated approval and required a postmarketing study to verify its clinical benefits. However, the postmarketing trial (PROLONG) failed to verify Makena’s clinical benefit to neonates and substantiate its effect on reducing the risk of recurrent PTB. This study examined the utilization of HPC, along with another progestogen (vaginal progesterone) used to reduce the risk of sPTB during pregnancy, to inform the landscape of HPC use in the United States.

    We included pregnant women aged 10–54 years with a live birth delivery from January 1, 2008 to December 31, 2018 in the Sentinel Distributed Database (SDD). We examined the prevalence of injectable HPC (Makena and its generics), compounded HPC, and vaginal progesterone use during the second and third trimesters during the study period. We also assessed the proportion of these HPC-exposed pregnancies with obstetrical conditions of interest as potential reasons for use: (1) history of pre-term delivery; (2) cervical shortening in the current pregnancy; and (3) pre-term labor in the current pregnancy.


    Mayura Shinde, Austin Cosgrove, Corinne M. Woods, Christina Chang, Christine P. Nguyen, David Moeny, Adebola Ajao, Joy Kolonoski, Huei-Ting Tsai

    Corresponding Author

    Huei-Ting Tsai, Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD