This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The recently completed trial by the NICHD sponsored MFMU Network has demonstrated that intramuscular 17-alpha-hydroxyprogesterone caproate (17-OHPC) substantially reduces the rate of preterm birth in women at high risk for preterm delivery because of a prior spontaneous preterm birth (1). No other strategy or treatment for prevention of preterm birth has proven to be effective. Consequently, the American college of Obstetricians and Gynecologists has cautiously supported this treatment but points out that much more information about this therapy and alternative therapies is required (2). Although a large body of evidence exists about the safety of this treatment almost nothing is known about the pharmacology caproate in pregnancy. This protocol will focus on pharmacokinetics and placental transport and provide preliminary data the pharmacoepidemiology of 1-OHPC. Ancillary studies to this protocol will focus on metabolism and In-vitro pharmacodynamics while future studies will focus on in-vvo pharmacodynamics and pharmacoepidemiology. Neonatal pharmacology will also be assessed in the future.
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