A STUDY OF THE PHARMACOLOGY OF 17-HYDROXYPROGESTERONE CAPROATE IN PREGNANCY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 由NICHD赞助的MFMU网络最近完成的试验表明，肌肉注射17-羟孕酮己酸酯(17-OHPC)大大降低了早产高危妇女的早产率，因为她们以前有过自然早产的经历(1)。没有其他预防早产的策略或治疗方法被证明是有效的。因此，美国妇产科医师学会谨慎地支持这种疗法，但指出需要更多关于这种疗法和替代疗法的信息(2)。尽管关于这种治疗的安全性存在大量证据，但对于孕期己酸酯的药理作用几乎一无所知。该方案将侧重于药代动力学和胎盘转运，并为1-OHPC的药物流行病学提供初步数据。该方案的辅助研究将集中在代谢和体外药效学上，而未来的研究将集中在体内药效学和药物流行病学上。未来还将对新生儿药理学进行评估。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for 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.