The purpose of this study is to evaluate the pharmacokinetics and effects of intramuscular and oral vitamin K1 administration in women between 26 and 32 weeks gestation. Twenty healthy, pregnant women (aged 18-44 years) will receive a single dose of vitamin K1 via the intramuscular or oral routes on two separate occasions. Each dose will be followed by the collection of several blood samples. This will be followed by a placebo controlled examination of the influence of 5 days of oral vitamin K1 on maternal coagulation profile. The study is designed as a preliminary investigation anticipating a larger clinical trial of antepartum vitamin K1 supplementation. We plan to have twenty subjects complete the course of vitamin K1 therapy in the CRC. Currently, eight subjects have completed the entire protocol. No samples have been evaluated yet for vitamin K1 or coagulation profiles. Samples will be stored in the CRC until ten subjects have completed the protocol, at which time an interim analysis will be conducted on all samples. If the results are inconclusive, we will continue to recruit subjects until all twenty have completed the protocol.
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