PHARMACOKINETICS AND PHARMACODYNAMICS OF SELECTED ANTIBIOTICS IN PREGNANCY

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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 purpose of this study is to learn more about how some medications are processed by the body during pregnancy. Gentamicin, azithromycin, and ciproflaxin are antibiotics used to treat infection. To learn more about how these drugs enter and leave the body in pregnancy, the US Food and Drug Administration has sponsored this study. To be eligible, participants must be in their second or third trimester of pregnancy, or must have given birth more than three months ago. Participants must also be using one of these antibiotics under a doctor's supervision to treat an infection. During the study, participants would continue to take the medication as directed by their doctor. Participants would keep track of their medicatoins, and have their blood drawn and analyzed two times during the study. Participants and their infants will also be monitored for any side effects, and information about medical history and current health will be collected from medical records. For pregnant participants, we will also collect information on the health of the newborn baby after birth. The blood will be analyzed to test the levels of medication in the blood at different times. There will be no other change in treatment for participants, so all decisions regarding how best to treat infections will be made by the participant and her doctor and should not be affected by the study. At some other centers, people who are not pregnant, or who are lactating (producing breast milk) may participate, but at the University of Michigan, only women in their second or third trimester of pregnancy or who gave birth more than three months ago will be participating.