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. This translational bench-to-bedside project is aiming to establish utility of direct ethanol metabolites in validating maternal self report with respect to drinking in pregnancy among polysubstance-using women. Pregnant women attending the UNM Addiction and Substance Abuse Program (aka Milagro program) will serve as the study population. The proposed project uniquely combines basic science and clinical components and is a collaborative effort between UNM College of Pharmacy, Departments of Pediatrics, Obstetrics and Gynecology, Neurosciences, and UNM Addiction and Substance Abuse Program. The multi-disciplinary team of clinicians (Dr. Renate Savich &Dr. William Rayburn), basic scientists (Dr. Daniel Savage &Dr. Jamie Barnhill) and an epidemiologist (Dr. Bakhireva) will ensure access to the study population, collection of biological samples, necessary laboratory procedures, and data analysis. The proposed project has obtained approval from all co-investigators and participating institutions (i.e., Milagro program). It also have been reviewed and approved by the Human Research Review Committee (HRRC #: 09-004). Dr. Bakhireva met with the CTSC/GCRC Biostatistician (Dr. Schrader) and research subject advocate (Cheryl Reich, RN) to discuss the study protocol, data analysis plan with power calculations, and provisions to ensure patients safety. Dr. Bakhireva (P.I.) and Dr. Savich (Co-Investigator) also had a series of discussions with the CTSC/GCRC Newborn/Pediatric Core (Dr. Ohls and Ms. Lacy) about study procedures related to data collection from women and their newborn children during the hospital stay after labor and delivery.
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