The University of Texas Medical Branch at Galveston (UTMB) has the capability to participate actively as a member of the NIH multisite Stillbirth Network. PI George R. Saade, MD, offers extensive experience within several NIH multisite clinical trials og: First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER);First Trimester Nuchal Translucency and the Risk of Congenital Heart Disease;Twin-Twin Transfusion Syndrome Trial;and Beneficial Effects of Antenatal Magnesium Sulfate Study (BEAM). We have achieved successful patient recruitment and retention by frequent involvement with UTMB's extensive Regional Maternal &Child Health Program (RMCHP). All of RMCHP's clinics follow protocols established by the Maternal-Fetal Medicine division, and the patients are delivered at UTMB in Galveston. Pregnant women in two counties served by UTMB--Galveston and Brazoria--will constitute the geographic-based population. More than 90% of these patients are cared for at a UTMB clinic and deliver at John Sealy Hospital. If needed, this target population can be expanded to other RMCHP clinics based on zip codes or counties, as appropriate. Further, the Department's Electronic Medical Record captures antepartum and intrapartum information, entered on-line, that is readily available for query by authorized investigators. In like manner, our Department's Tissue Bank has added broad efficiencies to clinical investigation. The excellent and productive collaboration between PI and Co-I, Radec Bukowski, MD, PhD, offers further benefits to the Stillbirth Network. In addition, our Department's genetics counselor, Jennifer Lee, who will serve as our site's outreach worker, brings considerable experience as an established grief counselor. Our Department has a very productive and well-funded basic science research group with expertise in many areas of relevance to the RFA, such as infection, vascular physiology, placental function, and fetal growth. Finally, we have well-established collaborative ties with our University's Department of Pathology and divisions of Genetics and Neonatology (see letters of support). In particular, UTMB has a highly regarded Perinatal Pathology division with expertise in various areas of interest to this RFA, including neuropathology and placental pathology. Following on our current interest in DNA microarray technology, our proposed study concept is to determine a single nucleotide polymorphism (SNP) marker profile particular to stillbirth. We accept the capitation and participatory stipulations of this RFA and stand ready to become a contributinq member of the NIH Stillbirth Network.
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