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Obstetric-Fetal Pharmacology Research Units Network

产科-胎儿药理学研究单位网络

基本信息

批准号：
7426900
负责人：
GARY D HANKINS
金额：
$ 57.09万
依托单位：
UNIVERSITY OF TEXAS MED BR GALVESTON
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-07-01 至 2010-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7426900
关键词：
Administrator Ambulatory Care Facilities Amniotic Fluid Embolism Aneuploidy Animal Model Area Aromatase Biomedical Research Blood Vessels Caring Chairperson Chronic Clinic Clinical Clinical Investigator Clinical Research Clinical Trials Collection Condition Consultations Critical Care Daily Data Diabetes Mellitus Diagnostic tests Discipline of obstetrics Doctor of Philosophy Down Syndrome Drug Kinetics Electronics Enrollment Ensure Enzymes Evaluation Evaluation Studies Fellowship First Pregnancy Trimester Foundations Funding Genetic Polymorphism Genus Capra Grant Gynecologist Gynecology Head Human Human Chorionic Gonadotropin Human Resources Hypoglycemic Agents In Vitro Individual Infection Inhibin A Inpatients Investigation Laboratories Ligands Lobule Magnesium Sulfate Maternal Age Maternal Physiology Maternal and Child Health Measurement Mediating Medical Medicine Metabolic Methods Modeling Multicenter Trials National Institute of Child Health and Human Development Neonatal Neonatology Nuchal Translucency Numbers Nurse Practitioners Opiates Outcome Outpatients Pan Genus Pan troglodytes Papio Papio cynocephalus Patient Recruitments Patients Performance Perfusion Pharmaceutical Preparations Pharmacodynamics Pharmacology Physician Executives Physicians Physiology Placenta Play Population Positioning Attribute Postdoctoral Fellow Pregnancy Pregnancy Proteins Pregnancy-Associated Plasma Protein-A Pregnant Women Prenatal Diagnosis Preparation Primates Principal Investigator Productivity Prospective Studies Protocols documentation Provider Range Recruitment Activity Registries Research Research Personnel Risk Role Sampling Scientist Screening procedure Second Pregnancy Trimester Serum Serum Markers Services Site Supervision System Texas Time Tissues Training Ultrasonography United States National Institutes of Health Universities Vagina Week Woman Work animal facility diabetic direct patient care experience falls fetal in vivo medical specialties member placental transfer programs protocol development receptor research facility response trophoblast

项目摘要

DESCRIPTION (provided by applicant): The University of Texas Medical Branch (UTMB) has the capability to participate actively as a member of the Obstetric-Fetal Pharmacology Research Units (OPRU) Network. Gary Hankins, MD, as PI, is responsible for the proposed clinical trial on the use of hypoglycemic drugs in the treatment of diabetes during pregnancy. He has extensive experience within several NIH multicenter trials, eg, First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER), Beneficial Effects of Antenatal Magnesium Sulfate Study (BEAM), and the Vaginal Ultrasound Cerclage Trial. Dr. Hankins has achieved successful patient recruitment and retention by involvement with UTMB's Regional Maternal & Child Health Program (RMCHP). All RMCHP clinics follow protocols established by the Maternal-Fetal Medicine division, headed by Dr. Hankins. Over 12,000 pregnant women are cared for annually within the RMCHP clinic system, approximately 7,000 of whom deliver at UTMB. The Pharmacology/Pharmacokinetics (PK) Co-Investigator, Mahmoud S. Ahmed, PhD, has over 25 years of expertise in utilizing human placenta and derived preparations in his investigations. Dr. Ahmed is a laboratory-pioneered investigator in placental receptors, their natural ligands and mediated responses, as well as the mechanism of hCG release from trophoblast tissue. They investigated the effects of in vitro and in vivo chronic administration of opiates on placental physiology and maternal-neonatal outcome. Utilizing dual perfusion of placental lobule, they demonstrated the influence of efflux protein and placental metabolic [enzymes on the PK for placental transfer of opiates. They identified placental aromatase as a drug-metabolizing enzyme and are investigating its polymorphism. Kenneth D. Carey, DVM, PhD, as Animal Model Co-Investigator, is responsible for coordinating the baboon studies to be conducted at the Southwest National Primate Research Center (SNPRC) in San Antonio. A population of normal and diabetic baboons will be studied. Dr. Hankins is an adjunct investigator at the SNPRC and has had extensive involvement with the Primate research staff. The Department of Ob/Gyn has well-funded scientists with expertise in areas relevant to this RFA including infection, vascular physiology, and placental functions. Clinical PK Co-Investigators Susan Abdel-Rahman, Pharm D., and Wayne Snodgrass, MD, PhD, have over 30 years of combined experience in the development of protocols for PK studies, evaluation of data obtained, and PK/PD modeling. The Division of Neonatology, the GCRC, and other departments at UTMB will provide support for this project.

描述（由申请人提供）：德克萨斯大学医学分部（UTMB）有能力作为产科-胎儿药理学研究单位（OPRU）网络的成员积极参与。医学博士加里·汉金斯（Gary Hankins）作为首席研究员，负责在妊娠期间使用降糖药治疗糖尿病的拟议临床试验。他在几个NIH多中心试验中拥有丰富的经验，例如，妊娠早期和中期非整倍体风险评估（FASTER），产前硫酸镁研究（BEAM）的有益效果，以及阴道超声环扎试验。汉金斯博士通过参与UTMB的区域妇幼保健计划（RMCHP），成功地招募和保留了患者。所有RMCHP诊所都遵循由Hankins博士领导的母胎医学部门制定的协议。每年有超过12,000名孕妇在RMCHP诊所系统内接受治疗，其中约7,000人在UTMB分娩。药理学/药代动力学（PK）联合研究员Mahmoud S. Ahmed博士在利用人胎盘及其衍生制剂的研究方面拥有超过25年的专业知识。Ahmed博士是胎盘受体，其天然配体和介导反应以及滋养细胞组织释放hCG机制的实验室先驱研究者。他们研究了体外和体内长期服用阿片类药物对胎盘生理和母婴结局的影响。他们利用胎盘小叶的双重灌注，证明了外排蛋白和胎盘代谢酶对阿片类药物胎盘转移的PK的影响。他们发现胎盘芳香化酶是一种药物代谢酶，并正在研究其多态性。Kenneth D. Carey， DVM，博士，作为动物模型合作研究者，负责协调在圣安东尼奥的西南国家灵长类动物研究中心（SNPRC）进行的狒狒研究。将对正常狒狒和糖尿病狒狒进行研究。汉金斯博士是SNPRC的一名兼职研究员，与灵长类动物研究人员有着广泛的联系。妇产科拥有资金雄厚的科学家，他们在感染、血管生理学和胎盘功能等与RFA相关的领域具有专业知识。临床PK共同研究者Susan Abdel-Rahman（药学博士）和Wayne Snodgrass（医学博士）在PK研究方案的开发、获得的数据评估和PK/PD建模方面拥有超过30年的综合经验。新生儿科、GCRC和UTMB的其他部门将为该项目提供支持。