MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS

母胎医学单位的多中心网络

• 批准号: 6746857
• 负责人: MARSHALL W CARPENTER
• 金额: $ 68.34万
• 依托单位: WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-03 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6746857
• 关键词: clinical trials; cooperative study; disease /disorder proneness /risk; embryo /fetus disorder; female; human pregnant subject; human subject; human therapy evaluation; mother /infant health care; neonatal intensive care; newborn human (0-6 weeks); obstetrics; patient oriented research; pediatrics; perinatal; pregnancy; pregnancy disorder; premature infant human; prenatal care; prenatal diagnosis; women' s health

DESCRIPTION (provided by applicant): WIH and the Department of Obstetrics and Gynecology at Brown University School of Medicine have the capability to participate actively as a new member of the Cooperative Multicenter Maternal-Fetal Medicine Units Network. WIH operates one of the nation?s larger obstetrical services. All obstetric care is supported by insurance in Rhode Island. Consequently, the State?s ethnic and racial diversity is reflected among both private and clinic patients. Providing care to 74 percent of the State s patients, WIH s demographic and clinical statistics wholly reflect those of Rhode Island. During fiscal year 1999, 9023 deliveries were performed at WIH, 2099 among WIH Clinic and Maternal-Fetal Medicine patients. Of the total WIH deliveries, 174 had ruptured membranes before 35 weeks, 556 delivered prior to 35 weeks, 207 had multi-fetal pregnancies, 179 had gestational or chronic diabetes, 794 had hypertensive disorders in pregnancy, 539 had asthma or other respiratory disease and 163 had cardiac or vascular disease. The academic faculty and private practice community have had a consistently collaborative relationship providing access to the entire obstetrical population for cohort studies. Consequently, WIH is particularly suited for performance of clinical trials. The Maternal-Fetal Medicine Division is composed of six board-certified and one active candidate for the Maternal-Fetal Medicine boards, all of whom will support Network research protocols. The Division also employs two research nurses and a sonographer, all presently supported by NICHD funding, and three additional clinical nurses, all with extensive experience in cohort research. The Division has successfully enlisted patients (53-100 percent enlistment rates) in complex tocolysis trials and exercise, and metabolic and hemodynamic cohort studies with retention rates of 79-93 percent. The Division has maintained strong clinical and investigational relationships with local and regional private obstetricians, reflected in the proportions of private patients in Divisional cohort studies of 54-80 percent. The Division is presently engaged in three multicenter cohort studies funded by NICHD. It was selected by the Network in April 2000 to participate in the Beneficial Effects of Antenatal Magnesium (BEAM) Study to increase patient enlistment in this protocol and is presently beginning to enroll subjects. The Division has been funded as one of five North American sites in an international study of the maternal and perinatal impact of maternal glucose intolerance, the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) Study. The Division is also a participant in the First and Second Trimester Evaluation of Risk (FASTER) Study examining combined biochemical and sonographic first trimester screening for Down syndrome. WIH and the Maternal-Fetal Medicine Division will enlist subjects for all Network protocols and actively participate in proposing, planning and executing Network studies. Local infrastructure available for participation in multicenter clinical trials at WIH include (1) a large patient volume and highly involved full-time and voluntary obstetrical faculty; (2) robust clinical patient, laboratory, anatomic pathology, and pharmacy databases; (3) a strong history of collaboration between Maternal-Fetal Medicine and Neonatology Divisions; (4) decades-old perinatal tissue samples and anatomic pathology; and (5) a strong Departmental commitment to outcomes research.

描述(由申请人提供)：世界卫生组织和妇产科 布朗大学医学院的妇科有能力 作为多中心母婴合作社的新成员积极参与 医疗单位网络。谁经营的国家之一？S更大 产科服务。所有产科护理都由罗德州的保险提供支持 小岛。因此，国家？S的民族和种族多样性得到了体现 在私人和诊所患者中都是如此。为74%的老年人提供医疗服务 状态S患者、WIH S的人口学和临床统计全面反映 罗德岛的那些。在1999财政年度，共进行了9023次交付 在世界卫生组织，2099人在世界卫生组织临床和母婴医学患者中。中的 WIH分娩总数，35周前有174例胎膜破裂，556例 在35周前分娩，207人有多胎妊娠，179人有 妊娠期或慢性糖尿病，794人在怀孕期间患有高血压疾病， 539人患有哮喘或其他呼吸系统疾病，163人患有心脏或血管疾病 疾病。学术人员和私人执业社区已经有了一个 始终如一的协作关系，提供对整个 用于队列研究的产科人群。因此，WIH特别 适用于临床试验的性能。 母胎医学部由六个委员会认证的和 母婴医学委员会的一名活跃候选人，所有人都会 支持网络研究协议。该司还雇用了两名研究人员。 护士和一名超声师，目前都得到了NICHD资金的支持，还有三名 增加临床护士，他们都有丰富的队列研究经验。 该司已成功招募病人(53%-100%招募 在复杂的产酵解试验和运动中，以及代谢和血流动力学 队列研究，保留率为79%-93%。该司有 与当地和研究机构保持密切的临床和研究关系 地区私立产科医生，反映在私立产科医生的比例上 分区队列研究中的患者占54%-80%。该部门是 目前参与了由NICHD资助的三项多中心队列研究。确实是 在2000年4月被网络选中参与惠益效果 产前镁(BEAM)研究以增加患者在这方面的入伍 协议，目前正在开始招收科目。该司一直被 作为一项国际研究中的北美五个地点之一获得资助 母体糖耐量异常对产妇和围产儿的影响 高血糖与不良妊娠结局(HAPO)研究。该部门是 也是第一和第二阶段风险评估的参与者 (更快)早孕早期生化和超声联合检查的研究 唐氏综合症的筛查。世界卫生组织和母胎医学部将 征集所有网络协议的主题并积极参与 提出、规划和执行网络研究。 可用于参与多中心临床的本地基础设施 WIH的试验包括：(1)患者数量大，全职参与程度高 和自愿的产科教师；(2)健壮的临床患者，实验室， 解剖病理学和药学数据库；(3)有很强的 母胎医学与新生儿科的协作；(4) 几十年前的围产期组织样本和解剖病理学；以及(5)强有力的 部门对成果研究的承诺。