MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS

母胎医学单位的多中心网络

• 批准号: 6603150
• 负责人: MARSHALL W CARPENTER
• 金额: $ 73.91万
• 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/6603150
• 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）：WIH和产科部门， 布朗大学医学院的妇科有能力 作为合作多中心母婴中心的新成员积极参与 医学单位网。WIH经营的国家之一？的更大 产科服务。在罗德岛，所有的产科护理都由保险提供支持。 岛因此，国家？美国的民族和种族多样性 在私人和诊所的病人中。为74%的 州的病人，WIH的人口统计和临床统计数据完全反映了 罗得岛的人。在1999财政年度期间，交付了9 023次 在WIH，WIH诊所和母婴医学患者中有2099例。的 WIH分娩总数中，174例在35周前发生胎膜破裂，556例 在35周之前分娩，207例多胎妊娠，179例 妊娠期或慢性糖尿病，794例妊娠期高血压疾病， 539人患有哮喘或其他呼吸道疾病，163人患有心脏或血管疾病。 疾病学术界和私人执业社区有一个 持续的合作关系，提供对整个 队列研究的产科人群。因此，WIH特别 适用于临床试验。 母胎医学部由六个委员会认证和 一个积极的候选人为母胎医学委员会，所有这些人都将 支持网络研究协议。该司还聘请了两名研究人员， 护士和一名超声波检查员，目前都由NICHD资助， 额外的临床护士，均在队列研究方面拥有丰富的经验。 该司已成功招募病人（53%-100%招募 率），以及代谢和血流动力学 保持率为79- 93%的队列研究。该司 与当地和国际组织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 54- 80%的患者。该司 目前正在进行由NICHD资助的三项多中心队列研究。这是 2000年4月被网络选定参加 镁（BEAM）研究，以增加患者在这方面的招募 方案，目前正在开始招募受试者。该司一直在 作为一项国际研究的五个北美地点之一， 母体葡萄糖耐受不良对母体和围产期的影响 高血压和不良妊娠结局（HAPO）研究。该司 也是第一和第二个三个月风险评估的参与者 （FASTER）研究检查联合生化和超声检查的妊娠早期 唐氏综合症筛查妇女健康所和母胎医学司将 招募所有网络协议的受试者，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研究的当地基础设施 WIH的试验包括（1）大量患者和高度参与的全职 和自愿产科教师;（2）强大的临床病人，实验室， 解剖病理学和药学数据库;（3） 母胎医学和新生儿医学部门之间的合作;（4） 几十年的围产期组织样本和解剖病理学;和（5）一个强大的 部门致力于成果研究。