Data and Clinical Core/L-Arginine Intermediate Outcome RCT

数据和临床核心/L-精氨酸中间结果随机对照试验

基本信息

批准号：
8375283
负责人：
NINA MARKOVIC
金额：
$ 21.64万
依托单位：
MAGEE-WOMEN'S RES INST AND FOUNDATION
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至 2014-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8375283
关键词：
Address Adipose tissue Arginine Biological Cesarean section Clinic Clinical Clinical Data Clinical Investigator Collection Conduct Clinical Trials Consultations Data Data Collection Data Quality Diagnostic Discipline of obstetrics Enrollment Ensure Epidemiology Functional disorder Gynecology Healthcare Hospitals Hypertension Individual Measures Monitor Morbidity - disease rate Obesity Outcome Overweight Participant Perinatal Placebos Population Pre-Eclampsia Pregnancy Pregnant Women Preparation Prevention Principal Investigator Program Research Project Grants Protocols documentation Public Health Schools Randomized Controlled Clinical Trials Recruitment Activity Research Research Institute Resources Safety Sampling Science Source Specimen System Weight Woman Work arm base care seeking data management design mortality prenatal prenatal exposure programs quality assurance reproductive success trial comparing

项目摘要

Preeclampsia is a major contributor to maternal and perinatal morbidity and mortality. Prevention and treatment require an understanding of both pathophysiology and clinical characterization. The Data and Clinical Core centralizes participant recruitment, data collection, data management, protocol implementation for clinically related projects within the Program Project. Specifically, these activities will entail recruiting, over a four-year period, an estimated 600 overweight (based upon pre-pregnancy measures) and 100 normal weighted nulliparous pregnant women without prior evidence of preexisting hypertension and with singleton gestations from Magee-Womens Hospital in Pittsburgh. Baseline clinical data will be obtained between 10 and 15 weeks gestation and additional biological specimens will be collected throughout the pregnancy. Approximately 100 of the recruited participants will be cross-enrolled in a randomized controlled clinical trial comparing L-arginine and placebo for 3 weeks beginning at 14 -16 weeks of gestation for intermediate outcomes in support of Projects II, III, and IV (Roberts, Hubel, and Gandley). Furthermore, 25 obese women with severe preeclampsia and 25 lean women with severe preeclampsia will be studied crosssectionally at labor and delivery (for Projects II, III, and IV). Women undergoing Caesarian- section deliveries will be recruited for collection of adipose tissue and placental samples (for Project IV, Gandley). The Clinical Data Core staff will be responsible for participant recruitment, data collection, and quality assurance. The Core will also characterize women with preeclampsia using a strict set of diagnostic criteria and a jury of clinical experts. Data will be organized and maintained using the expertise within the Center for Research on Health Care, Data Center. The Core will continue to build on current success. To date, in the Program Project, we have enrolled over 4000 women and have identified almost 900 preeclamptic women. We are confident in our abilities to continue successful recruitment of participants and maintaining quality data to support clinical projects in the Program Project.

先兆子痫是孕产妇和围产期发病率和死亡率的主要原因。预防和治疗需要了解病理生理学和临床特征。数据和临床核心集中参与者招募、数据收集、数据管理、方案实施用于计划项目内的临床相关项目。具体来说，这些活动将需要招募、在四年期间，估计有 600 人超重（根据孕前测量）和 100 人超重。体重正常、没有先前存在高血压证据且患有高血压的未产孕妇来自匹兹堡马吉妇女医院的单胎妊娠。将获得基线临床数据妊娠 10 至 15 周期间将采集额外的生物样本怀孕。大约 100 名招募的参与者将交叉入组随机对照研究比较 L-精氨酸和安慰剂的临床试验，从妊娠 14 -16 周开始为期 3 周，支持项目 II、III 和 IV（Roberts、Hubel 和 Gandley）的中间成果。此外，25 将对患有严重先兆子痫的肥胖女性和 25 名患有严重先兆子痫的瘦女性进行横断面研究临产和分娩（项目 II、III 和 IV）。接受剖腹产的妇女将招募分娩者来收集脂肪组织和胎盘样本（用于项目 IV，Gandley）。临床数据核心工作人员将负责参与者招募、数据收集和质量保证。核心还将使用一套严格的诊断标准来表征患有先兆子痫的女性以及由临床专家组成的评审团。将利用中心内的专业知识来组织和维护数据医疗保健研究，数据中心。核心将继续在当前成功的基础上再接再厉。迄今为止，在该计划项目中，我们已经注册了超过 4000 名女性，已识别出近 900 名先兆子痫女性。我们对自己的能力充满信心继续成功招募参与者并维护高质量数据以支持临床项目计划项目。