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NICHD Maternal-Fetal Medicine Units (MFMU) Network: Clinical Center

NICHD 母胎医学单位 (MFMU) 网络：临床中心

基本信息

批准号：
10680961
负责人：
SAMUEL I. PARRY
金额：
$ 35.75万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2030-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10680961
关键词：
Ancillary Study Area Biological Specimen Banks Caring Clinical Clinical Data Clinical Research Clinical Trials Clinical Trials Network Collaborations Collection Computerized Medical Record Conduct Clinical Trials Data Development Discipline of obstetrics Disparity Enrollment Ensure Environment Equity Ethnic Origin Faculty Fetus Functional disorder Funding Genetic Genomics Goals Good Clinical Practice Gynecology Health system Heart High-Risk Pregnancy Hospitals Hypertension Intervention Studies Leadership Longterm Follow-up Manuals Maternal and Child Health Maternal-Fetal Medicine Units Network Maternal-fetal medicine Medical Records Modeling Multicenter Neonatal Research Network Multicenter Studies Multicenter Trials National Institute of Child Health and Human Development Neonatal Network Infrastructure Nurses Observational Study Operations Research Outpatients Patients Pediatric Hospitals Pennsylvania Performance Persons Phase Philadelphia Population Population Heterogeneity Positioning Attribute Post-Acute Sequelae of SARS-CoV-2 Infection Postpartum Hypertension Postpartum Women Pregnant Women Premature Birth Proteomics Protocols documentation Publications Publishing Registered nurse Regulatory Affairs Research Research Infrastructure Research Personnel Second Labor Stage Shapes Site Text Translational Research United States Dept. of Health and Human Services United States National Institutes of Health Universities University Hospitals Women&apos s Health Work Writing clinical center clinical research site cohort data access data repository data sharing disparity reduction experience follow-up high risk improved improved outcome innovation maternal outcome neonatal outcome obstetric services operation participant enrollment patient population pregnant premature programs racial diversity randomized trial randomized, clinical trials recruit reproductive shared database support network

项目摘要

Abstract The University of Pennsylvania's Department of Obstetrics and Gynecology reflects a long tradition of excellence in clinical and translational research. In this application, information is provided on the obstetrical service and proven track record for conducting clinical trials at two hospitals in the University of Pennsylvania (Penn) Health System – the Hospital of the University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH). Each year, approximately 9,500 patients are delivered at Penn, and many of these patients have high- risk pregnancies. The obstetric population at Penn has a diverse racial and ethnic background, which is an important asset for enrollment in Maternal-Fetal Medicine Units (MFMU) Network studies. Key assets of the MFMU Network site at Penn are: 1) an experienced Nurse Coordinator who oversees all the clinical studies; 2) a second registered nurse who is critical for completion of complicated Network studies (e.g., PACT, PASC- PREG); 3) a biospecimens technician who has written manuals of operation and oversees collection, processing, and data banking for biospecimens; 4) successful outpatient recruitment at all major clinical sites at HUP and PAH; 5) the ability to expand to a 24/7 model that provides coverage on the labor and delivery units at HUP and PAH; 6) data abstraction manuals for each MFMU Network study that ensure accurate ascertainment of clinical data from the electronic medical record; and 7) support by the MFM Research Program and the Women's Health Clinical Research Center at Penn, which assist the MFMU Network team with recruitment of new staff, onboarding, regulatory affairs, and good clinical practices in all research operations. The MFMU Network research team works closely with the Neonatal Research Network clinical center at the Children's Hospital of Philadelphia to provide neonatal follow-up for MFMU Network studies. The investigative team for the MFMU Network clinical center at Penn has substantial experience directing multicenter studies, and each investigator has an exciting research agenda that adds unique perspectives to the MFMU Network. The investigators propose three specific aims for this application: 1) Develop and implement MFMU Network protocols, including recruitment, study interventions, and follow-up examinations; 2) Provide the highest quality data for MFMU Network studies and provide these data in a timely fashion; and 3) Collaborate with the other MFMU Network centers to identify areas for potential research and to analyze and publish studies performed by the MFMU Network. The investigative team at Penn has built a highly successful MFMU Network clinical site that will support the NICHD's guiding principles shaping the 21st century landscape for multi-site clinical research, including enhanced rigor for selecting studies, availability of Network infrastructure to a wider range of investigators, data sharing and access to biospecimens, and inclusion of diverse populations in Network studies.

摘要