Document text
Principal Investigator: SAMUEL I. PARRY
Organization: UNIVERSITY OF PENNSYLVANIA
Fiscal Year: 2024
Award: $357,498
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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.
Terms: <Active Follow-up><Ancillary Study><Area><Biological Specimen Banks><Biological Substance Banks><Caring><Cells Placenta-Tissue><Children's Hospital><Clinical><Clinical Data><Clinical Research><Clinical Study><Clinical Trials><Clinical Trials Network><Collaborations><Collection><Computerized Medical Record><Conduct Clinical Trials><Data><Data Banks><Databanks><Decrease disparity><Department of Health and Human Services><Development><Discipline of obstetrics><Disparities><Disparity><Dysfunction><Electronic Medical Record><Enrollment><Ensure><Environment><Equity><Ethnic Origin><Ethnicity><Faculty><Female Health><Fetus><Functional disorder><Funding><GCP standard><Genetic><Genomics><Goals><Good Clinical Practice><Gynecology><Health system><Heart><High-Risk Pregnancy><Hospitals><Hypertension><Intervention Studies><Investigators><Leadership><Long-term Follow-up><Longterm Follow-up><Lower disparity><MFMU network><Manuals><Maternal and Child Health><Maternal-Fetal Medicine Units><Maternal-Fetal Medicine Units (MFMU) Network><Maternal-Fetal Medicine Units Network><Maternal-fetal medicine><Medical Records><Modeling><Multi-center Neonatal Research Network><Multi-center studies><Multi-center trial><Multicenter Neonatal Research Network><Multicenter Studies><Multicenter Trials><NICHD><NIH><National Institute of Child Health and Human Development><National Institute of Children's Health and Human Development><National Institutes of Health><Neonatal><Neonatal Research Network><Network Infrastructure><Normal Placentoma><Nurses><Observation research><Observation study><Observational Study><Observational research><Obstetrics><Operations Research><Out-patients><Outpatients><PASC><Patients><Pediatric Hospitals><Pennsylvania><Performance><Persons><Phase><Philadelphia><Physiopathology><Placenta><Placenta Embryonic Tissue><Placentome><Population><Population Heterogeneity><Position><Positioning Attribute><Post Acute Sequelae of COVID19><Post Acute Sequelae of SARS-CoV-2><Post Acute Sequelae of SARS-CoV2><Post Acute Sequelae of severe acute respiratory syndrome coronavirus 2><Post-Acute Sequelae of SARS-CoV-2 Infection><Post-partum Women><Postpartum Hypertension><Postpartum Women><Pregnant Women><Premature Birth><Prematurely delivering><Preterm Birth><Proteomics><Protocol><Protocols documentation><Publications><Publishing><R.N.><Randomization trial><Registered nurse><Regulatory Affairs><Research><Research Infrastructure><Research Personnel><Researchers><Scientific Publication><Second Labor Stage><Shapes><Site><Text><Translational Research><Translational Science><United States Department of Health and Human Services><United States Dept. of Health and Human Services><United States National Institutes of Health><Universities><University Hospitals><Vascular Hypertensive Disease><Vascular Hypertensive Disorder><Women's Health><Work><Writing><active followup><adverse sequelae of COVID><adverse sequelae of COVID-19><adverse sequelae of coronavirus disease><adverse sequelae of coronavirus disease 2019><biological specimen repository><biosample repository><biospecimen bank><biospecimen repository><chronic COVID-19 sequelae><clinical center><clinical research site><clinical site><cohort><data access><data depository><data repository><data set repository><data sharing><dataset repository><developmental><disparity reduction><diverse populations><enroll><expectant mother><expecting mother><experience><follow up><follow-up><followed up><followup><heterogeneous population><high blood pressure><high risk><hyperpiesia><hyperpiesis><hypertensive disease><hypertensive disorder><improved><improved outcome><innovate><innovation><innovative><intervention research><interventional research><interventional study><interventions research><long haul sequelae of COVID-19><long haul sequelae of coronavirus disease 2019><long-term followup><long-term sequelae of COVID-19><long-term sequelae of SARS-CoV-2><long-term sequelae of coronavirus disease 2019><long-term sequelae of severe acute respiratory syndrome coronavirus 2><longterm followup><maternal outcome><mitigate disparity><mother outcome><neonatal outcome><nurse><obstetric services><operation><operations><participant enrollment><pathophysiology><patient enrollment><patient population><population diversity><post COVID-19 sequelae><post acute sequelae following COVID-19><post-acute sequelae following SARS-CoV-2 infection><post-acute sequelae of COVID-19><post-acute sequelae of acute COVID infection><post-acute sequelae of coronavirus disease 2019><pregnant><pregnant mothers><premature><premature childbirth><premature delivery><prematurity><preterm delivery><programs><racial diversity><racially diverse><randomized trial><randomized, clinical trials><recruit><reduce disparity><reduction in disparity><reproductive><shared data base><shared database><specimen bank><specimen repository><support network><translation research><translational investigation>