Clinical Centers for Completion of Ongoing MFMU Network Protocols

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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, we provide information on our obstetrical service and our proven track record for conducting clinical trials for the Maternal-Fetal Medicine Units (MFMU) Network at the two hospitals in the University of Pennsylvania Health System (Penn) – the Hospital of the University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH). Each year, approximately 9,500 women are delivered at Penn, and many of these women are high-risk pregnancies. The obstetric population at Penn also has a diverse racial and ethnic background, which is an important asset for enrollment in MFMU Network studies. Over the past five years, MFMU Network investigators and research staff at Penn have developed the clinical research infrastructure and proven track record to meet all of the objectives of the ongoing MFMU Network studies. Key assets of the MFMU Network clinical center at Penn are: 1) an experienced Nurse Coordinator who oversees all of the clinical studies; 2) a second registered nurse who will be critical for completion of the network’s PACT study; 3) a project manager who assists the Nurse Coordinator with management of the study protocols; 4) an experienced clinical research coordinator who is certified to conduct all MFMU Network studies; 5) a biospecimens technician who oversees collection, processing, and storage of biospecimens; 6) a 24/7 model that provides research staff coverage every day on the labor floors at HUP and PAH with call coverage at night; 7) outpatient recruitment at all major clinical sites at HUP and PAH; and 8) data abstraction manuals written by research staff and investigators that ensure accurate ascertainment of clinical data from the electronic medical record. The MFMU Network research staff work closely with coordinators from the Neonatal Research Network 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 significant experience directing multicenter studies, and each investigator has an exciting research agenda that adds unique perspectives to the MFMU Network. The PI (S Parry) serves on the TXA protocol and biospecimen committees, while the alternate PI (S Srinivas) serves on the PACT protocol committee and meta- analysis work group. The investigators propose three specific aims for this application: 1) To work within the collaborative environment of the MFMU Network toward the implementation of the ongoing MFMU Network studies; 2) To provide the highest quality data for MFMU Network studies and to provide these data in a timely fashion; and 3) To be involved in the analysis and publication of studies performed by the MFMU Network. The investigative team at Penn looks forward to continuing to work with the other clinical centers and the Data Coordinating Center to complete the ongoing MFMU Network protocols.