The National Perinatal Research Consortium (NPRC) is an integrated system of University based Perinatal research centers with large obstetrical volumes and extensive clinical and translational research expertise. We have come together to perform research requiring large and diverse patient cohorts, combining expertise through well-organized, well-structured and stimulated opportunities for research. Our collaborative approach provides a “one-stop” resource for research sponsors and grantors. We have major economies of scale and function, and we are dedicated to maternal fetal medicine (MFM) research. Our collaboration increases the patient base diversity and volume, strengthens the capacity of key institutions, and forms relationships that expand opportunities for innovation and discovery at the forefront of women’s health research. Structure The NPRC is a research collaborative directed by a steering committee consisting of 2 representatives from each site: a physician investigator and a nurse coordinator. While the NPRC functions as an independent entity, each site is integrated within their individual departments, hospitals and universities. The participating sites and their representatives are below.
Columbia University Ron Wapner, MD 
Dr. Wapner is a well-established, successful, clinical and translational investigator involved in multi-centered trials and observational studies of pregnant women for over 30 years. He is Professor and Vice Chair of Research in the Department of OB/GYN at Columbia and is certified by the subspecialty Boards of MFM and Clinical Genetics. He has authored or co-authored over 300 peer reviewed publications, 40 chapters and 156 published abstracts. Dr. Wapner has participated in a number of NIH Workshops and State of the Science meetings including the NICHD Stillbirth Workshop1 the NIH Consensus Development Panel on Antenatal Repeat Corticosteroids, the NIH Workshop “Sharpening the Tools: State of the Art Workshop on New Technologies for Early Prenatal Diagnosis Using Fetal Cells from Maternal Blood” , the State of the Science meeting on First Trimester Aneuploid Screening and chaired an NIH workshop on perinatal outcomes following assisted reproductive technologies. He is a repeat participant in the NICHD Fellow Research Training Course and has served on NICHD study sections. Dr. Wapner has been, or is, either a principal or co-investigator for numerous multicenter studies including much of the original work on chorionic villus sampling and multi-fetal pregnancy reductions. He has led multiple national and international studies including the initial US publication on first trimester aneuploidy screening; a nine center international consortium demonstrating the value of biochemistry and nuchal translucency in Down Syndrome screening. He was also PI of the recent 29 site prospective comparison of chromosomal microarray to karyotype for prenatal diagnosis which was published in the New England Journal of Medicine in 2012. This multicentered collaboration involved the participation of 4 molecular cytogenetic laboratories, 12 prenatal diagnostic clinical centers, an independent biostatistics center and three partners from industry (two microarray manufactures and one large national cytogenetic laboratory). He is currently PI of the ongoing follow-up study to this grant designed to ascertain the prenatal frequency of copy number variants (CNV) found on microarray testing and a long-term evaluation to detail the phenotypes associated with these CNVs identified in-utero. He has been involved as PI for many of the networks sponsored by NICHD including the Maternal Fetal Medicine Units Network for over 20 years, the Nulliparous Network and the Fetal Growth Consortium. He is also PI for the nuMoM2b Heart Health Study evaluating the role of pregnancy in predicting future maternal health by following the mothers in the nuMoM2b study longitudinally. Sites under his leadership consistently demonstrates stellar performance ranking among the top 3 in all of these initiatives. In 2006, Dr. Wapner established the Perinatal Research Consortium, a formalized group of hospitals with large obstetrical volumes located in New York, Pennsylvania, Delaware and New Jersey that perform collaborative perinatal research. This collaboration now has over 44,000 deliveries per year and functions as a single research entity performing both NIH and industry sponsored studies. Dr. Wapner is the chair of the consortium.
Michelle M. DiVito, RN, MSN, CCRP Ms. DiVito is presently the Senior Director of Research Administration in the Department of OB/GYN at Columbia. In this role, she has overall responsibility for all departmental research administration and operations. Ms. Divito has extensive experience coordinating multi-centered projects and protects a portion of her time to continue to be directly involved in project management. Previous studies she managed include the MFMU Network, the Columbia clinical site within the National Standard of Fetal Growth Study (NSFGS); the Central Sonology Center for the NSFGS (overseeing studies on almost 3000 subjects at 8 sites); the Columbia Center in the nuMoM2b parent grant; and the multisite study comparing array CGH to karyotype. She frequently teaches courses on research administration both locally and nationally and has served as a consultant to multiple outside university research programs. She was recently awarded an outstanding achievement award by the Society of Maternal Fetal Medicine for her work with their educational foundation; the first non-physician to receive this award. In her 20 years of experience overseeing complex multi-centered projects she has developed all of the skills necessary to manage the administrative and fiscal aspects of a grant of this size including data management, FDA regulations, audits, budgetary guidelines, regulatory specifications, personnel management, and study coordination and management.
University of Alabama – Birmingham Joseph Biggio, MD 
Dr. Biggio has approximately ten years of experience with multiple NICHD Multicenter networks including the Maternal Fetal Medicine Units (MFMU) Network and the Genomics and Proteomics Network for Preterm Birth Research. He is the Principal Investigator at the UAB site for the NICHD B-Well study of Asthma in Pregnancy. He also serves as chair of the NICHD MFMU PROsPECT Trial Subcommittee, a study examining the efficacy of pessary or progesterone for the prevention of preterm birth in twins with a short cervix. He is the Vice Chair for Research and Quality and the Director of the Division of Maternal Fetal Medicine. Dr. Biggio will provide both administrative and scientific oversight of projects to facilitate successful completion of NPRC projects at UAB and across the consortium.
Alan Tita, MD, PhD 
Dr. Tita is a practicing MFM specialist, perinatal epidemiologist, and current PI of UAB’s clinical site of the NICHD Maternal Fetal Medicine Units (MFMU) network. Therefore, he participates in the design and oversees several ongoing multicenter collaborative perinatal projects. He currently has NICHD R01 funding as PI/PD of an ongoing multicenter trial (n=2000 at 6 sites) to evaluate an innovative antibiotic prophylaxis strategy to prevent infection in women undergoing cesarean delivery during labor. He is also funded as a co-investigator for the UAB site of the NICHD/IMPAACT Network (conducting international perinatal HIV trials) and until recently was a co-investigator for the UAB site of the NICHD Pelvic Floor Disorders Network. He received advanced training in the design and implementation of complex trials as an NICHD Women’s Reproductive Health Research (WRHR) advanced scholar. In addition to the MFMU network trials and other ongoing studies, he has designed and overseen the successful implementation of other large perinatal randomized clinical trials, including a 3 arm double-blind trial of dose-regimens of oxytocin to prevent postpartum hemorrhage (n=1800) and a trial of suture versus staple closure after cesarean section to reduce post-cesarean wound complications (n=400). He frequently provides obstetric peer review for medical journals and serve on NIH review panels and committees.
Rachel LeDuke
University of North Carolina Alison Stuebe, MD, MSc 
Dr. Stuebe is Associate Professor of Obstetrics and Gynecology at the University of North Carolina School of Medicine and of Maternal and Child Health at the Gillings School of Global Public Health. Dr. Stuebe began her work in clinical epidemiology studying maternal lactation and incident metbolic disease in the Nurses’ Health Studies (NHS). She further developed my skills in clinical epidemiology with a Masters of Science in Epidemiology at the Harvard School of Public Health. She was recruited to UNC as a Women’s Reproductive Health Research Scholar in 2008, and she was awarded her first R01 in 2013. Her research interests include gestational diabetes, maternal obesity, postaprtum depression, and associations between pregnancy complications, lactation, and long-term maternal health. As UNC site PI for the National Perinatal Reseach Consortium, she led the Consortium’s CTSA application for the Rare Events registry.
Tracy Manuck, MD 
Dr. Manuck is an Assistant Professor in the Department of Obstetrics and Gynecology. She is board certified in Obstetrics and Gynecology and board certified in the subspecialty of Maternal-Fetal Medicine. She completed her Maternal-Fetal Medicine Fellowship at the University of Utah in 2010. Dr. Manuck has worked as a physician with CURE International in Honduras and speaks Spanish. Her research and clinical interests and expertise include preterm labor (including cervical insufficiency and preterm premature rupture of membranes), multiple gestations (including complicated twin, triplet, and higher order multiples), and caring for pregnancies complicated by fetal chromosomal or structural anomalies. She currently holds a K23 award from the NICHD and is investigating the pharmacogenomics of preterm birth prevention and treatment.
Karen Dorman, MSN
Ms. Dorman is the Director of Perinatal Research at UNC and a Research Instructor in the Division of Maternal Fetal Medicine. Ms. Dorman received a BS in Nursing from the University of Texas-Houston and a MS in Nursing at Texas Woman’s University with an education focus. After starting her nursing career in medical intensive care, Karen transitioned to the Labor and Delivery Unit where she work to pioneer the field of Critical Care Obstetrics. As a national speaker, she taught physicians and nurses the ‘hows and whys’ of managing critical care obstetric patients. She has spent a majority of her career working in obstetric research. After years at Baylor College of Medicine, she moved to the University of North Carolina where she led the MFMU research team for 12 years, successfully supervising recruitment of thousands of subjects in MFMU clinical studies. She has been promoted to Director of Perinatal Research where she continues to succeed in successful planning, implementation of and recruitment into the research ongoing in the Department of OB/GYN.
University of Texas Medical Branch George Saade, MD 
Dr. Saade is chief of Obstetrics and Maternal-Fetal Medicine at UTMB and the Director of the Perinatal Research Division. He has been involved in all aspects of research during the past 2 decades, including development of research concepts, design of experiments, troubleshooting, evaluation of data, and publication. He has a long track record in multicenter collaborative clinical and translational research, as evidenced by the fact that he is the PI on the NICHD-MFMU Network, the PI of the NICHD Stillbirth Collaborative Research Network, and the co-PI of the Genomic Proteomic Network at UTMB. He also chairs the steering committee for the NuMoM2B (study of preterm birth in nulliparous women) Network. He has served as site PI on numerous clinical trials in obstetrics, and he represented the MFMU network in an individual patient data meta-analysis of progestins to prevent preterm birth in twin pregnancies. He initiated, and currently serves as chair, of the MFMU Network meta-analysis working group. In addition, Dr. Saade runs a laboratory focusing on animal models of preeclampsia, growth restriction, and fetal programming. As such, he has expertise in vascular and metabolic function in pregnancy. He chaired the NHLBI conference on the long term health of mothers with preeclampsia. He is the editor-in-chief of the American Journal of Perinatology, and he has chaired several standing and ad hoc NIH study sections and have been a reviewer for NIH, CDC, and other international funding agencies.
Ashley Salazar, MSN, RN, WHNP Ashley is the Director of the Perinatal Research Division at The University of Texas Medical Branch (UTMB). She has the clinical expertise, leadership, and motivation to carry out the collaboration needed to perform maternal-fetal research. She has a strong foundation in obstetrical care, stemming from working in the high risk labor and delivery unit, she has also worked in the clinical setting providing prenatal care, performing dating ultrasounds, and carrying out research protocols. She has been involved in both unsponsored and sponsored clinical trials at the department, industry, and NIH Network levels, including the Maternal Fetal Medicine Units Network (MFMU). The strong combination of clinical and research experience makes Ashley well suited to serve as a clinical research coordinator. University of Utah Michael Varner, MD 
Dr. Varner has over fifteen years of experience with other NICHD Network Steering Committees as a Principal Investigator in the Maternal-Fetal Medicine Units Network, Global Network for Women’s and Children’s Health Research, and Genomic and Proteomic Network for Premature Birth Research. He is also the Co-Principal Investigator of the Utah site in the NICHD’s Collaborative Stillbirth Research Network, a Senior Investigator in the University of Utah National Children’s Study Vanguard Site, the Associate Director ofthe University of Utah’s Center for Clinical and Translational Science (CTSA), and is the Vice Chair for research. Dr. Varner will provide his extensive experience and community connections to ensure that recruitment, retention, and sample/data quality standards for this proposal are fulfilled.
Laurie Lesher, MBA, BNS, CCRP Laurie Lesher has over 22 years clinical nursing experience and over six years clinical research experience including the study coordinator for the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, a NICHD funded contract. Ms Lesher is the Associate Director of the Obstetric and Gynecology Research Network (OGRN) at the University of Utah. She supervises OGRN research personnel and the research management team. She works hand in hand with Dr. Varner to provide successful, high quality research.
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