The University of California, Irvine (UCI) has the required elements to participate in the consortium to evaluate genetic and environmental risk factors for preterm birth in nulliparous women. Deborah Wing (PI) and the Pathik Wadhwa (co-l) have extensive experience in study design, subject recruitment, data analysis, and publications from several NIH-funded and industry-sponsored single- and multiple-site studies. Dr. Wing directs the UCI Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine and oversees its fellowship and clinical research mission. Dr. Wadhwa, director of the UCI Behavioral Perinatology Research Program, examines the interface between biological and behavioral processes in pregnancy, directs an NIH program project on gene-environment interactions in pregnancy, and also has participated in large working groups to outline research needs for the genetic determinants of preterm birth. We propose recruitment of subjects from a richly diverse racial and ethnic mix from UCI and our affiliate at Long Beach Memorial Medical Center. Our clinical enterprise and patient population ("7000 deliveries/year) make us well-prepared to participate in this consortium. Most of our patients receive prenatal care in the first trimester. We can capitalize on the growing research infrastructure for the Orange County, California, Vanguard Center for the National Children's Study to aid in recruitment, and can bring to this new investigation the infrastructure of the National Standard for Normal Fetal Growth study. This includes pre-approved protocols for survey administration, physical and ultrasound exams, biosample collection, sonographer training, and quality assurance. We have multiple electronic databases in place for antepartum and intrapartum data. We have a dedicated team of research staff plus an oversight committee comprised of faculty members and our lead research coordinators who meet regularly. We recently recruited Dongbao Chen, PhD, to oversee our Perinatal Research Laboratory;his group can provide expertise relevant to this RFA. We have well-established collaborative ties with neonatology, genetics, perinatal pathology, clinical laboratory, and research pharmacies which can aid in successful completion of this investigation. Unique to UCI are its Center for Molecular and Mitochondrial Medicine and Genetics (MAMMAG), Genetic Epidemiology Research Institute (GERI), the Institute of Genomics and Bioinformatics (IGB), and the Pacific-Southwest Center for Emerging Diseases and Bioterrorism (PSW RCE), each of which lend particular strengths to the study of genetic and environmental determinants of preterm birth.

Public Health Relevance

Our concept proposal evaluates the mitochondrial DNA determinants of select causes of preterm birth, a leading cause of morbidity and mortality worldwide. Discoveries from this investigation could lead to novel methods of detection, treatment and prevention of prematurity.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10HD063046-03S1
Application #
8602021
Study Section
Special Emphasis Panel (ZHD1-DSR-K (29))
Program Officer
Higgins, Rosemary
Project Start
2010-01-10
Project End
2014-12-31
Budget Start
2013-01-01
Budget End
2013-12-31
Support Year
3
Fiscal Year
2013
Total Cost
$279,875
Indirect Cost
$97,843
Name
University of California Irvine
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
046705849
City
Irvine
State
CA
Country
United States
Zip Code
92697