In 1986, the National Institute of Child Health and Human Development created the Maternal-Fetal Medicine Units (MFMU) Network, consisting of a number of major academic clinical centers, a data coordinating center, and the Institute itself. The purpose ofthe Network was to conduct clinical research aimed at reducing the risk of adverse pregnancy and infant outcome with the ultimate goal of contributing a body of well-conducted studies on which to base medical decisions in perinatal medicine. At present, the MFMU Networkis planning, conducting and analyzingmultiple randomized clinical trials and observational studies in various aspects of maternal-fetal medicine such as preterm birth prevention, prediction and prevention of preeclampsia, measures of obstetrical safety and the management of pregnant women with potential risk factors such as subclinical hypothyroidism. The GeorgeWashington UniversityBiostatistics Center proposes to continue to serve as the data coordinating center for the Network. Our purpose is to provide expertise and support in study design, study conduct and statistical analysis. We will provide statistical leadership in the design ofeach research study and in the preparation of interim and final analyses. We will prepare study documents, including protocols, manuals of operations and data forms, and we will continueto provide a comprehensivedata processing system including distributed, web and central data entry, data base management and data quality control. We will assist investigators in the preparation of manuscripts and abstracts from study results and wewill prepare the final dataset for sharing per MFMU Networkpolicy. We will also provide administrative support such as arrangement of logistical services for provision of study drugs and laboratory assays, maintenance of the MFMU Networkwebsite, coordination of meetings, training sessions and outcome reviews. Wewill manage resources effectively and creatively, so that we can start new studies in a timely manner. The relevance ofthe proposed research to public health is clear and direct. The results ofthe Network studies potentially can benefit pregnant women and their children worldwide;for example, by finding methods to screen for problems in pregnancy, by finding maternal treatments that improve children's health, and especially by finding treatments that can help lessen the problem ofbabies being born too early.

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 #
5U10HD036801-15
Application #
8402865
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Ilekis, John V
Project Start
1998-04-15
Project End
2013-11-30
Budget Start
2012-12-01
Budget End
2013-11-30
Support Year
15
Fiscal Year
2013
Total Cost
$12,596,715
Indirect Cost
$954,258
Name
George Washington University
Department
Biostatistics & Other Math Sci
Type
Schools of Arts and Sciences
DUNS #
043990498
City
Washington
State
DC
Country
United States
Zip Code
20052
Sutton, Amelia L; Mele, Lisa; Landon, Mark B et al. (2014) Delivery timing and cesarean delivery risk in women with mild gestational diabetes mellitus. Am J Obstet Gynecol 211:244.e1-7
Caritis, Steve N; Venkataramanan, Raman; Thom, Elizabeth et al. (2014) Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth. Am J Obstet Gynecol 210:128.e1-6
Catalano, Patrick M; Mele, Lisa; Landon, Mark B et al. (2014) Inadequate weight gain in overweight and obese pregnant women: what is the effect on fetal growth? Am J Obstet Gynecol 211:137.e1-7
Graves, Steven W; Esplin, Michael S; McGee, Paula et al. (2014) Association of cord blood digitalis-like factor and necrotizing enterocolitis. Am J Obstet Gynecol 210:328.e1-5
Grobman, William A; Bailit, Jennifer L; Rice, Madeline Murguia et al. (2014) Can differences in obstetric outcomes be explained by differences in the care provided? The MFMU Network APEX study. Am J Obstet Gynecol 211:147.e1-147.e16
Sorokin, Yoram; Romero, Roberto; Mele, Lisa et al. (2014) Umbilical cord serum interleukin-6, C-reactive protein, and myeloperoxidase concentrations at birth and association with neonatal morbidities and long-term neurodevelopmental outcomes. Am J Perinatol 31:717-26
Chiossi, Giuseppe; Lai, Yinglei; Landon, Mark B et al. (2013) Timing of delivery and adverse outcomes in term singleton repeat cesarean deliveries. Obstet Gynecol 121:561-9
Andres, Robert L; Zhao, Yuan; Klebanoff, Mark A et al. (2013) The impact of tobacco use on preterm premature rupture of the membranes. Am J Perinatol 30:185-90
Gilbert, Sharon A; Grobman, William A; Landon, Mark B et al. (2013) Cost-effectiveness of trial of labor after previous cesarean in a minimally biased cohort. Am J Perinatol 30:11-20
Weissgerber, Tracey L; Gandley, Robin E; McGee, Paula L et al. (2013) Haptoglobin phenotype, preeclampsia risk and the efficacy of vitamin C and E supplementation to prevent preeclampsia in a racially diverse population. PLoS One 8:e60479

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