The Division of Maternal-Fetal Medicine at Brown University/Women and Infants Hospital of Rhode Island (WIH) has a strong commitment to a continued high-level of participation in the NICHD MFMU Network for the purpose of investigating problems in clinical obstetrics, particularly those related to low birth weight, prematurity, and medical problems of pregnancy. We have extensive experience in performing clinical trials in these areas, and a strong, stable, and proven research infrastructure. WIH, with 9,000 annual births, is one of the largest obstetric units in the country. We have been a participating center for the past two 5-year cycles of the MFMU Network. Dwight J. Rouse, MD, MSPH was recruited to be the Brown/WIH Network Principal Investigator in September, 2009. Prior to this he was the Principal Investigator for the University of Alabama at Birmingham (UAB) MFMU Network site from 2001 to 2009. In that role, he maintained UAB as a vital and leading Network center (consistently ranked in the top three). According to the most recent cumulative performance report issued by the Network's Biostatistical Coordinating Center (BCC) Brown/WIH was ranked 2nd highest in Data Quality (edits and audits) and 7th in Patient Recruitment and Retention among 14 centers. We are confident we can retain our high ranking in the former and improve our ranking in the latter. Dr. Rouse's faculty recruitment package included additional Departmental academic open-ended funding for the full time equivalent of two research nurses who are dedicated solely to the Network. With this funding we hired three research assistants (rather than two nurses) and re-configured the deployment of our personnel. Accordingly, our recruitment has increased dramatically. Indeed, since 9/09, Brown/WIH has screened the greatest number of patients, and recruited the second greatest number to the only randomized Network trial ongoing since that time-the SCAN Trial (17-a hydroxyprogesterone caproate for the prevention of preterm birth in nulliparas with a short cervix) We also dramatically increased screening for the TSH trial, to a maximum of 205 (individually-consented) patients in one month. We believe that we remain well positioned for competitive renewal as an NICHD MFMU Network center for the next five years. Our goal is not only to participate in the MFMU Network, but to turn Brown/WIH into one of its leading sites in terms of protocol development, start-up and completion, data interpretation, manuscript preparation and publication in top-tier journals, and support of Network functions across all protocols and centers.

Public Health Relevance

The health and economic burdens of pregnancy-specific disorders such as preeclampsia, and adverse pregnancy outcomes such as preterm birth are substantial and have proved largely intractable. Moreover, pregnancy outcomes in the United States compare unfavorably with many developed-world nations. Brown/WIH, by participating in the MFMU Network, can help provide the necessary, highest quality scientific evidence and redress these burdens.

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 #
5U10HD040500-14
Application #
8448197
Study Section
Special Emphasis Panel (ZHD1-DRG-D (50))
Program Officer
Ilekis, John V
Project Start
2001-04-03
Project End
2016-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
14
Fiscal Year
2013
Total Cost
$272,017
Indirect Cost
$85,064
Name
Women and Infants Hospital-Rhode Island
Department
Type
DUNS #
069851913
City
Providence
State
RI
Country
United States
Zip Code
02905
Caritis, Steve N; Feghali, Maisa N; Grobman, William A et al. (2016) What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth. Semin Perinatol 40:273-80
Yee, Lynn M; Sandoval, Grecio; Bailit, Jennifer et al. (2016) Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol 128:1039-1047
Landon, Mark B; Grobman, William A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network (2016) What We Have Learned About Trial of Labor After Cesarean Delivery from the Maternal-Fetal Medicine Units Cesarean Registry. Semin Perinatol 40:281-6
Froehlich, Rosemary J; Sandoval, Grecio; Bailit, Jennifer L et al. (2016) Association of Recorded Estimated Fetal Weight and Cesarean Delivery in Attempted Vaginal Delivery at Term. Obstet Gynecol 128:487-94
Manuck, Tracy A; Rice, Madeline Murguia; Bailit, Jennifer L et al. (2016) Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort. Am J Obstet Gynecol 215:103.e1-103.e14
Bloom, Steven L; Belfort, Michael; Saade, George et al. (2016) What we have learned about intrapartum fetal monitoring trials in the MFMU Network. Semin Perinatol 40:307-17
Salazar, Ashley; Tolivaisa, Susan; Allard, Donna et al. (2016) What we have learned about best practices for recruitment and retention in multicenter pregnancy studies. Semin Perinatol 40:321-7
Rice, Madeline Murguia; Landon, Mark B; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units (MFMU) Network (2016) What we have learned about treating mild gestational diabetes mellitus. Semin Perinatol 40:298-302
Blackwell, Sean C; Landon, Mark B; Mele, Lisa et al. (2016) Relationship Between Excessive Gestational Weight Gain and Neonatal Adiposity in Women With Mild Gestational Diabetes Mellitus. Obstet Gynecol 128:1325-1332
Basraon, Sanmaan K; Mele, Lisa; Myatt, Leslie et al. (2016) Relationship of Early Pregnancy Waist-to-Hip Ratio versus Body Mass Index with Gestational Diabetes Mellitus and Insulin Resistance. Am J Perinatol 33:114-21

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