Preeclampsia is a major contributor to maternal and perinatal morbidity and mortality. Prevention and treatment require an understanding of both pathophysiology and clinical characterization. The Data and Clinical Core centralizes participant recruitment, data collection, data management, protocol implementation for clinically related projects within the Program Project. Specifically, these activities will entail recruiting, over a four-year period, an estimated 600 overweight (based upon pre-pregnancy measures) and 100 normal weighted nulliparous pregnant women without prior evidence of preexisting hypertension and with singleton gestations from Magee-Womens Hospital in Pittsburgh. Baseline clinical data will be obtained between 10 and 15 weeks gestation and additional biological specimens will be collected throughout the pregnancy. Approximately 100 of the recruited participants will be cross-enrolled in a randomized controlled clinical trial comparing L-arginine and placebo for 3 weeks beginning at 14 -16 weeks of gestation for intermediate outcomes in support of Projects II, III, and IV (Roberts, Hubel, and Gandley). Furthermore, 25 obese women with severe preeclampsia and 25 lean women with severe preeclampsia will be studied crosssectionally at labor and delivery (for Projects II, III, and IV). Women undergoing Caesarian- section deliveries will be recruited for collection of adipose tissue and placental samples (for Project IV, Gandley). The Clinical Data Core staff will be responsible for participant recruitment, data collection, and quality assurance. The Core will also characterize women with preeclampsia using a strict set of diagnostic criteria and a jury of clinical experts. Data will be organized and maintained using the expertise within the Center for Research on Health Care, Data Center. The Core will continue to build on current success. To date, in the Program Project, we have enrolled over 4000 women and have identified almost 900 preeclamptic women. We are confident in our abilities to continue successful recruitment of participants and maintaining quality data to support clinical projects in the Program Project.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Program Projects (P01)
Project #
5P01HD030367-18
Application #
8375283
Study Section
Special Emphasis Panel (ZHD1-DSR-L)
Project Start
Project End
2014-03-31
Budget Start
2012-04-01
Budget End
2013-03-31
Support Year
18
Fiscal Year
2012
Total Cost
$216,447
Indirect Cost
$46,343
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Gandley, Robin E; Althouse, Andrew; Jeyabalan, Arundhathi et al. (2016) Low Soluble Syndecan-1 Precedes Preeclampsia. PLoS One 11:e0157608
Schmella, Mandy J; Clifton, Rebecca G; Althouse, Andrew D et al. (2015) Uric Acid Determination in Gestational Hypertension: Is it as Effective a Delineator of Risk as Proteinuria in High-Risk Women? Reprod Sci 22:1212-9
Hux, Vanessa J; Roberts, James M (2015) A potential role for allostatic load in preeclampsia. Matern Child Health J 19:591-7
Schmella, Mandy J; Ferrell, Robert E; Gallaher, Marcia J et al. (2015) The -93T/G LPL Promoter Polymorphism Is Associated With Lower Third-Trimester Triglycerides in Pregnant African American Women. Biol Res Nurs 17:429-37
Founds, Sandra; Zeng, Xuemei; Lykins, David et al. (2015) Developing Potential Candidates of Preclinical Preeclampsia. Int J Mol Sci 16:27208-27
Hassis, Maria E; Niles, Richard K; Braten, Miles N et al. (2015) Evaluating the effects of preanalytical variables on the stability of the human plasma proteome. Anal Biochem 478:14-22
Tan, Hong Chang; Roberts, James; Catov, Janet et al. (2015) Mother's pre-pregnancy BMI is an important determinant of adverse cardiometabolic risk in childhood. Pediatr Diabetes 16:419-26
Luiza, John W; Gallaher, Marcia J; Powers, Robert W (2015) Urinary cortisol and depression in early pregnancy: role of adiposity and race. BMC Pregnancy Childbirth 15:30
Founds, Sandra A; Ren, Dianxu; Roberts, James M et al. (2015) Follistatin-like 3 across gestation in preeclampsia and uncomplicated pregnancies among lean and obese women. Reprod Sci 22:402-9
Sween, Lindsay K; Althouse, Andrew D; Roberts, James M (2015) Early-pregnancy percent body fat in relation to preeclampsia risk in obese women. Am J Obstet Gynecol 212:84.e1-7

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