description): The purpose of this Midcareer Investigator Award in Patient-Oriented Research is to provide Dwight J. Rouse, Associate Professor of Obstetrics and Gynecology in the School of Medicine at the University of Alabama at Birmingham (UAB) with sufficient protected time to: 1) continue and expand his ongoing patient oriented research activities including serving as protocol chairman of a jointly funded NINDS and NICHD randomized clinical trial and as principal investigator of a funded RO1 randomized clinical trial of intrapartum chlorhexidine vaginal cleansing, and through the continued performance of decision and cost-effectiveness analyses of obstetric screening technologies and practices; 2) to enhance his activities and capabilities as a mentor, especially through the UAB NIH Women's Reproductive Health Research Center Career Development Program, and 3) to develop new patient oriented research skills. For this award, his new skill acquisition will be focused on """"""""pragmatic"""""""" clinical trials, i.e., trials in which the intervention to be tested is overlaid on the background of local usual clinical practice, with a minimum of study-related practice constraints, liberal inclusion and few exclusion criteria The design and conduct of these pragmatic clinical trials poses distinct challenges, from devising an implementable intervention to coordinating communication across centers often not otherwise organized into a formal research network. Through formal epidemiologic (and economic analysis) training (obtaining an M.P.H.) and planned visits to internationally-renowned trial coordinating units, he will substantially enhance his abilities as a perinatal clinical trialist (and his ability to conduct economic analyses alongside clinical trials), especially in the area of pragmatic, multi-centered national and international trials which, for at least three reasons, are likely to take on increasing importance in defining optimal obstetric care. First, the declining patient populations of many academic obstetric units in this country make it difficult to conduct single center trials with adequate sample sizes and expeditious patient accrual. Second, the incidence of some severe but preventable obstetric outcomes (e.g., eclampsia) is quite low, but even for such low incidence conditions, it is often desirable to evaluate interventions which may offer only modest protection. Thus, to achieve adequate statistical power, large sample sizes are necessary. Finally, the effectiveness of an intervention (how it would perform under conditions of actual clinical practice) is an attribute that, in many situations, is as important as its efficacy (how it performs under ideal conditions).

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24HD001375-04
Application #
6636735
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Ilekis, John V
Project Start
2000-08-28
Project End
2005-06-30
Budget Start
2003-07-01
Budget End
2004-06-30
Support Year
4
Fiscal Year
2003
Total Cost
$110,690
Indirect Cost
Name
University of Alabama Birmingham
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Nuthalapaty, Francis S; Rouse, Dwight J; Owen, John (2004) The association of maternal weight with cesarean risk, labor duration, and cervical dilation rate during labor induction. Obstet Gynecol 103:452-6
Kimberlin, David W; Rouse, Dwight J (2004) Clinical practice. Genital herpes. N Engl J Med 350:1970-7
Blanton, Elizabeth N; Rouse, Dwight J (2003) Trial of labor in women with transverse vaginal septa. Obstet Gynecol 101:1110-2
Rouse, D J; Lincoln, T; Cliver, S et al. (2003) Intrapartum chlorhexidine vaginal irrigation and chorioamnion and placental microbial colonization. Int J Gynaecol Obstet 83:165-9
Rouse, Dwight J (2003) Potential cost-effectiveness of nutrition interventions to prevent adverse pregnancy outcomes in the developing world. J Nutr 133:1640S-1644S
Rouse, Dwight J; Cliver, Suzanne; Lincoln, Tina L et al. (2003) Clinical trial of chlorhexidine vaginal irrigation to prevent peripartal infection in nulliparous women. Am J Obstet Gynecol 189:166-70
Rouse, Dwight J (2003) Data monitoring and safety committees and their operations. Obstet Gynecol Surv 58:329-36
Lu, George C; Luchesse, Angela; Chapman, Victoria et al. (2002) Screening for gestational diabetes mellitus in the subsequent pregnancy: is it worthwhile? Am J Obstet Gynecol 187:918-21
Rouse, D J; Owen, J; Savage, K G et al. (2001) Active phase labor arrest: revisiting the 2-hour minimum. Obstet Gynecol 98:550-4
Lu, G C; Rouse, D J; DuBard, M et al. (2001) The effect of the increasing prevalence of maternal obesity on perinatal morbidity. Am J Obstet Gynecol 185:845-9