The first portion of work conducted in 2007 related to analysis of concentrations of progesterone and estriol in weekly saliva samples collected as part of this trial. Results of this analysis were presented at the annual meetings of the Society for Maternal-Fetal Medicine in February 2007, and the Society for Pediatric and Perinatal Epidemiologic Research in June 2007. A manuscript describing the results is in preparation. It was found that compared with placebo, 17-alphahydroxyprogesterone did not alter the normal increase in salivary progesterone as pregnancy progressed. However, 17P did slow the rise in salivary estriol with increasing gestation. The salivary progesterone:estriol ratio increased with advancing gestation in women receiving placebo, but remained flat among women receiving 17P. The p-values for interaction were highly significant for salivary progesterone and the estriol: progesterone ratio. ? ? In the second portion of this project, DESPR investigators have participated in the design and conduct of a recently completed project to follow the children from the 17P trial at age 2-5 to assess the presence of morbidity at that age. No statistically or clinically significant adverse impact of in-utero exposure to 17P were observed in cognitive development, physical growth, blood pressure, gender specific play, birth defects or general health were found.
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Petrini, Joann R; Callaghan, William M; Klebanoff, Mark et al. (2005) Estimated effect of 17 alpha-hydroxyprogesterone caproate on preterm birth in the United States. Obstet Gynecol 105:267-72 |