Problems associated with labor during pregnancy are some of the most important issues for physicians. These problems include diagnosis of term and preterm labor, and treatments associated with labor. We have developed noninvasive methods to quantitatively evaluate the uterus and cervix during pregnancy based on recording of uterine electrical signals from the abdominal surface (uterine EMG) and measurement of light induced cervical collagen fluorescence (cervical LIF) with an optical device called the Collascope. Only these two devices can currently give a direct measure of uterine and cervical function, which is critical for assessing the state of pregnancy. Current methods, such as tocodynamometery, ultrasound, and fetal fibronectin, cannot do this, so current tools for obstetricians are completely inadequate for proper evaluation of pregnant patients. This application is to renew our previous grant and the associated initial studies. Three studies are proposed using uterine EMG recordings and cervical LIF measurements. The specific hypotheses are: 1.) Labor and delivery can be accurately predicted using cervical LIF and uterine EMG variables individually, and when combined in a multivariate model 2.) Parturition complications and c-section likelihood can be forecast using uterine EMG and cervical LIF measurements to identify high-risk groups. 3.) Uterine EMG and cervical LIF measurements can be used to determine differences in patients with cervical insufficiency.
The specific aims are to: 1.) Improve predictive capability of various uterine/cervical variables using LIF and EMG. 2.) Assess uterine EMG and cervical LIF as predictive indicators, and to determine their correlation with c-section and complication incidence in patients, specifically by ethnic subgroups and with infection. 3.) Characterize uterine EMG and cervical LIF in patients with cervical insufficiency. The potential benefits of these studies are substantial, and include effective diagnosis of term and preterm labor, reduction in rate of preterm labor, improvement in maternal and perinatal outcome, better selection of treatments, a decrease in cesarean section rate, and improvement in obstetrical research. In this second and final resubmission, we have responded to the reviewer's critiques, updated the data, and corrected or amended the specific aims and text of the grant. We have maintained Dr. Gary Hankins, Chief of Division of Maternal-Fetal Medicine, Department of Ob/Gyn, in the project (see Dr. Hankins' letter of support in the Appendix).
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