Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating

Journal of Clinical Medicine

Matthew K. Hoffman¹  Jay D. Iams²  George R. Saade³  Kim A. Boggess⁴  Dean V. Coonrod⁵  Leonardo M. Pereira⁶  Glenn R. Markenson⁷  Julja Burchard⁸  Ryan Treacy⁸  Todd L. Randolph⁸  Angela C. Fox⁸  J. Jay Boniface⁸  Thomas J. Garite⁸  Paul E. Kearney⁸  Ashoka D. Polpitiya⁸  Tracey C. Fleischer⁸  Max T. Dufford⁸  Gregory C. Critchfield⁸ 

[1] Department of Obstetrics & Gynecology, Christiana Care Health System, Newark, DE 19718, USA;Department of Obstetrics & Gynecology, The Ohio State University, Columbus, OH 43210, USA;Department of Obstetrics & Gynecology, The University of Texas Medical Branch, Galveston, TX 77555, USA;Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina, Chapel Hill, NC 27599, USA;Department of Obstetrics and Gynecology, Valleywise Health, Phoenix, AZ 85008, USA;Division of Maternal-Fetal Medicine, Oregon Health & Science University, Portland, OR 97239, USA;Maternal Fetal Medicine, Boston University School of Medicine, Boston, MA 02118, USA;Sera Prognostics, Incorporated, Salt Lake City, UT 84109, USA;

关键词: gestational age;    gestational age dating;    preterm birth;    spontaneous preterm birth;    proteomic biomarker risk predictor;   

DOI  :  10.3390/jcm11102885

来源: DOAJ

【 摘 要 】

The clinical management of pregnancy and spontaneous preterm birth (sPTB) relies on estimates of gestational age (GA). Our objective was to evaluate the effect of GA dating uncertainty on the observed performance of a validated proteomic biomarker risk predictor, and then to test the generalizability of that effect in a broader range of GA at blood draw. In a secondary analysis of a prospective clinical trial (PAPR; NCT01371019), we compared two GA dating categories: both ultrasound and dating by last menstrual period (LMP) (all subjects) and excluding dating by LMP (excluding LMP). The risk predictor’s performance was observed at the validated risk predictor threshold both in weeks 19^1/7–20^6/7 and extended to weeks 18^0/7–20^6/7. Strict blinding and independent statistical analyses were employed. The validated biomarker risk predictor showed greater observed sensitivity of 88% at 75% specificity (increases of 17% and 1%) in more reliably dated (excluding-LMP) subjects, relative to all subjects. Excluding dating by LMP significantly improved the sensitivity in weeks 19^1/7–20^6/7. In the broader blood draw window, the previously validated risk predictor threshold significantly stratified higher and lower risk of sPTB, and the risk predictor again showed significantly greater observed sensitivity in excluding-LMP subjects. These findings have implications for testing the performance of models aimed at predicting PTB.

【 授权许可】

Unknown