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Article

Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study

by
Julja Burchard
1,
Ashoka D. Polpitiya
1,
Angela C. Fox
1,
Todd L. Randolph
1,
Tracey C. Fleischer
1,*,
Max T. Dufford
1,
Thomas J. Garite
1,
Gregory C. Critchfield
1,
J. Jay Boniface
1,
George R. Saade
2 and
Paul E. Kearney
1
1
Sera Prognostics, Incorporated, Salt Lake City, UT 84109, USA
2
Department of Obstetrics & Gynecology, University of Texas Medical Branch, Galveston, TX 77555, USA
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2021, 10(21), 5088; https://doi.org/10.3390/jcm10215088
Submission received: 27 September 2021 / Revised: 20 October 2021 / Accepted: 22 October 2021 / Published: 29 October 2021
(This article belongs to the Special Issue Diagnostic or Therapeutic Strategies for Pregnancy Complications)
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Abstract

Preterm births are the leading cause of neonatal death in the United States. Previously, a spontaneous preterm birth (sPTB) predictor based on the ratio of two proteins, IBP4/SHBG, was validated as a predictor of sPTB in the Proteomic Assessment of Preterm Risk (PAPR) study. In particular, a proteomic biomarker threshold of −1.37, corresponding to a ~two-fold increase or ~15% risk of sPTB, significantly stratified earlier deliveries. Guidelines for molecular tests advise replication in a second independent study. Here we tested whether the significant association between proteomic biomarker scores above the threshold and sPTB, and associated adverse outcomes, was replicated in a second independent study, the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP). The threshold significantly stratified subjects in PAPR and TREETOP for sPTB (p = 0.041, p = 0.041, respectively). Application of the threshold in a Kaplan–Meier analysis demonstrated significant stratification in each study, respectively, for gestational age at birth (p < 001, p = 0.0016) and rate of hospital discharge for both neonate (p < 0.001, p = 0.005) and mother (p < 0.001, p < 0.001). Above the threshold, severe neonatal morbidity/mortality and mortality alone were 2.2 (p = 0.0083,) and 7.4-fold higher (p = 0.018), respectively, in both studies combined. Thus, higher predictor scores were associated with multiple adverse pregnancy outcomes.
Keywords: preterm birth; IBP4; SHBG; biomarkers preterm birth; IBP4; SHBG; biomarkers

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MDPI and ACS Style

Burchard, J.; Polpitiya, A.D.; Fox, A.C.; Randolph, T.L.; Fleischer, T.C.; Dufford, M.T.; Garite, T.J.; Critchfield, G.C.; Boniface, J.J.; Saade, G.R.; et al. Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study. J. Clin. Med. 2021, 10, 5088. https://doi.org/10.3390/jcm10215088

AMA Style

Burchard J, Polpitiya AD, Fox AC, Randolph TL, Fleischer TC, Dufford MT, Garite TJ, Critchfield GC, Boniface JJ, Saade GR, et al. Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study. Journal of Clinical Medicine. 2021; 10(21):5088. https://doi.org/10.3390/jcm10215088

Chicago/Turabian Style

Burchard, Julja, Ashoka D. Polpitiya, Angela C. Fox, Todd L. Randolph, Tracey C. Fleischer, Max T. Dufford, Thomas J. Garite, Gregory C. Critchfield, J. Jay Boniface, George R. Saade, and et al. 2021. "Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study" Journal of Clinical Medicine 10, no. 21: 5088. https://doi.org/10.3390/jcm10215088

APA Style

Burchard, J., Polpitiya, A. D., Fox, A. C., Randolph, T. L., Fleischer, T. C., Dufford, M. T., Garite, T. J., Critchfield, G. C., Boniface, J. J., Saade, G. R., & Kearney, P. E. (2021). Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study. Journal of Clinical Medicine, 10(21), 5088. https://doi.org/10.3390/jcm10215088

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