Performance of a proteomic preterm delivery predictor in a large independent prospective cohort
dc.contributor.author | Markenson, Glenn R. | |
dc.contributor.author | Saade, George R. | |
dc.contributor.author | Laurent, Louise C. | |
dc.contributor.author | Heyborne, Kent D. | |
dc.contributor.author | Coonrod, Dean V. | |
dc.contributor.author | Schoen, Corina N. | |
dc.contributor.author | Baxter, Jason K. | |
dc.contributor.author | Haas, David M. | |
dc.contributor.author | Longo, Sherri | |
dc.contributor.author | Grobman, William A. | |
dc.contributor.author | Sullivan, Scott A. | |
dc.contributor.author | Major, Carol A. | |
dc.contributor.author | Wheeler, Sarahn M. | |
dc.contributor.author | Pereira, Leonardo M. | |
dc.contributor.author | Su, Emily J. | |
dc.contributor.author | Boggess, Kim A. | |
dc.contributor.author | Hawk, Angela F. | |
dc.contributor.author | Crockett, Amy H. | |
dc.contributor.author | Fox, Angela C. | |
dc.contributor.author | Polpitiya, Ashoka | |
dc.contributor.author | Fleischer, Tracey C. | |
dc.contributor.author | Critchfield, Gregory C. | |
dc.contributor.author | Burchard, Julja | |
dc.contributor.author | Boniface, J. Jay | |
dc.contributor.author | Lam, Garrett K. | |
dc.contributor.department | Obstetrics and Gynecology, School of Medicine | en_US |
dc.date.accessioned | 2022-02-02T21:47:27Z | |
dc.date.available | 2022-02-02T21:47:27Z | |
dc.date.issued | 2020-08 | |
dc.description.abstract | Background Preterm birth remains a common and devastating complication of pregnancy. There remains a need for effective and accurate screening methods for preterm birth. Using a proteomic approach, we previously discovered and validated (Proteomic Assessment of Preterm Risk study, NCT01371019) a preterm birth predictor comprising a ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin. Objective To determine the performance of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin to predict both spontaneous and medically indicated very preterm births, in an independent cohort distinct from the one in which it was developed. Study Design This was a prospective observational study (Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor, NCT02787213) at 18 sites in the United States. Women had blood drawn at 170/7 to 216/7 weeks’ gestation. For confirmation, we planned to analyze a randomly selected subgroup of women having blood drawn between 191/7 and 206/7 weeks’ gestation, with the results of the remaining study participants blinded for future validation studies. Serum from participants was analyzed by mass spectrometry. Neonatal morbidity and mortality were analyzed using a composite score by a method from the PREGNANT trial (NCT00615550, Hassan et al). Scores of 0–3 reflect increasing numbers of morbidities or length of neonatal intensive care unit stay, and 4 represents perinatal mortality. Results A total of 5011 women were enrolled, with 847 included in this planned substudy analysis. There were 9 preterm birth cases at <320/7 weeks’ gestation and 838 noncases at ≥320/7 weeks’ gestation; 21 of 847 infants had neonatal composite morbidity and mortality index scores of ≥3, and 4 of 21 had a score of 4. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was substantially higher in both preterm births at <320/7 weeks’ gestation and there were more severe neonatal outcomes. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was significantly predictive of birth at <320/7 weeks’ gestation (area under the receiver operating characteristic curve, 0.71; 95% confidence interval, 0.55–0.87; P=.016). Stratification by body mass index, optimized in the previous validation study (22<body mass index≤37 kg/m2), resulted in an area under the receiver operating characteristic curve of 0.76 (95% confidence interval, 0.59–0.93; P=.023). The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio predicted neonatal outcomes with respective area under the receiver operating characteristic curve of 0.67 (95% confidence interval, 0.57–0.77; P=.005) and 0.78 (95% confidence interval, 0.63–0.93; P=.026) for neonatal composite morbidity and mortality scores of ≥3 or 4. In addition, the ratio of insulin-like growth factor-binding protein 4 to sex hormone binding globulin significantly stratified neonates with increased length of hospital stay (log rank P=.023). Conclusion We confirmed in an independent cohort the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio as a predictor of very preterm birth, with additional prediction of increased length of neonatal hospital stay and increased severity of adverse neonatal outcomes. Potential uses of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin predictor may be to risk stratify patients for implementation of preterm birth preventive strategies and direct patients to appropriate levels of care. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Markenson, G. R., Saade, G. R., Laurent, L. C., Heyborne, K. D., Coonrod, D. V., Schoen, C. N., Baxter, J. K., Haas, D. M., Longo, S., Grobman, W. A., Sullivan, S. A., Major, C. A., Wheeler, S. M., Pereira, L. M., Su, E. J., Boggess, K. A., Hawk, A. F., Crockett, A. H., Fox, A. C., … Lam, G. K. (2020). Performance of a proteomic preterm delivery predictor in a large independent prospective cohort. American Journal of Obstetrics & Gynecology MFM, 2(3), 100140. https://doi.org/10.1016/j.ajogmf.2020.100140 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/27670 | |
dc.language.iso | en | en_US |
dc.publisher | Elsevier | en_US |
dc.relation.isversionof | 10.1016/j.ajogmf.2020.100140 | en_US |
dc.relation.journal | American Journal of Obstetrics & Gynecology MFM | en_US |
dc.rights | Publisher Policy | en_US |
dc.source | Publisher | en_US |
dc.subject | biomarker | en_US |
dc.subject | insulin-like growth factor-binding protein 4 | en_US |
dc.subject | neonatal morbidity and mortality | en_US |
dc.title | Performance of a proteomic preterm delivery predictor in a large independent prospective cohort | en_US |
dc.type | Article | en_US |