Performance of a proteomic preterm delivery predictor in a large independent prospective cohort.

Journal Article (Journal Article;Multicenter Study)

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

Full Text

Duke Authors

Cited Authors

  • Markenson, GR; Saade, GR; Laurent, LC; Heyborne, KD; Coonrod, DV; Schoen, CN; Baxter, JK; Haas, DM; Longo, S; Grobman, WA; Sullivan, SA; Major, CA; Wheeler, SM; Pereira, LM; Su, EJ; Boggess, KA; Hawk, AF; Crockett, AH; Fox, AC; Polpitiya, A; Fleischer, TC; Critchfield, GC; Burchard, J; Boniface, JJ; Lam, GK

Published Date

  • August 2020

Published In

  • Am J Obstet Gynecol Mfm

Volume / Issue

  • 2 / 3

Start / End Page

  • 100140 -

PubMed ID

  • 33345877

Electronic International Standard Serial Number (EISSN)

  • 2589-9333

Digital Object Identifier (DOI)

  • 10.1016/j.ajogmf.2020.100140

Language

  • eng

Conference Location

  • United States