17: Clinical validation of a two-protein test for spontaneous preterm birth (sPTB) prediction in a large multicenter prospective study of asymptomatic women

Abstract

included non-anomalous singletons with complete information on exposures and outcomes. Multiple gestations and stillbirths were excluded. Our four exposure groups were: clinical chorioamnionitis (CC) defined by clinical diagnosis of chorioamnionitis and a maternal fever > 100 F, culture-proven sepsis (CPS), neither CC nor CPS (-CC/-CPS), or both CC and CPS (CC+CPS). Our primary outcome was abnormal neonatal brain US findings, as defined by the presence of either IVH or PVL. All infants in the study received at least one ultrasound after delivery, performed by a trained research sonographer. We conducted bivariate analyses assessing the effect of CC and CPS on our outcomes, and fit a logistic regression model, adjusting for possible confounders to assess factors related to IVH or PVL. RESULTS: 1855 patients were included; 1372 (74%) had -CC/-CPS, 175 (9%) had CC, 263 (14%) had CPS, and 45 (3%) patients had CC+CPS. Mean gestational age for the cohort was 29+5/7 (+/-2+5/7) wks. The groups differed by gestational age, mode of delivery, and Apgar scores. There was no difference between groups in exposure to magnesium, antibiotics, and betamethasone. IVH was significantly more common in infants exposed to CC+CPS (38%), followed by those with CC only (28%), or CPS only (28%), compared to those with -CC/-CPS (17%, p<0.001). PVL was also significantly more common in those infants exposed to CC+CPS (7%), followed by those with CPS (5%), compared to those with CC only (1%) or -CC/-CPS (1%, P<0.001). After adjusting for confounders, CC, CPS, and CC+CPS were all related to an increase in IVH, but CC alone was not associated with an increase in PVL (Table 1). CONCLUSION: Sepsis, rather than clinical chorioamnionitis is associ-ated with PVL. Understanding mechanisms to decrease neonatal sepsis may mitigate the development of CP. OBJECTIVE: To perform a blinded evaluation of the performance of a two-protein test for spontaneous preterm birth (sPTB) prediction. STUDY DESIGN: Pregnant women representative of the U.S. popula-tion were enrolled at 17-28 weeks of gestational age (GA) in the Proteomic Assessment of Preterm Risk (PAPR) study at 11 sites between 2011 and 2013. Biospecimens were collected at enrollment and outcomes ascertained following birth. Intensity values from a LC-MS (MRM) method were measured for 2 predictive analytes, insulin-like growth factor binding protein 4 (IBP4) and sex-hor-mone binding globulin (SHBG), that had been previously discovered and verified in separate studies with best performance in the 19-21 week GA interval. Strict blinding and double validation protocols were utilized consistent with the Institute of Medicine guidelines for classifier validation. RESULTS: All cases eligible for validation (those not used for classifier training, discovery or verification) and their respective independent matched controls drawn during the 19-21 week GA interval were analyzed (18 cases, 36 controls). The classifier performance was excellent (Table 1), with statistically significant AUC values and Odds Ratios. Addition of pregnancy and medical history variables did not improve the proteomic classifier performance. CONCLUSION: We validated a novel maternal serum proteomic clas-sifier consisting of IBP4 and SHBG for prediction of sPTB. This proteomic classifier can risk-stratify patients to test PTB preventive strategies or guide levels of care. OBJECTIVE: To evaluate whether racial and ethnic disparities exist in the use of and adherence to 17-hydroxyprogesterone caproate (17P) within a population of women eligible for preterm birth prevention. STUDY DESIGN: Retrospective cohort study of women with a prior spontaneous, singleton preterm birth who were eligible for 17P for preterm birth prevention and received care at a single institution from 2010-2014. Associations between self-identified race/ethnicity (non-Hispanic white, non-Hispanic black, Hispanic, Asian, and other/unknown) and documented counseling about 17P, receipt of 17P, and adherence to 17P administration (no more than 1 missed dose, initiation <20 weeks' gestational age, and continuation until Oral Concurrent Session 1 PREMATURITY ajog.org